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{"sheet":"PartA","index":0,"n_rows":666,"n_cols":3,"rows_kept":666,"cut":false,"hidden":false,"merged":[[590,2,595,2],[606,2,611,2],[629,2,637,2],[647,2,650,2],[358,2,359,2],[366,2,368,2],[665,0,666,2],[392,2,393,2],[460,2,461,2],[464,2,465,2],[471,2,472,2],[488,2,491,2],[412,0,413,2],[416,0,416,2],[417,2,418,2],[447,2,449,2],[518,2,520,2],[493,2,494,2],[497,2,498,2],[663,2,664,2],[422,2,423,2],[441,2,443,2],[401,2,404,2],[659,2,660,2],[574,2,575,2],[569,0,570,2],[654,0,654,2],[90,2,92,2],[94,2,97,2],[103,1,103,2],[655,2,658,2],[573,0,573,2],[381,1,381,2],[424,2,425,2],[428,2,431,2],[293,0,293,2],[311,2,313,2],[135,1,135,2],[136,2,137,2],[141,2,142,2],[138,2,139,2],[193,1,193,2],[194,2,195,2],[182,2,183,2],[144,2,145,2],[154,2,155,2],[576,2,581,2],[159,2,163,2],[164,2,166,2],[167,2,172,2],[203,2,205,2],[220,2,223,2],[104,2,105,2],[107,2,108,2],[111,2,112,2],[122,2,123,2],[188,2,191,2],[197,2,201,2],[130,0,131,2],[114,2,116,2],[127,2,128,2],[118,2,120,2],[134,0,134,2],[216,2,219,2],[19,1,19,2],[56,2,58,2],[63,2,65,2],[77,2,78,2],[80,2,83,2],[22,2,23,2],[26,2,27,2],[29,2,31,2],[99,2,101,2],[50,0,50,2],[51,0,51,2],[34,2,35,2],[47,0,48,2],[60,2,61,2],[67,2,70,2],[72,2,73,2],[44,2,45,2],[55,1,55,2],[85,2,87,2],[89,1,89,2],[75,2,76,2],[5,0,6,2],[8,0,8,2],[13,2,16,2],[10,0,10,2],[11,0,11,2],[12,0,12,2],[25,1,25,2],[653,0,653,2],[252,2,253,2],[254,2,255,2],[557,2,558,2],[320,2,321,2],[485,2,486,2],[387,2,390,2],[362,2,363,2],[371,2,373,2],[361,1,361,2],[419,2,420,2],[407,1,407,2],[451,2,452,2],[560,2,562,2],[564,2,565,2],[276,2,277,2],[317,2,318,2],[408,1,409,2],[522,1,523,2],[588,2,589,2],[596,2,597,2],[645,2,646,2],[638,2,639,2],[395,2,396,2],[505,2,506,2],[510,2,511,2],[515,2,516,2],[530,2,531,2],[617,2,618,2],[473,1,473,2],[477,1,477,2],[481,1,481,2],[543,2,544,2],[532,2,535,2],[572,0,572,2],[507,2,509,2],[545,2,546,2],[433,2,434,2],[438,2,439,2],[399,1,399,2],[501,2,502,2],[245,2,248,2],[262,2,264,2],[278,2,280,2],[175,1,175,2],[178,2,179,2],[307,2,309,2],[304,2,305,2],[285,2,286,2],[289,0,290,2],[292,0,292,2],[237,2,238,2],[212,2,214,2],[228,2,230,2],[232,1,233,2],[207,2,210,2],[185,2,186,2],[234,2,235,2],[226,2,227,2],[250,2,251,2],[240,2,243,2],[661,2,662,2],[585,2,587,2],[582,2,584,2],[598,2,604,2],[613,2,616,2],[619,2,627,2],[640,2,644,2],[651,0,651,2],[152,2,153,2],[283,2,284,2],[256,2,259,2],[270,2,271,2],[273,2,274,2],[268,2,269,2],[176,1,177,2],[332,2,334,2],[330,1,330,2],[300,2,301,2],[294,2,297,2],[298,2,299,2],[336,2,337,2],[348,2,349,2],[322,1,324,2],[325,1,325,2]]}
["Date:"]
["Facility:",null,"Select Facility…"]
["Facility Contact:"]
["Facility Email:"]
[]
["Submission of this form should occur no later than July 31, 2023.  If updated information becomes available after July 31, 2023, please contact ORO at OROIDA@va.gov. "]
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[]
["PART A - CHECKLIST OF RESEARCH - RELATED REQUIREMENTS"]
[]
["Medical Facility Director - Institutional Responsibilities"]
["Questions shaded in yellow are new questions from previous FDC versions."]
["Questions shaded in orange are related to Common Findings on ORO Combined Program Reviews. Clicking on the \"More Info\" button for these items will navigate to ORO's Common Findings List."]
["1.","Select…","Are there adequate resources and administrative support, including personnel, space, equipment, and training for the Research and Development Committee (R&DC) and its subcommittees to fulfill their responsibilities? If “No,” please provide comments in the space below."]
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[]
[]
[]
[null,null,"VHA Directive 1200.01(1) §5.f(6); VHA Directive 1200.02(1) §11.e(2)-(3)"]
["2.","Has the Medical Facility Director:"]
[null,"Select…","a.  Appointed members of the R&DC and its subcommittees in writing? "]
[null,null,"VHA Directive 1200.01(1) §5.f(3)"]
[null,"Select…","b.  Delegated authority in writing for the roles and responsibilities within the facility’s Human Research Protection Program (HRPP)?"]
[]
[null,null,"VHA Directive 1200.05(2) §5.f(2)(c)"]
["3. ","Has the Research Compliance Officer (RCO):"]
[" ","Select…","a.  Maintained auditing plans and/or standard operation procedures (SOPs) for accomplishing required RCO informed consent audits and regulatory audits?\n\nVHA Directive 1058.01 §5.i(1)  "]
[]
[null,null,"VHA Directive 1058.01 §5.i(1) "]
[null,"Select…","b.  Completed all required annual informed consent and triennial regulatory audits for this reporting period? If “No,” please provide details in the space below. Include audit type(s) and number of audits to be completed. "]
[]
[]
[null,null,"VHA Directive 1058.01 §5.i(1) "]
[]
["4. ","Select…","Are any of the following positions currently unfilled or held by acting or interim personnel? If \"Yes\", please select all that apply.   If “No,” skip to Question 5."]
[]
[null,null,"Medical Facility Director"]
[null,null,"Associate Chief of Staff/Research and Development (ACOS/R&D) or Coordinator for R&D"]
[null,null,"Administrative Officer/Research and Development"]
[null,null,"RCO "]
[null,null,"Research Committee Coordinator(s) Specify committee(s): "]
[]
[null,null,"For each position selected above, specify whether the positions are vacant or whether acting or interim personnel have been assigned to the positions and the length of time assigned or vacant."]
[]
[null,"Select…","a.  If the ACOS/R&D has been acting/vacant for longer than 6 months, has Chief Research and Development Officer (CRADO) approval been obtained? "]
[]
[null,null,"VHA Directive 1200.02(1) §11.b(4)"]
["NOTES: Use the space box below to provide any additional information about items in the Medical Facility Director-Institutional Responsibilities section: "]
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[]
[]
["R&DC and ACOS/R&D Program Oversight Responsibilities"]
["5. ","Select…","Does your facility use the R&DC of another VA facility?  If \"Yes,” please specify facility:"]
[]
[null,null,"If “Yes,” skip to Question 7."]
["6. ","Has the R&DC:"]
[null,"Select…","a.  Reviewed all research review committees and subcommittees, including external committees relied upon by the facility, at least annually and provided the Medical Facility Director with written summary reports of each review?"]
[]
[]
[null,null,"VHA Directive 1200.01(1) §6.f; VHA Directive 1200.01(1) §8.a"]
[null,"Select…","b.  Reviewed subcommittee minutes within 60 days of the subcommittee’s finalization of the minutes?"]
[]
[null,null,"VHA Directive 1200.01(1) §8.a(3)"]
[null,"Select…","c.  Implemented a mechanism(s) to ensure documentation of all applicable subcommittee review and non-contingent approval has been received by the R&DC before a study is given final approval?"]
[]
[]
[null,null,"VHA Directive 1200.01(1) §9.b"]
[null,"Select…","d.  Implemented a mechanism(s) to ensure the R&DC documents its determination as to whether proposed research, which has been approved by an external Institutional Review Board (IRB), supports the VA mission and is relevant to the care of Veterans, is scientifically meritorious, and is compliant with VA data and specimen storage requirements?"]
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[]
[]
[null,null,"VHA Directive 1200.01(1) §9.c"]
[null,"Select…","e.  Served as the review and approving committee of record for research not meeting criteria for assignment to any subcommittee?"]
[]
[null,null,"VHA Directive 1200.01(1) §9.d"]
[null,"Select…","f.  Ensured that the R&DC only approves those aspects of collaborative studies involving VA research?\nVHA Directive 1200.01(1) §10.a"]
[]
[null,"Select…","g.  Reviewed justification and provided specific approval for recruitment of non-Veterans?"]
[]
[null,null,"VHA Directive 1200.01(1) §13.a"]
[null,"Select…","h. Implemented a mechanism(s) to ensure the Information System Security Officer (ISSO) review of studies involving the collection, processing, storage, and transmission of research data and Privacy Officer (PO) review of studies using human data are complete before a study is given final approval?"]
[]
[]
[]
[null,null,"VHA Directive 1200.01(1) §5.h(6); §5.i; §5.k"]
["7. ","Select…","Does the Research Program have a process to ensure investigators submit a VHA Research Protocol Privacy Review Checklist (VA Form 10-250) and an Enterprise Research Data Security Plan (ERDSP) to the PO and ISSO for all new protocol submissions?"]
[]
[]
[null,null,"VHA Directive 1200.01(1) §5.l(3)"]
["8.  ","Does the ACOS/R&D or Coordinator/R&D have a process to ensure:"]
[null,"Select…","a.  Written notification is provided to investigators when a research project can be initiated, and the period for which the project is approved, once the research project has been approved by all applicable subcommittees and the R&D Committee?"]
[]
[]
[null,null,"VHA Directive 1200.01(1) §5.g(2)"]
[null,"Select…","b.  All research personnel hold an official VA appointment from Human Resources Management Service (HRMS) as a compensated full-time or part-time employee, a Without Compensation (WOC), or under the Intergovernmental Personnel Act (IPA) prior to conducting or being involved in any way in VA research activities?"]
[]
[]
[]
[null,null,"VHA Directive 1200.02(1) §12.a(4)(a)"]
[null,"Select…","c.  All requests for WOC appointments for research have been appropriately justified and the appointments are in compliance with all applicable research, HRMS, and other VA policies?"]
[]
[]
[null,null,"VHA Directive 1200.02(1) §12.a(4)(b)"]
["9. ","Does the Research Office have an established system to track:"]
[null,"Select…","a. Research studies, including study status, type of study, sponsor, funding source, PI, and required committee approvals?"]
[]
[null,null,"VHA Directive 1200.02(1) §5.b(1)(a)"]
[null,null,"If \"Yes,\" specify all tracking system(s) currently used for research committee management (e.g., VAIRRS, iMedris, affiliate research management systems, etc.): "]
[]
[]
[null,"Select…","Is VAIRRS the primary protocol tracking system utilized at your facility?"]
[null,"Select…","b.  Research review committee actions, including all initial and continuing review approvals?"]
[]
[null,null,"VHA Directive 1200.02(1) §5.b(1)(b)"]
[null,"Select…","c.  Agreements, including all local Cooperative Research and Development Agreements (CRADA), research contracts, research Memoranda of Understanding (MOUs), and other written research agreements?"]
[]
[]
[null,null,"VHA Directive 1200.02(1) §5.b(1)(c)"]
[null,"Select…","d.  Personnel, including all investigators, research coordinators, research assistants, research technicians, and others conducting any aspect of research at the VA medical facility?"]
[]
[]
[null,null,"VHA Directive 1200.02(1) §5.b(1)(d)"]
[null,"Select…","e.  Completion of all ORD-required training and Annual Government Ethics training (for investigators) for all research personnel?"]
[]
[null,null,"VHA Directive 1200.02(1) §5.b(1)(e)"]
[null,null,"f.  An inventory of all research data:"]
[null,"Select…","(1)  that are placed in a research data repository for future use?"]
[null,"Select…","(2)  that are being stored until the retention requirement has been met per Record Control Schedule 10-1?"]
[]
[null,null,"VHA Directive 1200.02(1) §5.b(1)(f)"]
["NOTES: Use the text box below to provide any additional information about items in the R&DC and ACOS/R&D Program Oversight Responsibilities section:"]
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[]
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["HRPP and IRB Responsibilities"]
["10. ","Institutional Review Board(s):"]
[null,"Select…","a.  Does your facility operate its own internal IRB to perform review and oversight of human subjects research?"]
[]
[null,"Select…","b.  Does your facility use an IRB operated by your facility's academic affiliate institution(s)? If \"Yes,\" specify affiliate:"]
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[]
[null,"Select…","c.  Does your facility use an IRB operated by another VA facility?  \nIf \"Yes,\" specify VA Facility: "]
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[]
[null,null,"d.  Does your facility use any of the following IRBs?  Select \"Yes\" if your facility currently relies on the IRB or is approved to rely on if research has not yet be reviewed by the IRB:"]
[]
[null,"Select…","VA Central IRB"]
[null,"Select…","National Cancer Institute (NCI) IRB"]
[null,"Select…","National Institutes of Health (NIH) All of Us IRB"]
[null,"Select…","Advarra, Inc. IRB"]
[null,"Select…","Oak Ridge Associated Universities IRB"]
[null,"Select…","Sterling IRB"]
[null,"Select…","e.  If “Yes” to any IRBs in #10d, has your facility received approval from ORD to use the IRB(s)? "]
[]
[null,"Select…","f.  Does your facility use any other IRB not already identified in questions #10a through 10d above? If \"Yes,\" specify IRB(s):"]
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[]
[null,"Select…","g.  If \"Yes\" to #10f, has your facility received approval from ORD to use the IRB(s)?"]
[null,null,"VHA Directive 1200.05(2) §5.f(9)"]
["11.","Select…","For IRBs other than an internal IRB operated by your facility, is there a current (i.e., not expired) reliance agreement or MOU in place documenting the facility's reliance on that IRB and the responsibilities that each entity will undertake to ensure compliance with the Common Rule and applicable VHA policies (e.g., VHA Directive 1200.05(2), VHA Directive 1058.01.)?"]
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["12.","Select…","For cooperative research subject to the single IRB requirement, is there a mechanism(s) in place to ensure the research is reviewed by a single IRB unless an exception has been granted by ORD or another Common Rule agency?\nIf cooperative research is not conducted, choose N/A."]
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[]
[null,null,"NOTE: Effective July 19, 2018, single IRB review is required for all VA non-exempt Human Subjects Research with more than one institution engaged and the other Institution(s) is a federal institution (including another VA Facility) or the other non-Federal institution(s) is a recipient of Federal government funding or support for that research activity, unless the research was granted an exception from the requirement by ORD or other Common Rule agency."]
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[]
[]
[]
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[null,null,"38 CFR 16.114; See also Single IRB Implementation in VAs at "]
[null,null,"www.research.va.gov/programs/orppe/single_irb.cfm"]
["13.","Does the IRB have a mechanism(s) (e.g., written policies, procedures, checklists) to ensure:"]
[null,"NOTE:  Questions #13-15 should be answered from the perspective of the primary IRB (facility-operated IRB or academic affiliate IRB)."]
[]
[" ","Select…","a.  For protocols reviewed by the convened IRB, the IRB minutes document that the IRB determined that all of the criteria for approval of the research were satisfied?"]
[]
[null,null,"VHA Directive 1200.05 §8.c(1); VHA Directive 1200.05 §12.a(1)-(8)"]
[null,"Select…","b.  Informed consent documents contain all required elements?"]
[null,null,"NOTE:  This includes all VA-specific elements, including a statement that the VA will provide payment for any research-related injury."]
[]
[null,null,"VHA Directive 1200.05 §17"]
[null,"Select…","c.  Requests to waive informed consent are appropriately reviewed and determinations to grant waivers are fully and appropriately documented? "]
[]
[null,null,"VHA Directive 1200.05 §17.h "]
[null,"Select…","d.  Requests to waive HIPAA authorization are appropriately reviewed and determinations to grant waivers are fully and appropriately documented and include the signature of the Chair of the IRB, or a qualified voting member of the IRB designated by the Chair?"]
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[]
[null,null,"VHA Directive 1200.05 §23.b "]
["14.","For research subject to the 2018 Common Rule requirements, does the IRB have a mechanism(s) (e.g., written policies, procedures, checklists) to ensure:"]
[null,"Select…","a.  Updated procedures are in place for exempt research including limited IRB review of certain exempt research categories?"]
[]
[null,null,"VHA Directive 1200.05(2) §10; VHA Directive 1200.05(2) §10.d-h  "]
[null,"Select…","b.  Documenting the rationale for conducting continuing review of research that otherwise would not require continuing review (i.e., research eligible for expedited review, research receiving a limited IRB review, and research that has progressed to only data analysis and/or only accessing follow-up clinical data as part of clinical care)?"]
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[]
[]
[]
[null,null,"VHA Directive 1200.05(2) §9.e(2)-(3) "]
[null,"Select…","c.  Documenting the rationale for an expedited reviewer's determination that research appearing on the expedited review list is more than minimal risk, and therefore not eligible for expedited review?"]
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[]
[null,null,"VHA Directive 1200.05(2) §16.a(8) "]
[null,"Select…","d.  Informed consent documents contain new requirements, including a concise and focused presentation of the key information at the beginning, and a statement about future use of identifiable private information or identifiable biospecimens for research that involves the collection of identifiable private information or biospecimens?"]
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[]
[]
[]
[null,null,"VHA Directive 1200.05(2) §17.b; VHA Directive 1200.05(2) §17.d(9)(a)&(b) as applicable; VHA Directive 1200.05(2) §17.e(7)-(9) as applicable; VHA Directive 1200.05(2) §17.g-h [waivers]; VHA Directive 1200.05(2) §18.b(2) as applicable     "]
[]
[]
[null,"Select…","e.  IRB-approved waivers of informed consent document new approval criteria?"]
[null,null,"NOTE:  If the research involves identifiable private information or identifiable biospecimens, approved waivers must document that the research could not practicably be carried out without using such information or biospecimens in an identifiable format."]
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[]
[]
[null,"Select…","f.  That one approved informed consent form is posted for clinical trials no later than 60 days after the last study visit by any subject to https://clinicaltrials.gov or http://Regulations.gov (Docket ID: HHS-OPHS-2018-0021)? If clinical trials are not conducted, choose N/A."]
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[null,null,"VHA Directive 1200.05(2) §17.j "]
["15.","Select…","Is broad consent allowed by local policy? If “No,” skip to Question 16."]
[null,"Select…","a.  If “Yes” to #15, has broad consent been approved in conjunction with any active human subject protocols at your facility?"]
[]
[null,"Select…","b.  If “Yes” to #15a, has the IRB ensured broad consent is only approved for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens that are collected solely for research purposes?"]
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[]
[null,null,"VHA Directive 1200.05(2) §17.f "]
["16.","Has the HRPP established written SOPs that are up-to-date and compliant with current Federal and VHA requirements including:"]
[]
[null,"Select…","a.  SOP(s) for review of research and reporting actions and determinations, including for expedited reviews?"]
[]
[null,null,"VHA Directive 1200.05 §8a; VHA Directive 1200.01(1) §6.e  "]
[null,"Select…","b.  A documented procedure for determining when research approved by the IRB prior to January 21, 2019, can transition to the 2018 Common Rule Requirements, if applicable?"]
[]
[null,null,"VHA Directive 1200.05(2) §5.f(5)"]
[null,"Select…","c.  Any SOP(s) for review and reporting of unanticipated problems involving risks to subjects or others and serious or continuing noncompliance (if developed) have been updated to align with reporting timelines and requirements in VHA Directive 1058.01, dated October 22, 2020?\n"]
[]
[]
[]
[null,null,"VHA Directive 1200.05(2) §8.a(4); VHA Directive 1058.01 §7.(b)-(c)  "]
["17. ","Select…","Is there a mechanism(s) in place to ensure the PO consistently reviews written HIPAA authorizations and waivers of HIPAA authorization approvals to ensure they contain all required elements and are consistent with all privacy requirements before investigators begin to use or collect individuals’ information? "]
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[]
[null,null,"VHA Directive 1200.05(2) §23.a(3); VHA Directive 1605.03(1) Appendix D §1.k(7) "]
["18. ","Select…","Does your facility conduct research involving investigational drugs as defined by VHA Handbook 1108.04? If \"No,\" skip to Question 19."]
[]
[null,"Select…","a.  Does the research include investigational drugs under an Investigational New Drug Application (IND)?"]
[]
[null,"Select…","b.  Does the research include human gene transfer therapy (e.g.,  treatments or vaccine trials involving administration of viral vectors or synthetic RNA/DNA) to human subjects?"]
[]
[null,"Select…","c.  If “Yes” to #18b, is there a process in place for such research to be reviewed by a properly constituted Institutional Biosafety Committee (IBC) (in addition to an IRB) as required by the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) - April 2019, Section III-C-1?"]
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[]
[]
[null,null,"https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf"]
[null,"Select…","d.  Are any investigational drugs stored outside of the research pharmacy?"]
[null,null,"If “Yes,” please provide details of all investigational drugs maintained outside of the research pharmacy including the protocol and rationale for storage outside the pharmacy: "]
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[]
[]
[null,"Select…","e.  If “Yes” to #18d, is a delegation of custody in place?"]
[null,null,"VHA Handbook 1108.04 §10.c "]
[null,"Select…","f.  Does your facility conduct human subjects research involving the use of controlled substances? If \"No,\" skip to Question 19."]
[]
[null,"Select…","g.  If “Yes” to #18f, are the controlled substances stored in accordance with VHA Directive 1108.01(1)?"]
[]
[null,null,"VHA Directive 1108.01(1) §4.g(9) "]
[null,"Select…","h.  If “Yes” to #18f, do the controlled substances receive monthly unannounced controlled substance inspections as required by VHA Handbook 1108.04 and VHA Directive 1108.02?"]
[]
[null,null,"VHA Handbook 1108.04 §10.b(5)(b); VHA Directive 1108.02(2) §7   "]
["19. ","Select…","Does your facility conduct research involving investigational devices? If \"No,\" skip to Question 20."]
[]
[null,"Select…","a.  Is there a process in place to ensure the IRB reviews sponsor risk determinations for every investigational device study (unless the FDA has already made a determination)?"]
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[]
[null,"Select…","b.  Does the research include significant risk device studies?"]
[null,null,"21 CFR 812.3(m)"]
[null,"Select…","c.  If “Yes” to #19b, have the studies received full Investigational Device Exemption (IDE) approval from the FDA?"]
[]
["20.","Select…","Has your facility approved any research involving: women who are known to be pregnant, human fetuses in utero, or neonates as subjects? If \"No,\" skip to Question 21."]
[]
[null,"Select…","a.  If “Yes” to #20, were the appropriate certifications and/or approvals in place? "]
[null,null,"VHA Directive 1200.05(2) §19"]
["NOTES: Use the text box below to provide any additional information about items in the HRPP and IRB Responsibilities section:"]
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[]
[]
["Animal Care and Use Program (ACUP) and\nInstitutional Animal Care and Use Committee (IACUC) Responsibilities"]
["21.","Select…","Does your facility have an Animal Care and Use Program (i.e., does any research, testing or training conducted by your facility staff, either in VA space or with VA funds or on VA time regardless of location, involving the use of laboratory animals)?\nIf \"No,\" skip to Question 34."]
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["22.","Select…","Does your facility have its own internal IACUC of record to perform review and oversight of animal research? If \"No,\" skip to Question 23."]
[]
[null,null,"If \"Yes\" to #22, are all IACUC members appointed in writing by the Medical Facility Director in accordance with VHA requirements prior to starting a term, including:"]
[]
[null,"Select…","a.  IACUC Chair?"]
[null,null,"VHA Handbook 1200.07 §8.a(2) "]
[null,"Select…","b.  Required Members, including scientist(s), non-scientist(s), non-affiliated member(s), and a veterinarian?"]
[]
[null,null,"VHA Handbook 1200.07 §8.a(1) "]
["23.","Select…","Does your facility use an affiliate IACUC(s), in lieu of a VA IACUC, as the IACUC-of- record (i.e., No VA IACUC)?\nIf “Yes,” specify affiliate(s):"]
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[]
[null,"Select…","a.  Are the Veterinary Medical Officer (VMO) or Veterinary Medical Consultant (VMC) and at least one other VA compensated scientist with animal research experience appointed to the affiliate’s IACUC as voting members with full committee privileges?"]
