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center-73152000Investigator ManualEffective September 22, 2020USF Institutional Review Board HYPERLINK "" Research Integrity & Compliance3702 Spectrum Blvd, Suite 165 MDC35Tampa, Florida 33612Email: RSCH-IRB@usf.edu Phone: 813-974-5638ARC Help Desk: RSCH-ARC@usf.eduTable of Contents TOC \o "1-3" \h \z \u 1.What is the purpose of this manual? PAGEREF _Toc51678143 \h 42.What is human subjects research? PAGEREF _Toc51678144 \h 43.What is the Human Research Protection Program? PAGEREF _Toc51678145 \h 44.What training do my staff and I need to conduct human subjects research? PAGEREF _Toc51678146 \h 55.What financial interests do my staff and I need to disclose to the USF IRB? PAGEREF _Toc51678147 \h 66.How do I submit new human subjects research to the IRB? PAGEREF _Toc51678148 \h 67.Who needs to review my research before I submit it to the IRB? PAGEREF _Toc51678149 \h 78.How do I request to use an external IRB? PAGEREF _Toc51678150 \h 79.How do I request the USF IRB to serve as the single IRB (sIRB) of record for my collaborative or multi-site research study? PAGEREF _Toc51678151 \h 910.How do I transfer IRB Oversight? PAGEREF _Toc51678152 \h 911.How do I write an Investigator Protocol? PAGEREF _Toc51678153 \h 1012.How do I submit an application for a Coordinating or Data Coordinating Center? PAGEREF _Toc51678154 \h 1113.Do case reports or limited case series need to be submitted to the IRB? PAGEREF _Toc51678155 \h 1114.Do I need a data and safety monitoring plan (DSMP)? PAGEREF _Toc51678156 \h 1115.What if I am doing my research at a non-USF (or non-affiliate) location? PAGEREF _Toc51678157 \h 1116.What if I am doing my research outside of the country? PAGEREF _Toc51678158 \h 1217.Are there any Florida Laws that I should be aware of that might affect my research plan? PAGEREF _Toc51678159 \h 1318.What if I want to conduct research in schools or obtain student records? PAGEREF _Toc51678160 \h 2119.What if I want to include deception in my research? PAGEREF _Toc51678161 \h 2220.How do I create a consent document? PAGEREF _Toc51678162 \h 2321.Do I need to include injury language in my consent? PAGEREF _Toc51678163 \h 2522.Can I compensate subjects for their participation? PAGEREF _Toc51678164 \h 2523.What are the different regulatory classifications that research activities may fall under? PAGEREF _Toc51678165 \h 2624.What are the decisions the IRB can make when reviewing proposed research? PAGEREF _Toc51678166 \h 2625.How does the IRB decide whether to approve human subjects research? PAGEREF _Toc51678167 \h 2726.What will happen after IRB review? PAGEREF _Toc51678168 \h 2727.What are my obligations after IRB approval? PAGEREF _Toc51678169 \h 2828.What are some examples of adverse events (AEs) and serious adverse events (SAEs) that need to be submitted within five (5) business days of becoming aware of the event? PAGEREF _Toc51678170 \h 3129.What are my obligations as the overall study Investigator for a single IRB (sIRB) study? PAGEREF _Toc51678171 \h 3230.What are my obligations as Investigator when relying on an external IRB? PAGEREF _Toc51678172 \h 3331.What do I need to know about recruiting subjects? PAGEREF _Toc51678173 \h 3432.How do I document consent? PAGEREF _Toc51678174 \h 3733.How do I submit a modification and when is reconsent required? PAGEREF _Toc51678175 \h 3834.What happens if I deviate from my protocol, HRPP policy, or federal regulations? PAGEREF _Toc51678176 \h 3835.How do I submit continuing review? PAGEREF _Toc51678177 \h 3936.How do I close out a study? PAGEREF _Toc51678178 \h 4137.How long do I keep records? PAGEREF _Toc51678179 \h 4138.What are my obligations to keep records and data private? PAGEREF _Toc51678180 \h 4139.What if I need to use an unapproved drug, biologic, or device for expanded access, compassionate use, or Humanitarian Use? PAGEREF _Toc51678181 \h 4240.What if I need to use an unapproved drug, biologic, or device and there is no time for IRB review? PAGEREF _Toc51678182 \h 4441.What if I want a non-affiliated volunteer on my study team? PAGEREF _Toc51678183 \h 4542.How do I get additional information and answers to questions? PAGEREF _Toc51678184 \h 4643.How can I make an anonymous report about suspected research misconduct? PAGEREF _Toc51678185 \h 46Appendices PAGEREF _Toc51678186 \h 48Appendix A-1 Additional Requirements for DHHS-Regulated Research PAGEREF _Toc51678187 \h 48Appendix A-2 Additional Requirements for FDA-Regulated Research PAGEREF _Toc51678188 \h 49Appendix A-3 Additional Requirements for Clinical Trials (ICH-GCP) PAGEREF _Toc51678189 \h 56Appendix A-4 Additional Requirements for Department of Defense (DOD) research PAGEREF _Toc51678190 \h 64Appendix A-5 Additional Requirements for Department of Energy (DOE) Research PAGEREF _Toc51678191 \h 65Appendix A-6 Additional Requirements for Department of Justice (DOJ) Research PAGEREF _Toc51678192 \h 66Additional Requirements for DOJ Research conducted in the Federal Bureau of Prisons PAGEREF _Toc51678193 \h 66Additional Requirements for DOJ Research Funded by the National Institute of Justice PAGEREF _Toc51678194 \h 67Appendix A-7 Additional Requirements for Department of Education (ED) Research PAGEREF _Toc51678195 \h 69Appendix A-8 Additional Requirements for Veterans Administration (VA) Research PAGEREF _Toc51678196 \h 70Appendix A-9 Single IRB Studies PAGEREF _Toc51678197 \h 80Appendix A-10 Additional Requirements for Research Subject to EU General Data Protection Regulations (GDPR) PAGEREF _Toc51678198 \h 81Appendix A-11 Additional Requirements for Environmental Protection Agency (EPA) Research PAGEREF _Toc51678199 \h 82Appendix B-1 Summary of Manual Changes PAGEREF _Toc51678200 \h 83ScopeThroughout this document, “institution” refers to The University of South Florida Board of Trustees. Defined terms can be found in HRP-001 - SOP - Definitions.What is the purpose of this manual?This document, HRP-103 - INVESTIGATOR MANUAL, is designed to guide you through policies and procedures related to the conduct of human subjects research that are specific to this institution.General information regarding human subjects research protections and relevant federal regulations and guidance is incorporated into the required human protections training. For additional information see Question #4 below.What is human subjects research?The HRP-101 - HUMAN RESEARCH PROTECTION PROGRAM PLAN defines the activities that this institution considers to be human subjects research. A tool for determining whether an activity is human subjects research can be found in the HRP-310 - WORKSHEET - Human Subjects Research Determination, located in the electronic IRB system (BullsIRB) Library. Use this document for guidance as to whether an activity meets either the DHHS or FDA definition of human subjects research, keeping in mind that the IRB makes the ultimate determination in questionable cases as to whether an activity constitutes human subjects research subject to IRB oversight.You must not conduct human subjects research without prior IRB review and approval. This includes exempt human subjects research determinations that must be made by the IRB Office. If you have questions about whether an activity is human subjects research, contact the IRB Office, which will provide you with a determination. The IRB’s contact information can be found on the cover page of this document.What is the Human Research Protection Program?The document HRP-101 - HUMAN RESEARCH PROTECTION PROGRAM PLAN describes this institution’s overall plan to protect subjects in human subjects research and includes:The mission of the Human Research Protection Program.The ethical principles that the institution follows governing the conduct of human subjects research.The applicable laws that govern human subjects research.When the institution becomes engaged in human subjects research and when someone is acting as an agent of the institution conducting human subjects research.The types of human subjects research that may not be conducted.The roles and responsibilities of individuals within the institution.Human Research Protection Program Supporting Programs:The Institutional Review Board (IRB)The Education ProgramThe Quality Assurance/Quality Improvement (QA/QI) ProgramThe IND/IDE Assistance ProgramThe HIPAA Research Compliance ProgramThe Institutional Biosafety Program/Committee (IBC)The Radiation Safety Program/CommitteeThe Conflict of Interest (COI) Program/CommitteeThe Export Controls OfficeSponsored Research (SR)Technology Transfer Office/Patents and Licensing (TTO)The Office of Clinical Research (OCR) – USF HealthOffice of Community Engagement and Partnerships (OCEP)Institutional Administration: The Senior Vice President for Research, Innovation & Knowledge EnterpriseThe Assistant Vice President of Research & InnovationThe Senior Director of Research Integrity & ComplianceThe Director of Research Integrity & Compliance The IRB ManagersThe IRB Staff/Research Compliance Administrators (RCAs)What training do my staff and I need to conduct human subjects research?This section describes the training requirements imposed by the IRB. You may have additional training imposed by other federal, state, or institutional policies. It is your responsibility to know which training requirements apply to your research. Investigators and staff conducting research involving human subjects research must complete human subjects protections (HSP) education. This requirement extends to anyone engaged in the research including individuals who collect data about human subjects, those conducting study procedures or interventions, and those who have access to private, identifiable information. This requirement applies to all human subjects research regardless of funding or source of sponsorship. Members of the research team who have not completed HSP training may not be engaged in human subjects research. The USF IRB has the authority to suspend or withhold approval of projects that involve investigators and research personnel who fail to meet the education requirements as outlined in this policy.Training is valid for a three (3) year period, after which time the training must be repeated or a refresher course taken.Study staff must complete one (1) of the following CITI courses (): Biomedical Investigators and Key PersonnelSocial/Behavioral Investigators and Key PersonnelIRB MembersVA Human Subjects ProtectionVA Human Subjects Protection and Good Clinical PracticesBiomedical Research (for H. Lee Moffitt Cancer Center affiliated investigators)Good Clinical Practice*Important Note: The CITI “Responsible Conduct of Research” and “GCP-Social and Behavioral Research Best Practices for Clinical Research*” courses are not valid for IRB Certification.Other courses eligible for IRB certification:USF IRB Annual Study Team Research RetreatUSF IRB Student Researcher Workshop"Research Ethics Training Curriculum for Community Representatives" (FHI360) Family Health International ProgramSome CITI courses from other institutions (validated on a case-by-case basis – contact the ARC Help Desk for details).What financial interests do my staff and I need to disclose to the USF IRB?Financial interests are related to a research project if the work to be performed on the project, or the results of such work, can be expected to have an effect on the individual’s interest(s). Institutional conflicts of interest are situations in which the financial interests of an institution or institutional official, acting in his or her authority on behalf of the institution, may affect or appear to affect the research conducted under the auspices of the institution. All study team members/research personnel are required to disclose institutional conflicts of which they are aware and related financial interests for themselves, their spouse, domestic partner, and dependent children in BullsIRB:On submission of an initial review;At least annually as part of continuing review if applicable; and/orWithin thirty (30) days of discovering or acquiring (e.g. through purchase, marriage, or inheritance) a new financial interest.Additional details, including thresholds for disclosure, can be found in HRP-055 – SOP - Financial Conflicts of Interest and HRP-054 – SOP - Institutional Conflicts of Interest.For additional information, contact the USF COI Program at coi-research@usf.edu or 813-974-5638.How do I submit new human subjects research to the IRB?Complete the New Study SmartForm in BullsIRB and attach all requested documents. The Investigator is the only individual that can submit the New Study SmartForm by clicking the “Submit” button. Please note, individuals with USF courtesy faculty appointments may be Investigators, but may not serve as a Principal Investigator on IRB research applications. Maintain electronic copies of all information submitted to the IRB in case revisions are required. Before submitting the research for initial review, you must:For student researchers, include your faculty advisor as a member of the study team in the SmartForm and in the consent document. Document the financial interest status (“yes” or “no”) of each research staff member.Document the agreement of research staff to his/her role in the research. Delegation log templates are available under investigator tools: needs to review my research before I submit it to the IRB?The IRB requires scientific and scholarly review to be conducted by the department or affiliate for all human subjects research prior to being presented to the IRB or other relied upon IRBs with which the institution has contracted to provide IRB oversight. It is the responsibility of the Investigator to select their department and/or the applicable affiliate institution to ensure that scientific and scholarly review is obtained for each new research proposal involving human subjects prior to submission to the IRB or relied upon IRBs. Criteria for scientific and scholarly review of the IRB application and study protocol for human subjects research are outlined in HRP 320 – WORKSHEET - Scientific or Scholarly Review. The Department/Affiliate Reviewer may send requested revisions to the Investigator in BullsIRB. How do I request to use an external IRB?Complete the New Study SmartForm in BullsIRB, indicating that an external (Reviewing) IRB will serve as the IRB of Record and attach all requested documents. The Investigator is the only individual that can submit the New Study SmartForm by clicking the “Submit” button. Maintain electronic copies of all information submitted to the IRB in case revisions are required.The Organizational Official or designee will determine, on a study-by-study basis, whether reliance on an external IRB is appropriate. In deciding whether or not to rely on an external IRB, the Organizational Official or designee will consider such factors as:Whether the use of a single IRB (sIRB) has been mandated by the study sponsor;The number of proposed studies involved in the collaboration;The anticipated level of risk associated with the proposed study;Whether the Reviewing IRB’s policies and procedures meet the IRB’s standards. If the Reviewing IRB is part of an AAHRPP-accredited HRPP, then it will be presumed that the IRB’s standards are being met. However, AAHRPP accreditation in and of itself does not necessarily suffice as a basis for reliance;The location in which the majority of study procedures will take place;The Investigators standing with the university and role in the overall research;The ability of the Reviewing IRB to be sufficiently informed about local context issues, including local laws and regulations; andThe terms and conditions of the proposed IRB reliance agreement.Investigators seeking to rely on an external IRB are responsible for providing the following documentation within BullsIRB:For industry-sponsored research being reviewed by commercial IRBs:The study protocol and informed consent document(s) that include local institutional template subject injury and HIPAA authorization language, as appropriate;For research being reviewed by academic or other IRBs:The approved study protocol and informed consent templates. The templates must be revised to include local institutional template subject injury and HIPAA authorization language, modified as applicable for the research;Contact information for the Reviewing IRB in order for the USF IRB to initiate conversations regarding the IRB reliance agreement;Documentation of the most recent external IRB approval of the research.Investigators relying on an external IRB are responsible for the following during the conduct of the research:Ensuring compliance with the policies and procedures of the Reviewing IRB, including but not limited to the following:Obtaining and appropriately documenting informed consent;Promptly reporting to the Reviewing IRB protocol deviations, subject complaints, non-compliance and Unanticipated Problems Involving Risks to Subjects or Others, pursuant to the timelines set forth in the Reviewing IRB’s policies;Obtaining approval for proposed changes to the research from the Reviewing IRB;Providing the Reviewing IRB with data safety monitoring reports, as specified in the protocol;Complying with the management controls set forth in any USF COI Committee-approved COI management plan(s) related to the research;Submitting Personnel Change Requests (PCRs) in BullsIRB to add/remove study team members;Maintaining documentation in a regulatory file of the Reviewing IRB’s regulatory determinations, including, for example, continuing reviews, modifications, and reportable new information;Reporting of subject complaints, non-compliance, and Unanticipated Problems Involving Risks to Subjects or Others in BullsIRB, as specified in the applicable IRB reliance agreement;Conducting monitoring in addition to, or in cooperation with, the Reviewing IRB, when appropriate;The USF IRB does not execute a formal IRB reliance agreement for research determined to be exempt, except when the exempt research requires a limited IRB review. For research that has been determined to be exempt by an external IRB, the Investigator is required to obtain documentation that states whether or not the external IRB is willing to oversee the work conducted by the USF Investigator.If the external IRB is not willing to oversee the USF Investigator, the protocol will have to be reviewed and approved by the local IRB. In both cases the external IRB determination will need to be included in the in BullsIRB application.If an external IRB is to be used, please contact the USF IRB Reliance Manager early in the process to ensure there is ample time to process the required agreements prior to the start of the research. How do I request the USF IRB to serve as the single IRB (sIRB) of record for my collaborative or multi-site research study?On the New Study SmartForm in the BullsIRB system, indicate if the study is a multi-site or collaborative research study, then select “Yes” to the question “Will the USF IRB act as the single IRB of record for other participating sites?” Complete the rest of the New Study SmartForm and attach all applicable supplements. Have the SmartForm submitted by the Investigator by clicking the “Submit” button.If another institution plans to rely on the USF IRB, is engaged in human subjects research, and possesses a Federalwide Assurance (FWA), an IRB reliance agreement between the site and USF must be established prior to the initiation of research activities at the site. The USF Investigator is responsible for consulting with USF IRB Reliance Manager to begin the process of documenting reliance with the additional institutions. The Relying institution and the USF IRB will each maintain the fully executed IRB reliance agreement for inspection by OHRP, as requested. An FWA is required for all sites receiving Public Health Service (PHS) funding for the conduct of research.Please contact the USF IRB Reliance Manager early in the process to ensure there is ample time to process the required agreements prior to the start of the research. How do I transfer IRB Oversight?In certain situations, the USF IRB may agree to transfer oversight of previously approved research to another IRB. The USF IRB may also agree to assume responsibility for oversight of research previously approved by an external IRB. Prior to entering into any agreement to transfer a study to another IRB, the study Investigator must contact a USF IRB manager to discuss the proposed transfer. The USF IRB may require that a plan for the transfer process be documented in a written agreement between the original and receiving IRBs. Such agreement will address how the IRBs will manage and document the following: 1) identifying the study(ies) for which IRB oversight is being transferred; 2) ensuring the availability and retention of pertinent records; 3) establishing an effective date for transfer of oversight, including records, for the study(ies); 4) conducting a review of the study(ies) by the receiving IRB, where appropriate, before it accepts responsibility for the study(ies); 5) confirming or establishing the date for the next continuing review; 6) determining whether the consent form needs to be revised; and 7) notifying the key parties.For research subjects that are transferred to a USF or USF affiliate site from another study site, the USF or USF affiliate site receiving the subject must reconsent the subject with the USF IRB-approved consent upon enrollment at the new site.How do I write an Investigator Protocol?Use the HRP-503 - Biomedical Protocol Template, HRP-503a- Social-Behavioral Protocol Template or HRP-504- Record Review Protocol Template as a starting point for drafting a new Investigator Protocol, and reference the instructions in italic text for the information the IRB looks for when reviewing research. USF investigators are required to use a USF protocol template for their research. Here are some key points to remember when developing an Investigator Protocol:The italicized bullet points in the HRP-503, 503a and 504- Protocol Templates serve as guidance to investigators when developing an Investigator Protocol for submission to the IRB. All italicized comments/directions should be deleted prior to submission.For industry-sponsored studies or multi-site studies for which the USF Investigator is not the lead Investigator, use the local protocol supplement document HRP-508 or HRP-508a - Site Supplement Protocol Template. For any items described in the main Investigator’s or sponsor’s protocol or other documents submitted with the application, investigators may simply reference the page numbers of these documents within the Investigator Protocol rather than repeat information.When writing an Investigator Protocol, always keep an electronic copy. You will need to modify this copy when making changes to the Investigator Protocol. If you believe your activity may not be human subjects research, contact the IRB Office prior to developing your Investigator Protocol and submitting an application in BullsIRB. Note that, depending on the nature of your research, certain sections of the template may not be applicable to your Investigator Protocol. Indicate this as appropriate with “N/A” after the section number.You may not involve any individuals and/or their data who are members of the following populations as subjects in your research unless you indicate this in your inclusion criteria; the inclusion of subjects in these populations has regulatory implications.Adults unable to provide legally effective consent (i.e. cognitively impaired)Individuals who are not yet adults (infants, children, teenagers <18 years)Pregnant womenPrisonersIf you are conducting community-based participatory research, you may contact the IRB Office for information about:Research studies using a community-based participatory research designUse of community advisory boardsUse of subject advocatesPartnerships with community-based institutions or organizationsHow do I submit an application for a Coordinating or Data Coordinating Center?If USF is serving as both a Coordinating Center and clinical site enrolling subjects, two separate applications must be submitted within BullsIRB – one for the Coordinating Center and another for the clinical site.Do case reports or limited case series need to be submitted to the IRB?A case report or limited case series is a description of the characteristics, evaluation, and/or treatment(s) of a single individual or a small group of individuals that share a common condition, but did not involve activities defined as research. The subject(s) of the case(s) may be patients, clients, students, or other individuals who have been evaluated, treated, counseled, or taught. The retrospective review of records for publication of a single case report or a limited case series involving data from three (3) or fewer individuals is not considered to be research involving human subjects, and therefore such a report does not require IRB review and approval. The IRB regards case reports or a limited case series as an educational activity, and therefore it is permissible under the Health Insurance Portability and Accountability Act (HIPAA) as a part of health care operations (45 CFR 164.501) when reviewing medical records.The use of a single subject in prospective research activity (n = 1) does constitute research that is subject to IRB review and approval when there is a clear intent before recruiting or interacting with the subject to use systematically collected data or information. Do I need a data and safety monitoring plan (DSMP)?Studies that pose greater than minimal risk to subjects must include a DSMP. A Data Safety Monitoring Board (DSMB) may also be required if the study involves blinding, multiple sites, vulnerable subjects, or employs high-risk interventions. The NIH requires the establishment of DSMBs for all Phase III multi-center clinical trials involving interventions that entail potential risk to the subjects.What if I am doing my research at a non-USF (or non-affiliate) location?Investigators at times may conduct research at sites that are not owned or operated by the Institution or its affiliates. Investigators must provide the IRB with information regarding the facility and population targeted in the research. A letter of support from the site where the research will be conducted is required by the IRB. A letter of support is also required of