HRPP and IRB Responsibilities



VETERANS HEALTH ADMINISTRATION (VHA)OFFICE OF RESEARCH OVERSIGHT (ORO)FACILITY DIRECTOR’S CERTIFICATION OF RESEARCH OVERSIGHT (FDC)REPORTING PERIOD: JUNE 1, 2020 TO MAY 31, 2021Date: Enter a date. Facility: Choose a facility. Facility Contact for Questions: Enter facility contact. Email: Enter contact email. Submission of this form should occur no later than August 2, 2021. ?If updated information becomes available after August?2, 2021?please contact ORO at OROIDA@.?PART A - CHECKLIST OF RESEARCH -RELATED REQUIREMENTSGo to Part BMedical Facility Director - Institutional ResponsibilitiesNote: Questions shaded in yellow are new questions from previous FDC versionsSelect.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.Click or tap here to enter text.VHA Directive 1200.01(1) §5.f(6)VHA Directive 1200.02(1) §6.aHas the Facility Director:Select.Appointed members of the R&DC and its subcommittees in writing? VHA Directive 1200.01(1) §5.f(3)Select.Delegated authority in writing for the roles and responsibilities within the facility’s Human Research Protection Program (HRPP)?VHA Directive 1200.05(2) §5.f(2)(c)Select.Received the R&DC annual review and evaluation of all research related committees and subcommittees? Note: Completion of the FDC in and of itself does not constitute a positive response to this item. VHA Directive 1200.01(1) §6.fHas the Research Compliance Officer (RCO):Select.Maintained auditing plans and/or standard operation procedures (SOPs) for accomplishing required RCO informed consent audits and regulatory audits?Select.Verified that all required informed consent and regulatory audits have been completed for this reporting period? If “No,” please provide details in the space below. Include audit type(s) and number of audits to be completed. Click or tap here to enter text.Select. Are any of the following positions currently unfilled or held by acting or interim personnel? If "Yes", please select all that apply and provide details in the space below including whether acting or interim personnel have been assigned and the length of time assigned.Click or tap here to enter text.?Medical Facility Director?Associate Chief of Staff/Research and Development (ACOS/R&D) or Coordinator for R&D?Administrative Officer/Research and Development?RCO ?Research Committee Coordinator(s) Specify committee(s): Click or tap here to enter text.NOTES: Use the space box below to provide any additional information about items in the Medical Facility Director-Institutional Responsibilities section: Click or tap here to enter text.R&DC and ACOS/R&D Program Oversight ResponsibilitiesSelect.Does your facility use the R&DC of another VA Facility? If "Yes", please specify facility:Click or tap here to enter text.Has the R&DC:Select.Reviewed all research related committees and subcommittees at least annually and provided the facility Director with written summary reports of each review?VHA Directive 1200.01(1) §6.f VHA Directive 1200.01(1) §8.aSelect.Reviewed subcommittee minutes within 60 days of the subcommittee’s finalization of the minutes?VHA Directive 1200.01(1) §8.a(3)Select.Ensured that documentation from all applicable subcommittees of review and non- contingent approval has been received before a study is given final approval?VHA Directive 1200.01(1) §9.bSelect.For research overseen by an external Institutional Review Board (IRB), determined and documented that the research 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?VHA Directive 1200.01(1) §9.cSelect.Served as the review and approving committee of record for research not meeting criteria for assignment to any subcommittee?VHA Directive 1200.01(1) §9.dSelect.Ensured that only VA research activities are approved for collaborative studies?VHA Directive 1200.01(1) §10.aSelect.Reviewed justification and provided specific approval for recruitment of non-Veterans?VHA Directive 1200.01(1) §13.aSelect.Ensured that Information System Security Officer (ISSO) review of studies that involve 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?VHA Directive 1200.01(1) §5.h(6)VHA Directive 1200.01(1) §5.iVHA Directive 1200.01(1) §5.kSelect.Has the Research Program ensured investigators submit a VHA Research Protocol Privacy Review Checklist and an Enterprise Research Data Security Plan (ERDSP) to the PO and ISSO for protocols as required by VHA Directive 1200.01(1)?Note: The requirement for submission of the ERDSP to the ISSO became effective on January 8, 2021. VHA Directive 1200.01(1) §5.l(3)Has the ACOS/R&D or Coordinator/R&D ensured:Select.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?VHA Directive 1200.01(1) §5.g(2)Select.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?VHA Directive 1200.02(1) §12.a(4)(a)Select.