[]
[]
[null,null,"VHA Handbook 1200.07 §8.b(1)(f) "]
[null,"Select…","b.  Do you have an MOU for use of the affiliate IACUC(s)?"]
[null,null,"VHA Handbook 1200.07 §8.b(1) "]
["24.","Select…","Does your facility use an affiliate IACUC(s) in addition to the VA IACUC-of-record for shared oversight of off-site VA animal research?  If “Yes,” specify affiliate(s):"]
[]
[]
[null,"Select…","a.  If “Yes” to #24, are shared oversight mechanisms between the VA and affiliate IACUC(s) established in an MOU?"]
[]
["25.  ","What is the status of the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accreditation for your institution (or the institution whose accreditation that covers your program) as of the date this form is submitted? "]
[]
[]
[null,"VHA Handbook 1200.07 §7.e "]
[null,null,"Select…"]
[null,null,"a.  Please provide the date of the last AAALAC accreditation determination letter: "]
[]
["26.","Select…","Is your institution registered with the United States Department of Agriculture (USDA)?"]
["27.","Animals used for VA research are housed:"]
[null,null,"Select…"]
["28.","Select…","Does your facility have any approved protocols involving non-USDA-regulated species (e.g.,  purpose-bred rats and mice, birds, amphibians) used for VA research? If “Yes,” please specify species AND locations (VA or affiliate) housed: "]
[]
[]
[]
["29.","Select…","Does your facility have any approved protocols that involve the following USDA-regulated species used for VA research?  If \"No,\" skip to Question 30."]
[]
[null,"Select…","a.  Canines; If \"No,\" skip to Question 29b; If “Yes,” specify if housed at VA or affiliate: "]
[]
[null,"Select…","(1)  Is the canine research funded by the VA?"]
[null,"Select…","(2)  Has the canine research been approved by the VA Secretary?"]
[null,null,"Consolidated Appropriations Act, 2022 (Public Law 117-103), dated 3/15/2022, Section 247(a)-(e) "]
[null,"Select…","b.  Felines; If \"No,\" skip to Question 29c;  If “Yes,” specify if housed at VA or affiliate: "]
[]
[null,"Select…","(1)  Is the feline research funded by the VA?"]
[null,"Select…","(2)  Has the feline research been approved by ORD and the VA Secretary?"]
[null,null,"Consolidated Appropriations Act, 2022 (Public Law 117-103), dated 3/15/2022, Section 247(a)-(e) "]
[null,"Select…","c.  Non-human primates (NHP); If \"No,\" skip to Question 29d;  If “Yes,” specify if housed at VA or affiliate: "]
[]
[]
[null,"Select…","(1)  Is the NHP research funded by the VA?"]
[null,"Select…","(2)  Has the NHP research been approved by ORD and the VA Secretary?"]
[null,null,"Consolidated Appropriations Act, 2022 (Public Law 117-103), dated 3/15/2022, Section 247(a)-(e) "]
[null,"Select…","d.  Swine; If \"No,\" skip to Question 29e;  If “Yes,” specify if housed at VA or affiliate: "]
[]
[null,"Select…","e.  Rabbit; If \"No,\" skip to Question 29f;  If “Yes,” specify if housed at VA or affiliate: "]
[]
[null,"Select…","f.  Other USDA-regulated Species; If “Yes,” please specify species AND if housed at VA or affiliate:"]
[]
[]
["30.","For VA animal facilities, has your facility ensured:"]
[null,"Select…","a.  Heating, Ventilation, and Air Conditioning (HVAC) system(s) reliably maintain temperature and humidity within required ranges in the VMU?  If \"No,\" explain:"]
[]
[]
[null,null,"VHA Handbook 1200.07 APP.E.§3.b(7)"]
[null,"Select…","b.  HVAC systems are designed to prevent catastrophic overheating of animal rooms?\nNOTE:  This includes areas outside of the VMU where animals are housed for more than 24 hours.  If \"No,\" explain:"]
[]
[]
[]
[null,null,"VHA Handbook 1200.07 §7.a(2)(a)&(b); APP.E.§3.b(9)"]
[null,"Select…","c.  Overheat tests of the animal facility are conducted at least once every year, the results are provided to the IACUC for review at the next convened IACUC meeting, and reviews are documented in the IACUC meeting minutes?"]
[]
[]
[null,null,"VHA Handbook 1200.07 §7.a(2)c"]
[null,null,"Provide the date of the IACUC meeting where the review was conducted:"]
[]
[null,"Select…","d.  Security measures are implemented to exclude the entry of unauthorized personnel? "]
[null,null,"VHA Handbook 1200.07 §7.i and VA Handbook 0730 Appendix B "]
[null,"Select…","e.  The animal facility is equipped with emergency power?"]
[null,null,"Guide for the Care and Use of Laboratory Animals, 8th Edition, pg. 141"]
["31.","How has the IACUC fulfilled requirements for ongoing assessment of the VA ACUP?\nSelect one option below:"]
[null,null,"Select…"]
[null,"Select…","a.  Were semi-annual program evaluations conducted at six-month intervals?"]
[null,null," VHA Handbook 1200.07 §8.f(1) "]
[null,"Select…","b.  Were semi-annual facility inspections conducted at six-month intervals?"]
[null,null," VHA Handbook 1200.07 §8.f(1) "]
[null,"Select…","c.  Was the Medical Facility Director briefed on the results of the semi-annual program evaluation and facility inspections during a meeting with the key personnel? "]
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[]
[]
[]
[null,"Select…","d.  Did semi-annual program review reports contain a plan and schedule for correction of deficiencies?"]
[]
[null,null,"VHA Handbook 1200.07 §8.f(1)(d)(2) "]
[null,"Select…","e.  Were all significant deficiencies identified corrected within the timeframe(s) specified by the IACUC? (Choose N/A if no significant deficiencies were identified.) \n"]
[]
[null,null,"If “No,” please provide additional details: "]
[]
["32.","For VA animal facilities, veterinary medical services are provided by:"]
[null,null,"Select…"]
[null,"Select…","a.  If part-time (including contracted) veterinary services are provided, did arrangements include regularly scheduled visits, not less than once per month, written documentation of veterinary visits and a written plan that has been developed and approved by the veterinarian and the ACOS/R&D?  If “No,” provide additional information:\nNOTE: VHA Directive 1200.07, dated May 23, 2023, has updated requirements for the written Program of Veterinary Care."]
[]
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[]
[null,null,"VHA Handbook 1200.07§6.b(8)"]
["33.","For affiliate animal facilities:"]
[null,"How has the IACUC fulfilled requirements for semi-annual assessment of the affiliate(s) ACUP as it relates to oversight of VA animal research?\nNOTE: VHA Directive 1200.07, dated May 23, 2023, has updated requirements for shared oversight of VA animal research"]
[]
[null,null,"Select…"]
[null,null,"VHA Handbook 1200.07§8.f(1)(a)"]
["NOTES:  Use the text box below to provide any additional information about items in the ACUP and IACUC Responsibilities section:"]
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[]
["Research Safety and Security Program (RSSP) and Subcommittee on Research Safety (SRS) Responsibilities"]
["34.","Select…","Does any research conducted by your facility staff involve biological, chemical, physical (including animal contact), or radiation hazards?"]
[]
[null,"Select…","a.  Has your facility obtained a waiver from the requirement for an SRS by the CRADO? If \"Yes,\" skip to Question 44."]
[]
[null,null,"VHA Directive 1200.08(1) §6.c(2)"]
["35.","Select…","Does your facility have an internal SRS administered within the VA facility that carries out duties described in VHA Directive 1200.08(1)? If \"No,\" skip to Question 36."]
[]
[null,null,"If \"Yes\" to #35, are SRS members appointed in writing by the Medical Facility Director for terms up to 3 years (renewable), including:"]
[]
[null,"Select…","a.  SRS Chair?"]
[null,null,"VHA Directive 1200.08(1) §5.f(7) "]
[null,"Select…","b.  At least 5 voting members exclusive of ex-officio members, including members with expertise regarding occupational safety and health, environmental protection, Department of Transportation (DOT) International Air Transport Association (IATA) requirements, knowledge of the space and facilities assigned to each PI?"]
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[null,null,"VHA Directive 1200.08(1) §6.b(1) "]
[null,"Select…","c.  A member from the facility Safety Committee (facility Safety Officer or a member of the facility Infection Control Committee) and an individual with radiation safety expertise?"]
[]
[null,null,"VHA Directive 1200.08(1) §6.b(1)(e) "]
[null,"Select…","d.  A liaison between the SRS and IACUC (if applicable; can be voting or non-voting)?"]
[null,null,"VHA Directive 1200.08(1) §6.b(1)(f) "]
[null,"Select…","e.  Required ex-officio members (R&DC liaison (non-voting), employee union safety representative or other union designee (voting status determined by local contract)?"]
[]
[null,null,"VHA Directive 1200.08(1) §6.b(2) "]
["36.","Select…","Does your facility use an external SRS/safety committee (not IBC) administered by another VA or an affiliated university?\nIf “Yes,” specify VA facility or affiliated university:"]
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[]
[null,"Select…","a.  If \"Yes,\" is there an MOU for the use of an external SRS/safety committee?"]
[null,null,"VHA Directive 1200.08(1) §6.a(2) "]
["37. ","Select…","Does your program conduct non-exempt recombinant DNA or synthetic nucleic acid  molecules research requiring review by an Institutional Biosafety Committee (IBC) as defined by NIH-Office of Science Policy (NIH-OSP)?   If \"No,\" skip to Question 38."]
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[]
[null,null,"VHA Directive 1200.08(1) §6.d(4) "]
[null,"Select…","a.  Does your facility have an internal IBC to review rDNA research in accordance with NIH guidelines?"]
[]
[null,null,"VHA Directive 1200.08(1) §7.a "]
[null,null,"b.  If “Yes” to #37a, please indicate below how your IBC is set up."]
[null,null,"Select…"]
[null,"Select…","c.  Is the VA IBC registered with NIH-OSP? "]
[null,null,"VHA Directive 1200.08(1) §7.b "]
[null,null,"Enter date of most recent registration/update for the VA IBC:"]
[]
[null,"Select…","d.  Does your facility use the services of an external IBC from another VA facility or an affiliated university to review rDNA research in accordance with NIH guidelines?"]
[]
[null,null,"If “Yes,” specify VA facility or affiliated university: "]
[]
[null,"Select…","e.  If \"Yes\" to #37d, is the institution's IBC registered with NIH-OSP as the IBC-of-Record for the VA facility?"]
[]
[null,null,"VHA Directive 1200.08(1) §7.e(5); VHA Directive 1200.08(1) §7.f(2)  "]
[null,null,"Enter date of most recent registration for the external IBC: "]
[]
[null,"Select…","f.  If using an affiliated university IBC, is there an MOU for use of the external IBC?"]
[null,null,"VHA Directive 1200.08(1) §5.m(2) "]
["38. ","Select…","Does your facility conduct any laboratory/bench research (excluding BSL-3)?  If \"No,\" skip to Question 39."]
[]
[null,"On-site VA laboratories:"]
[null,"Select…","Approximate number of active laboratories at on-site VA locations"]
[null,null,"Specify the locations (building name or number) of all on-site VA research laboratories"]
[]
[null,"Off-site VA-leased:"]
[null,"Select…","Approximate number of active laboratories at off-site VA-leased locations"]
[null,null,"Specify the locations (building name or number) of all off-site VA research laboratories"]
[]
[null,"Off-site Non-VA (i.e., non-leased):"]
[null,"Select…","Approximate number of active laboratories at off-site non-VA (non-leased) locations"]
[null,null,"Specify the locations (building name or number) of all off-site Non-VA (i.e., non-leased) research laboratories"]
[]
[null,"Select…","a.  For off-site non-VA (i.e., non-leased) laboratories, are the appropriate off-site waivers in place?"]
[]
[null,null,"VHA Program Guide 1200.16 §4.a-d (August 2, 2018) "]
[null,"Select…","b.  For VA research conducted in laboratories located in approved off-site facilities, has the ACOS/R&D (or equivalent) ensured there is a process in place for VA research to be reviewed with regard to research safety and security, and if necessary, provide feedback to the responsible party for the off-site facility on any deficiencies in such processes?"]
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[null,null,"VHA Directive 1200.08(1) §5.g(2)"]
["39.","Select…","Does your facility conduct any research that requires a BSL-3 laboratory? If \"No,\" skip to Question 40."]
[]
[null,null,"If “Yes,” specify infectious agent(s):"]
[]
[null,"Select…","a.  Does your facility have its own BSL-3 laboratory located in the facility or in VA-leased space?"]
[]
[null,null,"If “Yes,” specify location(s):"]
[]
[null,"Select…","b.  Does your facility conduct VA-funded research at any off-site non-VA (i.e., non-leased) BSL-3 laboratories?"]
[]
[null,null,"If “Yes,” specify location(s):"]
[]
["40.","Select…","Does your facility maintain long-term storage (>6 months) of any SARS-CoV-2 positive samples or viral isolates?"]
[]
["41.","Select…","Does your facility conduct any research that involves chemical hazards, as defined by the Occupational Safety and Health Administration (OSHA), Department of Transportation (DOT) and Environmental Protection Agency (EPA)?  If \"No,\" skip to Question 42."]
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[]
[null,"Select…","a.  Does your facility have a research-specific Chemical Hygiene Plan(CHP) (which may be included in the Research Safety Plan) that is reviewed annually?"]
[]
[null,null,"29 CFR §1910.1450 (e)(3) "]
[null,null,"Provide the date of last review:"]
[]
[null,"Select…","b.  Does your facility conduct semi-annual comprehensive inventory reviews of hazardous chemicals/agents used in research?"]
[]
[null,null,"VHA Directive 1200.08(1) §5.h(1); VHA Directive 1200.08(1) §5.k; VHA Directive 1200.08(1) §5.n(5)   "]
["42.","Select…","Does your facility conduct any research that involves the use of regulated and/or exempt quantities of Select Agents and Toxins (SATs), as defined by the Federal Select Agent Program (FSAP)?  If “Yes,” specify toxin(s) and category (exempt/nonexempt): "]
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["43.","Are the following items related to VA research laboratories and the RSSP current, in place, and/or conducted as specified:"]
[]
[null,"Select…","a.  Research Safety Plan?"]
[null,null,"VHA Directive 1200.08(1) §5.n(9)"]
[null,"Select…","b.  Research Security Plan?"]
[null,null,"VHA Directive 1200.08(1) §5.n(9)"]
[null,"Select…","c.  Emergency Management Plan?"]
[null,null,"VHA Directive 1200.08(1) §5.n(9)"]
[null,"Select…","d.  Bloodborne pathogen exposure control plan? (Select “Yes” if Research Service follows the hospital-wide plan.)"]
[]
[null,"Select…","e.  Bloodborne pathogen training (which should include an explanation of the OSHA standard and how to access the standard, an explanation of the facility Exposure Control Plan and how to access the plan, and an opportunity for questions and answers in real time during the training)?"]
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[]
[null,null,"29 CFR §1910.1030(g)(2)(vii) "]
[null,"Select…","f.  A process to activate, decommission, or transfer PI laboratories?"]
[null,null,"VHA Directive 1200.08(1) §5.g(8); VHA Directive 1200.08(1) §5.n(1)  "]
[null,"Select…","g.  SRS annual review of each PI’s VA laboratory program?"]
[null,null,"VHA Directive 1200.08(1) §6.f "]
[null,"Select…","h.  Annual safety inspections of all research laboratories?"]
[null,null,"VHA Directive 1200.08(1) §5.n(6) "]
[null,"Select…","i.  Annual drills to test the effectiveness of each research-specific plan:  safety/biosafety, security, chemical hygiene, and emergency management?"]
[]
[null,null,"NOTE:  A fire drill may test provisions in the emergency preparedness plan but is unlikely to test the provisions In the safety/biosafety or security plan."]
[]
[null,null,"VHA Directive 1200.08(1) §5.n(9); 21 CFR 1910.1450 (e)(4)  "]
[null,null,"Provide the date of most recent SRS review of the following drills:"]
[null,null,"Safety/biosafety:"]
[null,null," "]
[null,null,"Security:"]
[]
[null,null,"Chemical Hygiene:"]
[]
[null,null,"Emergency Management:"]
[]
[null,"Select…","j.  Eye wash stations/emergency showers located, installed, maintained, and tested in research areas in accordance with VHA Directive 7704?"]
[]
[null,null,"21 CFR §1910.151 (c); VHA Directive 7704 (including Appendices A-F)  "]
[null,"Select…","k.  Opportunity for enrollment in the animal-user specific component of the Occupational Safety and Health Program (OSHP) for personnel with potential contact with animals and annual medical follow-up of enrolled individuals is conducted?"]
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[]
[null,null,"VHA Handbook 1200.07 APP.C.§4.a "]
[null,"Select…","l.  Personal protective equipment (PPE) hazard assessments certified for hazards in VA research laboratories/animal facilities?"]
[]
[null,null,"29 CFR 1910.132 (d); VHA Directive 1200.08(1) §5.p(8)   "]
[null,"Select…","m.  Controlled access to all laboratories at all times? "]
[null,null,"VHA Handbook 1200.07 §7.i and VA Handbook 0730 Appendix B "]
["NOTES: Use the text box below to provide any additional information about items in the RSSP and SRS  Responsibilities section:"]
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["Research Information Security Practices (RISP)\nPlease consult with your ISSO and/or VA Office of Information and Technology (OIT) Area Manager when answering the following questions."]
["44. ","Select…","Do researchers use any system interconnections between the VA facility network and a non-VA network for VA research purposes?"]
[]
[null,null,"This question pertains to direct connections between the VAMC network and a non-VA network. These system interconnections involve configuration and approvals by OIT and sometimes exist for biomedical equipment. Current VA OIT policy requires that an approved Memorandum of Understanding/Interconnection Security Agreement for each interconnection. If any interconnections are used for research purposes, the MOU must include that business purpose of the interconnection. Reference: VA Office of Information Security (OIS) Knowledge Service (KS), Control Number CA-3, Control Correlation Identifier (CCI) CCI-000257."]
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["45.","Select…","Do researchers use any non-VA networks (e.g., air-gapped networks) and associated devices (e.g., affiliate computers) at the facility for VA research purposes? If \"No,\" skip to Question 46."]
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[]
[null,null,"This question pertains to non-VA networks physically located at the VAMC but are not directly connected to the VA network. These are typically affiliate networks or networks associated with external internet service providers. "]
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[null,"Select…","a.  If \"Yes\" to #45, do researchers use the non-VA network(s) to process, store, or transmit VA information? "]
[]
[null,null,"If a non-VA information system, such as an affiliate network, is used to transmit, process, or store VA data (data obtained or generated under an R&DC approved protocol, whether bench, animal, or human research), current VA OIT policy requires the establishment and documentation of terms and conditions, consistent with any trust relationships established with other organizations owning, operating, and/or maintaining external information systems, allowing for such uses of VA data on the external information system(s).  "]
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[null,"Select…","b. If \"Yes\" to #45a, are there instances where the VA information is considered VA sensitive information (VASI)?  "]
[]
[null,null,"If the information includes VA sensitive information (VASI), current VA OIT policy requires documenting the security controls/requirements of the non-VA information systems used to transmit, process, and/or store VASI in a contract or agreement (e.g., data use agreement) as specified in the procedures or templates provided for those types of agreements. This question does not apply to instances where a VA researcher properly discloses data to a non-VA entity and does not retain ownership (e.g., for future use in VA research), such as when VA provides data to a study coordinating site in a case report form and retains a copy for VA records. Reference: VA OIS KS, Control Number AC-20, CCI-002332, CCI-002334, CCI-002335, CCI-002336; Control Number AC-19, CCI-002329, CCI-002330 "]
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["46.","Select…","Do researchers transport VASI off-site/outside the VA?"]
[null,null,"This question pertains to the transportation, transmission, or storage of VA sensitive information (e.g., identifiable subject data, completed informed consent forms) in any format outside of VA managed facilities. Current VA policy requires that all employees must have documented approval from their supervisor before sensitive information can be removed from a VA facility that VASI is appropriately encrypted when transmitted, and that security controls are documented when VASI is stored outside (physically and/or electronically) of VA. References:  VHA Dir 1605.01 §2.g(6); VA Handbook 7002, Part 13 §5; VA OIS KS, Control Number  §MP-5, CCI-001024, and §AC-20, CCI-002338."]
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[]
["47.","Select…","Are non-VA external information systems (IT equipment) used on-site for VA research?"]
[null,null,"If so, current Logistics Management policy requires that equipment owned by an affiliated institution, or purchased by such institution from grant funds, and used by a VA investigator in a research project at the VA facility must be accounted for on an equipment inventory list (EIL) contained in the facility property management system. Reference: VA Handbook 7002 §11.3.a, Appendix I §10.c "]
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["48.","Select…","Are VA mobile devices (e.g., laptops, tablets) and VA portable devices (e.g., thumb drives, removable media) used for VA research?"]
[]
[null,null,"This question pertains to VA devices that are used for sensitive and non-sensitive VA data. When the information is VASI, VA OIT policy requires documented permission must be obtained from their supervisor. In addition, the ISSO, IT Area Manager, or designee must approve and document that the mobile or portable storage device to be used meets VA’s security requirements, including that the device employs VA-approved encryption, when required. Reference: VA OIS KS, Control Number AC-19, CCI-000082, CCI-000083, CCI-000084, CCI-002326, CCI-002329, CCI-002330, CCI-002331; Control Number AC-20, CCI-000097; Control Number SC-13, CCI-002449, CCI-002450 \nAdditionally, all VA mobile devices must be inventoried in the property accountability system, and the VA portable devices must be appropriately tracked/inventoried. References: VHA Handbook 7002 Part 8.5.b and VA Handbook 7002, Part 13, §10 "]
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["49.","Select…","Are non-VA mobile or portable devices used for VA research?"]
[null,null,"This question pertains to non-VA devices that are used for sensitive and non-sensitive VA data. If so, current VA OIT current VA OIT policy requires the establishment and documentation of terms and conditions for the use of those devices, consistent with any trust relationships established with other organizations owning, operating, and/or maintaining external information systems, allowing authorized individuals to process, store, and transmit VA-owned information using the external information system(s). Reference: VA OIS KS, Control Number AC-20, CCI-002332, CCI-002334, CCI-002335, CCI-002336\n\nIf a non-VA mobile or portable device is used to transmit or store VASI, it must also employ VA approved encryption. References: VA Handbook 6500, §2.c and VA OIS KS, Control Number SC-13, CCI-002449, CCI-002450   "]
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["50.","Select…","Is there a mechanism(s) in place to ensure access controls are applied to VA information on the VA network to ensure only appropriate staff have access to study-related data?  "]
[]
[null,null,"This would include VA data stored on shared drives on VA servers or in the VA cloud. Managements of permissions is often accomplished by restricting users’ access (either in security control groups or individually listed) to folders that contain the VA data.  Permissions management can be controlled by OIT or delegated to specific individuals (e.g., Research Service staff). In addition, the facility may have migrated to the use of the Shared Folder and File Exchange (SFFX) system to facilitate the management of folder permissions. Reference: VA OIS KS, Control Number AC-3, CCI-000213, CCI-002165 "]
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["51.","Select…","Have any research-related Plan of Action and Milestones (POAMs) been established by OIT for identified information systems deficiencies in accordance with OIT policies? "]
[]
[null,null,"This would likely require consultation with the ISSO and/or Area Manager.  A POAM would be required, for example, if a VA information system cannot meet OIT baseline information security requirements to document the vulnerability and compensating controls.  Reference: VA OIS KS, Control Number CA-5, CCI-000264"]
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["NOTES: Use the text box below to provide any additional information about items in the RISP section:"]
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["Research Misconduct"]
["52. ","Select…","Has the VA facility Director appointed, in writing, an individual to serve as the Research Integrity Officer (RIO)? (NOTE: Research Integrity Officers are responsible for receiving allegations of research misconduct and providing facility-level oversight of the handling of such allegations.)"]
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[]
[null,"Select…","a.  Are the name and contact information of the appointed RIO accurately recorded on this list of VHA RIOs posted on ORO’s website?"]
[]
[null,null,"If “No”, please contact Shara.Kabak@va.gov with current RIO name and appointment letter."]
[]
["53.","Select…","Has the facility received any formal allegations of research misconduct (fabrication, falsification, or plagiarism) during this reporting period?"]
[]
["NOTES: Use the text box below to provide any additional information about items in the Research Misconduct section: "]

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[{"$f":"PartA!C2","v":"Select Facility…"}]
["PART B - RESEARCH PROGRAM QUANTITATIVE DATA"]
[]
["All questions in Part B refer to reporting period June 1, 2022 to May 31, 2023"]
[]
["RESEARCH AND DEVELOPMENT PROGRAM AND R&DC"]
["Note: Questions shaded in yellow are new questions from previous FDC versions."]