an organization providing the Investigator with private information (e.g. contact information) about their employees, students, etc. for recruitment purposes.Investigators are responsible for ensuring the administrator signing the letter of support understands the IRB’s expectations of him/her and has the authority to make those assurances. Letters of support must be printed on the facility’s letterhead, signed by the administrator, and include the following:A statement that the site administrator has reviewed the research and has found it appropriate for the population of that facility; A statement allowing the Investigator to conduct the research activities on site and if applicable, indicating there are appropriate resources available to conduct the research; Contact information for an individual who will represent the facility in matters related to the conduct of human subjects research; andA statement that based on the risks associated with the research, there are adequate provisions to handle unanticipated problems and/or adverse events as applicable. If the facility has an IRB, or similar review committee, the facility should provide documentation that the research has been reviewed and approved by that committee. In situations where the site is relying upon the IRB for the review and approval of the research project, or conversely, if the IRB is relying on the site’s IRB for the review and approval of the research, the local study team must complete a new IRB submission through BullsIRB, noting that either the USF IRB or an external IRB will act as the IRB of record for the study. What if I am doing my research outside of the country?The Office of Human Research Protections (OHRP) provides guidelines that govern human subjects research in foreign countries, as well as standards from a number of international and regional organizations. The USF HRPP requires researchers to comply with these guidelines when conducting international research. For more information regarding these guidelines, please see . International research that involves the enrollment of children should consider the following:If the child is considered an adult in the country in which the research is taking place;The relationship between parents and their children and whether or not there is an acceptable and effective parental permission process;If the assent of the child is permissible by local customs; andIf there are laws pertaining to the enrollment of orphans in research.In addition to ensuring equivalent protections encompassing the ethical principles of respect for persons, beneficence, and justice, investigators conducting human subjects research outside the U.S. are responsible for the following:Obtain IRB approval and demonstrate approval from the local Ethics Committee (or similar committee) should one exist in the host country in which the research will be conducted. If an Ethics Committee does not exist, then a letter of support from a community leader or the local government must be obtained.Have the knowledge of and comply with local laws, regulations, political or socio-economic factors, and cultural context while conducting research. Care must be taken to ensure that the cultural norms of the host country are respected and that the subjects will not suffer adverse consequences from participation, such as being subjected to retaliation from local authorities or the local community. If the researcher is unfamiliar with the local laws, cultural norms, etc., he/she must involve a local collaborator in the conduct of the research.Implement an informed consent process that is consistent with the cultural norms of the country in which the research will be conducted. The informed consent document should be translated into a language that is understandable by the subject.If the Investigator does not speak the language of the country in which the research will be conducted, he/she must describe how communication with subjects will be conducted.Assist colleagues from the host country in obtaining a FWA if the research is federally funded and requires that the transnational institution receive an approved FWA from OHRP.Determine if an export license is required by contacting the USF Export Controls office (exportcontrol@usf.edu). Scenarios in which this may be required include: A physical transfer/disclosure of an item outside the U.S.; Any transfer/disclosure of a controlled item or information within the U.S. to a foreign national;Participation of foreign national faculty, staff, or student in the research; Presentation/discussion of previously unpublished research at conferences or meetings where foreign national scholars may be in attendance; Research collaborations with foreign nationals and technical exchange programs;Transfers of research equipment abroad; orVisits to the local Investigator’s lab by foreign national scholars.Review the U.S. Department of State’s U.S. Passports & International Travel website for a current list of noted high-risk countries and travel warnings and alerts. If any member of the study team is traveling to a noted high-risk country, the Investigator should contact the Export Controls Office prior to traveling to the host country. Are there any Florida Laws that I should be aware of that might affect my research plan?The Investigator is responsible for complying with Florida state laws and regulations as applicable in the conduct of human subjects research. The IRB, IRB Chairperson, or designees are responsible for ensuring proposed human subjects research is in compliance with Florida state laws and regulations, when applicable, prior to issuing approval. The following Florida Statutes will be applied to human subjects research, when applicable:HIV Testing (Florida Statutes §381.004) This law establishes the parameters for consent and disclosure of results relating to HIV testing in Florida and applies to all human research where an HIV test will be performed during either the eligibility screening or the research study itself. Informed consent for HIV testing is mandatory and must include: A prior explanation of the right to confidential treatment of the information identifying the subject and the results of the test to the extent provided by law; A disclosure that a positive HIV test result will be reported to the county health department with sufficient information to identify the subject; The availability and location of sites where anonymous testing is performed (each county health department maintains a list of sites at which anonymous testing is performed). Reasonable efforts must be made to notify the subject of the results. If the test is positive, notification must include information on the availability of appropriate medical and support services, the importance of notifying partners who may have been exposed, and the prevention of transmission of HIV. A positive preliminary test result may not be revealed to any person except:The licensed physicians or the medical or nonmedical personnel subject to the significant exposure;Health care providers and to the person tested when decisions about medical care or treatment of, or recommendation to, the person tested and, in the case of an intrapartum or postpartum woman, when care, treatment, or recommendations regarding her newborn, cannot await the results of confirmatory testing. Positive preliminary HIV test results may not be characterized to the patient as a diagnosis of HIV infection. The results of rapid testing technologies shall be considered preliminary and may be released in accordance with the manufacturer’s instructions as approved by the federal Food and Drug Administration. Corroborating or confirmatory testing must be conducted as follow up to a positive preliminary test. Results shall be communicated to the subject according to statute regardless of the outcome. If the test is negative, notification must include, as appropriate, information on preventing the transmission of HIV.The identity of the subject and the test results are confidential and may not be disclosed except to:The subject or the subject's legally authorized representative; Someone with a legally effective release for HIV test results executed by the subject or the subject’s legally authorized representative (a general release or subpoena does not permit the release of HIV testing or HIV test results); An authorized agent or employee of a health facility or health care provider if the health facility or health care provider itself is authorized to obtain the test results, the agent or employee participates in the administration or provision of patient care or handles or processes specimens of body fluids or tissues, and the agent or employee has a need to know, as defined by the Department of Health; Health care providers consulting between themselves or with health care facilities to determine diagnosis and treatment; The Department of Health/county health department; Authorized medical or epidemiological researchers who may not further disclose any identifying characteristics or information; Others as specified by statute. Disclosure of test results to anyone on the exception list must be accompanied by the following statement: "This information has been disclosed to you from records whose confidentiality is protected by state law. State law prohibits you from making any further disclosure of such information without the specific written consent of the person to whom such information pertains, or as otherwise permitted by state law. A general authorization for the release of medical or other information is NOT sufficient for this purpose." Capacity of Principal; Procedure (Florida Statutes §765.204) This law states the criteria for determining whether an individual is capable of giving informed consent. An individual is presumed to be capable of making health care decisions for herself or himself unless she or he is determined to be incapacitated. Incapacity may not be inferred from the person’s voluntary or involuntary hospitalization for mental illness or from her or his intellectual disability. If an individual’s capacity to make health care decisions for herself or himself or provide informed consent is in question, the primary or attending physician shall evaluate the individual’s capacity and, if the physician concludes that the individual lacks capacity, enter that evaluation in the individual’s medical record. If the primary or attending physician has a question as to whether the individual lacks capacity, another physician shall also evaluate the individual’s capacity, and if the second physician agrees that the individual lacks the capacity to make health care decisions or provide informed consent, the health care facility shall enter both physicians’ evaluations in the individual’s medical record. A determination made pursuant to this section that an individual lacks capacity to make health care decisions shall not be construed as a finding that the individual lacks capacity for any other purpose. The USF IRB applies this law when determining the requirement for signature of a legally authorized representative. Genetic Testing; Informed Consent; Confidentiality; Penalties; Notice of Use of Results (Florida Statutes §760.40) This law provides that informed consent must always be obtained prior to DNA testing and certain notice must be provided to the subject. DNA analysis means the medical and biological examination and analysis of a person to identify the presence and composition of genes in that person's body. The term includes DNA typing and genetic testing. DNA analysis may be performed only with the informed consent of the person to be tested. The results of such DNA analysis, whether held by a public or private entity, are the exclusive property of the person tested, are confidential, and may not be disclosed without the consent of the person tested, except as specified by statute. A person who performs DNA analysis or receives records, results, or findings of DNA analysis must provide the person tested with notice that the analysis was performed or that the information was received. The notice must state that, upon the request of the person tested, the information will be made available to his or her physician. The notice must also state whether the information was used in any decision to grant or deny any insurance, employment, mortgage, loan, credit, or educational opportunity. If the information was used in any decision that resulted in a denial, the analysis must be repeated to verify the accuracy of the first analysis, and if the first analysis is found to be inaccurate, the denial must be reviewed.Sexually Transmissible Disease; Reporting Required (Florida Statutes §384.25) This law provides that any person who diagnoses or treats a person with a sexually transmissible disease (i.e. in the course of screening for human research eligibility) must report the facts as required by the Department of Health, within the time period specified in 64D-3.029, F.A.C. Child abuse should be considered by a practitioner upon collection of a specimen for laboratory testing in any person 12 years of age or under, excluding neonates. Reporting of an STD case to a county health department does not relieve the practitioner of their mandatory reporting responsibilities regarding child abuse pursuant to Section 39.201, F.S.Reporting Requirements for Practitioners and Hospitals for Sexually Transmissible Diseases (STDs) Including HIV and AIDS. Florida Administrative Code Rule 64D-3.029 Pursuant to 64D-3.029, F.A.C. diseases or conditions that are of public health significance identified in 64D-3.029, F.A.C. must be reported in the timeframe and manner specified in 64D-3.029, F.A.C. Florida Patient's Bill of Rights and Responsibilities (Florida Statutes §381.026(4)(e)) Generally states that a patient has right to know if any part of his or her medical treatment is for purposes of experimental research and to consent prior to participation in such research. A patient’s participation must be a voluntary matter; and a patient has the right to refuse to participate. The patient’s consent or refusal must be documented in the patient’s care record. Rights of Persons Determined Incapacitated (Florida Statutes §744.3215(4)(b)) This law provides that a court-appointed guardian may not consent to participation by the ward in any biomedical or behavioral experiment without the specific authority of the court. A guardian may only consent to enroll a ward in a biomedical or behavioral experiment with the specific authority of the court. The court may only grant such specific authority where participation in the research is of direct benefit to, and is intended to preserve the life of or prevent serious impairment to the mental or physical health of the ward or is intended to assist the ward to develop or regain his or her abilities. Personal Treatment of Persons Who Are Developmentally Disabled (Florida Statutes §393.13(4)(c)(6)) This law requires that consent be given by a developmentally disabled person or the person’s legal guardian prior to instituting a plan of experimental medical treatment. Prior to instituting a plan of experimental medical treatment, express and informed consent shall be obtained from a developmentally disabled individual, if competent, or the individual’s parent or legal guardian. Information upon which the individual shall make the decision to participate shall include, but should not be limited to, the nature and consequence of such procedures, the risks, benefits, and purposes of such procedures, and available alternate procedures. Anatomical Donation (Florida Statutes §§765.512, 756.513 and 765.514)Research subjects may indicate their intent to make an anatomical gift for research in a document other than a will (i.e. in a consent document), so long as the consent is signed by both the donor and by two witnesses in the donor’s presence.? If the donor/subject did not provide consent to make an anatomical gift and expires or loses capacity to consent, persons enumerated in 765.512(3) may, in the absence of any actual notice of contrary indications by the donor/subject or notice of opposition by a prior class, provide consent to give all or part of the donor/subject’s body for any purpose specified in 765.513.?Confidentiality of Reports and Records (Florida Statutes §415.107) This law provides that records concerning reports of abuse, neglect, or exploitation of the vulnerable adult, including reports made to the central abuse hotline, and all records generated as a result of such reports are confidential; however, access to all records, excluding the name of the reporter, may be granted for bona fide human research. Information may be released to persons conducting bona fide research or auditing. However, information identifying the subjects of the report must not be made available to such researchers. Florida Sunshine and Public Records Law (Florida Statutes §§286.011; 286.012)This law allows open access to all official meetings and official records maintained by USF, including IRB meetings and records. There are specific exemptions that apply to certain meetings and documents. Florida’s public meetings law requires that meetings of the IRB and other compliance committees where final decisions are made, be open to the public at all times (i.e. that anyone may attend the meeting or any portion thereof), reasonable notice must be provided of the meeting, and minutes must be taken. The law also requires that two or more board members may not discuss a matter outside of the meeting on which foreseeable action will take place at the board meeting. The public meetings law also prohibits members from abstaining from a vote unless there is, or appears to be a conflict of interest as defined by the Florida Code of Ethics for Public Officers and Employees (Florida Statutes §112.313). However, where federal law requires a member to vote, the state law pertaining to abstaining from votes will be superseded. Federal guidance issued by OHRP recommends that, except when requested by the IRB to be present to provide information, IRB members absent themselves from the meeting room when the IRB discusses and votes on human research with which they have a conflicting interest. Regarding the requirement that the meeting be open to the public at all times, the USF General Counsel has advised the IRB to treat the federal policy as superseding the public meetings law. Therefore, members with conflicting interests are asked to leave the room temporarily during the public meeting while issues pertaining to the proposal are discussed by the IRB.Sovereign Immunity (Florida Statutes §768.28) This law provides for sovereign immunity for the State of Florida and its agencies, including state universities. Sovereign immunity protects individuals who are acting as agents of the university from tort liability exceeding the sum of $200,000 per claim and $300,000 per incident. Consent on Behalf of Children (referenced as minors in Florida law) to Participate in Medical or Behavioral ResearchA child/minor is an individual under the age of 18 whose disabilities have not been removed by marriage or by an act of the court. (Florida Statutes §743.01; §743.015; §743.07; §744.102(13)). Minors are generally presumed to be legally incompetent to consent to medical or mental health treatment. Parents are the minor’s natural guardians. A natural guardian is a guardian who can exercise all the legal rights and powers for the minor/ward that can be delegated. (Florida Statutes §744.301). Since a parent/natural guardian can exercise all of a minor’s legal rights and powers, a parent/natural guardian can consent to a minor’s participation in experimental research.In the absence of a natural guardian due to death, incapacity, removal of parental rights or other permanent absence, a minor will normally have a court-appointed guardian or will be a ward of the state. A guardian of a minor may be a permanent guardian or a plenary guardian. A plenary guardian is usually a temporary guardian who is authorized to exercise all the legal rights and powers for the minor that can be delegated. However, unless specifically authorized by the court, a temporary guardian cannot provide legally effective consent to allow a minor’s participation in research or experimental treatment. (Florida Statutes §744.3215(4)(b); §744.3725). Unlike a natural guardian or a permanent guardian, a court-appointed plenary guardian of a minor may not consent to the participation of the minor in research without the specific authority of the court. (Florida Statutes §744.3215(4)(b)).Parental consent is not required for the termination of a pregnancy of a minor; however, actual notice, notice that is given directly, in person or by telephone, must be provided to a parent or legal guardian of a minor, by a physician, at least 48 hours before the inducement or performance of a termination of pregnancy, and documentation must be made in the minor’s files. If actual notice is not possible after a reasonable effort has been made, the physician performing or inducing the termination of pregnancy or the referring physician must give constructive notice or notice in writing, signed by the physician, and mailed at least 72 hours before the inducement or performance of the termination of pregnancy, to the last known address of the parent or legal guardian of the minor, by first-class mail and by certified mail, return receipt requested, and delivery restricted to the parent or legal guardian. After the 72 hours have passed, delivery is deemed to have occurred. The notice requirement may be waived under certain circumstances. (Florida Statutes §390.01114).An unwed pregnant minor may consent to medical or surgical care or services relating to her pregnancy by a hospital, clinic or physician licensed in the state of Florida, and her consent is valid and binding as if she had achieved the age of majority. (Florida Statutes §743.065).Lotteries are Prohibited (Florida Statutes §§849.09(1)(c); 849.0935(4) (a) (b))This law states that is unlawful for any person in this state to conduct a lottery drawing for the distribution of a prize or prizes by lot or chance, or advertise any such lottery scheme or device in any newspaper or by circulars, posters, pamphlets, radio, telegraph, telephone, or otherwise. It is thus unlawful for researchers to use a random drawing of chance as a mechanism for compensating research subjects. Mandatory reports of child abuse, abandonment, or neglect; mandatory reports of death; central abuse hotline (Florida Statutes §39.201)The law states that any person who knows, or has reasonable cause to suspect, that a child is abused, abandoned, or neglected by a parent, legal custodian, caregiver, or other person responsible for the child’s welfare, as defined in this chapter, or that a child is in need of supervision and care and has no parent, legal custodian, or responsible adult relative immediately known and available to provide supervision and care shall report such knowledge or suspicion to the Florida Department of Children and Families by means of the central abuse hotline. ?Any person who knows, or who has reasonable cause to suspect, that a child is abused by an adult other than a parent, legal custodian, caregiver, or other person responsible for the child’s welfare, as defined in this chapter, shall report such knowledge or suspicion to the Florida Department of Children and Families in the manner prescribed in subsection two (2) of the statute.?Any person who knows, or has reasonable cause to suspect, that a child is the victim of childhood sexual abuse or the victim of a known or suspected juvenile sexual offender, as defined in this chapter, shall report such knowledge or suspicion to the Florida Department of Children and Families in the manner prescribed in subsection two (2) of the statute.Reporters in the following occupation categories are required to provide their names to the hotline staff:1.Physician, osteopathic physician, medical examiner, chiropractic physician, nurse, or hospital personnel engaged in the admission, examination, care, or treatment of persons;2.Health or mental health professionals other than those listed in subparagraph 1.;3.Practitioners who rely solely on spiritual means for healing;4.School teachers or other school officials or personnel;5.Social workers, day care center workers, or other professional child care, foster care, residential, or institutional workers;6.Law enforcement officers; or7. Judges.Areas Where State and Federal Laws DifferHRPP policies do not specifically identify where state and federal laws differ. Rather, the policies are drafted to incorporate the appropriate action required by the controlling law. Regarding most topics of importance to the HRPP, the federal law provides either broad guidance, or guidance specific to a particular area that state law may or may not address. The state law provides more specific guidance within the broad guidance provided by federal law; the two laws are read to be complementary and in such a way as not to defeat the purpose of either law. There is only one instance applicable to the HRPP where state law and federal law have incompatible interpretations, according to the USF General Counsel. Florida’s Sunshine law requires that meetings of the IRB and other compliance committees, where final decisions are made, be open to the public at all times (i.e. that anyone may attend the meeting or any portion thereof). However, the federal policy guidance, issued by OHRP, recommends that, except when requested by the IRB to be present to provide information, IRB members absent themselves from the meeting room when the IRB discusses and votes on human subjects research in which they have a conflicting interest. Although this policy is presented as a “recommendation” by the federal agency, The USF General Counsel has advised the IRB to treat the federal policy as superseding the Florida Sunshine law. Therefore, members with conflicting interest are asked to leave the room temporarily during the public meeting while issues pertaining to the proposal are discussed by the IRB.What if I want to conduct research in schools or obtain student records?Studies involving children in primary and secondary educational settings require documentation of approval from the school district/administrator and