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?VHA Directive 1200.02(1) §12.a(4)(b)Does the Research Office have an established system to track VA research activities including:Select.Research studies, including study status, type of study, sponsor, funding source, PI, required committee approvals?VHA Directive 1200.02(1) §5.b(1)(a)Please specify the PRIMARY tracking system(s) currently used: Click or tap here to enter text.mittee actions, including all initial and continuing review approvals?VHA Directive 1200.02(1) §5.b(1)(b)Select.Agreements, including all local Cooperative Research and Development Agreements (CRADA), research contracts, research Memoranda of Understanding (MOUs), and other written research agreements?VHA Directive 1200.02(1) §5.b(1)(c)Select.Personnel, including all investigators, research coordinators, research assistants, research technicians, and others conducting any aspect of research at the VA medical facility?VHA Directive 1200.02(1) §5.b(1)(d)pletion of all ORD-required training and Annual Government Ethics training (for Investigators) for all research personnel?VHA Directive 1200.02(1) §5.b(1)(e)Select. An inventory of all research data that are placed in a research data repository for future use and/or for all research data that are being stored until the retention requirement has been met per Record Control Schedule 10-1?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: Click or tap here to enter text.HRPP and IRB ResponsibilitiesInstitutional Review Board:Select.Does your facility operate its own internal IRB to perform review and oversight of human subjects research?Select.Does your facility use an IRB operated by your facility's academic affiliate institution (s)? If "Yes," specify affiliate: Click or tap here to enter text.Select.Does your facility use an IRB operated by another VA Facility? If "Yes," specify VA Facility: Click or tap here to enter text.Select.Does your facility use any of the following IRBs? If "Yes," select all IRBs for which the VHA Office of Research and Development (ORD) has approved your facility to rely upon for IRB review (even if research has not yet been reviewed by the IRB):?VA Central IRB?National Cancer Institute (NCI) IRB?National Institutes of Health (NIH) All of Us IRB?Advarra, Inc. IRB?Oak Ridge Associated Universities IRB?Sterling IRB?WIRB-Copernicus Group (WCG) IRBSelect.Does your facility use any other IRB (not already identified in the question above)? If "Yes," specify IRB(s): Click or tap here to enter text.Select.If “Yes” to #12, has your facility received approval from ORD to use the IRB(s)?Select.For IRBs other than the internal IRB operated by your facility, is there a current 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, etc.)?VHA Directive 1200.05(2) §16.a(9)Select.For cooperative research subject to the single IRB requirement, is the research reviewed by a single IRB unless an exception has been granted by ORD?If cooperative research is not conducted, choose N/ANOTE: 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.Select.Is the Federalwide Assurance (FWA) through the Office for Human Research Protection (OHRP) current and in good standing for your facility’s HRPP?Please provide expiration date of FWA: Click or tap to enter a date.Are all required SOPs related to the HRPP current?Select.SOP(s) for review of research and reporting actions and determinations to the R&DC?Select.Have IRB/HRPP SOPs been updated to implement the 2018 Common Rule requirements including a procedure for determining when research approved by the IRB prior to January 21, 2019, can transition to the 2018 Common Rule Requirements?VHA Directive 1200.05(2) §5.f(5)For research subject to the 2018 Common Rule requirements, has the IRB ensured the following:Select.Updated procedures are in place for exempt research?VHA Directive 1200.05(2) §10Select.Procedures are in place for limited IRB review of certain exempt research categories?VHA Directive 1200.05(2) §10.d-hSelect.Unless the IRB determines otherwise, continuing review is no longer required for 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?VHA Directive 1200.05(2) §9.e(2)Select.Documenting the rationale for conducting continuing review of research that otherwise would not require continuing review?VHA Directive 1200.05(2) §9.e(3)Select.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?VHA Directive 1200.05(2) §16.a(8)rmed consent forms contain new requirements?VHA Directive 1200.05(2) §17.bVHA Directive 1200.05(2) §17.d(9)(a)&(b) as applicableVHA Directive 1200.05(2) §17.e(7)-(9) as applicableVHA Directive 1200.05(2) §18.b(2) as applicableSelect.Broad consent is being used for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens that are collected solely for research purposes? If broad consent is not allowed by local policy, choose N/AVHA Directive 1200.05(2) §17.fSelect.For clinical trials, procedures are in place to ensure that one approved informed consent form is posted no later than 60 days after the last study visit by any subject to or (Docket ID: HHS-OPHS-2018-0021)? If clinical trials are not conducted, choose N/AVHA Directive 1200.05(2) §17.jSelect.Does the Privacy Officer review written HIPAA authorizations to ensure they contain all required elements and are consistent with all privacy requirements before investigators begin to use or collect individuals’ information?VHA Directive 1200.05(2) §23.a(3)Select.Does your facility conduct research involving investigational drugs as defined by VHA Handbook 1108.04? If "No," skip to Question 20Select.Does the research include investigational drugs under an Investigational New Drug Application (IND)?Select.Does the research include cellular therapy products and/or human gene therapy products?Select.Are any investigational drugs stored outside of the research pharmacy?