["Note: Questions #1 to 1a are not based on RCO audits and pertain only to events occurring during the current reporting period. These questions may be best addressed by the Research Service."]
[]
["1. ","Number of protocols followed only by the R&DC at any time during this reporting period (e.g., IRB-exempt human subjects protocols; protocols without human, animal, or safety hazards not followed by any research subcommittee):"]
[]
[]
[null,"Only include protocols that are solely followed by the R&DC and not followed by any other oversight committee (including any external IRBs)."]
[]
[null,"a.  Number in #1 that were NOT initially approved by the R&DC before research was initiated:"]
[]
[null,"Note: For answers greater than zero for item #1a, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[]
["HUMAN RESEARCH PROTECTION PROGRAM"]
["Note: Questions #2 to #9 are not based on RCO audits and pertain to research conducted and events occurring during the current reporting period. These questions may be best addressed by the Research Service."]
[]
["2.","Number of human subject protocols active (open) at any time during this reporting period:"]
[null,"Include all human subjects protocols, including IRB-exempt human subjects protocols and human subjects protocols followed by external IRBs. Do not include research activities that are not subject to the Common Rule, such as expanded access protocols."]
[]
[]
[null,"MVP is approved at site."]
[null,"All-of-Us is approved at site."]
["3. ","Number of protocols in #2:"]
[null,"a.  That were exempt from IRB oversight:"]
[null,"b.  That were nonexempt from IRB oversight:"]
[null,"Note: Items 3a + 3b should equal item #2."]
["4. ","Number of protocols in #3b for which the risk level was greater than minimal risk:"]
["5. ","Number of protocols in #3b:"]
[null,"a.  With informed consent waived per 38 CFR 16.116:"]
[null,"This is the number of protocols for which the IRB has granted a waiver of informed consent for the entire study. (Do not include protocols with waivers of informed consent for recruitment in this number.)"]
[]
[null,"b.  With documentation of informed consent waived per 38 CFR 16.117(c):"]
[null,"(This is the number of protocols for which the IRB has granted a waiver of documentation of informed consent for the entire study.)"]
[]
["6.","Number of protocols in #2:"]
[null,"a.  Subject to the 2018 Common Rule:"]
[null,"b.  Subject to the Pre-2018 Common Rule:"]
[null,"Note: Items 6a + 6b should equal item #2."]
["7.","Number of protocols suspended or terminated early (for local reasons) due to the protocol not being conducted in accordance with applicable regulations, policies, agreements, or IRB requirements or due to concerns about the safety, rights, or welfare of human subjects or others:"]
[]
[]
[]
[null,"Do not include suspensions/terminations due to approval lapses or other administrative issues. \nDo not include suspensions due to the COVID-19 administrative hold."]
[]
[null,"Note: For answers greater than zero in item #7, use the text box below to provide specific details about the protocol suspension / termination or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
["8.","Number of events determined by the IRB to constitute serious and/or continuing noncompliance:"]
[]
[null,"Do not include unanticipated problems involving risks to subjects or others (UPIRTSOs) or serious adverse events (SAEs) that are unrelated to noncompliance. VHA Directive 1058.01 §7.c(2) requires written notification to the VA Medical Facility Director, the RCO and the ACOS/R&D of any determinations of serious and/or continuing noncompliance by the IRB."]
[]
[]
[]
[null,"Note: For answers greater than zero in item #8, use the text box below to provide specific details about these events or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
["9.","Number of events determined by the IRB to constitute actual unanticipated problems involving risks to subjects or others (UPIRTSOs):"]
[]
[null,"A UPRIRSTO in human subjects research is an incident, experience or outcome that is: unexpected; related or possibly related to participation in the research; and indicative of the research placing subjects or others at substantively greater risk of harm."]
[]
[]
[null,"Note: For answers greater than zero in item #9, use the text box below to provide specific details about these events or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
["Informed Consent Audits"]
["Note: Questions #10 to #18 are based on RCO Informed Consent (IC) Audits for this reporting period. "]
["RCOs are required to conduct an IC audit on all active human subject protocols with the exception of protocols that have previously received at least one IC audit where 1) the research is permanently closed to the enrollment of new subjects, 2) all subjects have completed all research-related interactions and interventions, and 3) the research has progressed to the point that it involves only accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care; or where the remaining research activities are limited to data analysis.  Include all deficiencies found and confirmed at the time of the audit, even if deficiencies were eventually remediated."]
[]
[]
[]
[]
["10.","Number of protocols in #2 requiring an informed consent audit:"]
[null,"a.  Number of protocols in #10 receiving a required informed consent audit:"]
[null,"Note: If all required audits were not completed, use the text box below to provide additional information."]
[]
[null,"b. Number of additional protocols receiving an informed consent audit: "]
[null,"(This is the number of protocols that DID NOT REQUIRE an informed consent audit, yet received an informed consent audit.)"]
[]
[null,"c. Total number of protocols receiving an informed consent audit:",{"$f":"$C$81+$C$84","v":0}]
[null,"Note: This number is auto-calculated from #10a + #10b."]
["11.","Total number of protocols in #10c allowing the use of broad consent:"]
["12.","Number of protocols in #10c with informed consent waived per 38 CFR 16.116:"]
[null,"a.  Number of protocols in #12 without an appropriate waiver of informed consent:"]
[null,"(This is the number of protocols with \"N\" in \"Waiver appropriate\" under \"Informed consent waived per 38 CFR 16.116.\")"]
[]
[null,"Note: If waivers were not all appropriate, use the text box below to provide additional information."]
[]
["13.","Number of protocols in #10c with documentation of informed consent waived per 38 CFR 16.117:"]
[]
[null,"a.  Number of protocols in #13 without an appropriate waiver of documentation of informed consent:"]
[]
[null,"(This is the number of protocols with \"N\" in \"Waiver appropriate\" under \"Documentation of informed consent waived per 38 CFR 16.117(c).\")"]
[]
[null,"Note: If waivers were not all appropriate, use the text box below to provide additional information."]
[]
["14.","Number of protocols in #10c with HIPAA authorization waived per the HIPAA Privacy Rule 45 CFR 156.512(i):"]
[]
[null,"a.  Number of protocols in #14 without an appropriate waiver of HIPAA authorization:"]
[null,"[This is the number of protocols with \"N\" in \"Wavier appropriate\" under \"HIPAA authorization waived per HIPAA Privacy Rule (45 CFR sec. 164.512Ii).\"]"]
[]
[null,"Note: If waivers were not all appropriate, use the text box below to provide additional information."]
[]
["15.","Total number of informed consent documents (ICDs) audited in all protocols:"]
[null,"(This is the total number of entries in the \"Subject ID\" column in the tool. MVP ICDs audited should be included in this count.)"]
[]
[null,"a.  Number of individual ICDs audited found to have no audit deficiencies:"]
[null,"(This is the number of ICDs with \"Y\" in the \"Correct version,\" \"IRB-approved\" and \"ICD from correct study\" columns, and a \"N\" or \"N/A\" in all other ICD columns of the IC audit tool related to the ICD. Do not include deficiencies related to CPRS progress notes, HIPAA authorization deficiencies, or other deficiencies in local policy in this count.)"]
[]
[]
[null,"b.  Number of missing ICDs: "]
[null,"(This is the number of entries with \"N\" under \"ICD or copy found.\" Missing ICDs SHOULD be included in the count of total number of ICDs in item #15, but SHOULD NOT be included in counts for other deficiencies below. Do not count ICDs thought to be missing at the time of audit, but that were eventually located.)"]
[]
[]
[null,"Note: For answers greater than zero in item #15b, use the text box below to provide specific details about the missing consent forms (e.g., whether reported to a review board, board's determination, etc.) or to provide the ORO case number(s) if previously reported to ORO. "]
[]
[]
[]
[null,"c.  Number of ICDs with wrong version used:"]
[]
[null,"(This is the number of entries with “N\" under \"Correct version.\")"]
[null,"d.  Number of ICDs from another study used:"]
[null,"(This is the number of entries with “N” under “ICD from Correct study.”)"]
[null,"e.  Number of unapproved ICDs used:  "]
[null,"(This is the number of entries with “N” under “IRB-approved.”)"]
[null,"Note: For answers greater than zero in items #15d and/or #15e, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,"f.  Number of ICDs without a subject (or Legally Authorized Representative ) signature:"]
[null,"(This is the number of entries with “N” under “Subject signature present.”)"]
[null,"Note: For answers greater than zero in item #15f, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,"g.  Number of ICDs without a subject date:"]
[null,"(This is the number of entries with “N” under “Date of subject signature present.”)"]
["16.","Number of ICDs audited subject to the 2018 Common Rule Requirements:"]
[null,"a.  Number of ICDs in #16 without the required key information up front:"]
[null,"(This is the number entries with “N” under “Key info provided up front.”)"]
[null,"b.  Number of ICDs in #16 from protocols involving identifiable information or biospecimens:"]
[]
[null,"(This is the number of entries with “Y” under “Identifiable info/biospecimens collected.”)"]
[null,"c.  Number of ICDs in #16b without the required statement on future use of identifiable information or biospecimens:"]
[]
[null,"(This is the number of entries with “N” under “Information or biospecimen statement on future use.”)"]
["17.","Number of HIPAA authorizations required:"]
[null,"a.  Number of valid HIPAA authorizations not obtained (i.e., no HIPAA authorization or copy that could be located or HIPAA authorization missing signature or date):  "]
[]
[null,"(This is the number of HIPAA authorizations with “N” under \"Valid HIPAA authorization obtained.\")"]
[null,"Note: For answers greater than zero in item #17a, use the text box below to provide specific details  (e.g., whether reported to a review board or Privacy Office, board's determination, corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,"b.  Number of HIPAA authorizations obtained that required use of VA Form 10-0493 (i.e., HIPAA authorizations not combined with the ICD):  "]
[]
[null,"[This is the number of entries with \"Y\" under \"VA Form 10-0493 required (HIPAA separate from ICD).” VA Form 10-0493 is required for all protocols approved between March 12, 2015 and January 20, 2019, and for protocols approved on or after January 21, 2019 utilizing a separate HIPAA authorization document. Do not include MVP or All-of-Us HIPAA authorizations in this count; MVP and All-of-Us have waivers from the requirement to use the VA Form 10-0493.]"]
[]
[]
[]
[null,"c.  Number of HIPAA authorizations in #17b not using VA Form 10-0493 as required:"]
[null,"(This is the number of entries with \"N\" under \"VA Form 10-0493 used if separate HIPAA authorizations.\")"]
["18. ","Number of Veterans enrolled in the MVP during the reporting period:"]
[null,"(Only include enrollments from the main MVP; do not include enrollments in any MVP sub-studies.)"]
[null,"a.  Number of Veterans whose MVP ICD and HIPAA authorization were audited:  "]
[null,"(Items #18 and #18a are asked to ensure the requirement for auditing at least 10% of MVP ICDs has been met. The number of MVP ICDs audited should also be included in the count of ICDs audited in item #15 and the number of MVP HIPAA authorizations audited should be included in the count of HIPAA authorizations audited in item #17 above.)",{"$f":"C172/C170","v":{"$error":"#DIV/0!"}}]
[]
[]
[]
["Notes for ICD Section:"]
[]
[]
["HRPP Regulatory Audits"]
["Note: Questions #19 to #32 are based on RCO Regulatory Audits conducted for the current reporting period."]
["19. ","Total number of human subjects protocols receiving an HRPP regulatory audit for this period:"]
[]
[null,"a.  Number of audited protocols in #19 that were greater than minimal risk:"]
[null,"b.  Number of protocols in #19a (greater than minimal risk protocols) that received initial approval by expedited review:"]
[]
[null,"Note:  For answers greater than zero for item #19b, use the text box below to provide specific details or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
["20.","Number of protocols initiated or completed prior to approval by appropriate oversight committees:"]
[]
[null,"a.  Number of protocols audited in #19 initiated prior to required IRB approval:"]
[null,"(This is the number of protocols with \"N\" under \"IRB approval prior to research.\")"]
[null,"b.  Number of protocols in #20a completed without required IRB approval:"]
[null,"c.  Number of protocols audited in #19 initiated prior to required R&DC approval:"]
[null,"(This is the number of protocols with \"N\" under \"R&DC approval prior to research.\")"]
[null,"d.  Number of protocols in #20c completed without required R&DC approval:"]
[null,"e.  Number of protocols in #19 initiated prior to receiving the ACOS/R letter:"]
[null,"(This is the number of protocols with \"N\" under \"ACOS/R letter prior to research.\")"]
[null,"f. Number of protocols in #19 without final Privacy Officer (PO) review prior to final R&DC approval:"]
[]
[null,"(This is the number of protocols with \"N\" under \"Final PO review prior to final R&DC approval.\")"]
[null,"g. Number of protocols in #19 without final Information System Security Officer (ISSO) review prior to final R&DC approval:"]
[]
[null,"(This is the number of protocols with \"N\" under \"Final ISSO review prior to final R&DC approval.\")"]
[null,"Note: For answers greater than zero in any item #20a to #20g, use the text box below to provide specific details (whether reported to a review board, board's determination, corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
["21. ","Number of human subject protocols audited in #19 involving international research:"]
[null,"a.  Number of protocols in #21 that did not have documentation of Medical Facility Director approval (or CRADO approval as applicable):"]
[]
[null,"Note: For answers greater than zero in item #21a, use the text box below to provide specific details (e.g., corrective actions) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
["22.","Number of human subject protocols audited in #19 involving children:"]
[null,"a.  Number of protocols in #22 that did not have documentation of Medical Facility Director approval (or CRADO approval as applicable):"]
[]
[null,"Note: For answers greater than zero in item #22a, use the text box below to provide specific details (e.g., corrective actions) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
["23.","Number of human subject protocols audited in #19 involving prisoners:"]
[null,"a.  Number of protocols in #23 that did not have documentation of CRADO approval:"]
[null,"Note: For answers greater than zero in item #23a, use the text box below to provide specific details (e.g., corrective actions) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
["24.","Number of human subject protocols audited involving the use of investigational drugs:"]
[null,"(This is the number of protocols with \"Y\" under \"Does this protocol involve the use of investigational drugs.\")"]
[null,"a.  Number of protocols in #24 with investigational drug log / accountability record not containing all required elements:"]
[]
[null,"(This is the number of protocols with “N” under “Does the investigational drug log or accountability record contain the required elements.”)"]
[]
[null,"b.  Number of protocols in #24 with investigational drugs not stored separately from regular pharmacy stock:"]
[]
[null,"(This is the number of protocols with “N” under “Are investigational drugs stored separately from regular pharmacy stock.”)"]
[]
["25.","Number of protocols audited in #19 subject to the 2018 Common Rule requirements:"]
[null,"a.  Number of protocols in #25 that were IRB-exempt:"]
[null,"b.  Number of protocols in #25a with exempt category not documented:"]
[null,"(This is the number of protocols with “N” under “Exempt category documented.”)"]
[null,"c.  Number of protocols in #25a with incorrect exempt category:"]
[null,"(This is the number of protocols with “N” under “Does the exempt category determination appear to match the regulatory description of the category.”)"]
[]
[null,"Note: For answers greater than zero in items #25b or #25c, use the text box below to provide specific details  (e.g., corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[null,"d.  Number of protocols in #25a requiring limited IRB review:"]
[null,"(This is the number of protocols with “Y” under “Did the protocol require a limited IRB review.”)"]
[null,"e.  Number of protocols in #25d not receiving required limited IRB review:"]
[null,"(This is the number of protocols with “N” under “Did the protocol receive a limited IRB review.”)"]
[null,"Note: For answers greater than zero in item #25e, use the text box below to provide specific details (e.g., corrective actions, etc.) or to provide the ORO case number if previously reported to ORO."]
[]
[]
[null,"f.  Number of protocols in #25a involving direct interaction with human subjects without provision for providing subjects required information:"]
[]
[null,"(This is the number of protocols with “N” under “…did the study documents include provisions for giving the subjects the information outlined in VHA Directive 1200.05(2) § 10.c.”)"]
[]
[null,"Note: For answers greater than zero in item #25f, use the text box below to provide specific details (e.g., corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO. "]
[]
[]
["26.","Number of 2018 Common Rule protocols audited (#25) subject to the single IRB requirement:"]
[]
[null,"(This is the number of protocols with “Y” under “Is this protocol subject to the single IRB review requirement.”)"]
[null,"a.  Number of protocols in #26 that were reviewed by a single IRB:"]
[null,"(This is the number of protocols with “Y” under “Was the study reviewed by a single IRB.”)"]
[null,"b.  Number of protocols in #26a without a valid reliance agreement in place between the single IRB and the facility:"]
[]
[null,"(This is the number of protocols with “N” under “If the study was reviewed by a single IRB that was external to the VA medical facility, was a valid reliance agreement in place for the VA medical facility to rely on that external IRB.”)"]
[]
[null,"c.  Number of protocols in #26 not reviewed by a single IRB:"]
[null,"(This is the number of protocols with “N” under “Was the study reviewed by a single IRB.”)"]
[null,"d.  Number of protocols in #26c without a valid exception granted by the VHA ORD or another Federal entity supporting or conducting the research, as appropriate:"]
[]
[null,"(This is the number of protocols with “N” under “If that study was not reviewed by a single IRB, was a valid exception granted by ORD or another Federal entity supporting the research.”)"]
[]
[null,"Note: For answers greater than zero in item #26b or #26d, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
["27.","Number of protocols audited in #19 that required IRB continuing review per 1200.05(2):"]
[null,"(This is the number of protocols with “Y” under “Is IRB CR required by VHA Directive 1200.05(2).”)"]
["28.","Number of protocols audited in #19 not requiring IRB continuing review per 1200.05(2) but continuing review was required by the IRB:"]
[]
[null,"(This is the number of protocols with “Y” under “If CR was NOT required by 1200.05(2), did the IRB require CR.”)"]
["29.","a.  Number of protocols in #27 or #28 with a lapse of IRB continuing review:"]
[null,"(This is the number of protocols with \"N\" under \"If CR was required by either 1200.05(2) or the IRB, did CR occur as scheduled.\")"]
[]
[null,"b.  Number in #29a for which research activities occurred during lapse:"]
[null,"Do not count research activities occurring during the approval lapse period that were authorized by the IRB to continue in the best interests of already-enrolled subjects."]
[]
[null,"Note: For answers greater than zero in item #29b, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,"c.  Number in #28 with rationale for IRB-required continuing review not documented:"]
[null,"(This is the number of protocols with \"Y\" under \"If the IRB did required CR, was the rationale for requiring CR documented.\")"]
[]
[null,"Note: For answers greater than zero in item #28c, use the text box below to provide specific details about why the rationale for IRB-required continuing review was not documented. "]
[]
[]
["30.","For those protocols receiving an HRPP regulatory audit (#19), what was the total number of apparent unanticipated problems involving risks to subjects or others (UPIRTSOs) (including serious adverse events) reported to the reviewing IRB (local or external):"]
[]
[]
[null,"a.  Number of events in #30 that were determined by the reviewing IRB to constitute actual UPIRTSOs (unexpected, related or possibly related to the research, and placing subjects or others at substantively greater risk):"]
[]
[null,"(This is the number of apparent UPIRTSOs with \"Y\" under \"\"Unanticipated (U), related or possibly related to study participation(R), AND increased risk (↑risk).\""]
[]
[null,"b.  Number of UPIRTSOs in #30a not reported to the IRB within the required time period:"]
[null,"(This is the number of apparent UPIRTSOs with \"Y\" under \"\"Unanticipated (U), related or possibly related to study participation(R), AND increased risk (↑risk).\""]
[]
[null,"c.  Number of UPIRTSOs in #30a not reviewed and categorized by the IRB within the required time period:"]
[]
[null,"(This is the number of apparent UPIRTSOs with \"N\" under \"Reviewed and categorized within the required time period.\")"]
[]
[null,"Note: For answers greater than zero in item #30b or #30c, use the text box below to provide specific details about these events or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
["31.","Total number of research personnel records audited as part of the HRPP regulatory audits in #19:"]
[]
[null,"a.  Number of research personnel records in #31 with lapse in required human research training:"]
[]
[null,"(This is the number of records with “N” under “All human research training current.”)"]
[null,"b.  Number of research personnel records in #31 without initial training:"]
[null,"(This is the number of records with “N” under “If training not current, training ever completed.”)"]
[null,"Note: For answers greater than zero in item #31b, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
["32.","Total number of subject records reviewed as part of the HRPP regulatory audits in #19 for this period:"]
[]
[null,"(Subject records review can be found on page 6 of the HRPP audit tool.)"]
[null,"a.  Number of subjects in #32 with research initiated prior to consent:   "]
[null,"(This is the number of subject records with “N” under “Documentation that consent obtained prior to initiation of study procedures.”)"]
[]
[null,"Note: For answers greater than zero in item #32a, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,"b.  Number of subject records in #32 for which application of inclusion/exclusion criteria were audited:"]
[]
[null,"(This is the number of subject records with either \"Y\" or \"N\" under \"Subject included in research not meeting inclusion or meeting exclusion criteria.\" Auditing inclusion/exclusion criteria is only required for research involving intervention or interaction with subjects determined to be more than minimal risk by the IRB.) "]
[]
[]
[null,"c.  Number of subjects in #32b included in research without satisfying inclusion/exclusion criteria:"]
[]
[null,"(This is the number of subject records with “Y” under \"Subject included in research not meeting inclusion or meeting exclusion criteria.\")"]
[]
[null,"Note: For answers greater than zero in item #32c, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,"d.  Number of subjects in #32 without a progress note present in the health record when required:"]
[]
[null,"(This is the number of subject records with “N\" under \"If progress note was required in VHA health record, was it present.\")"]
[]
["Notes for HRPP/IRB Section: "]
[]
[]
["ANIMAL CARE AND USE PROGRAM AND IACUC"]
[null,"If your program does not have an ACUP, skip questions #33 to #40b."]
[]
["Note: Questions #33 to #35 are not based on RCO audits and pertain only to events occurring during the current reporting period. These questions may be best addressed by the Research Service."]
[]
["33.","Total number of animal protocols active (open) at any time during this reporting period:"]
["34.","Number of protocols that were suspended or terminated early by the IACUC due to the study not being conducted in accordance with applicable regulatory, policy, or IACUC requirements or due to animal or research personnel welfare concerns:"]
[]
[]
[null,"Note: If not yet reported to ORO, use the text box below to provide specific details for suspensions, including species and associated corrective actions (if applicable). If previously reported to ORO, provide the ORO case number(s). If an ORO case number is provided, no additional information is necessary."]
[]
[]
[]
["35.","Number of events determined by the IACUC to constitute serious and/or continuing noncompliance:"]
[]
[null,"(VHA Directive 1058.01 §9.d(2) requires written notification to the VA Medical Facility Director, the RCO, and the ACOS/R&D of any determinations of serious and/or continuing noncompliance by the IACUC.)"]
[]
[null,"Note: For answers greater than zero in item #35, use the text box below to provide specific details about these events or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
["Animal Welfare Audits"]
["Note: Questions #36 to #40b are based on RCO Regulatory Audits conducted for this reporting period."]
["36.","Total number of protocols receiving animal welfare regulatory audits during the reporting year:"]
[]
["37.","Number of protocols audited in #36 involving DEA controlled substances:"]
[null,"[This is the number of protocols with \"Y\" under \"Does this protocol involve drug enforcement administration (DEA) controlled substances.\"]"]
[]
[null,"a.  Number of protocols in #37 conducted at the VA:"]
[null,"(This is the number of protocols with \"Y\" under \"Is this protocol conducted at the VA.\")"]
[null,"b.  Number of protocols in #37a with DEA controlled substances not obtained through the VA pharmacy:"]
[]
[null,"(This is the number of protocols with \"N\" under \"Are controlled substances obtained through the VA Pharmacy.\")"]
[null,"Note: For answers greater than zero in item #37b, use the text box below to provide specific details or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[null,"c.  Number of protocols in #37a with controlled substances not properly stored:"]
[null,"(This is the number of protocols with “N” under “Controlled substances stored in a double-locked cabinet and only accessible to authorized personnel.”)"]