parental permission unless waived by the IRB. The IRB will require a copy of the district(s) approval letter prior to the commencement of research activities.Research involving children in schools or student education records require adherence to the Family Educational Rights and Privacy Act (FERPA) 34 CFR 99 and The Protection of Pupil Rights Amendment (PPRA) 20 U.S.C. §1232h; 34 CFR 98. Family Educational Rights and Privacy Act (FERPA) FERPA is a federal law that protects the privacy of student education records. The law applies to all schools that receive funds under an applicable program of the U.S. Department of Education (ED). FERPA applies when researchers obtain student records or personal education information from an education program. FERPA gives parents certain rights with respect to their children's education records. These rights transfer to the student when he or she reaches the age of 18 or attends a school beyond the high school level. Students to whom the rights have transferred are "eligible students." Generally, schools must have written permission from the parent or eligible student in order to release any information from a student's education record. Schools may disclose without consent "directory" information such as a student's name, address, telephone number, date and place of birth, honors and awards, and dates of attendance. An educational agency or institution may disclose personally identifiable information from an education record of a student without consent if the disclosure is to organizations conducting studies for, or on behalf of, educational agencies or institutions to develop, validate, or administer predictive tests, administer student aid programs, or to improve instruction. A school district or postsecondary institution that uses this exception is required to enter into a written agreement with the Organization or researcher conducting the research. Education records may also be released without consent under FERPA if all personally identifiable information has been removed. For more information on FERPA exceptions and requirements please see, HRP-331 - WORKSHEET - FERPA Compliance. Protection of Pupil Rights Amendment (PPRA) PPRA provides parents or guardians with some oversight of the content of third-party research and any instructional materials developed by researchers. PPRA identifies “sensitive topics” and “provisions for parental review and approval” for surveys and materials. PPRA applies to programs that receive funding from the ED and is intended to protect the rights of parents and students in two ways: It seeks to ensure that schools and contractors make instructional materials available for inspection by parents or guardians if those materials will be used in connection with an ED-funded survey, analysis, or evaluation in which their children participate; and No student shall be required, as part of any research project, to submit without prior consent to surveys, psychiatric or psychological examination, testing, or treatment, in which the primary purpose is to reveal information concerning one or more of the following:Political affiliations or beliefs of the student or student’s parents;Mental and psychological problems of the student and his/her family;Sex behavior and attitudes;Illegal, anti-social, self-incriminating, and demeaning behavior;Critical appraisals of other individuals with whom respondents have close family relationships;Legally recognized privileged or analogous relationships, such as those of lawyers, physicians, and ministers;Religious practices, affiliations or beliefs of the students or the student’s parents; orIncome other than that required by law to determine eligibility for participation in a program or for receiving financial assistance under such program. Schools and contractors must obtain prior written parental consent before minor students are required to participate in any ED-funded survey, analysis, or evaluation. What if I want to include deception in my research?While the use of deception may be a valuable methodology to avoid bias or test a hypothesis, these techniques raise important ethical issues. The federal regulations for obtaining informed consent require full disclosure of the research to the subject and therefore, the IRB must determine the extent to which the deception interferes with the subject’s ability to provide fully informed consent. Deception involves misleading subjects as to the true nature of the study procedures. Deception includes both active deception and deceptive incomplete disclosure:Active deception is a situation where an individual is provided false or misleading information regarding the true purpose of the study. Examples of active deception include providing a “cover story” which falsely describes the purpose of the research or using a “confederate” or study accomplice who is posing as a research subject whose behavior in the study is actually part of the research design.Deceptive incomplete disclosure is a situation in which an investigator withholds information about the specific purpose, nature, or other aspect of the research; and 1) that information, if provided during initial consent may have affected subjects’ decisions to participate and/or 2) when subjects learn of the information withheld, they would likely feel deceived. An example of deceptive incomplete disclosure includes audiotaping or videotaping subjects without their knowledge or consent. Not all incomplete disclosure is considered deception. An example of non-deceptive incomplete disclosure includes not revealing the hypotheses of the study. The researcher may provide information to the subject about the research that is true, yet not detailed enough to reveal the main aims or hypotheses of the study. In most cases, this would not be considered deception. The use of deception must be justified and there should be no reasonable alternative method that would be equally effective. To approve research involving deception, the study procedures cannot involve greater than minimal risk to subjects. The Investigator must clearly outline that the proposed research involves deception in their initial application to the IRB. The Investigator must provide a script to be used during the debriefing session after the subject’s participation in the research study and utilize this to debrief subjects unless the IRB determines that such debriefing would cause harm to the subject. After debriefing, the Investigator must ask subjects if they would like their study information withdrawn and withdraw the study information should this be requested by the subject. The IRB, Chair, or Vice Chair reviews applications for initial review. Studies involving deception can be reviewed by expedited procedures depending on the risks to subjects and level of deception used in the research. Research involving deception does not qualify for review by exempt procedures, except for research that meets the criteria for approval under 45 CFR 46.104(d)(3). In this case, deception while conducting benign behavioral interventions can only be used if the subject prospectively agrees to the use of deception. Subjects must be informed prior to initiating the intervention that they will be unaware of, or misled regarding the true nature or purpose of the research. They will also be told whether further information will be provided at the conclusion of the research activities. Researchers should still debrief subjects.How do I create a consent document?Use the HRP-502x - TEMPLATE CONSENT DOCUMENT to create a consent document. The currently available templates are:HRP-502a - Biomedical Adult ConsentHRP-502a(1) - Biomedical Adult Spanish ConsentHRP-502a(2) - Biomedical Assent HRP-502a(3) - Biomedical Parental PermissionHRP-502a(4) - Biomedical LAR HRP-502b - Social Behavioral Adult ConsentHRP-502b(1) - Social Behavioral Adult Spanish ConsentHRP-502b(2) - Social Behavioral Assent HRP-502b(3) - Social Behavioral Parental PermissionHRP-502b(4) - Generic Pre-Screening Consent ScriptHRP-502b(5) - Social Behavioral Combined Consent and Parental PermissionHRP-502b(6) - Social Behavioral Proxy (LAR) ConsentHRP-502b(7) - Social Behavioral Survey Consent (No Signature Line)HRP-502b(8) - Social Behavioral Verbal Consent ScriptHRP-502c - Genetic/Genomic Consent Addendum HRP-506 - Emergency Use or Compassionate Use ConsentNote that all consent documents must contain all of the required and all additional appropriate elements of informed consent. Review the “Written Consent Documentation” section in the IRB’s HRP-314 - WORKSHEET - Criteria for Approval, to ensure that these elements are addressed. See also HRP-090 - SOP - Informed Consent Process and HRP-091 - SOP - Written Documentation of Consent for additional special considerations related to the consent process. The consent templates include required language for USF research. USF will not allow the use of broad consent pending additional guidance on the topic from OHRP. The IRB will not approve language in the informed consent document which may be exculpatory, in which subjects (or their legally authorized representatives) are made to waive or appear to waive any legal rights or release the Investigator, sponsors, or institution from liability for negligence.Non-English Speaking Human SubjectsWhen recruiting subjects whose primary language is not English, these individuals must be consented and provided with an informed consent document in their native language. An individual who speaks the same language as the subject must be included in the consent process to translate questions or concerns between the subject and the individual obtaining consent. The translator does not need to be a member of the study team but must be able to communicate accurately and honestly between the subject and the research team. In addition, the USF IRB recommends that the translator not be a family member of the potential research subject. Once the IRB has reviewed and approved the English version of the informed consent document, the approved document must be translated into the language understandable by potential subjects and submitted as an Amendment for IRB approval. The translated copy may be submitted with the English consent form with the initial submission as an alternative to submitting an Amendment; however, changes requested to the English version must also be reflected in the non-English version. The translated document must be certified by a licensed translator or translation company, or back-translated. The certification must attest that the translation is accurate and complete. Back-translated documents should be translated by an individual who speaks the language fluently, and back-translated by a different, non-study team member who speaks the language fluently. Major discrepancies with the English version must be addressed. Informed Consent and the NIH Genomic Data Sharing (GDS) PolicyFor research that falls within the scope of the NIH GDS Policy, the IRB must review the informed consent document to determine whether it is appropriate for data to be shared for secondary research use. Investigators must obtain prospective consent for the use of genomic and phenotypic data to be used in future research and to be shared broadly. In addition, the informed consent document should include whether the subject’s data will be shared through unrestricted or controlled access repositories even though the data are submitted de-identified.Do I need to include injury language in my consent?For research that involves greater than minimal risk, the IRB reviews and approves language in the informed consent document related to compensation and treatment for research related injuries. Injury includes physical injury, as well as psychological or social harm, or harm to one’s dignity, depending on the nature of the research. The IRB provides required language in the consent templates that must be utilized for all applicable Institutional research. Can I compensate subjects for their participation? The IRB reviews the amount and method of compensation to research subjects and the proposed payment schedule to ensure the compensation does not present undue influence (an offer of an excessive or inappropriate reward or other overture in order to obtain compliance) to individuals participating in IRB approved research. Compensation should only be offered in accordance with the following:Compensation should not be contingent upon the subject completing the study, but should accrue as the study pensation given as a “bonus” or incentive for completing the study is acceptable provided that the amount is not coercive. The IRB is responsible for determining if the amount is not so large as to be coercive or represent undue influence.Pursuant to Florida law (Florida Statute 456.054), the IRB does not allow payments designed to accelerate recruitment (also known as bonus payments) or allow referrals that result in a “finder’s fee” pensation should be based on the time an individual will be involved with study procedures, the inconvenience or discomfort to the subject, and reimbursement for expenses incurred while participating.Pursuant to Florida law (Florida Statute 849.09(1)(c)), a random drawing for monetary or other awards cannot be used as an incentive for enrolling or continuing participation in human subjects pensation is not viewed as a benefit to participation in research and should not be outlined as such in the informed consent document or considered by the IRB in the assessment of the risks and benefits to subjects. Sponsor coupons for a discount on the purchase price of the product once it has been approved for marketing is prohibited as compensation for participation. Finally, investigators are responsible for collecting taxpayer information from research subjects in accordance with USF Research Clarification or Change in Procedure (CCHIP) #017. If extra credit or rewards are offered for participation, students must be provided with and informed of non-research alternatives involving comparable time and effort to obtain the extra credit in order for the possibility of undue influence to be minimized. What are the different regulatory classifications that research activities may fall under?Submitted activities may fall under one of the following four regulatory classifications:Not Human Subjects Research: Activities must meet the institutional definition of human subjects research to fall under IRB oversight. Activities that do not meet this definition are not subject to IRB oversight or review. Review the HRP-310 - WORKSHEET: Human Subjects Research Determination for reference. Contact the IRB in cases where it is unclear whether an activity is human subjects research.Exempt: Certain categories of human subjects research may be exempt from regulation but require IRB review. It is the responsibility of the IRB, not the Investigator, to determine whether human subjects research is exempt from IRB review. Review the HRP-312 – WORKSHEET- Exemption for reference on the categories of research that may be exempt.Review Using the Expedited Procedure: Certain categories of non-exempt human subjects research may qualify for review using the expedited procedure, meaning that the project may be approved by a single designated IRB reviewer, rather than the convened board. Review the HRP-313 - WORKSHEET - Expedited Review for reference on the categories of research that may be reviewed using the expedited procedure.Review by the Convened IRB: Non-Exempt human subjects research that does not qualify for review using the expedited procedure must be reviewed by the convened IRB.What are the decisions the IRB can make when reviewing proposed research?The IRB may approve research, require modifications to the research to secure approval, table research, or disapprove research:Approval: Made when all criteria for approval are met. See Question #25 below. Modifications Required to Secure Approval: Made when IRB members require specific modifications to the research before approval can be finalized. Tabled: Made when the IRB cannot approve the research at a meeting for reasons unrelated to the research, such as loss of quorum. When taking this action, the IRB automatically schedules the research for review at the next meeting.Deferred: Made when the IRB determines that the research cannot be approved without substantive changes to the protocol or informed consent form, the IRB suggests modifications that might make the research approvable. When making this motion, the IRB describes its reasons for this decision, describes modifications that might make the research approvable, and gives the Investigator an opportunity to respond to the IRB in writing. Research that is deferred must be reviewed again at a fully convened IRB meeting.Disapproval: Made when the IRB determines that the research is not approvable because it does not meet the criteria for IRB approval found in 45 CFR 46.111/21 CFR 56.111. When making this motion, the IRB describes its reasons for this decision and gives the Investigator an opportunity to respond to the IRB in writing.How does the IRB decide whether to approve human subjects research?The criteria for IRB approval can be found in the HRP-312 – WORKSHEET- Exemption for exempt human subjects research and the HRP-314 - WORKSHEET - Criteria for Approval for non-exempt human subjects research. The latter worksheet references other checklists that might be relevant. All checklists and worksheets can be found in BullsIRB. These checklists follow the 45 CFR 46.111/21 CFR 56.111 requirements.These checklists are used for initial review, continuing review, and review of modifications to previously approved human subjects research.You are encouraged to use the checklists to write your Investigator Protocol in a way that addresses the criteria for approval.What will happen after IRB review?The IRB will provide you with a written decision indicating that the IRB has approved the human subjects research, requires substantive or non-substantive modifications to secure approval, or has disapproved the human subjects research. If the IRB has approved the human subjects research: The human subjects research may commence once all other institutional approvals have been obtained. IRB approval is usually good for a limited period of time, which is noted in the approval letter. Approval letters may also have special instructions from the IRB.If the IRB requires modifications to secure approval: All required changes will be outlined in a letter. Make the requested modifications and submit them to the IRB. If all requested modifications are made, the IRB will issue a final approval. Research cannot commence until this final approval is received. If you do not agree with the modifications, write up your response with justification as to why the modifications cannot/should not be made and submit it to the IRB. If a response or request for an extension is not received by close of business on the thirtieth (30th) calendar day from receipt of the letter requesting modifications, the IRB will close the application. For continuing review applications, if a response is not received by close of business on the tenth (10th) calendar day from the date of expiration, IRB approval will lapse and the study will be suspended. If the IRB defers the human subjects research: The IRB will provide a statement of the reasons for deferral and suggestions to make the study approvable, and give you an opportunity to respond in writing. In most cases, if the IRB’s reasons for the deferral are addressed, the human subjects research can be approved. If a response or request for an extension is not received by close of business on the sixtieth (60th) calendar day from receipt of the letter stating the reasons for deferral and suggested changes, the IRB will close the application. If the IRB disapproves the human subjects research: The IRB will provide a statement of the reasons for disapproval and give you an opportunity to respond in writing.If the Investigator believes the decision of the IRB is unduly restrictive, the Investigator may contact the Chairperson, Chair Designee, or IRB administration to discuss the reasons for the determination. The Investigator may appeal the decision of the IRB in writing within thirty (30) calendar days of receiving notice of the determination. Extension to the deadline must be reviewed and approved by the IRB Chairperson. Appeals must be addressed to the IRB Chairperson or Chair Designee and include the reasons the Investigator believes the proposed research or issue at hand follows IRB policies and procedures, state and local laws, and federal regulations. The IRB will consider the appeal(s) based upon new information provided. The Investigator may attend the IRB meeting(s) where his/her research and appeal are reviewed to address issues raised by the convened IRB consistent with USF Research Integrity & Compliance Procedures for Appearances before Institutional Compliance Committees which can be found here.What are my obligations after IRB approval?Do not start human subjects research activities until you have read the final IRB approval letter.Do not start human subjects research activities until you have obtained all other required institutional approvals, including approvals of departments, divisions, or institutions where the research will be carried out that require approval prior to commencing research that involves their resources.Ensure that there are adequate resources to carry out the research safely. This includes, but is not limited to, sufficient investigator time, appropriately qualified research team members, equipment, and space.Ensure that research staff are qualified (e.g. including but not limited to appropriate training, education, expertise, credentials, protocol requirements and, when relevant, privileges) to perform procedures and duties assigned to them during the study.For research subject to ongoing IRB oversight, obtain IRB approval prior to making any changes to the list of study personnel.Ensure required trainings are kept current throughout the research.Personally conduct or supervise the human subjects research. Recognize that the Investigator is accountable for the failures of any study team member.Conduct the human subjects research in accordance with the relevant current protocol as approved by the IRB, and in accordance with applicable federal regulations and local laws.When required by the IRB, ensure that consent or permission is obtained in accordance with the relevant current protocol as approved by the IRB. For consents requiring a signature, study teams must utilize the consent with the IRB effective date stamp and watermark.Do not modify any portion of the human subjects research without prior IRB review and approval unless necessary to eliminate apparent immediate hazards to subjects.Protect the rights, safety, and welfare of subjects involved in the research.For exempt research, once the exempt determination is made, the application is closed in BullsIRB. This does not limit your ability to conduct the research. Any proposed or anticipated change to the study design that was previously declared exempt from IRB oversight must be submitted to the IRB as a new study prior to initiation of the change. However, administrative changes, including changes in research personnel, do not warrant a modification or new application. If changes are made and there are questions about whether these activities impact the exempt determination, please submit a new request to the IRB for a determination.Submit to the IRB:Proposed modifications as described in this manual for expedited and full IRB review applications. (See Question #33)Personnel Change Requests to add/remove study team members;A continuing review application as requested in the approval letter. (See Question #35)A continuing review application when the human subjects research is closed. (See Question #36)Complete the Reportable New Information (RNI) (similar to the previous “Reportable Event”) SmartForm within five (5) business days of being notified of the information for any of the following items:Information that indicates a new or increased risk, or a new safety issue. For example:New information (e.g. an interim analysis, safety monitoring report, publication in the literature, sponsor report, or Investigator finding) indicates an increase in the frequency or magnitude of a previously known risk, or uncovers a new risk.An Investigator’s Brochure, package insert, or device labeling is revised to indicate an increase in the frequency or magnitude of a previously known risk, or describe a new risk.Withdrawal, restriction, or modification of a marketed approval of a drug, device, or biologic used in a research protocol.Protocol violation that harmed subjects or others or that indicates subjects or others might be at increased risk of plaint from a subject that indicates subjects or others might be at increased risk of harm or at risk of a new harm.Any changes significantly affecting the conduct of the research that may increase risk.Harm experienced by a subject or other individual, which in the opinion of the Investigator are unexpected and probably related to the research procedures.A harm is “unexpected” when its specificity or severity are inconsistent with risk information previously reviewed and approved by the IRB in terms of nature, severity, frequency, or characteristics of the study population.A harm is “probably related” to the research procedures if in the opinion of the Investigator, the research procedures more likely than not caused the harm.Non-compliance with the federal regulations governing human subjects research or with the requirements, policies, or determinations of the IRB, or an allegation of such non-compliance.Audit, inspection, or inquiry by a federal agency or the USF QA/QI Program.Include any resulting reports with your responses (e.g. FDA Form 483). This should be reported to the IRB regardless of the reason for the inspection. Ideally, the Investigator should notify the IRB prior to the inspection. The USF QA/QI Program can assist with inspection preparations. (QA-QI@usf.edu)For-cause inspections or audits by sponsors and any resulting communication and/or report. Written reports from study monitors to be submitted as required by the sponsor and/or sponsor’s agent, or Data and Safety Monitoring Board (DSMB) reports.Failure to follow the protocol due to the action or inaction of the Investigator or research staff.Breach of confidentiality or possible breach by way of compromised data access (e.g. lost consent, stolen computer or misplaced records).Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a subject.An exception from the IRB approved protocol that has been approved by the sponsor of the research (e.g. enrollment of an incarcerated subject). Complaint from a subject that cannot be easily resolved by the research team. Premature suspension, termination, or hold of the research by the sponsor, Investigator, institution, or oversight body (e.g. DSMB or FDA) for any reason. Unanticipated adverse device effect (any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects).For Department of Veterans Affairs (VA) research, local deaths, unanticipated SAEs, or apparently serious research information security problems.Submit an updated disclosure of financial interests within thirty days of discovering or acquiring (e.g. through purchase, marriage, or inheritance) a new financial interest. See also Question #5 above.Do not accept or provide payments to professionals in exchange for referrals of potential subjects (i.e. “finder’s fees”) as required by law.Do not accept payments designed to accelerate recruitment that were tied to the rate or timing of enrollment (i.e. “bonus payments”).See additional requirements of various federal agencies in Appendix A. These represent additional requirements and do not override the baseline requirements of this section.If the study is a clinical trial and supported by a Common Rule agency, one IRB-approved version of a consent form that has been used to enroll subjects must be posted on a public federal website designated for posting such consent forms. The form must be posted after recruitment closes, and no later than sixty (60) days after the last study visit. Please contact the study sponsor with any questions. Contact the USF QA/QI Program for assistance at QA-QI@usf.edu or 813-974-5638.If certain information should not be made publicly available on a Federal website (e.g. confidential commercial information), the supporting Federal department or agency may permit or require redactions to the information posted. Contact the Federal department or agency supporting the clinical trial for a formal determination.Contact the supporting Federal department or agency sponsor with any other questions regarding consent form posting obligations.Report negative findings by a government oversight office, legal action related to human research protections, or unfavorable media coverage to the IRB (RSCH-IRB@usf.edu) within twenty-four (24) hours of learning of the findings or event. This includes: Any negative actions by a government oversight office, including, but not limited to, OHRP Determination Letters, FDA Warning Letters, FDA 483 Inspection Reports with official action indicated, FDA restrictions placed on IRBs or Investigators, and corresponding compliance actions taken under non-US authorities related to human subjects research protections. Any litigation, arbitration, or settlements initiated related to human research protections.Any press coverage (including but not limited to radio, TV, newspaper, online publications) of a negative nature regarding USF’s HRPP.What are some examples of adverse events (AEs) and serious adverse events (SAEs) that need to be submitted within five (5) business days of becoming aware of the event?A single occurrence of a serious, unexpected event that is uncommon and strongly associated with drug exposure (e.g. angioedema, agranulocytosis, hepatic injury, or Stevens-Johnson syndrome);A single occurrence, or more often a small number of occurrences, of a serious, unexpected event that is not commonly associated with drug exposure, but uncommon in the study population (e.g. tendon rupture, progressive multifocal leukoencephalopathy);Multiple occurrences of an AE that, based on aggregate analysis, is determined to be an unanticipated problem. There should be a determination that the series of AEs represents a signal that the AEs were not just isolated occurrences and involve risk to human subjects (e.g. a comparison of rates across treatment groups reveals higher rate in the drug treatment arm versus control arm);An AE that is described or addressed in the Investigator’s Brochure, protocol, or informed consent documents, but occurs at a frequency or severity that is inconsistent with prior observations. A discussion of the divergence from the expected frequency or severity should accompany the report;An SAE that is described or addressed in the Investigator’s Brochure, protocol, or informed consent documents, but for which the rate of occurrence in the study represents a clinically significant increase in the expected rate of occurrence. A discussion of the divergence from the expected rate should accompany the report;Any other AE or safety finding that would cause the sponsor to modify the Investigator’s Brochure, study protocol, or informed consent documents, or would prompt other action by the IRB to ensure the protection of human subjects. We recommend that an explanation of the conclusion accompany the report;Any breaches in confidentiality that would place the subject or others at risk;Any change in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in a research protocol;Any change to the protocol that was taken without prior IRB approval to eliminate apparent immediate hazard to a research subject;Incarceration of a subject when enrolled on a study not approved under Subpart C provisions; orBreach of privacy or confidentiality including the loss of data on a computer or any electronic device which holds private or confidential information.What are my obligations as the overall study Investigator for a single IRB (sIRB) study?Coordinating with HRPP personnel to determine whether this institution’s IRB can act as the sIRB for all or some institutions participating in the study or if an external IRB will assume oversight. See also Questions #8 and #9 above; Identifying all sites that will be engaged in the human subjects research and requiring oversight by the IRB;Ensuring that all sites receive a request to rely on the Reviewing IRB and that all institutional requirements are satisfied before a study is activated at a relying site;Collaborating with the Reviewing IRB to document roles and responsibilities for communicating and coordinating key information from study teams and the IRB or HRPP at relying sites;Responding to questions or information requests from study teams or the IRB or HRPP staff at relying sites;Providing relying site investigators with the policies of the Reviewing IRB; Providing relying site investigators with the IRB-approved versions of all study documents;Preparing and submitting IRB applications on behalf of all sites. This includes initial review, modifications, personnel updates, reportable new information, and continuing review information for all sites; Establishing a process for obtaining and collating information from all sites and submitting this information to the Reviewing IRB. This includes site-specific variations in study conduct, such as the local consent process and language, subject identification and recruitment processes, and local variations in study conduct;Ensuring that consent forms used by relying sites follow the consent template approved by the Reviewing IRB and include required language as specified by the relying sites;Providing site investigators with all determinations and communications from the Reviewing IRB;Submitting reportable new information from relying sites to the Reviewing IRB in accordance with the terms outlined in the authorization agreement or communication plan; Reporting the absence of continuing review information from relying sites if they do not provide the required information prior to submission of the continuing review materials to the Reviewing IRB. Notifying the relying site of their lapse in approval and applicable corrective actions; Providing study records to the relying institution, Reviewing IRB, or regulatory agencies upon request; andHaving a process for monitoring conduct of the research at the participating institution, including but not limited to ensuring all study staff have HSP training and data entered is reviewed for accuracy per your data monitoring plan. These efforts should be documented is the study’s regulatory file.What are my obligations as Investigator when relying on an external IRB?Obtaining appropriate approvals from this institution prior to seeking review by another IRB;Complying with determinations and requirements of the Reviewing IRB;Providing the Reviewing IRB with requested information about local requirements or local research context issues relevant to the IRB’s determination prior to IRB review;Notifying the Reviewing IRB when local policies that impact IRB review are updated;Cooperating in the Reviewing IRB’s responsibility for initial and continuing review, record keeping and reporting, and providing all information requested by the Reviewing IRB in a timely manner;Disclosing conflicts of interest as required by the Reviewing IRB and complying with management plans. See also Question #5 above;Promptly reporting to the Reviewing IRB any proposed changes to the research and not implementing those changes to the research without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subjects;When enrolling subjects, obtain, document and maintain records of consent for each subject or each subject’s legally authorized representative;Promptly reporting to the Reviewing IRB any Unanticipated Problems Involving Risks to Human Subjects or Others according to the requirements specified in the reliance agreement; Providing the Reviewing IRB with data safety monitoring reports in accordance with the Reviewing IRB’s reporting policy;Reporting non-compliance, subject complaints, protocol deviations, or other events according to the requirements specified in the reliance agreement; and Specifying the contact person and providing contact information for researchers and research staff to obtain answers to questions, express concerns, and convey suggestions regarding the use of the Reviewing IRB.What do I need to know about recruiting subjects?Investigators must provide detailed information regarding how subjects will be identified and recruited in the protocol. Recruitment methods and advertisements that will be used in human subjects research require prospective review and approval by the IRB. The IRB considers advertising or soliciting study subjects to be the start of the informed consent process.The IRB does not allow “cold calls/approaches” to potential research subjects. A letter of introduction from a direct care provider or organization leader (i.e. someone who has an established relationship with the potential subject) is an acceptable method of disseminating information regarding research opportunities. This information should contain pertinent information regarding the proposed research and contact information of the study team. Typically, this letter is sent under the name of the individual with whom the potential subject has a direct relationship (i.e. the individual’s primary or specialty care provider). Additionally, a direct care provider may verbally explain the study and if the subject expresses interest, introduce a study team member to discuss the study in more detail. However, the IRB may not deem these methods of recruitment appropriate for certain research topics, or may approve other methods of recruitment involving calling, emailing, or sending letters depending on the study population.Recruitment of Students or EmployeesThe research must not bestow upon participating students any competitive academic or occupational advantage over other students or staff who do not volunteer. The researchers must not impose any academic or occupational penalty on those not volunteering. One way investigators can reduce the potential to cause undue influence is to design the study so that the instructor, or employer, is blind to the identity of the subjects. If a study is designed in this way, potential subjects should be informed that the Investigator will not know who did and who did not participate. The study should also be designed so that the Investigator cannot infer who participated through indirect means (e.g. by seeing who walks into the laboratory, by getting a list of who earned extra credit for participating in the study, etc.). Another way investigators can minimize the possibility of undue influence in studies which offer extra credit or rewards for participation is to offer students non-research alternatives involving comparable time and effort of that which is involved in the research. Due to the potential for undue influence, investigators generally should avoid recruiting their employees or students from their own institution/class. Additional protections against undue influence will be required if investigators must recruit from their own courses. When recruiting students from academic courses where the investigators are not primary course instructors, the investigators must gain permission from the course professor who is in charge of the course. When recruiting employees or students is the only feasible way to conduct a study, investigators are expected to design the research in such a way that reduces the potential for subjects to feel pressured (unduly influenced) to participate. In these cases, the informed consent document should clearly state that the decision not to participate or to withdraw participation will not have any consequences (e.g. will not affect course grades, recommendations, access to courses or educational opportunities in the future, consideration for bonus, promotion, work evaluations).Research Subject PoolsA subject pool is a research resource used by some clinics, departments, and colleges as a registry of individuals who are interested in participating in research and agree to be contacted for potential participation in a study. These volunteers are utilized in studies for that clinic, college, or department. The IRB reviews all research requesting “pool” participation.Student subject pools serve to not only provide researchers a pool from which to recruit primarily student subjects for their studies, but also serve to familiarize students with the research process as subjects and researchers. Student participation in subject pool research must be completely voluntary. While course credit can be offered for participating, students cannot be penalized or “docked points” for not appearing for a scheduled research appointment. Departments may provide students with incentives to participate in the subject pool; however, reimbursement for participation must not jeopardize subject confidentiality or anonymity. In addition, pools offering extra credit to participating students must provide alternative opportunities to earn the same extra credit for those not wishing to participate in the research. Alternatives to the research subjects should require an equivalent amount of time and effort to complete for extra credit. Subject pools including subjects under eighteen (18) years of age are required to obtain parental permission prior to their involvement in research h unless those individuals are emancipated. Subject pool requirements and procedures vary by department so it is best to consult with your individual departments for specific guidelines and additional requirements.Recruitment of the Research Team and/or Family Members to Participate in ResearchThe enrollment of spouses, domestic partners, dependents, parents, siblings, grandparents, or research team members presents the perception, whether real or not, of research bias and coercion and is not allowed by the IRB. These individuals can participate in research conducted by the Institution but not in a study in which they are on the study team or an immediate family member of a study team member. The IRB may consider exceptions to this policy in certain extenuating circumstances. Contact an IRB manager before enrolling one of these individuals. AdvertisementsAdvertisements include printed material and electronic material (e.g. social media posts) that are intended to be seen or audio material that is intended to be heard by prospective research subjects to solicit and induce their participation in a study. Direct advertising includes, but is not necessarily limited to, newspaper, radio, TV, bulletin boards, posters, and flyers that are intended for prospective subjects. Direct advertising does not include communications intended to be seen or heard by health professionals, such as "dear doctor" letters and doctor-to-doctor letters (even when soliciting for study subjects), news stories, or information publicity intended for other audiences. Investigators are responsible for developing advertisement(s) in a non-biased manner without overemphasis of the font size, compensation, or any other items that would unduly influence subjects to participate in the research. Investigators must obtain any necessary approval(s) from sites where the advertisements will be placed (e.g. public transportation, businesses, and schools).Advertisements should use lay terms and must include the following information:The words “Research” or “Research Study;”The name of the institution conducting the research & the USF or other appropriate logo; The name and contact information of the Investigator conducting the research;The condition under study including the purpose of the research; Basic criteria used to determine eligibility; The IRB study number;A brief list of potential benefits to participation (note that compensation for participation is not a benefit to participate in research); Time commitment for participation; and Compensation or reimbursement (if applicable. Note: the amount should not be overemphasized with bold or enlarged print or other means of emphasis). Advertisements must not contain:Exculpatory language where the subjects would be required to give up some of their rights;A promise for a favorable outcome or benefits;Promotion of emphasis that subjects will be receiving medical treatment at no cost (free medical treatment) since the reality is that they will not be charged to participate in a research project;Explicit or implicit claims of equivalency or superiority to other standards of treatments or safety and efficacy;Wording that the study involves “new treatment,” “new medication,” or “new drug” without an explanation that the treatment is investigational; andClaims, explicitly or implicitly, about the drug, biologic or device under investigation that are inconsistent with FDA labeling.The IRB must review the final copy of printed advertisements to evaluate the relative size of font type used and other visual effects and must review the script of the final audio or video taped advertisements. Advertisement text for television and/or radio broadcasting may be submitted for review and approval prior to the final taping. Investigators should specify in their protocol all advertising formats that are anticipated. Once a study is approved by the IRB, any changes to recruitment and advertising material must be submitted as an amendment and approved prior to use. Advertisements regarding clinical trials posted on the web (i.e. institutional website or ) do not require prior approval by the IRB as long as the information is limited to basic study details such as: The title; The purpose of the study; The protocol summary; Basic eligibility criteria;Study site location; and Contact information for further information. Investigators of clinical trials are responsible for registering on as required by federal regulation. For additional information on registering studies on , please see the guidance document on the IRB website. How do I document consent?Use the consent approved by the IRB. Complete all items in the signature block, including dates.The following are the requirements for consent documents:The subject or legally authorized representative (LAR) signs and dates the consent document. LAR is sometimes known as a proxy. In accordance with Florida Statute 765.401(1), healthcare decisions may be made for the patient by certain individuals in order of priority. An LAR cannot be utilized unless it is an IRB approved process. The individual obtaining consent signs and dates the consent document after the subject signs.Whenever the IRB or the sponsor require a witness to the oral presentation, the witness signs and dates the consent document. The witness may be a family member or friend. The witness may not be a person involved in the design, conduct, or reporting of the research study. This process should be outlined in the protocol and IRB approved in advance. If the subject/representative cannot read, obtain an impartial witness to be present during the entire consent discussion to attest that the information in the consent form and any other information provided was accurately explained to, and apparently understood by, the subject/representative, and that consent was freely given. The witness may be a family member or friend. The witness may not be a person involved in the design, conduct, or reporting of the research study.A copy of the signed and dated consent document is to be provided to the subject unless otherwise instructed by the IRB. Reference policies HRP-090 - SOP - Informed Consent Process and HRP-091 - SOP: Written Documentation of Consent for more detailed information.How do I submit a modification and when is reconsent required?Complete the modification SmartForm in BullsIRB and attach all requested supplements, then have the SmartForm submitted by the Investigator by clicking the “Submit” activity. Maintain electronic copies of all information submitted to the IRB in case revisions are required. Please note that research must continue to be conducted without inclusion of the modification until IRB approval is received. The Investigator has the responsibility to ensure individuals participating in human subjects research are informed about new information that might affect the subject’s willingness to participate in the research study. Changes to the risks or benefits listed in the informed consent document should be submitted to the IRB as an amendment and approved by the USF IRB prior to reconsenting subjects. Subjects should be informed of the changes, asked if they wish to continue to participate, and signify their willingness by signing the amended consent document. Changes can also be documented in an addendum to the informed consent document should the study team choose to not amend the previous consent (this procedure may only be used if subject recruitment has ended). Minor administrative changes to the informed consent document do not require the reconsenting of subjects who are already participating. Investigators who have questions regarding whether or not subjects should reconsent should contact the USF IRB.What happens if I deviate from my protocol, HRPP policy, or federal regulations? Reporting of protocol deviations to the IRB is required regardless of the funding source, study sponsor, or whether the protocol involves an investigational or marketed drug, device, or biological product. All members of the research team are responsible for the appropriate reporting to the IRB and other applicable parties of deviations from the study protocol. The Investigator is ultimately responsible for ensuring the prompt reporting of protocol deviations that impact the rights, safety, and welfare of subjects and/or the integrity of the data. The Investigator is responsible for reviewing all protocol deviations to determine if they present a change in the risks and/or benefits to study subjects, and whether any changes in the informed consent document(s), the protocol, or other study-related documents are required. Failure to report protocol deviations in accordance with this policy may be considered serious and/or continuing non-compliance. Non-serious protocol deviations should be recorded on a protocol deviation log and submitted to the IRB at the time of continuing review or final report if a continuing review is required. Deviation logs will be reviewed by the fully convened IRB or by the IRB Chair or Vice Chair through expedited procedures as a part of the continuing review process.Serious protocol deviations are to be submitted to the IRB within five (5) business days of the study team’s knowledge of the event. Serious deviations should be submitted as RNI in BullsIRB. Reports should include a detailed description of the event and outcome, as well as a description of any changes to the protocol or other corrective actions taken to prevent recurrence. Failure to submit serious deviations within five (5) business days constitutes non-compliance with this policy. Researchers and their staff are expected to self-report all incidents of non-compliance regardless of whether the incident is minor, sporadic, serious or continuing. Allegations of non-compliance regarding human subjects research may be presented to any member of the IRB, Research Integrity and Compliance (RIC), the Office of Research & Innovation, or through Ethics Point (an anonymous hotline for reporting allegations or concerns).Non-compliance can be deemed by the IRB as serious or non-serious, continuing or non-continuing, and include, but is not limited to the following:Performing human subjects research without first obtaining IRB approval or an IRB declaration of exemption. Deviating from or violating the provisions of an IRB-approved protocol and/or procedures. Violation of institutional policies, state and local laws, federal laws, regulations and any conditions placed on the conduct of the research activity by the USF IRB.Permitting a protocol’s IRB approval to expire without stopping all research-related activities and/or submitting a Final Report to the IRB. Failure to obtain and document informed consent of research subjects unless appropriate waiver has been approved. The types of non-compliance that can be reported via the continuing review application: lapse in IRB approval, over-enrollment, and use of an unstamped but otherwise approved consent document.Investigators and their study teams are