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 Click or tap here to enter text.Select.If “Yes” to 19c, is a delegation of custody in place?Select.Does your facility conduct human subjects research involving the use of controlled substances? If "No," skip to Question 20Select.Are the controlled substances stored in accordance with VHA Directive 1108.01(1)?VHA Directive 1108.01(1) §4.g(9)Select.Do the controlled substances receive monthly unannounced controlled substance inspections as required by VHA Handbook 1108.04 and VHA Directive 1108.02?Select.Does your facility conduct research involving devices under an Investigational Device Exemption (IDE)? If "No," skip to Question 21Select.Does the research include significant risk devices?21 CFR 812.3(m)Select.Does your facility conduct human subjects collaborative research as defined by VHA Directive 1200.05(2)? If "No," skip to Question 22Select.Has the IRB ensured that informed consent documents for collaborative research studies clearly describe which procedures will be performed under VA’s auspices and which will be performed under a non-VA institution’s auspice?VHA Directive 1200.05(2) §15.a(3)Select.Has your facility approved any research involving women who are known to be pregnant, human fetuses or neonates as subjects?Select.If “Yes” to #22, were the appropriate certifications and/or approvals in place?VHA Directive 1200.05(2) §19NOTES: Use the text box below to provide any additional information about items in the HRPP and IRB Responsibilities section:Click or tap here to enter text.Animal Care and Use Program (ACUP) andInstitutional Animal Care and Use Committee (IACUC) ResponsibilitiesSelect.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)?If "No," skip to Question 35Select.Does your facility have its own internal IACUC of record to perform review and oversight of animal research?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)?If “Yes,” specify affiliate(s): Click or tap here to enter text.Select.If “Yes” to #24b, are the services of the affiliate IACUC(s) secured through an MOU?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? Choose an item.Please provide the date of the last AAALAC accreditation determination letter: Click or tap to enter a date.Select.Is your institution registered with the United States Department of Agriculture (USDA)?Select.Does your facility have any approved protocols involving non-USDA-regulated species used for VA research? If “Yes,” please specify species and locations housed: Click or tap here to enter text.Note: Examples of non-USDA regulated species include birds, amphibians, and purpose-bred rats, and miceSelect.Does your facility have any approved protocols that involve the following USDA-regulated species used for VA research? If "No," skip to Question 29Select.Dogs; If "No," skip to Question 28b; If “Yes,” please specify locations housed:Click or tap here to enter text.Select.Is the dog research funded by the VA?Select.Has the dog research been approved by the VA Secretary?Consolidated Appropriations Act, 2021, Division J, Title II, Section 247Select.Cats; If "No," skip to Question 28c; If “Yes,” please specify locations housed: Click or tap here to enter text.Select.Is the cat research funded by the VA?Select.Has the cat research been approved by ORD and the VA Secretary?Consolidated Appropriations Act, 2021, Division J, Title II, Section 247Select.Non-human primates (NHP); If "No," skip to Question 28d; If “Yes,” please specify locations housed:Click or tap here to enter text.Select.Is the NHP research funded by the VA?Select.Has the NHP research been approved by ORD and the VA Secretary?Consolidated Appropriations Act, 2021, Division J, Title II, Section 247Select.Swine; If "No," skip to Question 28e; If “Yes,” please specify locations housed:Click or tap here to enter text.Select.Rabbit; If "No," skip to Question 28f; If “Yes,” please specify locations housed:Click or tap here to enter text.Select.Other; If “Yes,” please specify species and locations housed:Click or tap here to enter text.Animals used for VA research are housed:Choose an item.For VA animal facilities, has your facility ensured:Select.Heating, Ventilation, and Air Conditioning (HVAC) motors, belts, and equipment are on a regular preventive maintenance program to prevent HVAC failures?VHA Handbook 1200.07 APP.E.§3.b(7)Select.Reheat coils in animal rooms are set to fail in the off position to prevent catastrophic overheating of animals?VHA Handbook 1200.07 APP.E.§3.b(9)Select.Overheat tests of the animal facility are conducted on an annual basis and the results provided to the IACUC for review by Veterinary Medical Unit (VMU) staff at the next convened IACUC meeting?VHA Handbook 1200.07 §7.a(2)cSelect.Access to the animal facility is controlled by a key card or better system?VHA Handbook 1200.07 §7.i.Select.The animal facility is equipped with emergency power?VHA Handbook 1200.07 APP.E.