[]
[null,"Note: For answers greater than zero in item #37c, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
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["38.","Number of protocols initiated or completed prior to approval by appropriate oversight committees:"]
[]
[null,"a.  Number of protocols audited in #36 initiated prior to IACUC approval:"]
[null,"(This is the number of protocols with \"N\" under \"Initial IACUC approval obtained prior to research.\")"]
[null,"b.  Number of protocols in #38a completed prior to IACUC approval:"]
[null,"c.  Number of protocols audited in #36 initiated prior to R&DC approval:"]
[null,"(This is the number of protocols with \"N\" under \"Initial R&DC approval obtained prior to research.\")"]
[null,"d.  Number of protocols in #38c completed prior to R&DC approval:"]
[null,"e.  Number of protocols in #36 initiated prior to receiving the ACOS/R letter:"]
[null,"(This is the number of protocols with \"N\" under \"Initial ACOS/R letter obtained prior to research.\")"]
[null,"Note: If not yet reported to ORO, use the text box below to specific provide details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) for research initiated or completed prior to committee approval. If previously reported to ORO, provide the ORO case number(s). If an ORO case number is provided, no additional information is necessary."]
[]
[]
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["39.","Number of protocols audited in #36 that required at least one IACUC annual review:"]
[null,"a.  Number of protocols in #36 with a lapse in annual review:"]
[null,"(This is the number of protocols with \"N\" under \"Has the protocol received the required annual IACUC approvals.\")"]
[null,"b.  Number of protocols audited in #36 that required a triennial review:"]
[null,"c.  Number of protocols in #39b with a lapse(s) in triennial review:"]
[null,"(This is the number of protocols with \"N\" under \"Has the protocol received the required triennial de-novo IACUC approvals.\")"]
[]
[null,"d.  Number of protocols in #39c in which research activities continued during the lapse in triennial review:"]
[]
[null,"(This is the number of protocols with \"Y\" under \"If NO, did any research occur during the lapse.\")"]
[null,"Note: If not yet reported to ORO, use the text box below to provide specific details for lapses in triennial reviews, including species and associated corrective actions (if applicable). If previously reported to ORO, provide the ORO case number(s). If an ORO case number is provided, no additional information is necessary."]
[]
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[]
["40.","Total number of research personnel records audited as part of the animal welfare audits in #36:"]
[]
[null,"a.  Total number of research personnel records in #40 with lapse in required continuing animal welfare training:"]
[]
[null,"(This is the number of records with “N” under “All animal welfare training current.”)"]
[null,"b.  Number of research personnel records in #40 without initial animal welfare training:"]
[null,"(This is the number of records with “N” under “If training not current, initial animal welfare training ever completed.”)"]
[]
[null,"Note: For answers greater than zero in item #40b, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
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["Notes for ACUP/IACUC Section: "]
[]
[]
["RESEARCH SAFETY AND SECURITY PROGRAM AND SRS"]
["If your program does not have research involving biological, chemical, physical, \nor radiation hazards, skip questions #41 to #50b."]
[]
["Note: Questions #41 to #43 are not based on RCO audits and pertain only to events occurring during the current reporting period. These questions may be best addressed by the Research Service."]
[]
["41.","Total number of safety protocols active (open) at any time during this reporting period:     "]
[null,"a.  Number of protocols in #41 with no IRB or IACUC approval components (i.e., only basic science, bench, or wet lab protocols):"]
[]
["42.","Number of protocols in #41 suspended or terminated early by the SRS due to research laboratory safety or security concerns, including concerns about the safety of individuals conducting VA laboratory research, or environmental concerns attributed to VA laboratory research:"]
[]
[]
[]
[null,"Note: If not yet reported to ORO, use the text box below to provide specific details for suspensions. If previously reported to ORO, provide the ORO case number(s). If an ORO case number is provided, no additional information is necessary."]
[]
[]
[]
["43.","Number of events determined by the SRS to constitute serious and/or continuing noncompliance:"]
[]
[null,"(VHA Directive 1058.01 §10.c(2) requires written notification to the VA Medical Facility Director, the RCO, and the ACOS/R&D of any determinations of serious and/or continuing noncompliance by the SRS.)"]
[]
[null,"Note: For answers greater than zero in item #43, use the text box below to provide specific details about the SRS determinations of serious and/or continuing noncompliance or to provide the ORO case number(s) if previously reported to ORO."]
[]
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[]
["Research Safety Audits"]
["Note: Questions #44 to #50b are based on RCO Regulatory Audits conducted for this reporting period. "]
["44.","Number of protocols receiving a Research Safety regulatory audit during the reporting period:"]
[]
["45.","Number of protocols audited in #44 conducted completely or partially at an off-site location:"]
[]
[null,"a.  Number of protocols in #45 with \"No\" in \"ORD approved waiver for off-site research\":"]
["46.","Number of protocols audited in #44 involving chemical hazards:"]
[null,"(This is the number of protocols with \"Y\" under \"Does this protocol involve chemical hazards.”)"]
[null,"a.  Number of protocols in #46 without required semi-annual laboratory chemical inventory review:"]
[]
[null,"(This is the number of protocols with \"N\" under \"Was the laboratory chemical inventory reviewed semi-annually as required by VHA policy.”)"]
[]
[null,"Note: For answers greater than zero in item #46a, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
["47.","Number of protocols audited in #44 involving radioisotopes or radiation sources:"]
[null,"a.  Number of protocols in #47 without required review by the Radiation Safety Officer or Research Safety Coordinator:"]
[]
[null,"(This is the number of protocols with \"N\" under \"Has the protocol been reviewed by the Radiation Safety Officer or Research Safety Coordinator.\")"]
[]
["48.","Number of protocols initiated or completed prior to approval by appropriate oversight committees:"]
[]
[null,"a.  Number of protocols audited in #44 initiated prior to SRS approval:"]
[null,"(This is the number of protocols with \"N\" under \"Initial SRS approval prior to research.”)"]
[null,"b.  Number of protocols in #48a completed prior to SRS approval:"]
[null,"c.  Number of protocols in #44 without appropriate written notification of outcome of SRS review:"]
[]
[null,"(This is the number of protocols with “N” under “Investigator notified in writing of the outcome of SRS review.”)"]
[null,"d.  Number of protocols audited in #44 initiated without required R&DC approval:"]
[null,"(This is the number of protocols with “N” under “Initial R&DC approval prior to research.”)"]
[null,"e.  Number of protocols in #48d completed without required R&DC approval:"]
[null,"f.  Number of protocols in #44 initiated prior to receiving the ACOS/R letter:"]
[null,"(This is the number of protocols with “N” under “ACOS/R letter prior to research.”)"]
[null,"Note: If not yet reported to ORO, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) for research initiated or completed prior to committee approval. If previously reported to ORO, provide the ORO case number(s). If an ORO case number is provided, no additional information is necessary."]
[]
[]
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["49.","Number of protocols audited in #44 involving use of non-exempt rDNA requiring IBC approval:"]
[]
[null,"a.  Number of protocols in #49 initiated prior to IBC approval:"]
[null,"b.  Number of protocols in #49a completed prior to IBC approval:"]
[null,"c.  Number of protocols in #49 without appropriate notification of IBC review:"]
[null,"(This is the number of protocols with “N” under “Was the investigator appropriately notified in writing or electronically of the outcome of the IBC’s review.”)"]
[]
[null,"Note: If not yet reported to ORO, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) for research initiated or completed prior to IBC approval or without appropriate notification of IBC review. If previously reported to ORO, provide the ORO case number(s). If an ORO case number is provided, no additional information is necessary."]
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[]
[]
[]
["50.","Total number of research personnel records audited as part of the research safety audits in #44:"]
[]
[null,"a.  Total number of research personnel records in #50 with lapse in required continuing research safety training:"]
[]
[null,"(This is the number of research personnel records with an “N” under “All safety training current.”)"]
[null,"b.  Number of research personnel records in #50 without initial research safety training:"]
[null,"(This is the number of personnel records with a “N” under “If training not current, research safety training ever completed.”)"]
[]
[null,"Note: For answers greater than zero in item #50b, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
["Notes for RSSP/SRS Section:"]

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[{"$f":"PartA!C2","v":"Select Facility…"}]
["Facility Director Attestation"]
[]
["I acknowledge that I am the Director of this VHA Facility and the Institutional Official responsible for this Facility’s compliance with all federal, VA, and VHA research requirements.  "]
[]
[]
["By submitting this document, I certify that the information contained in this document is accurate to the best of my knowledge."]
[]
[]
["Complete the following steps to submit this Certification:"]
["1. Type your name in the \"Name of the Medical Facility Director\" text box highlighted below."]
["2. Save the file by clicking the \"Save File\" button below."]
["3. Click the \"Email File\" button to attach this file to an email."]
["4. In the body of the email, please update \"[Insert Station Number and/or Facility Name] \" with your facility's station number and/or facility name and send the email."]
[]
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["Name of the Medical Facility Director:"]

{"sheet":"FDC Instructions","index":3,"n_rows":106,"n_cols":1,"rows_kept":106,"cut":false,"hidden":false,"merged":[[2,0,3,9],[18,0,18,9],[27,0,27,9],[10,0,10,9],[12,0,13,9],[22,0,22,9],[7,0,8,9],[5,0,5,9],[87,0,89,9],[105,0,105,9],[93,0,93,9],[95,0,96,9],[98,0,99,9],[101,0,101,9],[63,0,64,9],[15,0,16,9],[81,0,82,9],[84,0,85,9],[24,0,25,9],[68,0,71,9],[20,0,20,9],[50,0,52,9],[31,0,31,9],[45,0,48,9],[54,0,56,9],[58,0,61,9],[73,0,75,9],[77,0,79,9],[41,0,43,9],[33,0,39,9]]}
["GENERAL INSTRUCTIONS"]
[]
["1. Complete and submit the 2023 Facility Director’s Certification of Research Oversight (FDC) in MS Excel format.  "]
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[]
["2. Open the Excel tool in the MS Excel application. Do not open the tool through MS Teams or OneDrive."]
[]
["3. Save the tool as a macro-enabled workbook (.xlsm) so all functions work as intended. The tool has built-in logic to hide or gray out certain questions and rows depending on the answers to other questions. "]
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["4. Include your facility's name in the file name of the saved document."]
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["5. Adjust how zoomed in or out you are on the screen as needed if an item appears to be truncated. All items are formatted to be fully visible, but appearances may differ by screen. "]
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["6. Do not separate individual Worksheets from the overall Workbook for completion. The tool must remain as a single Workbook so that all functions work as intended. "]
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["7. Use the tab key to navigate through the items requiring a response on each Worksheet. "]
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["8. Do not copy and paste information into the text boxes. Type information directly into the text boxes. "]
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["9. Do not include any identifiable information (e.g., subject or investigator names) in the tool."]
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["10. To print a copy of the tool: Highlight the Worksheets that you would like to print by pressing Ctrl and click on the Worksheet tabs. Ensure \"Print Active Sheets\" is selected under print options."]
[]
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["11. Direct any questions related to the 2023 FDC to: OROIDA@va.gov."]
[]
["PART A"]
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["1. Use only the designated dropdowns and text boxes to respond. Do not copy and paste information."]
[]
["2. For dropdowns: Click in the bright blue box and the dropdown arrow will become visible. Select the appropriate response from the options shown. Most dropdown selections are in the column immediately to the right of the question number; however, a few dropdown selections are in the column with the question text, when a wider column is needed to view all options. After you select an option from one of the wider dropdown menus, all other dropdown menus may appear too wide for your screen. If this happens, make a selection from one of the dropdown menus in the column immediately to the right of the question number (the narrower column) and click save to restore all dropdown menus to the appropriate width. "]
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["3. To enter information into a tan text box: Click in the box and begin typing a response. Do not paste information into the text boxes. Text boxes will appear bright yellow when a response is required based on the selection in the dropdown menu. Text boxes will turn white once the required response has been entered."]
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["4. Use instructions with color-coded font to identify specific actions to take. Red font instructions provide clarification or indicate when additional information is needed. Blue font instructions provide direction to the next applicable question when rows with questions that are not applicable to your site (based on prior responses) become hidden. "]
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["5. Use designated text boxes at the end of each section for any additional notes you would like to provide to ORO or to further explain any answers that indicate outstanding noncompliance. Do not copy and paste text into the notes boxes. All notes sections will expand as you type in text. "]
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["6. Scan through the tool once all responses are entered to ensure there are no remaining colored cells that need to be completed. Response boxes will turn white once completed so you can easily identify which cells require a response. "]
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["7. To navigate to additional information about the Common Findings: Click on the blue \"More Info\" box to navigate to more information about the Common Findings applicable to that FDC item. Click on the blue \"back\" button to return to the FDC Part A. Common Findings are designated by orange boxes with black borders throughout the FDC tool. "]
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["8. To navigate to Definitions: Click on the yellow \"See Definition\" box to navigate to specific definitions throughout Part A. Click on the blue \"back\" button to return to the FDC Part A. "]
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["PART B"]
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["1. Enter whole number responses directly into the gray response boxes. Do not copy and paste responses into the gray responses boxes. Response boxes will turn bright yellow with red font text if a response is entered that is inconsistent with other information that you previously entered into the tool. Data validation prompts will also help you to identify potential data entry errors. "]
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["2. To enter information into a text box: Click in the box and begin typing a response. Do not copy and paste responses. Tan boxes for text responses will turn bright yellow when more information is required based on a prior response. Text boxes will turn white once the required response has been entered. "]
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["3. Use designated text boxes at the end of each section for any additional notes you would like to provide to ORO or to further explain any answers indicating outstanding noncompliance. Do not copy and paste text into the notes boxes. All notes sections will expand as you type in text. "]
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["4. Look for additional instructions in red font throughout Part B of the tool that provide guidance on what information to include for certain responses. "]
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["5.  Items will turn gray and responses boxes will disappear if you do not need to respond to that item based on your prior responses. "]
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["6. Scan through the tool once all responses are entered to ensure there are no remaining colored cells that need to be completed. Response boxes will turn white once completed so you can easily identify which cells require a response. "]
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["SUBMISSION (All submissions steps should be completed by the Medical Facility Director.)"]
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["1. Sign (print name) on the Director Attestation tab. An electronic signature is not required."]
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["2. Save a copy of the completed tool by clicking on the “Save File” button on the Director Attestation tab. Make sure the facility's name is in the file name of the saved document. "]
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["3.  Click on the “Email File” button after saving the file. An Outlook message with the file attached will appear."]
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["4. Enter the Station Number and/or Facility Name where prompted in the body of the Outlook message."]
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["5. Click \"send\" on the Outlook message with the file attached. "]
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["6. The FDC must be signed and submitted by the Medical Facility Director. "]

{"sheet":"Common Findings","index":4,"n_rows":275,"n_cols":1,"rows_kept":275,"cut":false,"hidden":false,"merged":[]}
["The Common Findings Tab lists recurring findings of programmatic noncompliance captured in ORO combined program review (CPR) reports issued in calendar years 2020 through 2022. \"Common Findings\" are those findings identified at 20% or more of the programs reviewed across the combined 3-year period (2020-2022). The numbered items (shaded in orange) list the Common Findings. The bulleted points below each listed Common Finding provide representative examples of that finding from the CPR reports. Red font denotes that the description of the finding aligns with a specific question on the FDC. \n\nIn the Part A Tab, FDC items related to a Common Findings are shaded in orange with a black border to provide information about which FDC questions correspond with the Common Findings. Information about the Common Findings from CPRs has been added to the FDC to bring awareness to the nature of the noncompliance ORO regularly finds during site visits. By raising awareness of these Common Findings, ORO hopes to try to reduce the occurrence of that noncompliance."]
[]
["Common Findings Related to General Research Administration"]
["1. Deficient R&DC Review / Approval of Research "]
["• All applicable committee reviews and approvals did not occur prior to R&DC approval and notification of permission to initiate the research, to include:"]
["◦ Final IRB approval was not secured prior to final R&DC approval."]
["◦ VA-approved laboratory studies were reviewed and approved by the R&DC prior to the SRS and IBC approvals required by the proposed research."]
["◦ Privacy Officer (PO) reviews were not completed prior to final R&DC approval."]
["◦ Information System Security Officer (ISSO) reviews were not completed prior to final R&DC approval. "]
["• The R&DC reviewed and approved VA research at convened meetings without a quorum present."]
["• Final approvals by Designated Member Review (DMR) were not reported to the full R&DC at the next convened meeting, as required by VHA policy. "]
["• The R&DC did not approve amendments to approved research for which it was the only oversight committee."]
["• Final approval contingent upon completion of the ISSO review was at times granted administratively by the R&DC coordinator rather than by the convened R&DC, R&DC Chair, or by DMR. "]
["• The R&DC did not document all required determinations for studies overseen by an external IRB."]
["• The R&DC reviewed and approved non-VA research that did not qualify as VA research based on the misunderstanding that such “approval” was required for purposes of Research and Development Information System (RDIS) reporting. "]
["2. Deficient R&DC Meeting Minutes"]
["• The R&DC meeting minutes did not include a list of all voting members."]
["• The R&DC meeting minutes did not document the names of voting members who were absent."]
["• The R&DC meeting minutes did not indicate when an alternate was present in place of a voting member and the name of the voting member being replaced."]
["• The R&DC meeting minutes did not document whether recused voting members were present during discussions of the item from which they were recused."]
["• The R&DC meeting minutes did not document whether members identified to have a conflict of interest were recused from voting on those items. "]
["• The R&DC meeting minutes contained inaccurate vote counts when voting members were recused."]
["• The R&DC meeting minutes did not accurately document the number voting for, against, and abstaining from actions. "]
["• The R&DC meeting minutes did not document when final approval was granted for a protocol that was previously contingently approved."]
["3. Inadequate R&DC Oversight of Subcommittees"]
["• The R&DC did not conduct annual reviews of all research-related committees and subcommittees. "]
["• The R&DC did not comprehensively review on an annual basis the facility-specific aspects of the facility’s relationships with research oversight committees that it relied upon aside from its own subcommittees, to include the VA Central IRB."]
["• The R&DC did not ensure the adequacy of  subcommittee review and approval of its SOPs."]
["• The R&DC did not provide a summary of its review of committees to the Medical Facility Director. "]
["4. Lack of or Deficient R&DC SOPs"]
["• R&DC policies were not updated to reflect all applicable VHA policy requirements related to recurring R&DC processes."]
["• The R&DC did not maintain SOPs or other written procedures for all recurring local processes."]
["• The R&DC SOP was not updated to reflect all recurring R&DC processes."]
["• The R&DC SOPs contained language in conflict with VHA requirements."]
["• The Research Service policies were not updated to reflect all VHA Directive 1200.01(1) requirements. "]
[]
["Common Findings Related to Human Research Protection Programs"]
["1.  Deficient IRB Meeting Minutes"]
["• The IRB meeting minutes did not consistently reflect the accurate number of members voting on actions taken by the IRB."]
["• The IRB meeting minutes did not consistently document all actions taken by the IRB. "]
["• The IRB meeting minutes did not consistently document that all criteria for approval of the research had been satisfied. "]
["2. Deficient IRB Review / Approval of Research"]
["• The IRB approved minimal risk studies via expedited review without ensuring that applicable requirements pertaining to informed consent were met."]
["• The IRB made an exempt determination for a study that did not qualify for exemption, resulting in the conduct of non-exempt human subjects research without IRB approval. "]
["• The IRB did not document its rationale for requiring continuing review (CR) for some protocols that were both subject to the 2018 Common Rule and eligible for expedited review."]
["• The IRB required CR for some protocols that transitioned to the 2018 Common Rule and were eligible for expedited review; however, the IRB assigned an approval period of 3 years instead of 1 year, as required by VHA policy."]
["• The IRB assigned an approval period of greater than 1 year for some protocols that were subject to the pre-2018 Common Rule requirements."]
["• The IRB did not ensure that all approval conditions (e.g., Privacy Officer review of proposed changes) were met prior to granting final approval of a protocol amendment. "]
["3. IRB-Approved ICD Did Not Contain All Required Elements or was Otherwise Deficient"]
["• The IRB did not consistently ensure that the approved ICD, information sheet (in lieu of a signed ICD), or IC script contained all applicable required elements of informed consent. Deficiencies included:"]
["◦ No description of foreseeable risks. "]
["◦ No statement that participation was voluntary."]
["◦ Noncompliant language on billing for research-related medical care, services, and injury."]
["◦ No statement that information about study participation would be included in the medical record for a study protected by a Certificate of Confidentiality. "]
["◦ No statement on future use of identifiable private information or biospecimens for items approved under the 2018 Common Rule."]
["• The Principal Investigator (PI) and the IRB did not consistently ensure that ICDs were updated to reflect changes in key personnel. "]
["• The IRB approved an ICD with information about storage of biospecimens for future research that contradicted the HIPAA authorization document and the protocol."]
["• The IRB approved an ICD with information about re-contact for potential participation in future research that contradicted the HIPAA authorization document and the protocol. "]
["• Data sharing provisions contained in ICDs for some studies were not consistent with their corresponding HIPAA authorizations. "]
["• Prospective human research subjects were not provided with required information during the informed consent process pertaining to a Certificate of Confidentiality issued to protect information for a research study."]
["• Electronic signatures on combined informed consent and HIPAA authorization documents did not meet VA requirements, resulting in invalid documentation of consent and the use of protected health information (PHI) for research without legal authority (i.e., a valid HIPAA authorization)."]
["• The IRB approved an ICD for a clinical investigation regulated by the Food and Drug Administration (FDA) that did not include: "]
["◦ Required statements providing awareness of the extent to which confidentiality of records identifying subjects would be maintained."]
["◦ Information on the possibility that the FDA may inspect records. "]
["◦ Information on the posting of a description on clinicaltrials.gov. "]
["• The ICD for one protocol included a misleading statement regarding the test article being studied that implied that the test article being studied had an FDA approval that it did not actually have. "]
["• The IRB approved ICDs for investigational device protocols that did not adequately identify which procedures were experimental. "]
["4. Noncompliant HIPAA Authorization Waiver(s)"]
["• The IRB did not consistently ensure that approved waivers of HIPAA authorization were signed in accordance with VHA policy, which resulted in protected health information (PHI) being used for research without valid waiver of HIPAA authorization."]
["• The IRB did not consistently document a brief description of the PHI for which the IRB determined use and disclosure to be necessary when approving waivers of HIPAA authorization."]
["• The IRB did not consistently ensure that the approved requests for waiver of HIPAA authorization included sufficient information to allow the IRB to make a fully informed decision. "]
["• The IRB-approved waiver of HIPAA authorization indicated that only de-identified information would be transcribed into an electronic data capture system; however, PHI was entered into the non-VA system without valid authority provided by either the waiver of HIPAA authorization or by a signed HIPAA authorization. "]
["5. Lack of or Deficient HRPP / IRB SOPs"]
["• The IRB did not establish written SOPs to reflect all applicable VHA policy requirements, to include: "]
["◦ Which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review."]
["◦ Documenting the IRB’s rationale for requiring CR for studies that do not otherwise require CR under the 2018 Common Rule. "]
["◦ Determining when a study subject to the 2018 Common Rule required limited IRB review. "]
["• The written SOPs included noncompliant language, including that pertaining to:"]
["◦ The IRB’s management authority for the Research Compliance Officer."]
["◦ Obtaining VA information for preparatory to research activities."]
["◦ VHA Records Control Schedule (RCS) 10-1 requirements for investigator records."]
["◦ Conducting research on human fetal tissue while on official VA duty, ta VA facilities, or at VA-approved off-site facilities. "]
["• The written SOPs included outdated references to the rescinded VHA Handbook 1058.01, which resulted in outdated and deficient reporting procedures. "]
["• The IRB did not have a written procedure in place to inform investigators and the Research and Development Committee (R&DC) of its approval decisions and the expedited review actions."]
["• The facility did not have a documented procedure for when research can transition to the 2018 Requirements."]
["6. Nonadherence to Local SOP"]
["• The IRB did not consistently follow its written procedures related to membership:"]
["◦ The IRB membership notification memos did not indicate the correct primary member for whom each alternate member could represent. "]
["◦ The IRB did not apply the same terms of appointment for alternate voting members as for regular IRB members. "]
["◦ The Investigational Drug Service pharmacist was not appointed as a voting member of the IRB, as required by local policy. "]
["◦ The IRB did not ensure that alternate IRB voting members attended at least one IRB meeting per quarter, as required by local policy. "]
["• The IRB did not consistently follow its written procedures related to reviews:"]
["◦ The IRB conducted business without a required voting member present. "]
["◦ The IRB provided conditional approval for two protocols, although some IRB stipulations constituted significant changes that should have been tabled."]
["◦ The convened IRB voted to approve a protocol pending substantive changes; however, the IRB SOP did not establish the category “approve pending substantive changes” as an allowable IRB action. "]
["◦ IRB approval was at times provided prior to other required subcommittee reviews. "]
["◦ The IRB transitioned a research protocol to the 2018 Common Rule against local policy.  "]
["• The IRB did not consistently follow its written procedures related to meeting minutes and documentation:"]
["◦ Minutes from the HRPP Working Group of the IRB were not reported at the following month’s IRB meeting, as required by local policy."]