expected to comply with all ethical standards, institutional policies, state and local laws, federal laws, regulations, and any conditions placed on the conduct of the research by the IRB. All reports or allegations of non-compliance will be investigated and addressed by the USF Human Research Protection Program (HRPP), the IRB Chairperson(s), the Institutional Official (IO), or the IO’s designee.In order to comply with 45 CFR 46.103(b)(5)(i), 21 CFR 56.108(b)(2) and 38 CFR 16.113 (as applicable), the USF HRPP will promptly report to the Office for Human Research Protection (OHRP), the US Food and Drug Administration (FDA) and the Veterans Affairs (VA) the necessary information that describes the serious and/or continuing non-compliance affecting human subjects research. How do I submit continuing review?Complete the continuing review SmartForm in BullsIRB. Attach a brief summary of research progress in section seven (7) of the SmartForm in addition to any other applicable supplemental documents. If there have been any protocol deviations or local serious adverse events (SAEs) since the last IRB review, upload a cumulative deviation and/or SAE log in section seven (7) of the SmartForm. Within forty-five (45) days of study expiration, submit the SmartForm by clicking the “Submit” activity. Maintain electronic copies of all information submitted to the IRB in case revisions are required. Before submitting the research for continuing review, you must:Determine whether any member of the research staff has a new financial interest related to the research. A “yes” or “no” answer is sufficient. See Question #5 for additional information. As a courtesy, the USF IRB sends reminders of continuing review to study teams 60, 45, and 30 days prior to study expiration date. However, it is ultimately the Investigator’s responsibility to complete and submit to the IRB an application for continuing review or study closure prior to the annual renewal date. If the IRB has determined that an expedited study does not require submission of an annual continuing review, the Investigator will be asked to use the “Confirm Ongoing Research” activity in BullsIRB on an annual basis. This activity will be made available within thirty (30) days of the study’s anniversary date. If the continuing review involves modifications to previously approved research, submit those modifications as a combined modification and continuing review.If the Investigator does not submit a continuing review or request study closure when required to do so, or if approval has not been granted prior to the expiration of the current IRB approval, the approval will expire. All research activities including enrollment of new subjects and continuation of research interventions or interactions with currently enrolled subjects must stop immediately.If a continuing review is approved pending recertification of a study team member’s human subjects protections (HSP) education, the recertification must be provided to the IRB within fifteen (15) business days of the previous study expiration date or the study will lapse in approval. If the study lapses in approval, a new IRB application must be submitted to continue the research. If the approval of human subjects research expires, all human subjects research procedures related to the protocol under review must cease, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection or analysis of private identifiable information. Continuing human subjects research procedures is a violation of IRB policy. If current subjects will be harmed by stopping human subjects research procedures that are available outside of the human subjects research context, provide these on a clinical basis as needed to protect current subjects. If current subjects will be harmed by stopping human subjects research procedures that are not available outside of the human subjects research context, immediately contact the IRB Chair and provide a de-identified list of the currently enrolled subjects and why they will be harmed by stopping human subjects research procedures.How do I close out a study?Complete the continuing review SmartForm in BullsIRB. Attach a brief summary of research progress in section seven (7) of the SmartForm in addition to any other applicable supplemental documents. When the research is complete or within forty-five (45) days of study expiration, submit the SmartForm by clicking the “Submit” activity. You will indicate that the research has concluded in the submission by selecting the specific research milestones. Maintain electronic copies of all information submitted to the IRB in case revisions are required.How long do I keep records?Maintain your human subjects research records, including the original signed and dated consent documents, for at least five (5) years after completion of the research. Maintain signed and dated HIPAA authorizations and consent documents that include HIPAA authorizations for at least six (6) years after completion of the research. Research data generated as part of USF research is owned by the University. Original source documents, including original signed consent documents and identifiable data, must remain at the University for the duration of the applicable record retention period. A researcher may leave the University with de-identified data/documents, but never original documents.If your human subjects research is sponsored, contact the sponsor before disposing of human subjects research records. See also Appendix A-2 item 2(d)(iii) for FDA-regulated record retention requirements and Appendix A-3 item 8(e) for Clinical Trials following GCP requirements. What are my obligations to keep records and data private?All human subjects research reviewed by the USF IRB, or a USF-relied upon IRB, must have adequate provisions to protect the privacy of subjects and the confidentiality of data in accordance with the applicable federal regulations, state and local laws, and Institutional policies and procedures as they relate to research. Investigators are responsible for ensuring the research is conducted in a manner consistent with the ethical principles outlined in the Belmont Report, the federal regulations, state and local laws, and USF HRPP policies and procedures. Investigators are responsible for outlining in the protocol the information to be collected as part of the research and the measures that will be taken to protect the confidentiality of the data while the research is being conducted as well as when it is complete. Investigators must store hard copy data (including original copies of the consent documents) and electronic data in a secure location. Storing data at a private residence is not permitted. Investigators seeking to store identifiable data on the cloud must either use or obtain approval from USF Information Technology to utilize another cloud platform. Study teams seeking to store Protected Health Information (PHI) or Sensitive Personally Identifiable Information (SPII) on must, prior to uploading such data into , notify USF Information Technology. The notice must include the name of the Investigator (folder owner), study title, data to be stored in and a list of approved study team members. Federal officials have the right to inspect research records, including informed consent documents and individual medical records, to ascertain compliance with the regulations. The FDA requires that information regarding this authority be included in the informed consent document for all research that it regulates. Identifiable information obtained by federal officials during such inspections is subject to both the privacy provisions and the disclosure provisions of the Privacy Act of 1974.What if I need to use an unapproved drug, biologic, or device for expanded access, compassionate use, or Humanitarian Use?Unapproved drugs, biologics, and devices can be used for expanded access, compassionate use, or Humanitarian Use with prospective IRB review and approval. To obtain IRB review and approval, a new study submission must be submitted in BullsIRB. Expanded Access of Drugs and BiologicsExpanded access is the use of investigational new drug products outside of clinical trials for the sole purpose of treating a patient or patients with serious or immediately life-threatening diseases or conditions when there are no comparable or satisfactory alternative treatment options. Types of expanded access include single patient IND, intermediate size patient population, and large patient populations. While expanded access is not considered a clinical investigation, prospective FDA submission and IRB review are required, and informed consent must be obtained. If the intended subject does not meet the criteria of an existing study protocol, or if an approved study protocol does not exist, the usual procedure is to contact the manufacturer and determine if they are willing to provide the drug or biologic. If the manufacturer agrees to provide the drug, the physician should submit an IND to the appropriate review division. The party who submits a request to open an expanded access IND application and receives FDA’s authorization to use the investigational product is considered the sponsor of the IND application.When considering an IND application for expanded access to an investigational product with the purpose of treating a patient or a group of patients, physicians and investigators should recognize that such applications would be suitable when all of the following criteria apply: Patient(s) have a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition; The potential patient benefit justifies the potential risks of the treatment and the potential risks are not unreasonable in the context of the disease or condition to be treated; andProviding the investigational drug for the requested use will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the product. For non-emergent single patient INDs, an IND application for individual patient use of an investigational drug must be received by the FDA before shipment of and treatment with the drug may begin. The FDA allows investigators to request, on FDA’s Form 3926, a waiver of the requirement for review and approval of single patient IND applications at a convened meeting. If such waiver is requested and granted by the FDA, expanded access applications for single patient INDs may be reviewed by the IRB Chair via expedited procedures. If an additional patient can benefit from the same treatment, a separate IND application must be submitted to the FDA. Once the FDA acknowledges the IND for the additional patient, the Investigator must submit an amendment to the IRB to increase the number of subjects enrolled under the existing application and upload the FDA IND passionate Use of DevicesSee HRP-325 – WORKSHEET -Device Compassionate Use for additional information. This provision allows access for patients who do not meet the requirements for participation in the clinical investigation but for whom the treating physician believes the device may provide a benefit in treating or diagnosing their disease or condition. The condition must be serious and there must be no available, generally acceptable alternatives for treatment. This provision is typically approved for single patients, but may be approved to treat a small group. Prior FDA approval is needed before compassionate use occurs. In order to obtain FDA approval, the sponsor should submit an IDE supplement requesting approval for a protocol deviation. The physician should not treat the patient (or patients) identified in the supplement until FDA and the IRB both approve the use of the device under the proposed circumstances. Compassionate use of devices require prospective IRB review and approval.Humanitarian Use Devices (HUDs)See HRP-323 - WORKSHEET - Criteria for Approval HUD for additional information. For a HUD to be used to diagnose or treat an illness/impairment, a Humanitarian Device Exemption (HDE) must be issued by the FDA. The IRB will not grant approval until it has ensured the HDE approval has been granted. The device’s labeling must state that the device is a HUD and that, although the device is authorized by Federal Law, the effectiveness of the device for the specific indication has not been proven or demonstrated. Complete the New Study SmartForm in the BullsIRB system and attach all requested supplements, have the SmartForm submitted by the PI by clicking the “Submit” activity. Maintain electronic copies of all information submitted to the IRB in case revisions are required. Before submitting the application for initial review, you must:Obtain the financial interest status (“yes” or “no”) of each individual involved in the clinical care of the patient receiving the HUD.Obtain the agreement of each individual involved in the clinical care of the patient receiving the HUD to his/her role.When a HUD is being used in non-research clinical care, the IRB encourages physicians to obtain prospective and documented informed consent from a patient prior to the use of a HUD, when feasible. This document must not use the term “research” to refer to the activities associated with the use of the device. If informed consent cannot be obtained, information regarding the labeling of the device (i.e. patient information packet), which incorporates information on the device may be used as an alternative. This information must be reviewed in detail with the patient. When the use of a HUD is for diagnosis or treatment, and not associated with research or data collection, HIPAA regulations for research do not apply as the use of the HUD is part of Treatment, Payment or Operations (TPO).When an investigator seeks to collect safety and effectiveness data about the device, if the use is within the approved labeling, no IDE is needed; however, IRB approval is required and informed consent must be obtained since the use constitutes research. FDA considers the research to be exempt from the requirement for an IDE as long as the HUD is used in accordance with its approved indication(s). If the Investigator plans to collect data for a new use of the device (a different indication), then the IDE regulations must be followed. If the device is a significant risk device, an FDA approved IDE is required (21 CFR 812.1, 812.20). HUDs being utilized in clinical investigations require prospective IRB approval, and informed consent and HIPAA authorization must be obtained.Whenever an Investigator receives or otherwise becomes aware of information from any source that reasonably suggests an HUD has or may have caused or contributed to the death or serious injury of a patient, or has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur, the Investigator must report such findings to the FDA and the IRB promptly. Serious injury means an injury or illness that (1) is life-threatening, (2) results in permanent impairment of a body function or permanent damage to a body structure, or (3) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure (21 CFR 803.3). This reporting is in addition to, not a substitute for, FDA and/or manufacturer reporting requirements in accordance with 21 CFR 803.30. Additionally, the Investigator must promptly report any FDA action(s) regarding the HUD to the USF IRB.What if I need to use an unapproved drug, biologic, or device and there is no time for IRB review?See HRP-322 - WORKSHEET - Emergency Use for the regulatory criteria allowing such a use and make sure these are followed. Complete HRP-200 - FORM - Emergency Use of a Test Article and use HRP-506 - Emergency Use or Compassionate Use Consent to prepare your consent document. The IRB requires notification prior to the emergency use of a drug, biologic or device unless the determination is made after business hours. You will need to submit a report of the use to the IRB within five (5) business days of the use by sending the completed HRP-200 - FORM - Emergency Use of a Test Article to RSCH-IRB@usf.edu. The report should also include a copy of the Investigator’s Brochure or device manual if available, and either the consent template that will be used or a redacted copy of the signed informed consent form. Under very limited circumstances, the requirements for informed consent may be waived in an emergency situation. For additional information regarding notification to the IRB of emergency use of test articles, please contact 813-974-5638. If you fail to submit the report within five (5) business days, you will be in non-compliance. Emergency use of an unapproved drug or biologic in a life-threatening situation without prior IRB review is “research” as defined by FDA, the individual getting the test article is a “subject” as defined by FDA, and therefore is governed by FDA regulations for IRB review and informed consent. Emergency use of an unapproved device without prior IRB review is not “research” as defined by FDA and the individual getting the test article is not a “subject” as defined by FDA. However, FDA guidance recommends following similar rules as for emergency use of an unapproved drug or biologic.Note: The IRB does not allow planned emergency research.What if I want a non-affiliated volunteer on my study team?Persons who do not have a current USF affiliation may be eligible to be added to an IRB-approved study if a volunteer appointment is obtained from USF Human Resources. Volunteers who will be engaged in conducting human subjects research are required to undergo a background check. The background check level will be determined by the nature of the research and the individual’s proposed role in the research. Individuals who will have access to Personally Identifiable Information (PII) or who will interact with study subjects who are not members of vulnerable populations will be required to undergo a Level I background check. Individuals who will have access to Sensitive Personally Identifiable Information (SPII), PHI or who will interact with vulnerable populations including, but not limited to, children or individuals with disabilities, must undergo a Level II background check. To obtain a volunteer appointment for an individual who wants to be engaged in conducting human subjects research, the Investigator of a study is responsible for the following:Completing Human Resource’s Volunteer Appointment form and submitting it to their college/department HR administrator. On the Volunteer Appointment form, the Investigator must specify that the individual will be engaged in USF human subjects research and provide a brief description of the study(ies) the individual will be engaged in and describe the individual’s proposed role. oIn regards to roles, the Investigator must specify whether the individual will have access to PII, PHI or Sensitive Identifiable Information. Additionally, the Investigator must indicate whether, via conducting the research, the individual will be interacting with vulnerable populations (e.g. children, individuals with disabilities, etc.). oThe Investigator must also specify the level of background check requested, consistent with this policy. Ensuring that all volunteers are qualified by training and experience for their research roles, including knowledge of applicable laws, regulations, codes and guidance, relevant professional standards, and USF HRPP policies regarding the protection of research subjects. Ensuring that all volunteers complete any USF-required training prior to engaging in the research (e.g. if the volunteer will have access to PHI, ensuring that the volunteer completes HIPAA training).Submitting amendments to and obtaining approval from the IRB to add volunteers to a study team, before the volunteers engage in conducting human subjects research. Ensuring that all volunteers engaged in conducting human subjects research have current, active volunteer appointments. This includes submitting amendments to remove individuals whose volunteer appointments have expired from the study team (per USF HR policies, volunteer appointments expire at the end of each calendar year). Individuals requesting a volunteer appointment are responsible for the following:Submitting a request for a BullsIRB account, once the background check has been completed and the volunteer appointment has been approved by HR. The signed Volunteer Appointment Form and documentation of background check completion will be required before an ARC account will be set up. Indicating on the volunteer’s CV or resume, which is required in order to obtain a BullsIRB account, the length of the proposed volunteer appointment and the level of the background check that was completed. Submitting approved volunteer re-appointment paperwork to the ARC Help Desk via RSCH-ARC@usf.edu, when a previous volunteer appointment expires. How do I get additional information and answers to questions?This document and the policies and procedures for the Human Research Protection Program are available on the IRB website at you have any questions or concerns, about the Human Research Protection Program, contact the IRB Office at:University of South Florida Institutional Review Board3702 Spectrum Boulevard, Suite 165Tampa FL 33612 (813) 974-5638 RSCH-IRB@usf.edu If you have questions, concerns, complaints, allegations of undue influence, allegations or findings of non-compliance, or input regarding the Human Research Protection Program that cannot be addressed by contacting the IRB Office, follow the directions in the HRP-101 - HUMAN RESEARCH PROTECTION PROGRAM PLAN under “Reporting and Management of Concerns.”How can I make an anonymous report about suspected research misconduct? Concerns, complaints, or allegations regarding the conduct of human subjects research, the actions, policies, or procedures of the IRB members, IRB administrators, or IRB staff must be appropriately investigated and handled in a consistent and timely manner.IRB members, staff, faculty, study teams, students, research subjects, or any other person who has a concern or complaint or feels they have been subjected to or witnessed coercion or undue influence can contact Research Integrity and Compliance (RIC) at:Research Integrity and Compliance3702 Spectrum Blvd., Suite 165Tampa, FL 33620Phone: (813) 974-5638Fax: (813) 974-7091Website: Reports can be made to any member of the IRB, RIC, the Office of Research & Innovation, or anonymously through EthicsPoint. These concerns/complaints are accepted in any format including verbal, written, or electronic. Reports of concerns, complaints, or allegations of coercion, undue influence, research misconduct or non-compliance are thoroughly investigated. If necessary, corrective action is taken to correct the situation and/or protect subjects in research. The Organizational Official (OO) or designee is ultimately responsible for ensuring that all concerns, complaints, and allegations have been addressed appropriately. The person being notified of the concern/complaint forwards it to the highest level administrator within the HRPP or the Office of Research & Innovation as is necessary to receive appropriate attention and actions. Allegations that include issues that appear to constitute research misconduct will be reported to the Research Integrity Officer (RIO) and handled pursuant to the process outlined in USF Policy 0-301. There may be situations in which both HRPP policies and USF Policy 0-301 apply. In such cases, both policies will be followed. AppendicesAppendix A-1 Additional Requirements for DHHS-Regulated ResearchWhen a subject decides to withdraw from a clinical trial, the Investigator conducting the clinical trial should ask the subject to clarify whether the subject wishes to withdraw from all components of the trial or only from the primary interventional component of the trial. If the latter, research activities involving other components of the clinical trial, such as follow-up data collection activities, for which the subject previously gave consent may continue. The Investigator should explain to the subject who wishes to withdraw the importance of obtaining follow-up safety data about the subject.Investigators are allowed to retain and analyze already collected data relating to any subject who chooses to withdraw from a research study or whose participation is terminated by an investigator without regard to the subject’s consent, provided such analysis falls within the scope of the analysis described in the IRB-approved protocol. This is the case even if that data includes identifiable private information about the subject.For research not subject to regulation and review by FDA, investigators, in consultation with the funding agency, can choose to honor a research subject’s request that the Investigator destroy the subject’s data or that the Investigator exclude the subject’s data from any analysis.When seeking the informed consent of subjects, investigators should explain whether already collected data about the subjects will be retained and analyzed even if the subjects choose to withdraw from the research.For federally-funded research involving genomic testing, see HRP-064 – SOP - NIH GDS Institutional Certification and HRP-332 – WORKSHEET - NIH GDS Institutional Certification for additional requirements and guidance, including information about dbGaP and GWAS.Appendix A-2 Additional Requirements for FDA-Regulated ResearchInvestigators are responsible for determining whether research in which they are engaged requires an IND or IDE and, if so, for securing the necessary approvals.The regulations may permit a sponsor to charge for an investigational drug, biologic, or device.Investigator-sponsors must comply with all applicable FDA regulations. For additional information, see HRP-306 - WORKSHEET - Drugs and Biologics ()” and HRP-307 - WORKSHEET – Devices.See Appendix A-3 item for clinical trial registration and results reporting (). For FDA-regulated research involving investigational drugs:Investigators must abide by FDA restrictions on promotion of investigational drugs:An investigator, or any person acting on behalf of an investigator, must not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug.This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution.An investigator must not commercially distribute or test market an investigational new drug.Follow FDA requirements for general responsibilities of investigatorsAn investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation.An investigator must, in accordance with the provisions of 21 CFR §50, obtain the informed consent of each human subject to whom the drug is administered, except as provided in 21 CFR §50.23 or §50.24 of this chapter.Additional specific responsibilities of clinical investigators are set forth in this part and in 21 CFR §50 and 21 CFR §56.Follow FDA requirements for control of the investigational drugAn investigator must administer the drug only to subjects under the Investigator's personal supervision or under the supervision of a sub-investigator responsible to the Investigator.The Investigator must not supply the investigational drug to any person not authorized under this part to receive it.Follow FDA requirements for investigator recordkeeping and record retentionDisposition of drug:An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects.If the investigation is terminated, suspended, discontinued, or completed, the Investigator must return the unused supplies of the drug to the sponsor, or otherwise provide for disposition of the unused supplies of the drug under 21 CFR §312.59.Case histories.An investigator is required to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation.Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual's hospital charts, and the nurses' notes. The case history for each individual must document that informed consent was obtained prior to participation in the study.Record retention: An investigator must retain required records for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified.Follow FDA requirements for investigator reportsProgress reports: The Investigator must furnish all reports to the sponsor of the drug who is responsible for collecting and evaluating the results obtained.Safety reports: An investigator must promptly report to the sponsor any adverse effect that may reasonably be regarded as caused by, or probably caused by, the drug. If the adverse effect is alarming, the Investigator must report the adverse effect immediately.Final report: An investigator must provide the sponsor with an adequate report shortly after completion of the Investigator's participation in the investigation.Financial disclosure reports:The clinical investigator must provide the sponsor with sufficient accurate financial information to allow an applicant to submit complete and accurate certification or disclosure statements as required under 21 CFR §54.The clinical investigator must promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following the completion of the study.Follow FDA requirements for assurance of IRB reviewAn investigator must assure that an IRB that complies with the requirements set forth in 21 CFR §56 will be responsible for the initial and continuing review and approval of the proposed clinical study.The Investigator must also assure that he or she will promptly report to the IRB all changes in the research activity and all unanticipated problems involving risk to human subjects or others, and that he or she will not make any changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects.Follow FDA requirements for inspection of investigator's records and reportsAn investigator must upon request from any properly authorized officer or employee of FDA, at reasonable times, permit such officer or employee to have access to, and copy and verify any records or reports made by the Investigator pursuant to 312.62.The Investigator is not required to divulge subject names unless the records of particular individuals require a more detailed study of the cases, or unless there is reason to believe that the records do not represent actual case studies, or do not represent actual results obtained.Follow FDA requirements for handling of controlled substancesIf the investigational drug is subject to the Controlled Substances Act, the Investigator must take adequate precautions, including storage of the investigational drug in a securely locked, substantially constructed cabinet, or other securely locked, substantially constructed enclosure, access to which is limited, to prevent theft or diversion of the substance into illegal channels of distribution.For FDA-regulated research involving investigational devices:General responsibilities of investigators.An investigator is responsible for ensuring that an investigation is conducted according to the signed agreement, the investigational plan and applicable FDA regulations, for protecting the rights, safety, and welfare of subjects under the Investigator's care, and for the control of devices under investigation. An investigator also is responsible for ensuring that informed consent is obtained in accordance with 21 CFR §50.The significant risk (SR)/non-significant risk (NSR) determination for devices is made initially by the sponsor or investigator-sponsor.Specific responsibilities of investigatorsAwaiting approval: An investigator may determine whether potential subjects would be interested in participating in an investigation, but must not request the written informed consent of any subject to participate, and must not allow any subject to participate before obtaining IRB and FDA pliance: An investigator must conduct an investigation in accordance with the signed agreement with the sponsor, the investigational plan, and other applicable FDA regulations, and any conditions of approval imposed by an IRB or FDA.Supervising device use: An investigator must permit an investigational device to be used only with subjects under the Investigator's supervision. An investigator must not supply an investigational device to any person not authorized to receive it.Financial disclosure:A clinical investigator must disclose to the sponsor sufficient accurate financial information to allow the applicant to submit complete and accurate certification or disclosure statements required under 21 CFR §54.The Investigator must promptly update this information if any relevant changes occur during the course of the investigation and for one (1) year following completion of the study.Disposing of device: Upon completion or termination of a clinical investigation or the Investigator's part of an investigation, or at the sponsor's request, an investigator must return to the sponsor any remaining supply of the device or otherwise dispose of the device as the sponsor directs.Maintain the following accurate, complete, and current records relating to the Investigator's participation in an investigation:All correspondence with another investigator, an IRB, the sponsor, a monitor, or FDA, including required reports.Records of receipt, use or disposition of a device that relate to:The type and quantity of the device, the dates of its receipt, and the batch number or code mark.The names of all persons who received, used, or disposed of each device.Why and how many units of the device have been returned to the sponsor, repaired, or otherwise disposed of.Records of each subject's case history and exposure to the device. Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual's hospital charts, and the nurses' notes. Such records must include:Documents evidencing informed consent and, for any use of a device by the Investigator without informed consent, any written concurrence of a licensed physician and a brief description of the circumstances justifying the failure to obtain informed consent.Documentation that informed consent was obtained prior to participation in the study.All relevant observations, including records concerning adverse device effects (whether anticipated or unanticipated), information and data on the condition of each subject upon entering, and during the course of, the investigation, including information about relevant previous medical history and the results of all diagnostic tests.A record of the exposure of each subject to the investigational device, including the date and time of each use, and any other therapy.The protocol, with documents showing the dates of and reasons for each deviation from the protocol.Any other records that FDA requires to be maintained by regulation or by specific requirement for a category of investigations or a particular investigation.InspectionsEntry and inspection: A sponsor or an investigator who has authority to grant access must permit authorized FDA employees, at reasonable times and in a reasonable manner, to enter and inspect any establishment where devices are held (including any establishment where devices are manufactured, processed, packed, installed, used, or implanted or where records of results from use of devices are kept).Records inspection: A sponsor, IRB, or investigator, or any other person acting on behalf of such a person with respect to an investigation, must permit authorized FDA employees, at reasonable times and in a reasonable manner, to inspect and copy all records relating to an investigation.Records identifying subjects: An investigator must permit authorized FDA employees to inspect and copy records that identify subjects, upon notice that FDA has reason to suspect that adequate informed consent was not obtained, or that reports required to be submitted by the Investigator to the sponsor or IRB have not been submitted or are incomplete, inaccurate, false, or misleading.Prepare and submit the following complete, accurate, and timely reportsUnanticipated adverse device effects. An investigator must submit to the sponsor and to the Reviewing IRB a report of any unanticipated adverse device effect occurring during an investigation as soon as possible, but in no event later than ten (10) working days after the Investigator first learns of the effect.Withdrawal of IRB approval. An investigator must report to the sponsor, within five (5) working days, a withdrawal of approval by the Reviewing IRB of the Investigator's part of an investigation.Progress. An investigator must submit progress reports on the investigation to the sponsor, the monitor, and the Reviewing IRB at regular intervals, but in no event less often than yearly.Deviations from the investigational plan:An investigator must notify the sponsor and the Reviewing IRB of any deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency.Such notice must be given as soon as possible, but in no event later than five (5) working days after the emergency occurred.Except in such an emergency, prior approval by the sponsor is required for changes in or deviations from a plan, and if these changes or deviations may affect the scientific soundness of the plan or the rights, safety, or welfare of human subjects, FDA and IRB also is rmed consent. If an investigator uses a device without obtaining informed consent, the Investigator must report such use to the sponsor and the Reviewing IRB within five (5) working days after the use occurs.Final report. An investigator must, within three (3) months after termination or completion of the investigation or the Investigator's part of the investigation, submit a final report to the sponsor and the Reviewing IRB.Other. An investigator must, upon request by a Reviewing IRB or FDA, provide accurate, complete, and current information about any aspect of the investigation.When a subject withdraws from a study:The data collected on the subject to the point of withdrawal remains part of the study database and may not be removed.An investigator may ask a subject who is withdrawing whether the subject wishes to provide continued follow-up and further data collection subsequent to their withdrawal from the interventional portion of the study. Under this circumstance, the discussion with the subject would distinguish between study-related interventions and continued follow-up of associated clinical outcome information, such as medical course or laboratory results obtained through non-invasive chart review, and address the maintenance of privacy and confidentiality of the subject’s information.If a subject withdraws from the interventional portion of the study, but agrees to continued follow-up of associated clinical outcome information as described in the previous bullet, the Investigator must obtain the subject’s informed consent for this limited participation in the study (assuming such a situation was not described in the original informed consent form). IRB approval of informed consent documents is required.If a subject withdraws from the interventional portion of a study and does not consent to continued follow-up of associated clinical outcome information, the Investigator must not access for purposes related to the study the subject’s medical record or other confidential records requiring the subject’s consent.An investigator may review study data related to the subject collected prior to the subject’s withdrawal from the study, and may consult public records, such as those establishing survival status.FDA Guidance on E6(R2) GCP: Appendix A-3 Additional Requirements for Clinical Trials (ICH-GCP)Investigator's Qualifications and AgreementsThe clinical trial should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with good clinical practice and the applicable regulatory requirements.The Investigator should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirements, and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB, and/or the regulatory authorities.The Investigator should be thoroughly familiar with the appropriate use of the investigational product, as described in the protocol, in the current Investigator's Brochure, in the product information and in other information sources provided by the sponsor.The Investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements.The Investigator/institution should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authorities.The Investigator should maintain a list of appropriately qualified persons to whom the Investigator has delegated significant trial-related duties.Adequate ResourcesThe Investigator should be able to demonstrate (e.g. based on retrospective data) a potential for recruiting the required number of suitable subjects within the agreed recruitment period.The Investigator should have sufficient time to properly conduct and complete the trial within the agreed trial period.The Investigator should have available an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely.The Investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product, and their trial-related duties and functions.Medical Care of Trial SubjectsA qualified physician (or dentist, when appropriate), who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical (or dental) decisions.During and following a subject's participation in a trial, the Investigator/institution should ensure that adequate medical care is provided to a subject for any adverse events, including clinically significant laboratory values, related to the trial. The Investigator/institution should inform a subject when medical care is needed for intercurrent illnesses of which the Investigator becomes aware.It is recommended that the Investigator inform the subject's primary physician about the subject's participation in the trial if the subject has a primary physician and if the subject agrees to the primary physician being informed.Although a subject is not obliged to give his/her reasons for withdrawing prematurely from a trial, the Investigator should make a reasonable effort to ascertain the reasons, while fully respecting the subject's munication with IRBBefore initiating a trial, the Investigator/institution should have written and dated approval opinion from the IRB for the trial protocol, written informed consent form, consent form updates, subject recruitment procedures (e.g. advertisements), and any other written information to be provided to subjects.As part of the Investigator’s/institution’s written application to the IRB, the Investigator/institution should provide the IRB with a current copy of the Investigator's Brochure. If the Investigator's Brochure is updated during the trial, the Investigator/institution should supply a copy of the updated Investigator’s Brochure to the IRB.During the trial the Investigator/institution should provide to the IRB all documents subject to pliance with ProtocolThe Investigator/institution should conduct the trial in compliance with the protocol agreed to by the sponsor and, if required, by the regulatory authorities and which was given approval opinion by the IRB. The Investigator/institution and the sponsor should sign the protocol, or an alternative contract, to confirm agreement.The Investigator should not implement any deviation from, or changes of the protocol without agreement by the sponsor and prior review and documented approval opinion from the IRB of an amendment, except where necessary to eliminate an immediate hazards to trial subjects, or when the changes involves only logistical or administrative aspects of the trial (e.g. change in monitors, change of telephone numbers).The Investigator, or person designated by the Investigator, should document and explain any deviation from the approved protocol.The Investigator may implement a deviation from, or a change of, the protocol to eliminate an immediate hazard to trial subjects without prior IRB approval opinion. As soon as possible, the implemented deviation or change, the reasons for it, and, if appropriate, the proposed protocol amendments should be submitted: a) to the IRB for review and approval opinion, b) to the sponsor for agreement and, if required, c) to the regulatory authorities.Investigational ProductResponsibility for investigational product accountability at the trial site rests with the Investigator/institution.Where allowed/required, the Investigator/institution may/should assign some or all of the Investigator’s/institution’s duties for investigational product accountability at the trial site to an appropriate pharmacist or another appropriate individual who is under the supervision of the Investigator/institution.The Investigator/institution and/or a pharmacist or other appropriate individual, who is designated by the Investigator/institution, should maintain records of the product's delivery to the trial site, the inventory at the site, the use by each subject, and the return to the sponsor or alternative disposition of unused product. These records should include dates, quantities, batch/serial numbers, expiration dates (if applicable), and the unique code numbers assigned to the investigational product and trial subjects. Investigators should maintain records that document adequately that the subjects were provided the doses specified by the protocol and reconcile all investigational product received from the sponsor.The investigational product should be stored as specified by the sponsor and in accordance with applicable regulatory requirements.The Investigator should ensure that the investigational product is used only in accordance with the approved protocol.The Investigator, or a person designated by the Investigator/institution, should explain the correct use of the investigational product to each subject and should check, at intervals appropriate for the trial, that each subject is following the instructions properly.Randomization Procedures and Unblinding: The Investigator should follow the trial's randomization procedures, if any, and should ensure that the code is broken only in accordance with the protocol. If the trial is blinded, the Investigator should promptly document and explain to the sponsor any premature unblinding (e.g. accidental unblinding, unblinding due to a serious adverse event) of the investigational rmed Consent of Trial SubjectsIn obtaining and documenting informed consent, the Investigator should comply with the applicable regulatory requirements, and should adhere to GCP and to the ethical principles that have their origin in the Declaration of Helsinki. Prior to the beginning of the trial, the Investigator should have the IRB's written approval opinion of the written informed consent form and any other written information to be provided to subjects.The written informed consent form and any other written information to be provided to subjects should be revised whenever important new information becomes available that may be relevant to the subject’s consent. Any revised written informed consent form, and written information should receive the IRB's approval opinion in advance of use. The subject or the subject’s legally acceptable representative should be informed in a timely manner if new information becomes available that may be relevant to the subject’s willingness to continue participation in the trial. The communication of this information should be documented.Neither the Investigator, nor the trial staff, should coerce or unduly influence a subject to participate or to continue to participate in a trial.None of the oral and written information concerning the trial, including the written informed consent form, should contain any language that causes the subject or the subject's legally acceptable representative to waive or to appear to waive any legal rights, or that releases or appears to release the Investigator, the institution, the sponsor, or their agents from liability for negligence.The Investigator, or a person designated by the Investigator, should fully inform the subject or, if the subject is unable to provide informed consent, the subject's legally acceptable representative, of all pertinent aspects of the trial including the written information and the approval opinion by the IRB.The language used in the oral and written information about the trial, including the written informed consent form, should be as non-technical as practical and should be understandable to the subject or the subject's legally acceptable representative and the impartial witness, where applicable.Before informed consent may be obtained, the Investigator, or a person designated by the Investigator, should provide the subject or the subject's legally acceptable representative ample time and opportunity to inquire about details of the trial and to decide whether or not to participate in the trial. All questions about the trial should be answered to the satisfaction of the subject or the subject's legally acceptable representative.Prior to a subject’s participation in the trial, the written informed consent form should be signed and personally dated by the subject or by the subject's legally acceptable representative, and by the person who conducted the informed consent discussion.If a subject is unable to read or if a legally acceptable representative is unable to read, an impartial witness should be present during the entire informed consent discussion. After the written informed consent form and any other written information to be provided to subjects, is read and explained to the subject or the subject’s legally acceptable representative, and after the subject or the subject’s legally acceptable representative has orally consented to the subject’s participation in the trial and, if capable of doing so, has signed and personally dated the informed consent form, the witness should sign and personally date the consent form. By signing the consent form, the witness attests that the information in the consent form and any other written information was accurately explained to, and apparently understood by, the subject or the subject's legally acceptable representative, and that informed consent was freely given by the subject or the subject’s legally acceptable representative.Both the informed consent discussion and the written informed consent form and any other written information to be provided to subjects should include explanations of the following:That the trial involves research.The purpose of the trial.The trial treatments and the probability for random assignment to each treatment.The trial procedures to be followed, including all invasive procedures.The subject's responsibilities.Those aspects of the trial that are experimental.The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or nursing infant.The reasonably expected benefits. When there is no intended clinical benefit to the subject, the subject should be made aware of this.The alternative procedures or courses of treatment that may be available to the subject, and their important potential benefits and risks.The compensation and/or treatment available to the subject in the event of trial related injury.The anticipated prorated payment, if any, to the subject for participating in the trial.The anticipated expenses, if any, to the subject for participating in the trial.That the subject's participation in the trial is voluntary and that the subject may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled.That the monitors, the auditors, the IRB, and the regulatory authorities will be granted direct access to the subject's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the subject or the subject's legally acceptable representative is authorizing such access.That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are published, the subject’s identity will remain confidential.That the subject or the subject's legally acceptable representative will be informed in a timely manner if information becomes available that may be relevant to the subject's willingness to continue participation in the trial.The persons to contact for further information regarding the trial and the rights of trial subjects, and whom to contact in the event of trial-related injury.The foreseeable circumstances and/or reasons under which the subject's participation in the trial may be terminated.The expected duration of the subject's participation in the trial.The approximate number of subjects involved in the trial.Prior to participation in the trial, the subject or the subject's legally acceptable representative should receive a copy of the signed and dated written informed consent form and any other written information provided to the subjects. During a subject’s participation in the trial, the subject or the subject’s legally acceptable representative should receive a copy of the signed and dated consent form updates and a copy of any amendments to the written information provided to subjects.When a clinical trial (therapeutic or non-therapeutic) includes subjects who can only be enrolled in the trial with the consent of the subject’s legally acceptable representative (e.g. minors, or patients with severe dementia), the subject should be informed about the trial to the