§3.b(8)Has the IACUC fulfilled requirements for ongoing assessment of the VA ACUP?Select one option below:?The VA IACUC performs the program review and facility inspection of the VA animal program.?The affiliate IACUC-of-record (i.e., no VA IACUC) performs the program review and facility inspection of the VA animal program.Select.Semi-annual program evaluations were conducted at six-month intervalsSelect.Semi-annual facility inspections were conducted at six-month intervalsSelect.The Facility Director was briefed on the results of the semi-annual program evaluation and facility inspections during a meeting with the IACUC Chair, the veterinarian, and the Associate Chief of Staff for Research in compliance with ORD/ORO joint guidance found hereSelect.Semi-annual program review reports contained a plan and schedule for correction of deficienciesSelect.All significant deficiencies identified were corrected within the timeframe(s) specified by the IACUC If “No,” please provide additional detailsClick or tap here to enter text.Select.For VA animal facilities, are veterinary medical services are provided by a full-time or a part-time veterinarian?Select.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:Click or tap here to enter text.VHA Handbook 1200.07§6.b.For affiliate animal facilities:Select.Does your facility use an affiliate IACUC(s) in addition to the VA IACUC for shared oversight of off-site VA animal research? If “Yes,” specify affiliate(s):Click or tap here to enter text.Select.If “Yes” to #33a, are shared oversight mechanisms between the VA and affiliate IACUC(s) established in an MOU?Has the IACUC fulfilled requirements for ongoing assessment of the affiliate(s) ACUP as it relates to oversight of VA animal research?Select one option below:?The VA IACUC performs its own program review and facility inspection of the affiliate(s) animal program.?The VA IACUC accepts the semiannual reports of the affiliate IACUC in lieu of performing its own facility inspection and program review.For facilities that use more than one affiliate IACUC-of-record, please provide additional details here:Click or tap here to enter text.NOTES: Use the text box below to provide any additional information about items in the ACUP and IACUC Responsibilities section:Click or tap here to enter text.Research Safety and Security Program (RSSP) and Subcommittee on Research Safety (SRS) ResponsibilitiesSelect.Does any research conducted by your facility staff involve biological, chemical, physical, or radiation hazards? If "No," skip to Question 43Select.Does the research only involve the collection and analysis of biospecimens by VA personnel within clinical areas or clinical research areas, or the performance of standard clinical procedures in clinical areas or offices AND/OR research that clearly does not involve collection of specimens or use of VA laboratories, such as health services research, chart reviews, and database research?Select.Has your facility obtained a waiver for the requirement for an SRS by the CRADO? If "Yes," skip to Question 43VHA Directive 1200.08(1) §6.c(2)Delegation of Research Safety Oversight Responsibilities:Select.Does your facility have an internal SRS administered within the VA facility that carries out duties described in VHA Directive 1200.08(1)?Select.Does your facility use an external SRS/safety committee (not IBC) administered by another VA or an affiliated university?If “Yes,” specify VA facility or affiliated university:Click or tap here to enter text.Select.If yes to #36b, are the MOUs for the use of an external SRS/safety committee current?Select.Does your program conduct recombinant DNA (rDNA) research requiring review by an Institutional Biosafety Committee (IBC) as defined by NIH-Office of Science Policy (NIH-OSP)? If "No," skip to Question 38Select.Does your facility have an internal IBC to review rDNA research in accordance with NIH guidelines?If “Yes” to #37a, is the VA IBC a separate committee from the SRS?Choose an item.Select.Is the VA IBC registered with NIH-OSP? Enter date of most recent registration:Click or tap to enter a date.Select.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?If “Yes,” specify VA facility or affiliated university: Click or tap here to enter text.Select.If yes to #37d, is the institution's IBC registered with NIH-OSP as the IBC-of-Record for the VA facility?Select.If using an affiliated university IBC, is the MOU for use of the external IBC current?Select.Does your facility conduct any laboratory/bench research (excluding BSL-3) at BSL-1/BSL- 2? If "No," skip to Question 39Select.Does your facility conduct any VA-funded BSL-1/BSL-2 laboratory/bench research (excluding BSL-3) at any off-site locations?If “Yes,” specify:VA-leased location(s):Click or tap here to enter text.Non-VA (i.e., non-leased) locations:Click or tap here to enter text.Select.If “Yes” to #38a, are the appropriate off-site waivers in place?Select.For VA research conducted in laboratories located in approved off-site facilities, is a process in place to review research safety and security, and if necessary, provide feedback to the responsible party for the off-site facility on any deficiencies?VHA Directive 1200.08(1) §5.g(2)Select.Does your facility conduct any research that requires a BSL-3 laboratory? If "No," skip to Question 40If “Yes,” specify infectious agent(s):Click or tap here to enter text.Select.Does your facility have its own BSL-3 laboratory located in the facility or in VA-leased space?If “Yes,” specify location(s):Click or tap here to enter text.Select.Does your facility conduct VA-funded research at any off-site non-VA (i.e., non-leased) BSL-3 laboratories?If “Yes,” specify location(s):Click or tap here to enter text.Select.Does your facility have a laboratory-specific safety manual for research requiring BSL-3 containment?