["◦ The IRB did not consistently list research that was approved via expedited review procedures in the IRB minutes of the next convened meeting. "]
["◦ The expedited review eligibility category was not documented in the IRB meeting minutes or in the letter conveying the IRB’s decision to the investigator. "]
["◦ IRB meeting minutes were not prepared in a timely manner in accordance with local policy. Consequently, review of meeting minutes by the IRB was frequently delayed, as was finalization and submission of IRB meeting minutes to the R&DC. "]
["• The IRB did not consistently review and approve FDA-regulated clinical investigations in accordance with local policies:"]
["◦ The IRB did not determine whether a protocol met any of the Investigational New Drug application exemption criteria. "]
["◦ The IRB did not make the required risk determinations at a convened meeting. "]
["◦ The IRB did not document a device risk determination and rationale in the meeting minutes."]
["◦ The IRB did not provide written notification of a device risk determination to the study PI. "]
[]
["Common Findings Related to Animal Care and Use Programs"]
["1. Deficient IACUC Research Review / Approval of Protocol(s)"]
["• The IACUC did not consistently ensure that approved protocols included:"]
["◦ Complete, clear, congruent, and/or accurate information."]
["◦ Sufficient information to weigh potential concerns about animal welfare against the benefits to be gained from the work."]
["◦ Adequate descriptions and scientific justifications for the proposed use of non-pharmaceutical grade compounds."]
["◦ Adequate scientific justifications for the use of single housing. "]
["• The IACUC did not consistently ensure that approved protocols included all required scientific justifications for category E activities."]
["• The IACUC designated member review (DMR) process did not meet regulatory expectations for the unanimous agreement of two reviewers."]
["• The IACUC consistently used DMR subsequent to full committee review (FCR) without specifically voting unanimously to use this method in each instance. "]
["• The IACUC did not consistently assign compliant approval dates when using the DMR process for protocols contingently approved by the full committee. "]
["• The IACUC did not consistently use compliant approval practices when reviewing modifications to approved protocols, to include:"]
["◦ Administrative review rather than FCR or DMR was used to approve changes in PI in animal protocols. "]
["◦ Changes that should only be approved using FCR or DMR were reviewed and approved by two or three committee members between IACUC meetings without first giving all committee members an opportunity to request FCR. "]
["2. IACUC Not Properly Constituted or Appointed"]
["• Required committee members participated in official IACUC business as voting members without valid appointments."]
["• The Veterinary Medical Consultant (VMC) served as the attending veterinarian and attended IACUC meetings as a voting member without an appointment from the Medical Facility Director."]
["• One individual participated in official IACUC business as a non-required voting member prior to being officially appointed to the committee."]
["3. Inadequate Oversight of Off-Site VA Animal Research"]
["• The IACUC did not consistently receive and review affiliate semiannual reports as required."]
["• The IACUC did not conduct semiannual program reviews and facility inspections at the affiliate as required."]
["• The IACUC did not participate in the affiliate semiannual self-assessments as described in the existing memorandum of agreement. "]
["• The IACUC did not consistently conduct semiannual assessments of affiliate space used for VA animal research or, alternatively, review the affiliate semiannual self-assessment reviews as an IACUC business item.   "]
["4. Noncompliant Semiannual Program Review / IACUC Facility Inspections"]
["• The IACUC reports of semiannual evaluations did not consistently describe plans or schedules for correction of each identified deficiency."]
["• Semiannual program review reports to the Medical Facility Director did not specify departures from the approved protocol, the Guide for the Care and Use of Laboratory Animals, or the PHS Policy on Humane Care and Use of Laboratory Animals."]
["• The final, signed IACUC semiannual reports were not provided to the R&DC or the VHA Office of Research & Development (ORD) as required."]
["• The IACUC did not conduct semiannual evaluations at compliant intervals."]
["• The IACUC did not maintain required documentation for the required retention period. "]
["• The IACUC did not discuss the semiannual evaluation reports with the Medical Facility Director. "]
["• Meetings to discuss the semiannual evaluation report with the Medical Facility Director did not include all required participants."]
["5. Overheat Tests in Animal Research Facility Not Conducted, Documented, or Reviewed in Compliance with VHA Policy"]
["• Overheat tests were not conducted at the required intervals. "]
["• The IACUC did not review overheat test results to determine if the response was adequate."]
["• The IACUC did not document the review of overheat test results in the IACUC meeting minutes."]
["6. Unapproved Deviation from Approved Animal Research Protocol"]
["• Post-surgical medications were administered at doses not approved in the protocol."]
["• Some animal procedures performed significantly deviated from the approved protocol and had the potential to impact animal welfare."]
["• Animals were not monitored following surgery at the intervals approved in the protocol."]
["• Animals were not weighed at the intervals approved in the protocol."]
["• Antibiotics were not administered pre• and post-surgery as approved in the protocol."]
["• An individual who was not approved as an animal researcher was listed as the surgeon in the surgical records. "]
[]
["Common Findings Related to Research Safety and Security Programs"]
["1. Deficient SRS Review / Approval of Protocol(s) / Hazards"]
["• The SRS did not review / approve new hazards added to animal protocols."]
["• The SRS did not consistently evaluate all research-related hazards associated with the protocols it reviewed (i.e., adequate risk assessment not performed)."]
["• The SRS did not consistently ensure that a description of all risks of chemical, physical, and biological hazards to personnel, the facility, and the environment were provided to the SRS for its review and assessment."]
["• The SRS did not review IBC findings prior to its final approval for VA research involving recombinant DNA (rDNA)."]
["• Amendments were approved using designated member review (DMR); however, the SRS had not established the criteria for amendments to be considered minor and therefore eligible for DMR."]
["2. Deficient Communication / Notification of IBC Review / Approval"]
["• The IBC did not notify the PI in writing or electronically of the assigned biosafety level for rDNA protocols. "]
["• The IBC did not notify the PI in writing or electronically of the protocol approval date."]
["• The affiliate IBC’s meeting minutes pertaining to the IBC’s review of VA rDNA research and copies of the IBC approval letters for VA rDNA research were not forwarded to the VA facility, as required by the memorandum of agreement. "]
["3. Deficient Documentation of SRS Reviews and Committee Operations"]
["• The SRS minutes did not document the recusal of persons with conflicts of interest."]
["• The SRS did not ensure the outcome of DMRs were documented in the SRS meeting minutes. "]
["• The SRS did not ensure that annual evaluations of the effectiveness of the RSSP were documented in the SRS meeting minutes.  "]
["4. SRS Not Properly Constituted or Appointed"]
["• Individuals voted on SRS business and were counted toward quorum in absence of having current, written appointments to serve as members of the SRS.  "]
["• Members of the SRS had standing appointment memos that did not specify a term of up to 3 years, as required. "]
["• The SRS temporarily had fewer than the number of required members due to lapses in appointment memos. "]
["• The required non-voting, ex-officio union representative was not formally appointed to the SRS by the Medical Facility Director. "]
["• The SRS did not include the required non-voting, ex-officio liaison member from the R&DC."]
["• The SRS ex-officio liaison member from the R&DC was appointed as a voting member rather than as a non-voting member, as required. "]
["5. IBC Not Properly Constituted or Appointed"]
["• The designated community member(s) on the IBC were employed by the academic affiliate, and thus were ineligible to serve as non-affiliated member(s)."]
["6. Inadequate Oversite of Off-Site Research "]
["• The SRS did not review inspection reports from affiliate laboratories where VA research was conducted."]
["• No process was in place to review research safety or to provide feedback to the responsible party for VA research conducted in off‐site facilities."]
["7. Process to Activate, Decommission, or Transfer Laboratories Deficient / Not Established"]
["• The SRS did not have a process in place to activate, decommission, or transfer laboratories."]
["• The SRS did not have a process in place to ensure that hazardous chemicals were appropriately disposed of in decommissioned laboratories."]
["8. Noncompliant Eyewash Stations and / or Emergency Showers"]
["• Emergency shower equipment was not installed in research locations where personnel may be exposed to corrosive chemicals."]
["• Emergency showers / eyewashes in research areas were not tested and inspected annually (i.e., measurements of water flow and water temperature)."]
["• Emergency shower equipment in research laboratory areas was not flushed at required monthly intervals."]
["• Emergency eyewashes in research laboratories did not deliver tepid water."]
["9. Initial and / or Annual Medical Evaluations Not Offered or Conducted"]
["• Annual medical follow-up was not completed for all personnel with animal contact or exposure enrolled in the OHSP."]
["• No initial or recurring risk assessments were conducted specific to hazards encountered by individuals working with research animals."]
["10. OHSP Services Not Offered to All Research Personnel"]
["• Some IACUC members had not been offered enrollment in the institutional OHSP."]
["• Some Veterinary Medical Unit (VMU) staff had not been offered enrollment in the institutional OHSP. "]
["• Some researchers working with animals had not been offered enrollment in the institutional OHSP. "]
["• Some personnel who had intermittent contact with the animal facility (e.g., Police and Engineering Services) had not been offered enrollment in the OHSP and were not risk assessed with regards to the unique hazards potentially associated with indirect animal exposure. "]
["11. Chemical Hygiene Plan Not Established / Not Available or Lacking Required Elements"]
["• The CHP was missing required elements of the Occupational Safety and Health Administration (OSHA) standard, to include:  "]
["◦ Designation of personnel responsible for implementing the CHP, including assignment of a Chemical Hygiene Officer. "]
["◦ Provisions for additional worker protection for work with reproductive toxins and substances with high degree of acute toxicity."]
["◦ Provisions for medical consultation and medical examinations in the event of a chemical exposure incident."]
["• The CHP was not readily available to all employees.   "]
["12. Lapsed or Noncompliant Annual Review of PI’s VA Laboratory Program"]
["• Required elements were not assessed during the SRS annual review of the PI laboratory program, to include: "]
["◦ A review of personnel safety training."]
["◦ Changes in space allocation."]
["◦ A review of inspection reports for the PI’s laboratory."]
["◦ A review of amendments to the safety components of protocols."]
["◦ A review of any reports of employee-related safety and security issues. "]
["13. Research-Specific Safety, Security, and / or Emergency Preparedness Drills Not Conducted at Required Intervals"]
["• Drills or exercises to test the effectiveness of the research‐specific safety, security, and/or emergency preparedness plans were not conducted on an annual basis."]
["14. PPE Hazard Assessments Not Performed and / or Certified"]
["• PPE hazard assessments were not performed and certified for biological, chemical, and/or physical hazards in research laboratories."]
["• PPE hazard assessments did not include all required elements to include:"]
["◦ The name of the person certifying the evaluation."]
["◦ The date of the hazard assessment. "]
["15. Personnel Exposure Monitoring Deficient / Not Conducted"]
["• Initial exposure monitoring was not conducted to determine if exposure limits were being exceeded when formaldehyde was used outside of a chemical fume hood."]
["• The facility did not notify affected employees of formaldehyde monitoring results. "]
["16. Required Safety Training Not Completed"]
["• Required bloodborne pathogen (BBP) training was not completed annually."]
["• Required formaldehyde awareness training was not completed."]
["• Required hazard communication training (e.g., Safety Data Sheets, pictograms, chemical labeling) was not completed."]
["• Site‐specific initial and refresher safety, security, and emergency management training was not provided to research employees.  "]
["• IBC members were not trained on the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules."]
["17. Safety Training Curriculum Did Not Include All Required Elements"]
["• BBP training did not include an opportunity for real-time interactive questions and answers."]
["• BBP training did not cover all required content, to include: "]
["◦ Description of symptoms of bloodborne diseases."]
["◦ Explanation of modes of transmission of bloodborne pathogens. "]
["◦ Explanation of the contents of the regulatory text and the BBP standard, and how employees can obtain a copy. "]
["◦ Explanation of facility exposure control plan, and how employees can obtain a copy."]
["◦ Explanation of the appropriate methods for recognizing tasks and other activities that may involve exposure to blood and other potentially infectious materials."]
["◦ Explanation of limitations of methods that will prevent or reduce exposure."]
["◦ Information on the types, proper use, location, removal, handling, decontamination, and disposal of PPE."]
["◦ Explanation of basis for selection of PPE. "]
["◦ Information on efficacy, safety, and administration of the Hepatitis B vaccine."]
["◦ Explanation of the procedures following exposure."]
["◦ Explanation of signs and labels and/or color coding required by OSHA’s BBP standard."]
["18. Deficient Documentation of Safety Training"]
["• The Research Office did not maintain all required safety training records, to include: "]
["◦ Records related to BBP training."]
["◦ Records related to CHP training."]
["◦ Records related to formaldehyde training."]
["◦ Records related to training on lab-specific SOPs."]
["◦ Records related to methylene chloride training."]
["◦ Records related to training on NIH Guidelines."]
["◦ Records related to radiation training. "]
[]
["Common Findings Related to Research Information Security Practices"]
["1. Inadequate Restrictions on Access to VA Information"]
["• Research-related electronic storage folders containing VASI were not appropriately restricted."]
["• Hard copy research information containing VASI was not securely stored when not in use."]
["2. No or Inappropriate Terms and Conditions for VA Research Information on Non-VA Information Systems"]
["• VA research data was used on non-VA (external) information systems (e.g., non-VA computers, portable storage devices, air-gapped networks, wireless access points) without first establishing appropriate terms and conditions for such use by authorized individuals."]
["3. No or Inappropriate Agreement for Research VASI on Non-VA Information Systems"]
["• VASI was stored on non-VA (external) information systems without documenting the security controls / requirements in an agreement. "]
["4. VASI Transferred / Transmitted / Stored without Proper Security or Approvals"]
["• Paper printouts of VASI were transported outside the VA facility without appropriate approvals."]
["• Researchers emailed VASI without using VA-approved encryption."]
["• VASI was stored outside the VA facility without proper approvals or a retrieval plan."]
["• Hard copy research documents containing PHI were transported from the affiliate to the VA facility without proper approval. "]
["• Hard copy research documents containing PHI were transported from the VA research facility to the academic affiliate without prior written approval to transport Individually Identifiable Information outside of the VA facility. "]
["• Electronic research documents containing VASI were transported to the PI’s personal residence on a VA encrypted Universal Serial Bus (USB) flash drive without proper approval."]
["• VASI was stored in the VA Research Electronic Data Capture application without authorization. "]
["• VASI was processed and stored on a non-VA device without documenting any applicable restrictions for such use. "]
["• A VA researcher transferred data collected during the VA portion of a collaborative research study to a non-VA collaborator without a required DUA."]
["• PHI was entered into a non-VA web-based electronic data capture system in a manner that did not conform with the approved study documents, which specified that the information entered into the system would be de-identified. "]
["5. Research Data Used / Shared without Proper Approvals / Agreements (e.g., DUA, CRADA)"]
["• Data obtained from VHA national databases were downloaded to facility servers without required permissions."]
["• Neither the protocol documents nor the actual data storage arrangements conformed to the stipulations in the data access request agreements in the DUAs for data obtained from VHA national databases."]
["• A DUA required for the release of de-identified VA research data to a non-VA entity did not include all required details."]
["• Identifiable information gathered during a research study was shared in contradiction to the terms allowed by the ICD under which it was collected. "]
["6. No or Incomplete Inventory of IT Equipment Used for VA Research"]
["• Affiliate-owned IT equipment was not contained in the appropriate equipment inventory list."]
["• VA-owned IT equipment was not contained in the appropriate inventory list."]
["• IT equipment of undetermined ownership (i.e., lacking identification tags) was not contained in the appropriate inventory list."]

{"sheet":"Definitions","index":5,"n_rows":6,"n_cols":1,"rows_kept":6,"cut":false,"hidden":false,"merged":[]}
["DEFINITIONS"]
["VHA Handbook 1108.04 §2.q."]
["q. Investigational Drug. An investigational drug is a chemical or biological drug that is used in a clinical investigation. \n(1) An investigational drug can be:\n(a) A new chemical compound, which has not been approved by the FDA, or \n(b) An approved drug that is being studied for an approved or unapproved use, dose, dosage form, administration schedule, or under an IND application, in a clinical investigation. This includes: prescription drugs, over-the-counter drugs, nutritional supplements, herbal preparations, and legend items used for the diagnosis, treatment, cure, mitigation or prevention of disease and meeting the above definition. "]
[]
["21 CFR 812.3(m)"]
["(m) Significant risk device means an investigational device that:\n(1) Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;\n(2) Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;\n(3) Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or\n(4) Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject."]

{"sheet":"Show_Hide Notes","index":6,"n_rows":41,"n_cols":10,"rows_kept":41,"cut":false,"hidden":true,"merged":[]}
[null,"Question Number","Target Cell","Target Rows","Comments"]
["R&DC of another facility = YES",5,"B53","56:85","Collapse R&DC question","Grayed out cell and font",null,null,null,"Border color"]
["Broad consent = NO",15,"B226","227:232","Collapse broad consent questions","#808080",null,null,null,"#D0CECE"]
["Investigational Drugs = NO",18,"B251","253:276","Collapse investigational drug questions"]
["Controlled substances = NO","18f","B269","271:276","Collapse controlled substance questions"]
["Investigational Devices = NO",19,"B277","279:285","Collapse investigational device questions"]
["Animal Program = NO",21,"B295","299:415","Collapse entire section"]
["Animal Program = NO",21,"B295","Part B 352:436","Collapse PART B animal section"]
["Internal IACUC-of-record = YES",22,"B299","308:317","Collapse affiliate IACUC questions"]
["Internal IACUC-of-record = NO",22,"B299","301:307","Collapse VA IACUC questions"]
["Affiliate IACUC-of-record = YES",23,"B308","318:322","Collapse ADDITIONAL affiliate IACUC questions"]
["Animals Housed = Only at the VA animal facility",27,"B332","408:412","Collapse affiliate facility question (33)"]
["Animals Housed =  Only at the affiliate animal facility",27,"C332","362:381","Collapse VA animal facility question (30)"]