extent compatible with the subject’s understanding and, if capable, the subject should sign and personally date the written informed consent.Except as described above, a non-therapeutic trial (i.e. a trial in which there is no anticipated direct clinical benefit to the subject), should be conducted in subjects who personally give consent and who sign and date the written informed consent form.Non-therapeutic trials may be conducted in subjects with consent of a legally acceptable representative provided the following conditions are fulfilled: a) The objectives of the trial cannot be met by means of a trial in subjects who can give informed consent personally. b) The foreseeable risks to the subjects are low. c) The negative impact on the subject’s well-being is minimized and low. d) The trial is not prohibited by law. e) The approval opinion of the IRB is expressly sought on the inclusion of such subjects, and the written approval opinion covers this aspect. Such trials, unless an exception is justified, should be conducted in patients having a disease or condition for which the investigational product is intended. Subjects in these trials should be particularly closely monitored and should be withdrawn if they appear to be unduly distressed.In emergency situations, when prior consent of the subject is not possible, the consent of the subject's legally acceptable representative, if present, should be requested. When prior consent of the subject is not possible, and the subject’s legally acceptable representative is not available, enrolment of the subject should require measures described in the protocol and/or elsewhere, with documented approval opinion by the IRB, to protect the rights, safety and well-being of the subject and to ensure compliance with applicable regulatory requirements. The subject or the subject's legally acceptable representative should be informed about the trial as soon as possible and consent to continue and other consent as appropriate should be requested.Records and ReportsThe Investigator should ensure the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the CRFs and in all required reports.Data reported on the CRF, that are derived from source documents, should be consistent with the source documents or the discrepancies should be explained.Any change or correction to a CRF should be dated, initialed, and explained (if necessary) and should not obscure the original entry (i.e. an audit trail should be maintained); this applies to both written and electronic changes or corrections. Sponsors should provide guidance to investigators and/or the Investigator’s designated representatives on making such corrections. Sponsors should have written procedures to assure that changes or corrections in CRFs made by sponsor's designated representatives are documented, are necessary, and are endorsed by the Investigator. The Investigator should retain records of the changes and corrections.The Investigator/institution should maintain the trial documents as specified in Essential Documents for the Conduct of a Clinical Trial and as required by the applicable regulatory requirements. The Investigator/institution should take measures to prevent accidental or premature destruction of these documents.Essential documents should be retained until at least two (2) years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least two (2) years have elapsed since the formal discontinuation of clinical development of the investigational product. These documents should be retained for a longer period however if required by the applicable regulatory requirements or by an agreement with the sponsor. It is the responsibility of the sponsor to inform the Investigator/institution as to when these documents no longer need to be retained.The financial aspects of the trial should be documented in an agreement between the sponsor and the Investigator/institution.Upon request of the monitor, auditor, IRB, or regulatory authority, the Investigator/institution should make available for direct access all requested trial-related records.Investigators of clinical trials are responsible for registering on as required by federal regulation. For additional information on registering studies on , please see the guidance document on the IRB website.Progress ReportsThe Investigator should submit written summaries of the trial status to the IRB annually, or more frequently, if requested by the IRB.The investigator should promptly provide written reports to the sponsor, the IRB and, where applicable, the institution on any changes significantly affecting the conduct of the trial, and/or increasing the risk to subjects.Safety ReportingAll serious adverse events (SAEs) should be reported immediately to the sponsor except for those SAEs that the protocol or other document (e.g. Investigator's Brochure) identifies as not needing immediate reporting. The immediate reports should be followed promptly by detailed, written reports. The immediate and follow-up reports should identify subjects by unique code numbers assigned to the trial subjects rather than by the subjects' names, personal identification numbers, and/or addresses. The Investigator must comply with the applicable regulatory requirements related to the reporting of unexpected SAEs to the regulatory authorities and the IRB. SAEs that are expected or unrelated are to be submitted during continuing review. Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations should be reported to the sponsor according to the reporting requirements and within the time periods specified by the sponsor in the protocol.For reported deaths, the Investigator should supply the sponsor and the IRB with any additional requested information (e.g. autopsy reports and terminal medical reports).Premature Termination or Suspension of a Trial If the trial is prematurely terminated or suspended for any reason, the Investigator/institution should promptly inform the trial subjects, should assure appropriate therapy and follow-up for the subjects, and, where required by the applicable regulatory requirements, should inform the regulatory authorities. In addition:If the Investigator terminates or suspends a trial without prior agreement of the sponsor, the Investigator should inform the institution where applicable, and the Investigator/institution should promptly inform the sponsor and the IRB, and should provide the sponsor and the IRB a detailed written explanation of the termination or suspension.If the sponsor terminates or suspends a trial, the Investigator should promptly inform the institution where applicable and the Investigator/institution should promptly inform the IRB and provide the IRB a detailed written explanation of the termination or suspension.If the IRB terminates or suspends its approval opinion of a trial, the Investigator should inform the institution where applicable and the Investigator/institution should promptly notify the sponsor and provide the sponsor with a detailed written explanation of the termination or suspension.Final Reports by Investigator: Upon completion of the trial, the Investigator, where applicable, should inform the institution; the Investigator/institution should provide the IRB with a summary of the trial’s outcome, and the regulatory authorities with any reports required.ICH Good Clinical Practice (GCP) Rev 2: Efficacy Guidelines to which all researchers should be aware: Registration requirementsAppendix A-4 Additional Requirements for Department of Defense (DOD) researchWhen appropriate, research protocols must be reviewed and approved by the IRB prior to the Department of Defense approval. Consult with the Department of Defense funding component to see whether this is a requirement.Civilian researchers attempting to access military volunteers should seek collaboration with a military researcher familiar with service-specific requirements.Employees of the Department of Defense (including temporary, part-time, and intermittent appointments) may not be able to legally accept payments to participate in research and should check with their supervisor before accepting such payments. Employees of the Department of Defense cannot be paid for conducting research while on active duty.Service members must follow their command policies regarding the requirement to obtain command permission to participate in research involving human subjects while on-duty or off-duty. Components of the Department of Defense might have stricter requirements for research-related injury than the DHHS regulations.There may be specific educational requirements or certification required.When assessing whether to support or collaborate with this institution for research involving human subjects, the Department of Defense may evaluate this institution’s education and training policies to ensure the personnel are qualified to perform the research.When research involves U.S. military personnel, policies and procedures require limitations on dual compensation:Prohibit an individual from receiving pay of compensation for research during duty hours.An individual may be compensated for research if the subject is involved in the research when not on duty.Federal employees while on duty and non-Federal persons may be compensated for blood draws for research up to $50 for each blood draw.Non-Federal persons may be compensated for research participating other than blood draws in a reasonable amount as approved by the IRB according to local prevailing rates and the nature of the research.When conducting multi-site research, a formal agreement between institutions is required to specify the roles and responsibilities of each party.Other specific requirements of the Department of Defense research be found in the “Additional Requirements for Department of Defense (DOD) Research” section in the IRB’s HRP-318 – WORKSHEET - Additional Federal Criteria.Appendix A-5 Additional Requirements for Department of Energy (DOE) ResearchResearch that involves one or more of the following is considered by DOE to be human subjects research and requires IRB review:Intentional modification of the human environmentStudy of human environments that use tracer chemicals, particles or other materials to characterize airflow.Study in occupied homes or offices that:Manipulate the environment to achieve research aims.Test new materials.Involve collecting information on occupants’ views of appliances, materials, or devices installed in their homes or their energy-saving behaviors through surveys and focus groups.You must complete and submit to the IRB the DOE “DOE Institutional Review Board Template for Reviewing Human Subjects Research Protocols that Utilize Personally Identifiable Information (PII)” if your research includes Personally Identifiable Information.You must report the following to the DOE human subjects research program manager:Any significant adverse events, unanticipated risks; and complaints about the research, with a description of any corrective actions taken or to be takenAny suspension or termination of IRB approval of researchAny significant non-compliance with HRPP procedures or other requirements.Events must be reported within 48 hours.Any compromise of personally identifiable information must be reported immediately.The time frame for “immediately” is defined as upon discovery.Requirements for human subject protections for classified research apply to all research conducted or supported by the DOE, including contracts, and including Human Terrain Mapping research.Requirements for human subject protections and their accompanying Contractor Requirements Documents (CRDs) apply to all research conducted at DOE institutions regardless of funding source, or by DOE employees/contractor personnel regardless of funding source or location conducted, and whether done domestically or in an international environment, and including Human Terrain Mapping research. DOE workers are considered vulnerable subjects and shall be afforded additional protections as determined by the IRB.Other specific requirements of the DOE research can be found in the “Additional Requirements for Department of Energy (DOE) Research” section in the IRB’s HRP-318 – WORKSHEET - Additional Federal Criteria.Appendix A-6 Additional Requirements for Department of Justice (DOJ) ResearchAdditional Requirements for DOJ Research conducted in the Federal Bureau of PrisonsImplementation of Bureau programmatic or operational initiatives made through pilot projects is not considered to be research.The project must not involve medical experimentation, cosmetic research, or pharmaceutical testing.The research design must be compatible with both the operation of prison facilities and protection of human subjects.Investigators must observe the rules of the institution or office in which the research is conducted.Any investigator who is a non-employee of the Bureau of Prisoners must sign a statement in which the Investigator agrees to adhere to the requirements of 28 CFR §512.The research must be reviewed and approved by the Bureau Research Review Board.Incentives cannot be offered to help persuade inmate subjects to participate. However, soft drinks and snacks to be consumed at the test setting may be offered. Reasonable accommodations such as nominal monetary recompense for time and effort may be offered to non-confined research subjects who are both: No longer in Bureau of Prisons custody. Participating in authorized research being conducted by Bureau employees or contractors.A non-employee of the Bureau may receive records in a form not individually identifiable when advance adequate written assurance that the record will be used solely as a statistical research or reporting record is provided to the agency.Except as noted in the consent statement to the subject, you must not provide research information that identifies a subject to any person without that subject’s prior written consent to release the information. For example, research information identifiable to a particular individual cannot be admitted as evidence or used for any purpose in any action, suit, or other judicial, administrative, or legislative proceeding without the written consent of the individual to whom the data pertain.Except for computerized data records maintained at an official DOJ site, records that contain non-disclosable information directly traceable to a specific person may not be stored in, or introduced into, an electronic retrieval system.If you are conducting a study of special interest to the Office of Research and Evaluation but the study is not a joint project involving Office of Research and Evaluation, you may be asked to provide Office of Research and Evaluation with the computerized research data, not identifiable to individual subjects, accompanied by detailed documentation. These arrangements must be negotiated prior to the beginning of the data collection phase of the project.Required elements of disclosure additionally include:Identification of the investigators.Anticipated uses of the results of the research.A statement that participation is completely voluntary and that the subject may withdraw consent and end participation in the project at any time without penalty or prejudice (the inmate will be returned to regular assignment or activity by staff as soon as practicable).A statement regarding the confidentiality of the research information and exceptions to any guarantees of confidentiality required by federal or state law. For example, an investigator may not guarantee confidentiality when the subject indicates intent to commit future criminal conduct or harm himself or herself or someone else, or, if the subject is an inmate, indicates intent to leave the facility without authorization.A statement that participation in the research project will have no effect on the inmate subject's release date or parole eligibility.You must have academic preparation or experience in the area of study of the proposed research.The IRB application must include a statement regarding assurances and certification required by federal regulations, if applicable.You must assume responsibility for actions of any person engaged to participate in the research project as an associate, assistant, or subcontractor.At least once a year, you must provide the Chief, Office of Research and Evaluation, with a report on the progress of the research.At least twelve (12) working days before any report of findings is to be released, you must distribute one copy of the report to each of the following: the chairperson of the Bureau Research Review Board, the regional director, and the warden of each institution that provided data or assistance.You must include an abstract in the report of findings.In any publication of results, you must acknowledge the Bureau's participation in the research project.You must expressly disclaim approval or endorsement of the published material as an expression of the policies or views of the Bureau.Prior to submitting for publication the results of a research project conducted under this subpart, You must provide two copies of the material, for informational purposes only, to the Chief, Office of Research and Evaluation, Central Office, Bureau of Prisons.Other specific requirements of the DOJ Research Conducted within the Federal Bureau of Prisons (BOP) can be found in the “Additional Requirements for Department of Justice (DOJ) Research Conducted within the Federal Bureau of Prisons (BOP)” section in the IRB’s HRP-318 – WORKSHEET - Additional Federal Criteria.Additional Requirements for DOJ Research Funded by the National Institute of JusticeThe project must have a privacy certificate approved by the National Institute of Justice Human Subjects Protection Officer.All investigators and research staff are required to sign employee confidentiality statements, which are maintained by the responsible investigator.The confidentiality statement on the consent document must state that confidentiality can only be broken if the subject reports immediate harm to subjects or others.Under a privacy certificate, investigators and research staff do not have to report child abuse unless the subject signs another consent document to allow child abuse reporting.A copy of all data must be de-identified and sent to the National Archive of Criminal Justice Data, including copies of the informed consent document, data collection instruments, surveys, or other relevant research materials.Other specific requirements of the DOJ Research Funded by the National Institute of Justice can be found in the “Additional Requirements for Department of Justice (DOJ) Research” section in the IRB’s HRP-318 - WORKSHEET - Additional Federal Criteria.Appendix A-7 Additional Requirements for Department of Education (ED) ResearchEach school at which the research is conducted must provide an assurance that they comply with the Family Educational Rights and Privacy Act (FERPA) and the Protection of Pupil Rights Amendment (PPRA). Please see HRP-331- WORKSHEET- FERPA Compliance. Provide a copy of all surveys and instructional material used in the research. Upon request parents of children involved in the research must be able to inspect these materials.The school in which the research is being conducted must have policies regarding the administration of physical examinations or screenings that the school may administer to students.Other specific requirements of the Department of Education (ED) Research can be found in the “Additional Requirements for Department of Education (ED) Research” section in the IRB’s HRP-318 – WORKSHEET - Additional Federal Criteria.Appendix A-8 Additional Requirements for Veterans Administration (VA) ResearchThe Investigator must follow this Institution’s procedures to ensure reporting in writing to the IRB within five (5) business days of becoming aware of Unanticipated Problems Involving Risks to Subjects or Others (local SAEs or serious problems that are unanticipated and related to the research), apparent serious or continuing non-compliance, suspension of IRB approval, or termination of IRB approval. Any Unanticipated Problem Involving Risks to Subjects or Others that is a local research death must be reported orally to the IRB immediately upon becoming aware of the information.The Investigator must give first priority to the protection of research subjects, uphold professional and ethical standards and practices, and adhere to all applicable VA and other federal requirements, including the local VA facility’s and this Institution’s policies and procedures, regarding the conduct of research and the protection of human subjects. The Investigator must hold a current VA appointment to conduct VA research.The responsibilities of the Investigator may be defined in the protocol or IRB application. Specifically, the Investigator’s responsibilities include, but are not limited toQualifications to Conduct Human Subjects Research. VA investigators must have the appropriate training, education, expertise, and credentials to conduct the research according to the research protocol.Investigators must ensure that all research staff are qualified (e.g. including but not limited to appropriate training, education, expertise, and credentials) to perform procedures assigned to them during the course of the study.Investigators and their staff conducting human subjects research must be credentialed and privileged as required by current local and VA requirements (see VHA Handbook 1100.19 and VHA Directive 2012-030, Credentialing of Health Care Professionals, or successor policy). Investigators and their research staff may only perform those activities in a research study for which they have the relevant credentials and privileges.Investigators must be identified on the IRB application and must provide credentials, conflict of interest statements or other documentation required by VA and local facility policies.VHA Program Office employees acting as investigators, regardless of duty station, must prospectively document their research with their supervisor in writing.All individuals involved in conducting VA human subjects research are required to complete training in ethical principles on which human subjects research is to be conducted. Specific requirements regarding the type and frequency of training are found on ORD’s Web site at: . All other applicable VA and VHA training requirements at the local and national level must be met (e.g. privacy and information security training).Research Protocol. The Investigator must develop and submit a research protocol that is scientifically valid, describes the research objectives, background and methodology, and is relevant to the health or welfare of the Veteran population. When applicable, the protocol must include the following safety measures:The type of safety information to be collected including AEs;Frequency of safety data collection;Frequency or periodicity of review of cumulative safety data;Statistical tests for analyzing the safety data to determine if harm is occurring; andConditions that trigger an immediate suspension of the research, if applicable.Approvals. The Investigator must submit the protocol for initial review and obtain written approvals from the IRB, other applicable committees, and from the R&D Committee. In addition, the Investigator must receive written notice from the ACOS/R&D that the research may commence before initiating the research.The Investigator may not self-certify that a study is exempt.Once approved by the IRB, the protocol must be implemented as approved. All modifications to the approved research protocol or consent form must be approved by the IRB prior to initiating the changes except when necessary to eliminate apparent immediate hazards to the subject.The Investigator must also obtain continuing review and approval at a frequency established by the IRB, but not less than once every year and is expected to submit all materials required for continuing review in sufficient time to assure approval prior to the expiration date. No research activities may be conducted at any time without a currently valid IRB approval.Conflict Of Interest. The Investigator must disclose to the IRB any potential, actual, apparent, or perceived conflict of interest of a financial, professional, or personal nature that may affect any aspect of the research, and comply with all applicable VA and other federal requirements regarding conflict of interest.Initial Contact. During the recruitment process, members of the research team must make initial contact with potential subjects in person or by letter prior to initiating any telephone contact, unless there is written documentation that the subject is willing to be contacted by telephone about the study in question or a specific kind of research as outlined in the study. (NOTE: This does not apply to situations where a Veteran calls in response to an advertisement. If existing information from sources such as a medical record or database (research or non-research) are used to identify human subjects, there must be an IRB approved HIPAA waiver for this activity in the new protocol.)Any initial contact by letter or telephone must provide a telephone number or other means that the potential subject can use to verify that the study constitutes VA research.If a contractor makes the initial contact by letter, the VA Investigator must sign the rmed Consent for Research. The Investigator must obtain and document legally effective informed consent of the subject or the subject's LAR prospectively (i.e. no screening or other interaction or intervention involving a human subject can occur until after the IRB-approved informed consent requirements have been met) that is in alignment with ethical principles that govern informed consent for research. The only exceptions are if the IRB determines the research is exempt, or approves a waiver of the informed consent process, or approves a waiver of the signed informed consent document.If the Investigator does not personally obtain informed consent, the Investigator must delegate this responsibility in writing (e.g. by use of a delegation letter) to research staff sufficiently knowledgeable about the protocol and related concerns to answer questions from prospective subjects, and about the ethical basis of the informed consent process and protocol.If the Investigator contracts with a firm (e.g. a survey research firm) to