["Animals Housed =  Only at the affiliate animal facility",27,"C332","400:407","Collapse VA vet services question (31)"]
["SRS Waiver = YES","34a","B420","423:572","Collapse safety section"]
["SRS Waiver = YES","34a","B420","Part B 438:526","Collapse Part B safety section"]
["Internal SRS = NO",35,"B423","425:441","Collapse SRS questions"]
["rDNA = NO",37,"B448","452:471","Collapse rDNA question"]
["lab research = NO",38,"B472","474:493","Collapse lab questions"]
["BSL3 = NO",38,"B494","496:505","Collapse BSL3 questions"]
["Chemicals = NO",41,"B508","511:518","Collapse chemical questions"]
["AGN = NO",45,"B583","589:605","Collapse AGN questions"]
[]
["Notes"]
["Added alert to rDNA question"]
[]
[]
[]
["VA IACUC, animals housed only VA - only answer VA animal facility questions"]
["VA IACUC, animal housed both VA and affiliate (additional affiliate IACUC), - answer both animal VA and affiliate facility questions"]
["VA IACUC, animals housed only affiliate (THIS IS THE WEIRD ONE)"]
["Affiliate IACUC, animals housed only VA - answer only VA animal facility questions"]
["Affiliate IACUC, animals housed only affiliate - only answer affiliate facility questions (WEIRD ONE)"]
["Affiliate IACUC, animals housed both VA and affiliate - answer both VA and affiliate facility questions"]
[null,null,null,null,null,null,"IACUC","Housing","Answer"]
[null,null,null,null,null,null,"VA IACUC","Only VA","Only VA questions"]
[null,null,null,null,null,null,"VA IACUC","Only Affiliate","VA ACUP questions"]
[null,null,null,null,null,null,"VA IACUC ","Both","All questions"]
[null,null,null,null,null,null,"Affiliate IACUC","Only VA","Only VA questions"]
[null,null,null,null,null,null,"Affiliate IACUC","Only Affiliate","VA ACUP questions"]
[null,null,null,null,null,null,"Affiliate IACUC","Both","All questions"]

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["Question#","QuestionText","id-facility","id-question","FDCdate","FDCresult"]
["1","Adequate Resources",{"$f":"LEFT(PartA!C2,FIND(\" \",PartA!C2,1)-1)","v":"Select"},"FD2","2023-07-31",{"$f":"PartA!B14","v":"Select…"}]
["1_detail","DETAILS Adequate Resources",{"$f":"C2","v":"Select"},"FD20","2023-07-31",{"$f":"IF(PartA!C18=\"\",\"\",PartA!C18)","v":""}]
["2a","R&DC Appointed in Writing","Select","FD9","2023-07-31",{"$f":"PartA!B21","v":"Select…"}]
["2b","Delegated Roles","Select","FD1","2023-07-31",{"$f":"PartA!B23","v":"Select…"}]
["3a","RCO Audit Plan","Select","FD6","2023-07-31",{"$f":"PartA!B27","v":"Select…"}]
["3b","Audits Completed","Select","FD7","2023-07-31",{"$f":"PartA!$B$30","v":"Select…"}]
["3b_detail","DETAILS Audits Not Completed","Select","FD11","2023-07-31",{"$f":"IF(PartA!C34=\"\",\"\",PartA!C34)","v":""}]
["4","Any Acting Position(s)","Select","FD3","2023-07-31",{"$f":"PartA!B35","v":"Select…"}]
["4_acting_detail","DETAILS Acting Positions","Select","FD21","2023-07-31",{"$f":"IF(PartA!C44=\"\",\"\",PartA!C44)","v":""}]
["4_FD","Acting Facility Director","Select","FD12","2023-07-31",false]
["4_ACOS","Acting ACOS/Research or Coordinator","Select","FD14","2023-07-31",false]
["4_AO","Acting Administrative Officer/Research","Select","FD15","2023-07-31",false]
["4_RCO","Acting Research Compliance Officer","Select","FD16","2023-07-31",false]
["4_CC","Acting Research Committee Coordinator(s)","Select","FD17","2023-07-31",false]
["4_CC_detail","Acting Committee Coordinator details","Select","FD18","2023-07-31",{"$f":"IF(PartA!C42=\"\",\"\",PartA!C42)","v":""}]
["4a","CRADO Approval for Acting ACOS/R","Select","FD22","2023-07-31",{"$f":"PartA!B45","v":"Select…"}]
["FDNotes","Facility Director Section Notes","Select","FD8","2023-07-31",{"$f":"IF(PartA!C50=\"\",\"\",PartA!C50)","v":""}]
["5","Another VA R&DC","Select","RD29","2023-07-31",{"$f":"PartA!B53","v":"Select…"}]
["5_detail","DETAILS Another VA R&DC","Select","RD30","2023-07-31",{"$f":"IF(PartA!C54=\"\",\"\",PartA!C54)","v":""}]
["6a","Committees Reviewed Annually, Reported to FD","Select","RD18","2023-07-31",{"$f":"PartA!B57","v":"Select…"}]
["6b","Subcommittee Minutes Review within 60 Days","Select","RD19","2023-07-31",{"$f":"PartA!B61","v":"Select…"}]
["6c","Subcommittee Approval before R&DC Approval","Select","RD20","2023-07-31",{"$f":"PartA!B64","v":"Select…"}]
["6d","External IRB Meets Requirements","Select","RD21","2023-07-31",{"$f":"PartA!B68","v":"Select…"}]
["6e","Approval of Research Not Assigned to Committees","Select","RD22","2023-07-31",{"$f":"PartA!B73","v":"Select…"}]
["6f","Only VA Research for Collaborative Studies","Select","RD23","2023-07-31",{"$f":"PartA!B76","v":"Select…"}]
["6g","Approval for Recruitment of Non-Veterans","Select","RD24","2023-07-31",{"$f":"PartA!B78","v":"Select…"}]
["6h","ISSO and PO review","Select","RD36","2023-07-31",{"$f":"PartA!B81","v":"Select…"}]
["7","Privacy Review Checklist and ERDSP","Select","RD31","2023-07-31",{"$f":"PartA!B86","v":"Select…"}]
["8a","ACOS Notification to PI","Select","RD16","2023-07-31",{"$f":"PartA!B91","v":"Select…"}]
["8b","Research Personnel Hold VA Appointment","Select","RD25","2023-07-31",{"$f":"PartA!B95","v":"Select…"}]
["8c","WOC Appointments in Place","Select","RD26","2023-07-31",{"$f":"PartA!B100","v":"Select…"}]
["9a","Protocol Tracking Systems","Select","RD8","2023-07-31",{"$f":"PartA!B105","v":"Select…"}]
["9a_detail1","Protocol Tracking Name","Select","RD9","2023-07-31",{"$f":"IF(PartA!C110=\"\",\"\",PartA!C110)","v":""}]
["9a_detail2","VAIRRS Primary System","Select","RD38","2023-07-31",{"$f":"PartA!B111","v":"Select…"}]
["9b","Tracking of Committee Actions","Select","RD32","2023-07-31",{"$f":"PartA!B112","v":"Select…"}]
["9c","Tracking of Written Agreements","Select","RD33","2023-07-31",{"$f":"PartA!B115","v":"Select…"}]
["9d","Tracking of Research Personnel","Select","RD34","2023-07-31",{"$f":"PartA!B119","v":"Select…"}]
["9e","Tracking of Training","Select","RD27","2023-07-31",{"$f":"PartA!B123","v":"Select…"}]
["9f(1)","Tracking of Research Data (Repository)","Select","RD35","2023-07-31",{"$f":"PartA!B127","v":"Select…"}]
["9f(2)","Tracking of Research Data (RCS)","Select","RD37","2023-07-31",{"$f":"PartA!B128","v":"Select…"}]
["RDCNotes","FD/RDC Section Notes","Select","RD17","2023-07-31",{"$f":"IF(PartA!C133=\"\",\"\",PartA!C133)","v":""}]
["10a","Internal (Local) IRB","Select","IR1","2023-07-31",{"$f":"PartA!B137","v":"Select…"}]
["10b","External (Academic Affiliate) IRB","Select","IR2","2023-07-31",{"$f":"PartA!B139","v":"Select…"}]
["10b_detail","Academic Affiliate Detail","Select","IR3","2023-07-31",{"$f":"IF(PartA!C141=\"\",\"\",PartA!C141)","v":""}]
["10c","Other VA IRB","Select","IR4","2023-07-31",{"$f":"PartA!B142","v":"Select…"}]
["10c_detail","Other VA IRB Detail","Select","IR5","2023-07-31",{"$f":"IF(PartA!C144=\"\",\"\",PartA!C144)","v":""}]
["10d_CIRB","VA Central IRB","Select","IR67","2023-07-31",{"$f":"PartA!B147","v":"Select…"}]
["10d_NCI","National Cancer Institute (NCI) IRB","Select","IR68","2023-07-31",{"$f":"PartA!B148","v":"Select…"}]
["10d_AOU","NIH All of Us IRB","Select","IR60","2023-07-31",{"$f":"PartA!B149","v":"Select…"}]
["10d_Advarra","Advarra, Inc. IRB","Select","IR83","2023-07-31",{"$f":"PartA!B150","v":"Select…"}]
["10d_OakRidge","Oak Ridge Associated Universities IRB","Select","IR85","2023-07-31",{"$f":"PartA!B151","v":"Select…"}]
["10d_Sterling","Sterling IRB","Select","IR84","2023-07-31",{"$f":"PartA!B152","v":"Select…"}]
["10e_ORD","DETAILS Other IRB ORD Approval","Select","IR78","2023-07-31",{"$f":"PartA!B153","v":"Select…"}]
["10f_Other","Other IRB(s)","Select","IR76","2023-07-31",{"$f":"PartA!B155","v":"Select…"}]
["10f_detail","DETAILS Other IRB","Select","IR77","2023-07-31",{"$f":"IF(PartA!C157=\"\",\"\",PartA!C157)","v":""}]
["10g_ORD","DETAILS Other IRB ORD Approval","Select","IR97","2023-07-31",{"$f":"PartA!B158","v":"Select…"}]
["11","IRB Reliance Agreement","Select","IR80","2023-07-31",{"$f":"PartA!B160","v":"Select…"}]
["12","Single IRB Review of Cooperative Research","Select","IR81","2023-07-31",{"$f":"PartA!B165","v":"Select…"}]
["13a","IRB Minutes Document Approval Criteria","Select","IR86","2023-07-31",{"$f":"PartA!B179","v":"Select…"}]
["13b","ICDs with All Required Elements","Select","IR87","2023-07-31",{"$f":"PartA!B182","v":"Select…"}]
["13c","IC Waivers Reviewed and Documented","Select","IR88","2023-07-31",{"$f":"PartA!B186","v":"Select…"}]
["13d","HIPAA Authorizations Waivers Reviewed and Documented","Select","IR89","2023-07-31",{"$f":"PartA!B189","v":"Select…"}]
["14a","2018 CR Exempt Research and Limited IRB Review","Select","IR90","2023-07-31",{"$f":"PartA!B195","v":"Select…"}]
["14b","2018 CR Continuing Review and Documentation of Rationale","Select","IR91","2023-07-31",{"$f":"PartA!B198","v":"Select…"}]
["14c","2018 CR Min Risk Documentation","Select","IR45","2023-07-31",{"$f":"PartA!B204","v":"Select…"}]
["14d","2018 CR ICDs Contain New Requirements",{"$f":"C66","v":"Select"},"IR46","2023-07-31",{"$f":"PartA!B208","v":"Select…"}]
["14e","2018 CR ICDs Document New Approval Criteria","Select","IR98","2023-07-31",{"$f":"PartA!B216","v":"Select…"}]
["14f","ICD Posted","Select","IR48","2023-07-31",{"$f":"PartA!B221","v":"Select…"}]
["15","2018 CR Broad Consent Allowed","Select","IR92","2023-07-31",{"$f":"PartA!B226","v":"Select…"}]
["15a","2018 CR Broad Consent Approved","Select","IR96","2023-07-31",{"$f":"PartA!B227","v":"Select…"}]
["15b","2018 CR Broad Consent on Specimens Collected for Research","Select","IR47","2023-07-31",{"$f":"PartA!B229","v":"Select…"}]
["16a","IRB/HRPP SOPs (Review of Research)","Select","IR17","2023-07-31",{"$f":"PartA!B235","v":"Select…"}]
["16b","Transition to 2018 CR SOP","Select","IR40","2023-07-31",{"$f":"PartA!B238","v":"Select…"}]
["16c","HRPP SOP for Review and Reporting UPIRTSOs and Serious Noncompliance","Select","IR93","2023-07-31",{"$f":"PartA!B241","v":"Select…"}]
["17","PO Review of HIPAA Authorizations","Select","IR49","2023-07-31",{"$f":"PartA!B246","v":"Select…"}]
["18","Investigational Drugs","Select","IR23","2023-07-31",{"$f":"PartA!B251","v":"Select…"}]
["18a","New Drug Application (IND)","Select","IR50","2023-07-31",{"$f":"PartA!B253","v":"Select…"}]
["18b","Cellular Therapy or Human Gene Therapy","Select","IR51","2023-07-31",{"$f":"PartA!B255","v":"Select…"}]
["18c","Process for IBC Review","Select","IR94","2023-07-31",{"$f":"PartA!B257","v":"Select…"}]
["18d","Inv Drugs Stored Outside VA Pharmacy","Select","IR52","2023-07-31",{"$f":"PartA!B262","v":"Select…"}]
["18d_detail","DETAILS Inv Drugs Storage","Select","IR53","2023-07-31",{"$f":"IF(PartA!C266=\"\",\"\",PartA!C266)","v":""}]
["18e","Delegation of Custody","Select","IR54","2023-07-31",{"$f":"PartA!B267","v":"Select…"}]
["18f","Controlled Substances","Select","IR26","2023-07-31",{"$f":"PartA!B269","v":"Select…"}]
["18g","Controlled Substance Storage","Select","IR27","2023-07-31",{"$f":"PartA!B271","v":"Select…"}]
["18h","Controlled Substance Inspections","Select","IR28","2023-07-31",{"$f":"PartA!B274","v":"Select…"}]
["19","Investigational Device Exemption (IDE)","Select","IR55","2023-07-31",{"$f":"PartA!B277","v":"Select…"}]
["19a","IRB Review of Sponsor Device Risk Determination","Select","IR99","2023-07-31",{"$f":"PartA!B279","v":"Select…"}]
["19b","Significant Risk Devices","Select","IR56","2023-07-31",{"$f":"PartA!B282","v":"Select…"}]
["19c","IDE Approval from FDA","Select","IR95","2023-07-31",{"$f":"PartA!B284","v":"Select…"}]
["20","Pregnant Women, Fetuses, Neonates","Select","IR58","2023-07-31",{"$f":"PartA!B286","v":"Select…"}]
["20a","Pregnant Women Research Certifications/Approvals","Select","IR59","2023-07-31",{"$f":"PartA!B288","v":"Select…"}]
["HRPPNotes","HRPP Section Notes","Select","IR34","2023-07-31",{"$f":"IF(PartA!C292=\"\",\"\",PartA!C292)","v":""}]
["21","Animal Program","Select","IA1","2023-07-31",{"$f":"PartA!B295","v":"Select…"}]
["22","Internal (Local) IACUC","Select","IA2","2023-07-31",{"$f":"PartA!B299","v":"Select…"}]
["22a","IACUC Chair Appointed","Select","IA82","2023-07-31",{"$f":"PartA!B303","v":"Select…"}]
["22b","Required IACUC Members Appointed","Select","IA83","2023-07-31",{"$f":"PartA!B305","v":"Select…"}]
["23","Academic Affiliate IACUC (in lieu of VA IACUC)","Select","IA51","2023-07-31",{"$f":"PartA!B308","v":"Select…"}]
["23_detail","Academic Affiliate IACUC (in lieu of VA IACUC) Detail","Select","IA52","2023-07-31",{"$f":"IF(PartA!C311=\"\",\"\",PartA!C311)","v":""}]
["23a","VMO/VMC and Scientist Appointed to Affiliate","Select","IA84","2023-07-31",{"$f":"PartA!B312","v":"Select…"}]
["23b","Academic Affiliate IACUC (in lieu of VA IACUC) MOU","Select","IA53","2023-07-31",{"$f":"PartA!B316","v":"Select…"}]
["24","Additional Affiliate IACUC","Select","IA54","2023-07-31",{"$f":"PartA!B318","v":"Select…"}]
["24_detail","Additional Affiliate IACUC Detail","Select","IA55","2023-07-31",{"$f":"IF(PartA!C320=\"\",\"\",PartA!C320)","v":""}]
["24a","MOU for Shared Oversight","Select","IA9","2023-07-31",{"$f":"PartA!B321","v":"Select…"}]
["25","AAALAC Accreditation Status","Select","IA14","2023-07-31",{"$f":"PartA!C327","v":"Select…"}]
["25a","Date of Accreditation Determination Letter","Select","IA15","2023-07-31",{"$f":"IF(PartA!C329=\"\",\"\",PartA!C329)","v":""}]
["26","USDA Registration","Select","IA16","2023-07-31",{"$f":"PartA!B330","v":"Select…"}]
["27","Animals Housed","Select","IA7","2023-07-31",{"$f":"PartA!C332","v":"Select…"}]
["28","Non USDA-Regulated Species","Select","IA72","2023-07-31",{"$f":"PartA!B333","v":"Select…"}]
["28_detail","DETAILS Non USDA-regulated species","Select","IA73","2023-07-31",{"$f":"IF(PartA!C336=\"\",\"\",PartA!C336)","v":""}]
["29","Use of USDA Regulated Species","Select","IA17","2023-07-31",{"$f":"PartA!B337","v":"Select…"}]
["29a","Dogs","Select","IA18","2023-07-31",{"$f":"PartA!B339","v":"Select…"}]
["29a_detail","Dogs Housed","Select","IA19","2023-07-31",{"$f":"IF(PartA!C340=\"\",\"\",PartA!C340)","v":""}]
["29a1","Dog Research Funded by VA","Select","IA56","2023-07-31",{"$f":"PartA!B341","v":"Select…"}]
["29a2","Dog Research Approved by VA Secretary","Select","IA70","2023-07-31",{"$f":"PartA!B342","v":"Select…"}]
["29b","Cats","Select","IA20","2023-07-31",{"$f":"PartA!B344","v":"Select…"}]
["29b_detail","Cats Housed","Select","IA21","2023-07-31",{"$f":"IF(PartA!C345=\"\",\"\",PartA!C345)","v":""}]
["29b1","Cat Research Funded by VA","Select","IA79","2023-07-31",{"$f":"PartA!B346","v":"Select…"}]
["29b2","Cat Research Approved by VA Secretary","Select","IA74","2023-07-31",{"$f":"PartA!B347","v":"Select…"}]
["29c","Non-Human Primates","Select","IA22","2023-07-31",{"$f":"PartA!B349","v":"Select…"}]
["29c_detail","Non-Human Primates Housed","Select","IA23","2023-07-31",{"$f":"IF(PartA!C351=\"\",\"\",PartA!C351)","v":""}]
["29c1","NHP Research Funded by VA","Select","IA80","2023-07-31",{"$f":"PartA!B352","v":"Select…"}]
["29c2","NHP Research Approved by VA Secretary","Select","IA75","2023-07-31",{"$f":"PartA!B353","v":"Select…"}]
["29d","Swine","Select","IA57","2023-07-31",{"$f":"PartA!B355","v":"Select…"}]
["29d_detail","Swine Housed","Select","IA58","2023-07-31",{"$f":"IF(PartA!C356=\"\",\"\",PartA!C356)","v":""}]
["29e","Rabbit","Select","IA59","2023-07-31",{"$f":"PartA!B357","v":"Select…"}]
["29e_detail","Rabbit Housed","Select","IA60","2023-07-31",{"$f":"IF(PartA!C358=\"\",\"\",PartA!C358)","v":""}]
["29f","Other USDA","Select","IA24","2023-07-31",{"$f":"PartA!B359","v":"Select…"}]
["29f_detail","Other USDA Housed","Select","IA25","2023-07-31",{"$f":"IF(PartA!C361=\"\",\"\",PartA!C361)","v":""}]
["30a","VA Animal Facility HVAC","Select","IA61","2023-07-31",{"$f":"PartA!B363","v":"Select…"}]
["30a_detail","DETAIL VA Animal Facility HVAC",{"$f":"C130","v":"Select"},"IA86","2023-07-31",{"$f":"IF(PartA!C365=\"\",\"\",PartA!C365)","v":""}]
["30b","VA Animal Facility Reheat Coils Fail-Safe","Select","IA62","2023-07-31",{"$f":"PartA!B367","v":"Select…"}]
["30b_detail","DETAIL Animal Facility Reheat Coils Fail-Safe","Select","IA87","2023-07-31",{"$f":"IF(PartA!C370=\"\",\"\",PartA!C370)","v":""}]
["30c","Overheat Tests Conducted and Reviewed","Select","IA76","2023-07-31",{"$f":"PartA!B372","v":"Select…"}]
["30c_detail","DETAIL Overheat Test Date","Select","IA88","2023-07-31",{"$f":"IF(PartA!C377=\"\",\"\",PartA!C377)","v":""}]
["30d","VA Animal Facility Access","Select","IA63","2023-07-31",{"$f":"PartA!B378","v":"Select…"}]
["30e","VA Animal Facility Emergency Power","Select","IA64","2023-07-31",{"$f":"PartA!B380","v":"Select…"}]
["31","VA ACUP Review and Facility Inspection","Select","IA71","2023-07-31",{"$f":"PartA!C383","v":"Select…"}]
["31a","VA ACUP Semi-Annual Program Evaluations","Select","IA32","2023-07-31",{"$f":"PartA!B384","v":"Select…"}]
["31b","VA ACUP Semi-Annual Facility Inspections","Select","IA33","2023-07-31",{"$f":"PartA!B386","v":"Select…"}]
["31c","VA ACUP  Director Briefed","Select","IA34","2023-07-31",{"$f":"PartA!B388","v":"Select…"}]
["31d","VA ACUP Semi-Annual Reports Contain Plan and Schedule for correction","Select","IA77","2023-07-31",{"$f":"PartA!B393","v":"Select…"}]
["31e","VA ACUP - Significant Defeciencies Corrected","Select","IA37","2023-07-31",{"$f":"PartA!B396","v":"Select…"}]
["31e_detail","VA ACUP - Significant Defeciencies Corrected Detail","Select","IA38","2023-07-31",{"$f":"IF(PartA!C399=\"\",\"\",PartA!C399)","v":""}]
["32","Veterinary Medical Services","Select","IA67","2023-07-31",{"$f":"PartA!C401","v":"Select…"}]
["32a","PT Vet Service Arrangements","Select","IA68","2023-07-31",{"$f":"PartA!B402","v":"Select…"}]
["32a_detail","PT Vet Service Arrangements Details","Select","IA69","2023-07-31",{"$f":"IF(PartA!C406=\"\",\"\",PartA!C406)","v":""}]
["33","Affiliate ACUP Review and Facility Inspection","Select","IA66","2023-07-31",{"$f":"IF(PartA!C411=\"\",\"\",PartA!C411)","v":"Select…"}]
["ACUPNotes","ACUP Section Notes","Select","IA50","2023-07-31",{"$f":"IF(PartA!C415=\"\",\"\",PartA!C415)","v":""}]
["34","RSSP","Select","RS1","2023-07-31",{"$f":"PartA!B418","v":"Select…"}]
["34a","SRS Waiver","Select","RS56","2023-07-31",{"$f":"PartA!B420","v":"Select…"}]
["35","Internal (Local) SRS","Select","RS5","2023-07-31",{"$f":"PartA!B423","v":"Select…"}]
["35a","SRS Chair","Select","RS62","2023-07-31",{"$f":"PartA!B427","v":"Select…"}]
["35b","Voting Members on SRS","Select","RS63","2023-07-31",{"$f":"PartA!B429","v":"Select…"}]
["35c","Safety and Radiation Safety Members on SRS","Select","RS64","2023-07-31",{"$f":"PartA!B434","v":"Select…"}]
["35d","IACUC Liaison to SRS","Select","RS65","2023-07-31",{"$f":"PartA!B437","v":"Select…"}]
["35e","Required SRS Ex-Officio Members","Select","RS66","2023-07-31",{"$f":"PartA!B439","v":"Select…"}]
["36","External (Another VAMC) SRS","Select","RS8","2023-07-31",{"$f":"PartA!B442","v":"Select…"}]
["36_detail","External SRS Name","Select","RS9","2023-07-31",{"$f":"IF(PartA!C445=\"\",\"\",PartA!C445)","v":""}]
["36a","External SRS MOU","Select","RS13","2023-07-31",{"$f":"PartA!B446","v":"Select…"}]
["37","rDNA Research","Select","RS18","2023-07-31",{"$f":"PartA!B448","v":"Select…"}]
["37a","Internal (Local) IBC","Select","RS19","2023-07-31",{"$f":"PartA!B452","v":"Select…"}]
["37b","Internal IBC Separate from SRS","Select","RS50","2023-07-31",{"$f":"PartA!C456","v":"Select…"}]
["37c","Internal IBC Registered with NIH-OSP","Select","RS51","2023-07-31",{"$f":"PartA!B457","v":"Select…"}]
["37c_detail","Date of IBC Registration","Select","RS60","2023-07-31",{"$f":"IF(PartA!C460=\"\",\"\",PartA!C460)","v":""}]
["37d","External (Affiliate) IBC","Select","RS20","2023-07-31",{"$f":"PartA!B461","v":"Select…"}]
["37d_detail","External (Affiliate) name","Select","RS21","2023-07-31",{"$f":"IF(PartA!C464=\"\",\"\",PartA!C464)","v":""}]
["37e","External (Affiliate) IBC Registered with NIH-OSP","Select","RS23","2023-07-31",{"$f":"PartA!B465","v":"Select…"}]
["37e_detail","Date of External (Affiliate) IBC Registration","Select","RS67","2023-07-31",{"$f":"IF(PartA!C469=\"\",\"\",PartA!C469)","v":""}]
["37f","External (Affiliate) IBC MOU","Select","RS22","2023-07-31",{"$f":"PartA!B470","v":"Select…"}]
["38","Laboratory Research","Select","RS24","2023-07-31",{"$f":"PartA!B472","v":"Select…"}]
["38_detail_#VALabs","Number of VA Labs","Select","RS69","2023-07-31",{"$f":"PartA!B475","v":"Select…"}]
["38_detail_VALab","VA Lab Locations","Select","RS68","2023-07-31",{"$f":"IF(PartA!C477=\"\",\"\",PartA!C477)","v":""}]
["38_detail_#VALeasedLabs","Number of Off-Site VA-Leased Labs","Select","RS70","2023-07-31",{"$f":"PartA!B479","v":"Select…"}]
["38_detail_OffsiteVALeasedLab","Offsite VA Leased Lab Location","Select","RS57","2023-07-31",{"$f":"IF(PartA!C481=\"\",\"\",PartA!C481)","v":""}]
["38_detail_#NonVALabs","Number of Off-Site Non-VA Labs","Select","RS71","2023-07-31",{"$f":"PartA!B483","v":"Select…"}]
["38_detail_OffsiteNonVALab","Offsite Non-VA Lab Location","Select","RS26","2023-07-31",{"$f":"IF(PartA!C485=\"\",\"\",PartA!C485)","v":""}]
["38a","Offsite Waivers","Select","RS27","2023-07-31",{"$f":"PartA!B486","v":"Select…"}]
["38b","Review of Offsite Laboratories","Select","RS58","2023-07-31",{"$f":"PartA!B489","v":"Select…"}]
["39","BSL-3","Select","RS28","2023-07-31",{"$f":"PartA!B494","v":"Select…"}]
["39_detail","BSL-3 Infectious Agents","Select","RS55","2023-07-31",{"$f":"IF(PartA!C497=\"\",\"\",PartA!C497)","v":""}]
["39a","VA BSL-3","Select","RS30","2023-07-31",{"$f":"PartA!B498","v":"Select…"}]
["39a_detail","VA BSL-3 Location","Select","RS59","2023-07-31",{"$f":"IF(PartA!C501=\"\",\"\",PartA!C501)","v":""}]
["39b","Offsite BSL-3","Select","RS31","2023-07-31",{"$f":"PartA!B502","v":"Select…"}]
["39b_detail","Offsite BSL-3 Location","Select","RS32","2023-07-31",{"$f":"IF(PartA!C505=\"\",\"\",PartA!C505)","v":""}]
["40","SARS-Co-V-2 Positive Sample Storage","Select","RS72","2023-07-31",{"$f":"PartA!B506","v":"Select…"}]
["41","Chemical Hazards","Select","RS34","2023-07-31",{"$f":"PartA!B508","v":"Select…"}]
["41a","Chemical Hygiene Plan","Select","RS36","2023-07-31",{"$f":"PartA!B511","v":"Select…"}]
["41a_detail","Chemical Hygiene Plan Date of Last Review","Select","RS77","2023-07-31",{"$f":"IF(PartA!C515=\"\",\"\",PartA!C515)","v":""}]
["41b","Chemical Inventories","Select","RS37","2023-07-31",{"$f":"PartA!B516","v":"Select…"}]
["42","Select Agents/Toxins","Select","RS38","2023-07-31",{"$f":"PartA!B519","v":"Select…"}]
["42_detail","Select Agents/Toxins Detail","Select","RS39","2023-07-31",{"$f":"IF(PartA!C522=\"\",\"\",PartA!C522)","v":""}]
["43a","Research Safety Plan","Select","RS42","2023-07-31",{"$f":"PartA!B525","v":"Select…"}]
["43b","Research Security Plan","Select","RS43","2023-07-31",{"$f":"PartA!B527","v":"Select…"}]
["43c","Emergency Management Plan",{"$f":"C194","v":"Select"},"RS44","2023-07-31",{"$f":"PartA!B529","v":"Select…"}]
["43d","Bloodborne Pathogen Plan","Select","RS48","2023-07-31",{"$f":"PartA!B531","v":"Select…"}]
["43e","Bloodborne Pathogen Training","Select","RS73","2023-07-31",{"$f":"PartA!B533","v":"Select…"}]
["43f","Activate, Decommission, Transfer Labs","Select","RS74","2023-07-31",{"$f":"PartA!B538","v":"Select…"}]
["43g","SRS Annual Review of PI Lab Program","Select","RS75","2023-07-31",{"$f":"PartA!B540","v":"Select…"}]
["43h","Annual Lab Safety Inspections","Select","RS45","2023-07-31",{"$f":"PartA!B542","v":"Select…"}]
["43i","Annual Drills","Select","RS46","2023-07-31",{"$f":"PartA!B544","v":"Select…"}]
["43i_detail1","Date of SRS Review of Biosafety Drill","Select","RS78","2023-07-31",{"$f":"IF(PartA!C551=\"\",\"\",PartA!C551)","v":" "}]
["43i_detail2","Date of SRS Review of Security Drill","Select","RS79","2023-07-31",{"$f":"IF(PartA!C553=\"\",\"\",PartA!C553)","v":""}]
["43i_detail3","Date of SRS Review of Chemical Hygiene Drill","Select","RS80","2023-07-31",{"$f":"IF(PartA!C555=\"\",\"\",PartA!C555)","v":""}]
["43i_detail4","Date of SRS Review of Emergency Management Drill","Select","RS81","2023-07-31",{"$f":"IF(PartA!C557=\"\",\"\",PartA!C557)","v":""}]
["43j","Eyewash Stations/Emergency Showers","Select","RS76","2023-07-31",{"$f":"PartA!B558","v":"Select…"}]
["43k","Occupational Health & Safety Plan","Select","RS53","2023-07-31",{"$f":"PartA!B561","v":"Select…"}]
["43l","PPE Hazard Assessments","Select","RS61","2023-07-31",{"$f":"PartA!B565","v":"Select…"}]
["43m","Laboratory Access","Select","RS54","2023-07-31",{"$f":"PartA!B568","v":"Select…"}]
["RSSPNotes","RSSP Section Notes","Select","RS49","2023-07-31",{"$f":"IF(PartA!C572=\"\",\"\",PartA!C572)","v":""}]
["44","System Interconnections","Select","IS1","2023-07-31",{"$f":"PartA!B575","v":"Select…"}]
["45","Air-Gapped Networks","Select","IS3","2023-07-31",{"$f":"PartA!B583","v":"Select…"}]
["45a","VA Information on Non-VA Network","Select","IS21","2023-07-31",{"$f":"PartA!B589","v":"Select…"}]
["45b","VASI on Non-VA Systems","Select","IS20","2023-07-31",{"$f":"PartA!B597","v":"Select…"}]
["46","VASI Transported Offsite/Outside VA","Select","IS6","2023-07-31",{"$f":"PartA!B606","v":"Select…"}]
["47","Non-VA External Info Systems (IT Equipment)","Select","IS8","2023-07-31",{"$f":"PartA!B613","v":"Select…"}]
["48","Use of VA Mobile and Portable Devices","Select","IS10","2023-07-31",{"$f":"PartA!B618","v":"Select…"}]
["49","Use of Non-VA Mobile or Portable Devices","Select","IS14","2023-07-31",{"$f":"PartA!B629","v":"Select…"}]
["50","Access Controls","Select","IS22","2023-07-31",{"$f":"PartA!B639","v":"Select…"}]
["51","Plan of Action and Milestones","Select","IS23","2023-07-31",{"$f":"PartA!B646","v":"Select…"}]
["RISPNotes","RISP Section Notes","Select","IS17","2023-07-31",{"$f":"IF(PartA!C653=\"\",\"\",PartA!C653)","v":""}]
["52","RIO Appointed","Select","RM1","2023-07-31",{"$f":"PartA!B656","v":"Select…"}]
["52a","RIO Contact Info","Select","RM2","2023-07-31",{"$f":"PartA!B660","v":"Select…"}]
["53","Misconduct Allegations","Select","RM4","2023-07-31",{"$f":"PartA!B664","v":"Select…"}]
["RMNotes","Research Misconduct Section Notes","Select","RM5","2023-07-31",{"$f":"IF(PartA!C668=\"\",\"\",PartA!C668)","v":""}]

{"sheet":"ExportB","index":8,"n_rows":182,"n_cols":8,"rows_kept":182,"cut":false,"hidden":true,"merged":[]}
["Question#","QuestionText","id-facility","id-question","ROC_QuestionKey","FDCdate","FDCresult","FDCdetail"]
["1","Total number of protocols followed by the R&DC only",{"$f":"LEFT(PartA!C2,FIND(\" \",PartA!C2,1)-1)","v":"Select"},1,"R1","2023-07-31",{"$f":"IF(PartB!C10=\"\",\"\",PartB!C10)","v":""}]
["1a","Protocols initiated prior to R&DC approval",{"$f":"C2","v":"Select"},2,"R2","2023-07-31",{"$f":"IF(PartB!C15=\"\",\"\",PartB!C15)","v":""}]
["1aDetails","DETAILS Protocols initiated prior to R&DC approval",{"$f":"C3","v":"Select"},147,"R5","2023-07-31",null,{"$f":"IF(PartB!B20=\"\",\"\",PartB!B20)","v":""}]
["2","Active human protocols","Select",5,"H1","2023-07-31",{"$f":"IF(PartB!C25=\"\",\"\",PartB!C25)","v":""}]
["MVP","DETAILS MVP active at site","Select",155,"H82","2023-07-31",null,false]
["AllOfUs","DETAILS All of Us active at site","Select",187,"H123","2023-07-31",null,false]
["3a","IRB-exempt human subjects protocols","Select",6,"H2","2023-07-31",{"$f":"IF(PartB!C32=\"\",\"\",PartB!C32)","v":""}]
["3b","Non-exempt human subjects protocols","Select",7,"H3","2023-07-31",{"$f":"IF(PartB!C33=\"\",\"\",PartB!C33)","v":""}]
["4","Greater than minimal risk protocols","Select",129,"H72","2023-07-31",{"$f":"IF(PartB!C35=\"\",\"\",PartB!C35)","v":""}]
["5a","Protocols with waivers of informed consent per 38CFR16.116","Select",9,"H5","2023-07-31",{"$f":"IF(PartB!C37=\"\",\"\",PartB!C37)","v":""}]
["5b","Protocols with waiver of documentation of informed consent per 38CFR16.117(c)","Select",8,"H4","2023-07-31",{"$f":"IF(PartB!C40=\"\",\"\",PartB!C40)","v":""}]
["6a","Protocols subject to 2018 Common Rule","Select",249,"H146","2023-07-31",{"$f":"IF(PartB!C44=\"\",\"\",PartB!C44)","v":""}]
["6b","Protocols subject to Pre-2018 Common Rule","Select",250,"H147","2023-07-31",{"$f":"IF(PartB!C45=\"\",\"\",PartB!C45)","v":""}]
["7","Protocols suspended/terminated early by IRB","Select",212,"H124","2023-07-31",{"$f":"IF(PartB!C47=\"\",\"\",PartB!C47)","v":""}]
["7Details","DETAILS Protocols suspended or terminated (Human)","Select",150,"H78","2023-07-31",null,{"$f":"IF(PartB!B55=\"\",\"\",PartB!B55)","v":""}]
["8","Number of serious or continuing noncompliance events (Human)","Select",110,"H64","2023-07-31",{"$f":"IF(PartB!C56=\"\",\"\",PartB!C56)","v":""}]
["8Details","DETAILS Serious/continuing noncompliance events (Human)","Select",151,"H79","2023-07-31",null,{"$f":"IF(PartB!B64=\"\",\"\",PartB!B64)","v":""}]
[9,"Number of events determined to be UPIRTSO","Select",263,"H158","2023-07-31",{"$f":"IF(PartB!C65=\"\",\"\",PartB!C65)","v":""}]
["9Details","DETAILS Number of events determined to be UPIRTSO","Select",264,"H159","2023-07-31",null,{"$f":"IF(PartB!B72=\"\",\"\",PartB!B72)","v":""}]
[10,"Number of protocols REQUIRING IC audit","Select",265,"H160","2023-07-31",{"$f":"IF(PartB!C80=\"\",\"\",PartB!C80)","v":""}]
["10a","Number of protocols that received REQUIRED IC audit","Select",266,"H161","2023-07-31",{"$f":"IF(PartB!C81=\"\",\"\",PartB!C81)","v":""}]
["10aDetails","DETAILS Required audits not completed","Select",267,"H162","2023-07-31",null,{"$f":"IF(PartB!B83=\"\",\"\",PartB!B83)","v":""}]
["10b","Number of ADDITIONAL protocols with IC audit","Select",268,"H163","2023-07-31",{"$f":"IF(PartB!C84=\"\",\"\",PartB!C84)","v":""}]
["10c","Total number of protocols RECEIVING IC audit","Select",12,"H8","2023-07-31",{"$f":"IF(PartB!C87=\"\",\"\",PartB!C87)","v":0}]
[11,"Number of IC audit protocols allowing broad consent","Select",285,"H179","2023-07-31",{"$f":"IF(PartB!C89=\"\",\"\",PartB!C89)","v":""}]
["12","Number of IC audit protocols with consent waived","Select",269,"H164","2023-07-31",{"$f":"IF(PartB!C90=\"\",\"\",PartB!C90)","v":""}]
["12a","Number of IC audit protocols with APPROPRIATE waiver of informed consent","Select",270,"H165","2023-07-31",{"$f":"IF(PartB!C91=\"\",\"\",PartB!C91)","v":""}]
["12aDetails","DETAILS Inappropriate ICD waiver  ",null,271,"H166",null,null,{"$f":"IF(PartB!B95=\"\",\"\",PartB!B95)","v":""}]
["13","Number of IC audit protocols with documentation of consent waived",{"$f":"C28","v":"Select"},272,"H167","2023-07-31",{"$f":"IF(PartB!C96=\"\",\"\",PartB!C96)","v":""}]
["13a","Number of IC audit protocols with APPROPRIATE waiver of documentation of consent","Select",273,"H168","2023-07-31",{"$f":"IF(PartB!C98=\"\",\"\",PartB!C98)","v":""}]
["13aDetails","DETAILS Inappropriate ICD waiver of documentation",null,274,"H169",null,null,{"$f":"IF(PartB!B103=\"\",\"\",PartB!B103)","v":""}]
["14","Number of IC audit protocols with HIPAA authorization waived",{"$f":"C31","v":"Select"},275,"H170","2023-07-31",{"$f":"IF(PartB!C104=\"\",\"\",PartB!C104)","v":""}]
["14a","Number of IC audit protocols with APPROPRIATE waiver of HIPAA authorization","Select",276,"H171","2023-07-31",null,{"$f":"IF(PartB!B110=\"\",\"\",PartB!B110)","v":""}]
["14aDetails","DETAILS Inappropriate HIPAA authorization",null,277,"H172"]
[15,"Total number of ICDs audited",{"$f":"C34","v":"Select"},16,"H12","2023-07-31",{"$f":"IF(PartB!C111=\"\",\"\",PartB!C111)","v":""}]
["15a","ICDs with zero deficiency","Select",17,"H13","2023-07-31",{"$f":"IF(PartB!C114=\"\",\"\",PartB!C114)","v":""}]
["15b","Missing informed consent documents","Select",18,"H14","2023-07-31",{"$f":"IF(PartB!C118=\"\",\"\",PartB!C118)","v":""}]
["15bDetails","DETAILS Missing informed consent documents","Select",156,"H83","2023-07-31",null,{"$f":"IF(PartB!B125=\"\",\"\",PartB!B125)","v":""}]
["15c","Incorrect version of ICD used","Select",188,"H121","2023-07-31",{"$f":"IF(PartB!C126=\"\",\"\",PartB!C126)","v":""}]
["15d","Incorrect ICDs used (from another study)","Select",116,"H67","2023-07-31",{"$f":"IF(PartB!C129=\"\",\"\",PartB!C129)","v":""}]
["15e","Incorrect ICDs used (unapproved)","Select",117,"H68","2023-07-31",{"$f":"IF(PartB!C131=\"\",\"\",PartB!C131)","v":""}]
["15eDetails","DETAILS ICDs unapproved or ICD from another study used","Select",216,"H128","2023-07-31",null,{"$f":"IF(PartB!B136=\"\",\"\",PartB!B136)","v":""}]
["15f","ICDs without subject signature","Select",20,"H16","2023-07-31",{"$f":"IF(PartB!C137=\"\",\"\",PartB!C137)","v":""}]
["15fDetails","DETAILS ICDs without subject signature","Select",157,"H84","2023-07-31",null,{"$f":"IF(PartB!B142=\"\",\"\",PartB!B142)","v":""}]
["15g","ICDs without subject date","Select",21,"H17","2023-07-31",{"$f":"IF(PartB!C143=\"\",\"\",PartB!C143)","v":""}]
["16","ICDs subject to 2018 CR","Select",190,"H101","2023-07-31",{"$f":"IF(PartB!C145=\"\",\"\",PartB!C145)","v":""}]
["16a","ICDs without key information up front","Select",191,"H102","2023-07-31",{"$f":"IF(PartB!C146=\"\",\"\",PartB!C146)","v":""}]
["16b","ICDs with identifiable info/biospecimens collected","Select",192,"H103","2023-07-31",{"$f":"IF(PartB!C148=\"\",\"\",PartB!C148)","v":""}]
["16c","ICDs without information/biospecimen statement on future use","Select",193,"H104","2023-07-31",{"$f":"IF(PartB!C151=\"\",\"\",PartB!C151)","v":""}]
[17,"Number of HIPAA authorizations required","Select",26,"H22","2023-07-31",{"$f":"IF(PartB!C154=\"\",\"\",PartB!C154)","v":""}]
["17a","Valid HIPAA authorizations not obtained","Select",27,"H23","2023-07-31",{"$f":"IF(PartB!C155=\"\",\"\",PartB!C155)","v":""}]
["17aDetails","DETAILS HIPAA authorizations not obtained or missing subject signature","Select",159,"H86","2023-07-31",null,{"$f":"IF(PartB!B161=\"\",\"\",PartB!B161)","v":""}]
["17b","HIPAA template VA-Form 10-0493 required","Select",132,"H75","2023-07-31",{"$f":"IF(PartB!C162=\"\",\"\",PartB!C162)","v":""}]
["17c","HIPAA template VA-Form 10-0493 not used","Select",133,"H76","2023-07-31",{"$f":"IF(PartB!C168=\"\",\"\",PartB!C168)","v":""}]
[18,"Number of Veterans enrolled in MVP","Select",197,"H108","2023-07-31",{"$f":"IF(PartB!C170=\"\",\"\",PartB!C170)","v":""}]
["18a","MVP ICDs and HIPAA authorization audited","Select",198,"H109","2023-07-31",{"$f":"IF(PartB!C172=\"\",\"\",PartB!C172)","v":""}]
["ICDSectionNotes","DETAILS ICD Section Notes","Select",160,"H98","2023-07-31",null,{"$f":"IF(PartB!B178=\"\",\"\",PartB!B178)","v":""}]
[19,"Total number of human protocols receiving a regulatory audit","Select",33,"H29","2023-07-31",{"$f":"IF(PartB!C182=\"\",\"\",PartB!C182)","v":""}]
["19a","Protocols audited greater than minimal risk","Select",203,"H114","2023-07-31",{"$f":"IF(PartB!C184=\"\",\"\",PartB!C184)","v":""}]
["19b","Min risk protocols approved by expedited review","Select",204,"H115","2023-07-31",{"$f":"IF(PartB!C185=\"\",\"\",PartB!C185)","v":""}]
["19bDetails","DETAILS GMR receiving expedited review","Select",218,"H130","2023-07-31",null,{"$f":"IF(PartB!B189=\"\",\"\",PartB!B189)","v":""}]
["20a","Protocols intiated without IRB approval","Select",38,"H34","2023-07-31",{"$f":"IF(PartB!C192=\"\",\"\",PartB!C192)","v":""}]
["20b","Protocols completed without IRB approval","Select",39,"H35","2023-07-31",{"$f":"IF(PartB!C194=\"\",\"\",PartB!C194)","v":""}]
["20c","Protocols intiated without R&DC approval (Human)","Select",40,"H36","2023-07-31",{"$f":"IF(PartB!C195=\"\",\"\",PartB!C195)","v":""}]
["20d","Protocols completed without R&DC Approval (Human)","Select",41,"H37","2023-07-31",{"$f":"IF(PartB!C197=\"\",\"\",PartB!C197)","v":""}]
["20e","Protocols initiated prior to ACOS/R letter (Human)","Select",254,"H151","2023-07-31",{"$f":"IF(PartB!C198=\"\",\"\",PartB!C198)","v":""}]
["20f","Protocols without final PO review","Select",278,"H173","2023-07-31",{"$f":"IF(PartB!C200=\"\",\"\",PartB!C200)","v":""}]
["20g","Protocols without final ISSO review","Select",279,"H174","2023-07-31",{"$f":"IF(PartB!C203=\"\",\"\",PartB!C203)","v":""}]
["20gDetails","DETAILS Protocols without approval","Select",182,"H99","2023-07-31",null,{"$f":"IF(PartB!B209=\"\",\"\",PartB!B209)","v":""}]
["21","Number of international research protocols",{"$f":"C70","v":"Select"},60,"H56","2023-07-31",{"$f":"IF(PartB!C210=\"\",\"\",PartB!C210)","v":""}]
["21a","International protocols without FD/CRADO approval","Select",61,"H57","2023-07-31",{"$f":"IF(PartB!C211=\"\",\"\",PartB!C211)","v":""}]
["21aDetails","DETAILS No approval for international protocol","Select",178,"H93","2023-07-31",null,{"$f":"IF(PartB!B215=\"\",\"\",PartB!B215)","v":""}]
["22","Number of protocols involving children","Select",62,"H58","2023-07-31",{"$f":"IF(PartB!C216=\"\",\"\",PartB!C216)","v":""}]
["22a","Protocols involving children without FD/CRADO approval","Select",63,"H59","2023-07-31",{"$f":"IF(PartB!C217=\"\",\"\",PartB!C217)","v":""}]
["22aDetails","DETAILS No approval for protocol with children","Select",179,"H94","2023-07-31",null,{"$f":"IF(PartB!B221=\"\",\"\",PartB!B221)","v":""}]
[23,"Number of protocols involving prisoners","Select",64,"H60","2023-07-31",{"$f":"IF(PartB!C222=\"\",\"\",PartB!C222)","v":""}]
["23a","Protocols without CRADO approval","Select",65,"H61","2023-07-31",{"$f":"IF(PartB!C223=\"\",\"\",PartB!C223)","v":""}]
["23aDetails","DETAILS no approval for protocol with prisoners","Select",180,"H95","2023-07-31",null,{"$f":"IF(PartB!B226=\"\",\"\",PartB!B226)","v":""}]
[24,"Number of protocols using investigational drugs","Select",280,"H175","2023-07-31",{"$f":"IF(PartB!C227=\"\",\"\",PartB!C227)","v":""}]
["24a","Investigational drug log not containing required elements","Select",281,"H176","2023-07-31",{"$f":"IF(PartB!C229=\"\",\"\",PartB!C229)","v":""}]
["24b","Investigational drugs not stored separately","Select",282,"H177","2023-07-31",{"$f":"IF(PartB!C233=\"\",\"\",PartB!C233)","v":""}]
[25,"Protocols audited subject to 2018 Common Rule","Select",202,"H113","2023-07-31",{"$f":"IF(PartB!C237=\"\",\"\",PartB!C237)","v":""}]
["25a","Protocols audited that were IRB-exempt","Select",205,"H116","2023-07-31",{"$f":"IF(PartB!C238=\"\",\"\",PartB!C238)","v":""}]
["25b","Exempt category not documented","Select",206,"H117","2023-07-31",{"$f":"IF(PartB!C239=\"\",\"\",PartB!C239)","v":""}]
["25c","Exempt category does not match regulatory description","Select",207,"H118","2023-07-31",{"$f":"IF(PartB!C241=\"\",\"\",PartB!C241)","v":""}]
["25cDetails","DETAILS Incorrect exempt category","Select",219,"H131","2023-07-31",null,{"$f":"IF(PartB!B246=\"\",\"\",PartB!B246)","v":""}]
["25d","IRB-exempt protocols requiring limited IRB review","Select",208,"H119","2023-07-31",{"$f":"IF(PartB!C247=\"\",\"\",PartB!C247)","v":""}]
["25e","Protocols not receiving required limited IRB review","Select",209,"H120","2023-07-31",{"$f":"IF(PartB!C249=\"\",\"\",PartB!C249)","v":""}]
["25eDetails","DETAILS No limited IRB review","Select",220,"H132","2023-07-31",null,{"$f":"IF(PartB!B253=\"\",\"\",PartB!B253)","v":""}]
["25f","Exempt protocols without required information provided to subjects","Select",221,"H133","2023-07-31",{"$f":"IF(PartB!C254=\"\",\"\",PartB!C254)","v":""}]
["25fDetails","DETAILS Exempt protocols without required information provided to subjects","Select",222,"H134","2023-07-31",null,{"$f":"IF(PartB!B260=\"\",\"\",PartB!B260)","v":""}]
["26","Protocols subject to single IRB requirement","Select",225,"H137","2023-07-31",{"$f":"IF(PartB!C261=\"\",\"\",PartB!C261)","v":""}]
["26a","Single IRB protocols","Select",255,"H152","2023-07-31",{"$f":"IF(PartB!C264=\"\",\"\",PartB!C264)","v":""}]
["26b","Single IRB protocols without valid reliance agreement","Select",256,"H153","2023-07-31",{"$f":"IF(PartB!C266=\"\",\"\",PartB!C266)","v":""}]
["26c","Single IRB protocols NOT reviewed by single IRB","Select",257,"H154","2023-07-31",{"$f":"IF(PartB!C270=\"\",\"\",PartB!C270)","v":""}]
["26d","Single IRB protocols without valid exception","Select",258,"H155","2023-07-31",{"$f":"IF(PartB!C272=\"\",\"\",PartB!C272)","v":""}]
["26dDetails","DETAILS No reliance agreement or exception","Select",240,"H142","2023-07-31",null,{"$f":"IF(PartB!B279=\"\",\"\",PartB!B279)","v":""}]
["27","Protocols requiring IRB continuing review (HRPP audit)","Select",45,"H41","2023-07-31",{"$f":"IF(PartB!C280=\"\",\"\",PartB!C280)","v":""}]
[28,"Protocols with CR required by IRB (not required by 1200.05)","Select",223,"H135","2023-07-31",{"$f":"IF(PartB!C282=\"\",\"\",PartB!C282)","v":""}]
["29a","Protocols with lapse in IRB continuing review (HRPP audit)","Select",46,"H42","2023-07-31",{"$f":"IF(PartB!C285=\"\",\"\",PartB!C285)","v":""}]
["29b","Protocols with activity during lapse (HRPP audit)","Select",47,"H43","2023-07-31",{"$f":"IF(PartB!C288=\"\",\"\",PartB!C288)","v":""}]
["29bDetails","DETAILS Protocols with activity during lapse (HRPP audit)","Select",175,"H90","2023-07-31",null,{"$f":"IF(PartB!B294=\"\",\"\",PartB!B294)","v":""}]
["29c","Protocols with rationale for IRB-required CR documented","Select",224,"H136","2023-07-31",{"$f":"IF(PartB!C295=\"\",\"\",PartB!C295)","v":""}]
["29cDetails","DETAILS No continuing review documentation","Select",239,"H141","2023-07-31",null,{"$f":"IF(PartB!B300=\"\",\"\",PartB!B300)","v":""}]
[30,"Local adverse events and apparent UPIRTSOs","Select",259,"H156","2023-07-31",{"$f":"IF(PartB!C301=\"\",\"\",PartB!C301)","v":""}]
["30a","Local AEs determined to be serious, unanticipated and related","Select",42,"H38","2023-07-31",{"$f":"IF(PartB!C304=\"\",\"\",PartB!C304)","v":""}]
["30b","SAEs not reported to IRB in a timely manner","Select",119,"H70","2023-07-31",{"$f":"IF(PartB!C308=\"\",\"\",PartB!C308)","v":""}]
["30c","SAEs not reviewed and categorized by the IRB in a timely manner","Select",120,"H71","2023-07-31",{"$f":"IF(PartB!C311=\"\",\"\",PartB!C311)","v":""}]
["30cDetails","DETAILS SAEs not reported or reviewed within required timeframe","Select",227,"H139","2023-07-31",null,{"$f":"IF(PartB!B317=\"\",\"\",PartB!B317)","v":""}]
[31,"Total number of research personnel in human protocols audited","Select",55,"H51","2023-07-31",{"$f":"IF(PartB!C318=\"\",\"\",PartB!C318)","v":""}]
["31a","Personnel with lapse in required training (Human)","Select",58,"H54","2023-07-31",{"$f":"IF(PartB!C320=\"\",\"\",PartB!C320)","v":""}]
["31b","Personnel without initial training (Human)","Select",59,"H55","2023-07-31",{"$f":"IF(PartB!C323=\"\",\"\",PartB!C323)","v":""}]
["31bDetails","DETAILS No initial human subjects training","Select",228,"H140","2023-07-31",null,{"$f":"IF(PartB!B328=\"\",\"\",PartB!B328)","v":""}]
[32,"Total number of subject records reviewed","Select",48,"H44","2023-07-31",{"$f":"IF(PartB!C329=\"\",\"\",PartB!C329)","v":""}]
["32a","Number of records without documentation of IC prior to research","Select",49,"H45","2023-07-31",{"$f":"IF(PartB!C332=\"\",\"\",PartB!C332)","v":""}]
["32aDetails","DETAILS Research prior to IC","Select",176,"H91","2023-07-31",null,{"$f":"IF(PartB!B338=\"\",\"\",PartB!B338)","v":""}]