obtain consent from subjects, collect private individually identifiable information from human subjects, or are involved in activities that would institutionally engage the firm in human subjects research, the firm must have its own IRB oversight of the activity. In addition, the Privacy Officer must determine that there is appropriate authority to allow the disclosure of individual names and other information to the contracted firm.The Investigator must ensure that all original signed and dated informed consent documents are maintained in the Investigator’s research files, readily retrievable, and secure.For exempt research activities involving the Investigator interacting with human subjects or obtaining information by educational tests, survey or interview procedures, or behavioral interventions, the following information must be given to the prospective human subject as applicable in writing or orally: The activity is research; Participation is voluntary; Permission to participate can be withdrawn; Permission for use of data can be withdrawn for exempt research activities involving the collection and use of identifiable data; and Contact information for the VA Investigator.HIPAA Authorization. The Investigator or designee must obtain HIPAA authorization for the use and disclosure of the subject’s PHI, or obtain an IRB-approved waiver of HIPAA authorization unless there is a limited data set and appropriate DUA. The written HIPAA authorization may either be a standalone document or combined with the research informed consent approved by the IRB. If a standalone document is used as the written HIPAA authorization, VA Form 10-0493: Authorization for Use and Release of Individually Identifiable Health Information Collected for VHA Research must be used to document the authorization.Reporting. The Investigator is responsible for reporting problems, adverse events, local research deaths, and apparent serious or continuing non-compliance in accordance with local facility or IRB SOPs and VHA Handbook 1058.01.Research Records. The Investigator is responsible for ensuring research records include all information made or received by a VA investigator over the entire lifecycle of a research activity. This includes, but is not limited to, as applicable, the research protocol and all amended versions of the protocol; the grant application; documentation on each subject including informed consent, interactions with subjects by telephone or in person, observations, interventions, and other data relevant to the research, codes and keys used to de-identify and re-identify subjects protected health information; documents related to budget and funding; and other forms required by VA policy and Federal regulations. If the Investigator leaves the VA, all research records must be retained for the applicable retention period by the VA facility where the research was approved. All records regardless of format (paper, electronic, electronic systems) must be managed per NARA approved records schedules found in VHA RCS 10-1 and therefore must be retained until disposition instructions, as approved by NARA, are published in VHA RCS 10-1. NOTE: Once the disposition schedule is determined, records should be disposed in accordance with VHA RCS 10-1.VHA Health Record. A VHA health record must be created or updated, and a progress note created, for all research subjects (Veterans or non-Veterans) who receive research procedures or interventions as inpatients or outpatients at VA medical facilities that are either used in or may impact the medical care of the research subject at a VA medical facility or at facilities contracted by VA to provide services to Veterans (e.g. Community-Based Outpatient Clinics or nursing homes) (see VHA Handbook 1907.01). Informed consent and HIPAA authorization documents are not required to be in the health record.Investigational Drugs and Devices. The Investigator must conduct VA human subjects research involving investigational drugs and devices in accordance with all applicable VA policies and other federal requirements including, but not limited to: VHA Directive 1200.05, VHA Handbook 1108.04, Investigational Drugs and Supplies dated February 29, 2012, and applicable FDA regulations. The storage and security procedures for test articles used in research must be reviewed and approved by the IRB and follow all applicable federal rules.Initiation of Research Projects. IRB approval is for a specified time period based on the degree of risk of the study, not to exceed one (1) year except for research subject to the 2018 Requirements where continuing review is not required. The IRB determines the expiration date based upon its date of review and communicates that date to the Investigator in the written approval letter. The Investigator must not initiate the IRB approved research protocol until all applicable requirements in VHA Directive 1200.01 have also been met including obtaining R&D Committee approval and obtaining written notification from the ACOS/R&D that the research can be initiated.Expiration of IRB Approval. There is no provision for any grace period to extend the conduct of research beyond the expiration date of IRB approval. Therefore, continuing review and re-approval of research must occur on or before the date when IRB approval expires. If approval expires, the Investigator must:Stop all research activities including, but not limited to, enrollment of new subjects, analyses of individually identifiable data, and research interventions or interactions with currently participating subjects, except where stopping such interventions or interactions could be harmful to those subjects; andImmediately submit to the IRB Chair a de-identified list of research subjects who could be harmed by stopping specified study interventions or interactions. The IRB Chair must determine within two (2) business days whether or not such interventions or interactions may continue.Documentation of Informed ConsentWhen documentation of informed consent is not waived by IRB, the Investigator or designee must ensure that the informed consent document is signed and dated by:The subject or the subject’s legally authorized representative.If consent is obtained electronically, the following must be met:Authentication controls on electronic consent provide reasonable assurance that such consent is rendered by the proper individual; andThe subject dates the consent as is typical or that the software provides the current date when signed.Other specific requirements of Veterans Administration (VA) research be found in the “Additional Requirements for Veterans Administration (VA) Research” section in the IRB’s HRP-318 – WORKSHEET - Additional Federal Criteria.The following populations are considered categorically vulnerable and have specific VA requirements for their inclusion in research: Fetuses. Research in which the focus is a fetus, either in-utero or ex-utero cannot be conducted by VA investigators while on official duty, at VA facilities, or at VA approved off-site facilities.Neonates. Interventional research enrolling neonates cannot be conducted by VA investigators while on official duty, or at VA facilities, or at VA approved off-site facilities. Noninvasive monitoring involving minimal risk, prospective observational and retrospective record review studies that involve neonates or neonatal outcomes are permitted. See HRP-414 – CHECKLIST - Neonates of Uncertain Viability.Pregnant Women. The VA medical facility Director must certify that the medical facility has sufficient expertise in women’s or reproductive health to conduct the proposed research if the research includes interventional studies or invasive monitoring of pregnant women as subjects. See HRP-412 – CHECKLIST -Pregnant Women.Prisoners. See HRP-415 – CHECKLIST - Prisoners.Children. See HRP-416 - CHECKLIST - Children.Subjects who Lack Decision-making Capacity. See HRP-417 - CHECKLIST - Cognitively Impaired Adults.Research Involving PrisonersResearch involving prisoners cannot be conducted by VA investigators while on official VA duty, at VA facilities, or at VA-approved off-site facilities unless a waiver has been granted by the CRADO.Waiver requests must be submitted electronically to the CRADO by the VA medical facility Director with the following documents:A letter from the VA medical facility Director supporting the conduct of the VA study involving prisoners;Rationale for conducting the research involving prisoners to include additional ethical protections taken by the proposed research for prisoners to make voluntary and uncoerced decisions whether or not to participate as subjects in research;Documentation of the VA investigator’s qualifications to conduct the research involving prisoners, such as a biosketch and a list of all research team members;Location of institutions where the research is proposed to be conducted;A copy of the IRB approval letter specifically documenting its review determinations according to 45 CFR 46.305(a);A copy of the IRB minutes approving the research with documentation that at least one member of the IRB included a prisoner or a prisoner representative for the review of the research;A copy of the IRB-approved research study;A copy of the IRB-approved informed consent document; andA copy of the written HIPAA authorization.If such a waiver is granted, the research must comply with the requirements of 45 CFR 46.301 - 46.306.Research Involving ChildrenResearch involving children must not present greater than minimal risk.The VA medical facility Director must approve participation in the proposed research that includes children.Research involving biological specimens or data obtained from children is considered to be research involving children even if de-identified. If the biological specimens or data were previously collected, they must have been collected under applicable policies and ethical guidelines.The IRB must have the appropriate expertise to evaluate VA research involving children and must comply with the requirements of 45 CFR 46.401 - 46.404 and 46.408.Research Involving Persons Who Lack Decision-Making CapacityThe protocol must include a plan, that it is appropriate given the population and setting of the research, for how investigators will determine when a legally authorized representative will be required to provide informed consent. In general, the research staff must perform or obtain and document a clinical assessment of decision-making capacity for any subject suspected of lacking decision-making capacity.When the potential subject is determined to lack decision-making capacity, investigators must obtain consent from the LAR of the subject (i.e. surrogate consent). The following persons are authorized to consent on behalf of persons who lack decision-making capacity in the following order of priority:Health care agent (i.e. an individual named by the subject in a Durable Power of Attorney for Health Care);Legal guardian or special guardian;Next of kin: a close relative of the patient 18 years of age or older, in the following priority: spouse, adult child, parent, adult sibling, adult relative; Close friend; orA clinical social worker licensed pursuant to Chapter 491, or who is a graduate of a court-approved guardianship program.If feasible, the Investigator must explain the proposed research to the prospective research subject even when the legally authorized representative gives consent. Although unable to provide informed consent, some persons may resist participating in a research protocol approved by their representatives. Under no circumstances may a subject be forced or coerced to participate in a research study even if the LAR has provided consent.Legally authorized representatives must be told that their obligation is to try to determine what the subjects would do if able to make an informed decision. If the potential subjects’ wishes cannot be determined, the legally authorized representatives must be told they are responsible for determining what is in the subjects’ best interest.Research Involving Certificates of Confidentiality (CoC) (see HRP-333 – WORKSHEET - Certificate of Confidentiality)If information about the subject’s participation will be included as part of the VHA medical record that information must be given to the prospective subject as part of the informed consent process that information regarding study participation will be included in the medical record.In instances where a written informed consent form is used, inclusion of a statement that the study has been issued a CoC is required.Investigators should work with the research office in their facility to assure that when Veterans are enrolled in a study protected by a Certificate of Confidentiality, they are not simultaneously enrolled in other interventional studies unless it is absolutely clear that this enrollment does not raise safety issues.Collaborative Research. This addresses collaborations between VA and non-VA investigators. Collaboration is encouraged when VA investigators have a substantive role in the design, conduct, and/or analysis of the research. VA may also serve as a Coordinating Center for collaborative studies. IRB of Record Approval. Each institution is responsible for safeguarding the rights and welfare of human subjects and providing oversight of the research activities conducted at that institution.Each collaborating institution engaged in human subjects research must obtain approval from its IRB of Record and hold a FWA or another assurance acceptable to VA (e.g. DOD assurance).VA investigators must submit a protocol or other documentation to their VA IRB of Record that delineates which research activities will be conducted as the VA portion of the overall Collaborative Research study (e.g. by VA investigators on VA time or VA property).Each institution engaged in the collaborative research must use the informed consent document and HIPAA authorization required by their respective institutional policies for subjects recruited from that institution, or procedures requiring participation of the subject at that institution. The informed consent document may contain information on the project as a whole as long as the document clearly describes which procedures will be performed under VA auspices and which will be performed under a non-VA institution’s auspice.The VA informed consent document must clearly state when procedures mentioned at other institutions are part of the VA’s portion of the study.The informed consent document and HIPAA authorization must not contain inconsistent provisions.Waivers. PHI obtained in research for which the IRB of Record has waived the requirements to obtain a HIPAA authorization and a signed informed consent document may not be disclosed outside VA unless the VA facility Privacy Officer ensures and documents VA’s authority to disclose the PHI to another institution. A waiver of HIPAA authorization is not sufficient to fulfill the requirements of other applicable privacy regulations such as the Privacy Act of 1974 (5 U.S.C. 552a).Research Data. The protocol, addendum, and/or IRB of Record application must describe the data to be disclosed to collaborators, the entity(ies) to which the data are to be disclosed, and how the data are to be transmitted. This includes data from individual subjects as well as other data developed during the research such as the analytic data and the aggregate data.Each VA facility must retain a complete record of all data obtained during the VA portion of the research in accordance with privacy requirements, the Federal Records Act, and VHA Records Control Schedule (RCS) 10-1.All disclosures and data transmission must meet privacy and security requirements per VA Directive 6500, VHA Handbook 6500, and VHA Handbook 1605.1.Agreements regarding data use and transmission must be executed as required as applicable in VHA Handbook 1200.12, Use of Data and Data Repositories in VHA Research, dated March 9, 2009, or any superseding policies revising or replacing it.Photography, Video and/or Audio Recording for Research PurposesThe informed consent for research must include information describing any photographs, video, and/or audio recordings to be taken or obtained for research purposes, how the photographs, video, and/or audio will be used for the research, and whether the photographs, video, and/or audio will be disclosed outside the VA.An informed consent to take a photograph, video, and/or audio recording cannot be waived by the IRB.The consent for research does not give legal authority to disclose the photographs, video, and/or audio recordings outside the VA. A HIPAA authorization is needed to make such disclosures.International ResearchVA international research is defined as any VA-approved research conducted at international sites (i.e. not within the United States (U.S.), its territories, or Commonwealths), any VA-approved research using either identifiable or de-identified human biological specimens or identifiable or de-identified human data originating from international sites, or any VA-approved research that entails sending such specimens or data out of the U.S. This definition applies regardless of the funding source (funded or unfunded) and to research conducted through any mechanism of support including MOUs, CRADAs, grants, contracts, or other agreements. NOTE: Research conducted at U.S. military bases, ships, or embassies is not considered international research.Sending specimens or data to individuals with VA appointments at international sites (e.g. a WOC appointment, a VA investigator on sabbatical at an international site) is considered international research. Remote use of data that is maintained on VA computers within the U.S. or Puerto Rico and accessed via a secure connection is not considered international research.International research includes multi-site trials involving non-U.S. sites where VA is the study sponsor, a VA investigator is the overall study-wide Investigator, VA holds the Investigational New Drug (IND), or the VA manages the data collection and the data analyses.International research does not include studies in which VA is only one of multiple participating sites where the overall study-wide Investigator is not a VA investigator (i.e. the Investigator for the study as a whole is not a VA investigator).Before approving international research involving human subjects research, the IRB must ensure that human subjects outside of the U.S. who participate in research projects in which VA is a collaborator receive equivalent protections as research subjects inside the U.S. (see OHRP guidance at ). NOTE: The VA medical facility Director must approve participation in the proposed international research.All international research must also be approved explicitly in a document signed by the VA medical facility Director, except for Cooperative Studies Program activities which must be approved by the CRADO.Use Preparatory to ResearchVA investigators may use individually-identifiable health information to prepare a research protocol prior to submission of the protocol to the IRB for approval without obtaining a HIPAA authorization or waiver of authorization.VA investigators must not arbitrarily review PHI based on their employee access to PHI until the Investigator documents the following required information as “Preparatory to Research” in a designated file that is readily accessible for those required to audit such information (e.g. Health Information Manager or Privacy Officer):Access to PHI is only to prepare a protocol;No PHI will be removed from the covered entity (i.e. VHA); andAccess to PHI is necessary for preparation of the research protocol.Non-VA researchers may not obtain VA information for preparatory to research activities without appropriate VA approvals (see VHA Directive 1605.01).During the preparatory to research activities the VA investigator:Must only record aggregate data. The aggregate data may only be used for background information to justify the research or to show that there are adequate numbers of potential subjects to allow the Investigator to meet enrollment requirements for the research study;Must not record any individually identifiable health information; andMust not use any individually identifiable information to recruit research subjects.Preparatory activities can include reviewing database output (computer file or printout) containing identifiable health information generated by the database owner, if the Investigator returns the database output to the database owner when finished aggregating the information.Contacting potential research subjects and conducting pilot or feasibility studies are not considered activities preparatory to research.Activities preparatory to research only encompass the time to prepare the protocol and ends when the protocol is submitted to the IRB. Posting of Clinical Trial Consent Forms. For studies subject to the 2018 Requirements, if a VA research study is a clinical trial, one IRB-approved informed consent form used to enroll subjects, unless the IRB waived documentation of informed consent, must be posted by either the Investigator or the Federal department or agency conducting or supporting the study. The informed consent form must be posted after the clinical trial is closed to recruitment and no later than sixty (60) days after the last study visit by any subject as described in the IRB-approved protocol. For multi-site studies, it applies when the entire study has closed to subject recruitment. Any proprietary or personal information (such as names and phone numbers) must be redacted prior to posting the informed consent form.For any ORD-funded clinical trial, the applicable ORD funding service will be responsible for posting the informed consent form.For a clinical trial funded or supported by a Federal agency or department other than VA, the awardee is responsible for posting the informed consent form.For a clinical trial funded or supported by a non-Federal agency or department (e.g. university, industry, nonprofit organization) or not funded, the VA Investigator conducting the clinical trial is responsible for ensuring that the informed consent form is posted. If the clinical trial includes multiple sites engaged in the clinical trial, an agreement must exist specifying who is responsible for posting the informed consent form.Appendix A-9 Single IRB StudiesThat National Institutes of Health expects that all sites participating in multi-site studies involving non-exempt human subjects research funded by the NIH will use a single Institutional Review Board (sIRB) to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects at 45 CFR Part 46.This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. It does not apply to career development, research training or fellowship awards.This policy applies to domestic awardees and participating domestic sites. Foreign sites participating in NIH-funded, multi-site studies will not be expected to follow this policy.Exceptions to the NIH policy will be made where review by the proposed sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy. Requests for exceptions that are not based on a legal, regulatory, or policy requirement will be considered if there is a compelling justification for the exception. The NIH will determine whether to grant an exception following an assessment of the need.Appendix A-10 Additional Requirements for Research Subject to EU General Data Protection Regulations (GDPR)Human subjects research involving personal data about individuals located in (but not necessarily citizens of) European Union member states, Norway, Iceland, Liechtenstein, and Switzerland is subject to EU General Data Protection Regulations.For all prospective human subjects research subject to EU GDPR, contact institutional legal counsel or your institution’s Data Protection Officer to ensure that the following elements of the research are consistent with institutional policies and interpretations of EU GDPR:Any applicable study design elements related to data security measures.Any applicable procedures related to the rights to access, rectification, and erasure of data. Procedures related to broad/unspecified future use consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens.Where FDA or DHHS regulations apply in addition to EU GDPR regulations, ensure that procedures related to withdrawal from the research, as well as procedures for managing data and biospecimens associated with the research remain consistent with Appendices A-1 and A-2 above.Appendix A-11 Additional Requirements for Environmental Protection Agency (EPA) ResearchResearch conducted, supported, or intended to be submitted to EPA is subject to Environmental Protection Agency Regulations.Intentional exposure of pregnant women or children to any substance is prohibited.Observational research involving pregnant women and fetuses are subject to additional DHHS requirements for research involving pregnant women (45 CFR §46 Subpart B) and additional DHHS requirements for research involving children (45 CFR §46 Subpart D.)Research involving children must meet category #1 or #2.Other specific requirements of the Environmental Protection Agency (EPA) Research can be found in the “Additional Requirements for Environmental Protection Agency (EPA) Research and Research Intended to be Submitted to the Environmental Protection Agency” section in the IRB’s HRP-318 - WORKSHEET - Additional Federal Agency Criteria.Appendix B-1 Summary of Manual ChangesVersionDate Approved (Date in document header)Date Released212/2/201912/2/2019-Clarified the timeline for submitting a continuing review/study closure request.-Revised “IRB approval date stamp” to “IRB effective date stamp.”-Included information regarding USF courtesy faculty not being able to serve as PI.-Updated USF logo on first page.35/1/20205/1/2020-Toolkit 4.3 release and other administrative updates.-Updated USF logo.45/22/20205/22/2020-Clarified protocol requirements in Question 11.56/11/20206/11/2020-Updated references to the consent templates.-Clarified what should be provided to the IRB at the time of continuing review.-Updated the table of contents.69/22/20209/22/2020-Updated the document to remove “USF System” throughout.-Removed information about the “Confirm Ongoing Research” activity for external studies.

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