["32b","Number of records with Inclusion/Exclusion criteria","Select",50,"H46","2023-07-31",{"$f":"IF(PartB!C339=\"\",\"\",PartB!C339)","v":""}]
["32c","Number of subjects included in research not meeting incl/excl","Select",54,"H50","2023-07-31",{"$f":"IF(PartB!C344=\"\",\"\",PartB!C344)","v":""}]
["32cDetails","DETAILS Subjects included not meeting Incl/Excl criteria","Select",177,"H92","2023-07-31",null,{"$f":"IF(PartB!B351=\"\",\"\",PartB!B351)","v":""}]
["32d","Number of subjects without progress note","Select",283,"H178","2023-07-31",{"$f":"IF(PartB!C352=\"\",\"\",PartB!C352)","v":""}]
["HRPPNotes","DETAILS HRPP/IRB section notes","Select",184,"H97","2023-07-31",null,{"$f":"IF(PartB!B357=\"\",\"\",PartB!B357)","v":""}]
["33","Active animal protocols","Select",66,"A1","2023-07-31",{"$f":"IF(PartB!C364=\"\",\"\",PartB!C364)","v":""}]
["34","Protocols suspended/terminated early by IACUC","Select",229,"A42","2023-07-31",{"$f":"IF(PartB!C365=\"\",\"\",PartB!C365)","v":""}]
["34Details","DETAILS Suspensions or terminations","Select",173,"A38","2023-07-31",null,{"$f":"IF(PartB!B371=\"\",\"\",PartB!B371)","v":""}]
["35","Number of serious or continuing noncompliance events (Animal)","Select",243,"A46","2023-07-31",{"$f":"IF(PartB!C372=\"\",\"\",PartB!C372)","v":""}]
["35Details","DETAILS serious/continuing noncompliance events (Animal)","Select",244,"A47","2023-07-31",null,{"$f":"IF(PartB!B378=\"\",\"\",PartB!B378)","v":""}]
["36","Total number of animal research protocols audited","Select",72,"A7","2023-07-31",{"$f":"IF(PartB!C381=\"\",\"\",PartB!C381)","v":""}]
["37","Protocols with controlled substances (Animal)","Select",122,"A31","2023-07-31",{"$f":"IF(PartB!C383=\"\",\"\",PartB!C383)","v":""}]
["37a","Protocols  with controlled substances conducted at the VA","Select",135,"A34","2023-07-31",{"$f":"IF(PartB!C386=\"\",\"\",PartB!C386)","v":""}]
["37b","Protocols with CS not obtained through VA pharmacy","Select",136,"A35","2023-07-31",{"$f":"IF(PartB!C388=\"\",\"\",PartB!C388)","v":""}]
["37bDetails","DETAILS CS not obtained through VA pharmacy","Select",230,"A43","2023-07-31",null,{"$f":"IF(PartB!B393=\"\",\"\",PartB!B393)","v":""}]
["37c","Controlled substance not properly stored","Select",210,"A41","2023-07-31",{"$f":"IF(PartB!C394=\"\",\"\",PartB!C394)","v":""}]
["37cDetails","DETAILS CS not properly stored","Select",231,"A44","2023-07-31",null,{"$f":"IF(PartB!B400=\"\",\"\",PartB!B400)","v":""}]
["38a","Protocols initiated prior to IACUC approval",{"$f":"C134","v":"Select"},78,"A13","2023-07-31",{"$f":"IF(PartB!C403=\"\",\"\",PartB!C403)","v":""}]
["38b","Protocols completed without IACUC approval","Select",79,"A14","2023-07-31",{"$f":"IF(PartB!C405=\"\",\"\",PartB!C405)","v":""}]
["38c","Protocols initated prior to R&DC approval (Animal)","Select",80,"A15","2023-07-31",{"$f":"IF(PartB!C406=\"\",\"\",PartB!C406)","v":""}]
["38d","Protocols completed without R&DC approval (Animal)","Select",81,"A16","2023-07-31",{"$f":"IF(PartB!C408=\"\",\"\",PartB!C408)","v":""}]
["38e","Protocols initiated prior to ACOS/R letter (animal)","Select",260,"A49","2023-07-31",{"$f":"IF(PartB!C409=\"\",\"\",PartB!C409)","v":""}]
["38eDetails","DETAILS research initiated prior to approval","Select",183,"A39","2023-07-31",null,{"$f":"IF(PartB!B415=\"\",\"\",PartB!B415)","v":""}]
["39","Protocols requiring IACUC annual review","Select",123,"A32","2023-07-31",{"$f":"IF(PartB!C416=\"\",\"\",PartB!C416)","v":""}]
["39a","Protocols with lapse in IACUC annual review","Select",113,"A27","2023-07-31",{"$f":"IF(PartB!C417=\"\",\"\",PartB!C417)","v":""}]
["39b","Protocols requiring IACUC triennial review","Select",124,"A33","2023-07-31",{"$f":"IF(PartB!C419=\"\",\"\",PartB!C419)","v":""}]
["39c","Protocols with lapse in IACUC triennial review","Select",114,"A28","2023-07-31",{"$f":"IF(PartB!C420=\"\",\"\",PartB!C420)","v":""}]
["39d","Protocols with activity during  triennial review lapse","Select",115,"A29","2023-07-31",{"$f":"IF(PartB!C423=\"\",\"\",PartB!C423)","v":""}]
["39dDetails","DETAILS Protocols with activity during triennial review lapse","Select",172,"A37","2023-07-31",null,{"$f":"IF(PartB!B429=\"\",\"\",PartB!B429)","v":""}]
["40","Total number of research personnel in animal protocols audited","Select",87,"A22","2023-07-31",{"$f":"IF(PartB!C430=\"\",\"\",PartB!C430)","v":""}]
["40a","Personnel with lapse in required training (Animal)","Select",90,"A25","2023-07-31",{"$f":"IF(PartB!C432=\"\",\"\",PartB!C432)","v":""}]
["40b","Personnel without initial training (Animal)","Select",91,"A26","2023-07-31",{"$f":"IF(PartB!C435=\"\",\"\",PartB!C435)","v":""}]
["40bDetails","DETAILS No initial animal welfare training","Select",232,"A45","2023-07-31",null,{"$f":"IF(PartB!B441=\"\",\"\",PartB!B441)","v":""}]
["ACUPSectionNotes","DETAILS ACUP/IACUC section notes","Select",171,"A36","2023-07-31",null,{"$f":"IF(PartB!B443=\"\",\"\",PartB!B443)","v":""}]
["41","Active safety protocols","Select",92,"S1","2023-07-31",{"$f":"IF(PartB!C450=\"\",\"\",PartB!C450)","v":""}]
["41a","Active basic science protocols","Select",137,"S21","2023-07-31",{"$f":"IF(PartB!C451=\"\",\"\",PartB!C451)","v":""}]
["42","Protocols suspended/terminated early by SRS","Select",233,"S38","2023-07-31",{"$f":"IF(PartB!C453=\"\",\"\",PartB!C453)","v":""}]
["42Details","DETAILS Suspensions or terminations","Select",170,"S35","2023-07-31",null,{"$f":"IF(PartB!B460=\"\",\"\",PartB!B460)","v":""}]
["43","Number of serious or continuing noncompliance events (Safety)","Select",245,"S44","2023-07-31",{"$f":"IF(PartB!C461=\"\",\"\",PartB!C461)","v":""}]
["43Details","DETAILS serious/continuing noncompliance events (Safety)","Select",246,"S45","2023-07-31",null,{"$f":"IF(PartB!B468=\"\",\"\",PartB!B468)","v":""}]
["44","Total number of safety protocols audited","Select",97,"S6","2023-07-31",{"$f":"IF(PartB!C471=\"\",\"\",PartB!C471)","v":""}]
["45","Protocols conducted completely or partially off-site","Select",125,"S17","2023-07-31",{"$f":"IF(PartB!C473=\"\",\"\",PartB!C473)","v":""}]
["45a","Protocols without required off-site waiver","Select",139,"S27","2023-07-31",{"$f":"IF(PartB!C475=\"\",\"\",PartB!C475)","v":""}]
["46","Protocols with chemical hazards","Select",127,"S19","2023-07-31",{"$f":"IF(PartB!C476=\"\",\"\",PartB!C476)","v":""}]
["46a","Protocols without required semi-annual chemical inventory review","Select",234,"S39","2023-07-31",{"$f":"IF(PartB!C478=\"\",\"\",PartB!C478)","v":""}]
["46aDetails","DETAILS Protocols without required semi-annual chemical inventory review","Select",284,"S47","2023-07-31",null,{"$f":"IF(PartB!B485=\"\",\"\",PartB!B485)","v":""}]
["47","Protocols with radiation hazards","Select",128,"S20","2023-07-31",{"$f":"IF(PartB!C486=\"\",\"\",PartB!C486)","v":""}]
["47a","Protocol not reviewed by radiation/safety officer","Select",144,"S28","2023-07-31",{"$f":"IF(PartB!C487=\"\",\"\",PartB!C487)","v":""}]
["48a","Protocols initiated prior to SRS approval","Select",98,"S7","2023-07-31",{"$f":"IF(PartB!C493=\"\",\"\",PartB!C493)","v":""}]
["48b","Protocols completed without SRS approval","Select",99,"S8","2023-07-31",{"$f":"IF(PartB!C495=\"\",\"\",PartB!C495)","v":""}]
["48c","Protocols without written notification of SRS review","Select",235,"S40","2023-07-31",{"$f":"IF(PartB!C496=\"\",\"\",PartB!C496)","v":""}]
["48d","Protocols intiated prior to R&DC approval (Safety)","Select",103,"S12","2023-07-31",{"$f":"IF(PartB!C499=\"\",\"\",PartB!C499)","v":""}]
["48e","Protocols completed without R&DC approval (Safety)","Select",104,"S13","2023-07-31",{"$f":"IF(PartB!C501=\"\",\"\",PartB!C501)","v":""}]
["48f","Protocols initiated priot to ACOS/R letter (safety)","Select",261,"S46","2023-07-31",{"$f":"IF(PartB!C502=\"\",\"\",PartB!C502)","v":""}]
["48fDetails","DETAILS Protocols without SRS approval","Select",167,"S32","2023-07-31",null,{"$f":"IF(PartB!B508=\"\",\"\",PartB!B508)","v":""}]
["49","Protocols requiring IBC approval","Select",100,"S9","2023-07-31",{"$f":"IF(PartB!C509=\"\",\"\",PartB!C509)","v":""}]
["49a","Protocols initiated prior to IBC approval","Select",101,"S10","2023-07-31",{"$f":"IF(PartB!C511=\"\",\"\",PartB!C511)","v":""}]
["49b","Protocols completed without IBC approval","Select",102,"S11","2023-07-31",{"$f":"IF(PartB!C512=\"\",\"\",PartB!C512)","v":""}]
["49c","Protocols without written notification of IBC review","Select",236,"S41","2023-07-31",{"$f":"IF(PartB!C513=\"\",\"\",PartB!C513)","v":""}]
["49cDetails","DETAILS Protocols without IBC approval","Select",237,"S42","2023-07-31",null,{"$f":"IF(PartB!B520=\"\",\"\",PartB!B520)","v":""}]
["50","Total number of research personnel in safety protocols audited","Select",164,"S29","2023-07-31",{"$f":"IF(PartB!C521=\"\",\"\",PartB!C521)","v":""}]
["50a","Personnel with lapse in required training (Safety)","Select",165,"S30","2023-07-31",{"$f":"IF(PartB!C523=\"\",\"\",PartB!C523)","v":""}]
["50b","Personnel without initial training (Safety)","Select",166,"S31","2023-07-31",{"$f":"IF(PartB!C526=\"\",\"\",PartB!C526)","v":""}]
["50bDetails","DETAILS No initial safety training","Select",238,"S43","2023-07-31",null,{"$f":"IF(PartB!B532=\"\",\"\",PartB!B532)","v":""}]
["RSSSectionNotes","RSSP/SRS Section Notes","Select",186,"S36","2023-07-31",null,{"$f":"IF(PartB!B534=\"\",\"\",PartB!B534)","v":""}]

{"sheet":"Drop-down","index":9,"n_rows":111,"n_cols":32,"rows_kept":111,"cut":false,"hidden":true,"merged":[[23,30,23,31],[24,30,25,31]]}
["VISN","Facility #","Facility","Select Facility…",null,"Select…",null,"Select…",null,"Select…",null,"Select…",null,"Select…",null,"Select…",null,"Select…",null,"Select…",null,"Select…",null,"Select…"]
[1,402,"VA Maine Healthcare System - Togus","402 VA Maine Healthcare System - Togus",null,"Yes",null,"Yes",null,"Continued full accreditation",null,"Only at the VA animal facility",null,"Full-time",null,"A full-time VA employed veterinarian",null,"The VA IACUC performs the program review and facility inspection of the VA animal program.",null,"The VA IACUC performs its own program review and facility inspection of the affiliate(s) animal program.",null,0,null,"The IBC is a separate committee from the SRS. "]
[1,405,"White River Junction VA Medical Center","405 White River Junction VA Medical Center",null,"No",null,"No",null,"Conditional accreditation",null,"Only at the affiliate animal facility",null,"Part-time",null,"A part-time VA employed veterinarian",null,"The affiliate IACUC-of-record (i.e., no VA IACUC) performs the program review and facility inspection of the VA animal program.",null,"The VA IACUC accepts the semi-annual reports of the affiliate IACUC (in lieu of performing its own facility inspection and program review) as a business item during a convened meeting.",null,"1-10",null,"The SRS is constituted as an IBC, and convenes as an IBC/SRS (a single set of minutes are produced)."]
[23,437,"Fargo VA Health Care System","437 Fargo VA Health Care System",null,"N/A",null,null,null,"Deferred accreditation",null,"Both at the VA and affiliate animal facility",null,null,null,"A full-time contracted veterinarian",null,null,null,"The affiliate IACUC-of-record (i.e., no VA IACUC) performs the program review and facility inspection of the VA animal program",null,"11-20",null,"The SRS is constituted as an IBC, but separate IBC and SRS meetings are convened (two sets of minutes are produced)."]
[23,438,"Sioux Falls VA Health Care System","438 Sioux Falls VA Health Care System",null,null,null,null,null,"Probation",null,null,null,null,null,"A part-time contracted veterinarian",null,null,null,null,null,"21-30"]
[21,459,"VA Pacific Islands Health Care System","459 VA Pacific Islands Health Care System",null,null,null,null,null,"Revoked accreditation",null,null,null,null,null,null,null,null,null,null,null,"31-40"]
[4,460,"Wilmington VA Medical Center","460 Wilmington VA Medical Center",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,">40"]
[22,501,"New Mexico VA Health Care System","501 New Mexico VA Health Care System"]
[10,506,"VA Ann Arbor Healthcare System","506 VA Ann Arbor Healthcare System"]
[7,508,"Atlanta VA Medical Center","508 Atlanta VA Medical Center"]
[7,509,"Charlie Norwood VA Medical Center","509 Charlie Norwood VA Medical Center"]
[5,512,"VA Maryland Health Care System","512 VA Maryland Health Care System"]
[10,515,"Battle Creek VA Medical Center","515 Battle Creek VA Medical Center"]
[8,516,"Bay Pines VA Healthcare System","516 Bay Pines VA Healthcare System"]
[1,518,"Edith Nourse Rogers Memorial VA Hospital","518 Edith Nourse Rogers Memorial VA Hospital"]
[16,520,"Gulf Coast Veterans Health Care System","520 Gulf Coast Veterans Health Care System"]
[7,521,"Birmingham VA Medical Center","521 Birmingham VA Medical Center"]
[1,523,"VA Boston Healthcare System","523 VA Boston Healthcare System"]
[2,526,"James J. Peters VA Medical Center","526 James J. Peters VA Medical Center"]
[2,528,"VA Western New York Healthcare System","528 VA Western New York Healthcare System"]
[2,"528A6","VA Finger Lakes Healthcare System","528A6 VA Finger Lakes Healthcare System"]
[2,"528A7","Syracuse VA Medical Center","528A7 Syracuse VA Medical Center"]
[2,"528A8","Albany VA Medical Center: Samuel S. Stratton","528A8 Albany VA Medical Center: Samuel S. Stratton"]
[20,531,"Boise VA Medical Center","531 Boise VA Medical Center",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"33.","For affiliate animal facilities:"]
[7,534,"Ralph H. Johnson VA Medical Center","534 Ralph H. Johnson VA Medical Center",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"How has the IACUC fulfilled requirements for semi-annual assessment of the affiliate(s) ACUP as it relates to oversight of VA animal research?"]
[12,537,"Jesse Brown VA Medical Center","537 Jesse Brown VA Medical Center"]
[10,538,"Chillicothe VA Medical Center","538 Chillicothe VA Medical Center",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Select…"]
[10,539,"Cincinnati VA Medical Center","539 Cincinnati VA Medical Center",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"VHA Handbook 1200.07§8.f(1)(a) "]
[5,540,"Louis A. Johnson VA Medical Center","540 Louis A. Johnson VA Medical Center"]
[10,541,"VA Northeast Ohio Healthcare System","541 VA Northeast Ohio Healthcare System"]
[4,542,"Coatesville VA Medical Center","542 Coatesville VA Medical Center"]
[7,544,"Wm. Jennings Bryan Dorn VA Medical Center","544 Wm. Jennings Bryan Dorn VA Medical Center"]
[8,546,"Miami VA Healthcare System","546 Miami VA Healthcare System"]
[8,548,"West Palm Beach VA Medical Center","548 West Palm Beach VA Medical Center"]
[17,549,"VA North Texas Health Care System","549 VA North Texas Health Care System"]
[10,552,"Dayton VA Medical Center","552 Dayton VA Medical Center"]
[10,553,"John D. Dingell VA Medical Center","553 John D. Dingell VA Medical Center"]
[19,554,"VA Eastern Colorado Health Care System","554 VA Eastern Colorado Health Care System"]
[12,556,"Captain James A. Lovell Federal Health Care Center","556 Captain James A. Lovell Federal Health Care Center"]
[6,558,"Durham VA Health Care System","558 Durham VA Health Care System"]
[2,561,"VA New Jersey Health Care System","561 VA New Jersey Health Care System"]
[16,564,"Veterans Health Care System of the Ozarks","564 Veterans Health Care System of the Ozarks"]
[21,570,"VA Central California Health Care System","570 VA Central California Health Care System"]
[8,573,"North Florida/South Georgia Veterans Health System","573 North Florida/South Georgia Veterans Health System"]
[12,578,"Edward Hines Jr. VA Hospital","578 Edward Hines Jr. VA Hospital"]
[16,580,"Michael E. DeBakey VA Medical Center","580 Michael E. DeBakey VA Medical Center"]
[5,581,"Hershel Woody Williams VA Medical Center","581 Hershel Woody Williams VA Medical Center"]
[10,583,"Richard L. Roudebush VA Medical Center","583 Richard L. Roudebush VA Medical Center"]
[16,586,"G.V. (Sonny) Montgomery VA Medical Center","586 G.V. (Sonny) Montgomery VA Medical Center"]
[15,589,"Kansas City VA Medical Center","589 Kansas City VA Medical Center"]
[15,"589A4","Harry S. Truman Memorial Veterans' Hospital","589A4 Harry S. Truman Memorial Veterans' Hospital"]
[15,"589A6","VA Eastern Kansas Health Care System","589A6 VA Eastern Kansas Health Care System"]
[15,"589A7","Robert J. Dole VA Medical Center","589A7 Robert J. Dole VA Medical Center"]
[6,590,"Hampton VA Medical Center","590 Hampton VA Medical Center"]
[21,593,"VA Southern Nevada Healthcare System","593 VA Southern Nevada Healthcare System"]
[9,596,"Lexington VA Healthcare System","596 Lexington VA Healthcare System"]
[16,598,"Central Arkansas Veterans Healthcare System","598 Central Arkansas Veterans Healthcare System"]
[22,600,"VA Long Beach Healthcare System","600 VA Long Beach Healthcare System"]
[9,603,"Robley Rex VA Medical Center","603 Robley Rex VA Medical Center"]
[22,605,"VA Loma Linda Healthcare System","605 VA Loma Linda Healthcare System"]
[12,607,"William S. Middleton Memorial Veterans Hospital","607 William S. Middleton Memorial Veterans Hospital"]
[1,608,"Manchester VA Medical Center","608 Manchester VA Medical Center"]
[21,612,"VA Northern California Health Care System","612 VA Northern California Health Care System"]
[5,613,"Martinsburg VA Medical Center","613 Martinsburg VA Medical Center"]
[9,614,"Memphis VA Medical Center","614 Memphis VA Medical Center"]
[23,618,"Minneapolis VA Health Care System","618 Minneapolis VA Health Care System"]
[2,620,"VA Hudson Valley Health Care System","620 VA Hudson Valley Health Care System"]
[9,621,"James H. Quillen VA Medical Center","621 James H. Quillen VA Medical Center"]
[19,623,"Eastern Oklahoma VA Health Care System","623 Eastern Oklahoma VA Health Care System"]
[9,626,"Tennessee Valley Healthcare System","626 Tennessee Valley Healthcare System"]
[16,629,"Southeast Louisiana Veterans Health Care System","629 Southeast Louisiana Veterans Health Care System"]
[2,630,"VA NY Harbor Healthcare System","630 VA NY Harbor Healthcare System"]
[1,631,"VA Central Western Massachusetts Healthcare System","631 VA Central Western Massachusetts Healthcare System"]
[2,632,"Northport VA Medical Center","632 Northport VA Medical Center"]
[19,635,"Oklahoma City VA Health Care System","635 Oklahoma City VA Health Care System"]
[23,636,"VA Nebraska-Western Iowa Health Care System","636 VA Nebraska-Western Iowa Health Care System"]
[23,"636A8","Iowa City VA Health Care System","636A8 Iowa City VA Health Care System"]
[6,637,"Charles George VA Medical Center","637 Charles George VA Medical Center"]
[21,640,"VA Palo Alto Health Care System","640 VA Palo Alto Health Care System"]
[4,642,"Corporal Michael J. Crescenz VA Medical Center","642 Corporal Michael J. Crescenz VA Medical Center"]
[22,644,"Phoenix VA Health Care System","644 Phoenix VA Health Care System"]
[4,646,"VA Pittsburgh Healthcare System","646 VA Pittsburgh Healthcare System"]
[20,648,"VA Portland Healthcare System","648 VA Portland Healthcare System"]
[22,649,"Northern Arizona VA Health Care System","649 Northern Arizona VA Health Care System"]
[1,650,"VA Providence Healthcare System","650 VA Providence Healthcare System"]
[6,652,"Central Virginia VA Health Care System","652 Central Virginia VA Health Care System"]
[21,654,"VA Sierra Nevada Health Care System","654 VA Sierra Nevada Health Care System"]
[10,655,"Aleda E. Lutz VA Medical Center","655 Aleda E. Lutz VA Medical Center"]
[23,656,"St. Cloud VA Health Care System","656 St. Cloud VA Health Care System"]
[15,657,"VA St. Louis Health Care System","657 VA St. Louis Health Care System"]
[6,658,"Salem VA Medical Center","658 Salem VA Medical Center"]
[6,659,"W.G. (Bill) Hefner VA Medical Center","659 W.G. (Bill) Hefner VA Medical Center"]
[19,660,"VA Salt Lake City Health Care System","660 VA Salt Lake City Health Care System"]
[21,662,"San Francisco VA Health Care System","662 San Francisco VA Health Care System"]
[20,663,"VA Puget Sound Health Care System","663 VA Puget Sound Health Care System"]
[22,664,"VA San Diego Healthcare System","664 VA San Diego Healthcare System"]
[16,667,"Overton Brooks VA Medical Center","667 Overton Brooks VA Medical Center"]
[20,668,"Mann-Grandstaff VA Medical Center","668 Mann-Grandstaff VA Medical Center"]
[17,671,"South Texas Veterans Health Care System","671 South Texas Veterans Health Care System"]
[8,672,"VA Caribbean Healthcare System","672 VA Caribbean Healthcare System"]
[8,673,"James A. Haley Veterans' Hospital","673 James A. Haley Veterans' Hospital"]
[17,674,"Central Texas Veterans Health Care System","674 Central Texas Veterans Health Care System"]
[8,675,"Orlando VA Medical Center","675 Orlando VA Medical Center"]
[22,678,"Southern Arizona VA Health Care System","678 Southern Arizona VA Health Care System"]
[7,679,"Tuscaloosa VA Medical Center","679 Tuscaloosa VA Medical Center"]
[5,688,"Washington DC VA Medical Center","688 Washington DC VA Medical Center"]
[1,689,"VA Connecticut Healthcare System","689 VA Connecticut Healthcare System"]
[22,691,"VA Greater Los Angeles Healthcare System","691 VA Greater Los Angeles Healthcare System"]
[4,693,"Wilkes-Barre VA Medical Center","693 Wilkes-Barre VA Medical Center"]
[12,695,"Clement J. Zablocki VA Medical Center","695 Clement J. Zablocki VA Medical Center"]
[10,757,"Chalmers P. Wylie VA Ambulatory Care Center","757 Chalmers P. Wylie VA Ambulatory Care Center"]