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 41Select.Does your facility have a research-specific Chemical Hygiene Plan (which may be included in the Research Safety Plan) that is reviewed annually?Select.Does your facility conduct semi-annual comprehensive inventories of hazardous chemicals/agents used in research?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): Click or tap here to enter text.Are the following items related to the RSSP current and/or met?Select.Research Safety PlanSelect.Research Security PlanSelect.Emergency Management PlanSelect.Bloodborne pathogen exposure control plan (select “Yes” if Research Service follows the hospital-wide plan)Select.Annual safety inspections of all research laboratoriesSelect.Annual drills to test the effectiveness of the research-specific safety/biosafety, security, chemical hygiene and emergency management plansSelect.All employees are offered participation in an Occupational Safety and Health Program that includes other facility safety programs (e.g., the Respiratory Protection program, the Fire Safety program, etc.)Select.Personal protective equipment (PPE) hazard assessments performed and certified for hazards in VA research laboratories/animal facilitySelect.Access to all laboratories is controlled at all timesNOTES: Use the text box below to provide any additional information about items in the RSSP and SRS Responsibilities section:Click or tap here to enter text.Research Information Security Practices (RISP)Please consult with your ISSO and/or VA Office of Information and Technology (OIT) Area Manager when answering the following questions.Select.Do researchers use any system interconnections between the VA facility network and a non-VA network for VA research purposes?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.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?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. In an air-gapped network is used for VA research, current VA OIT policy requires the establishment and documentation of terms and conditions for the use of those, 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.Select.Do researchers store VA sensitive information (VASI) on non-VA information systems?If so, current VA OIT policy requires documenting the security controls/requirements of the non-VA information systems used to transmit, process and/or store VASI 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 research 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-002335; Control Number AC-19, CCI-002329, CCI-002330.Select.Do researchers transport VASI off-site/outside the VA?This question includes the transport 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 all instances must be approved by the Facility Director, or designee, the Supervisor and the Area Manager, or designee. References: VA Handbook 7002, Part 13 §10.a(4); VHA Dir 1605.01 §2.g(6); VA OIS KS, Control Number AC-19, CCI-002329, CCI-002330.Select.Are non-VA external information systems (IT equipment) used on-site for VA research?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, 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.cSelect.Are VA mobile devices (e.g., laptops, tablets) and VA portable devices (e.g., thumb drives, removable media) used for VA research?This would include VA devices that are used for sensitive and non-sensitive VA data. If so, current VA OIT policy requires if the devices are used to transmit or store VASI documented permission from their supervisor, and 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 they employ VA approved encryption (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). Additionally, all VA mobile devices must be inventoried in the property accountability system and the VA portable devices appropriately tracked/inventoried (References: VHA Handbook 7002 Part 8.5.b and VA Handbook 7002, Part 13, §10)Select.Are non-VA mobile or portable devices used for VA research?This would include 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, 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). If 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).NOTES: Use the text box below to provide any additional information about items in the RISP section: Click or tap here to enter text.Research MisconductSelect.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.)Select.Are the name and contact information of the appointed RIO accurately recorded on this list of VHA RIOs posted on ORO’s website?If “No”, please contact Shara.Kabak@ with current RIO name and appointment letter.Select.Does the RIO promote awareness and understanding of VHA Directive 1058.02 among VA medical facility employees who are engaged in research activities in their capacities as VA employees? 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: Click or tap here to enter text.PART B - RESEARCH PROGRAM QUANTITATIVE DATAREPORTING PERIOD: JUNE 1, 2020 TO MAY 31, 2021All questions in Part B refer to reporting period June 1, 2020 to May 31, 2021RESEARCH AND DEVELOPMENT PROGRAM AND R&DCNote:? Questions #1-1c are not based on RCO audits and pertain only to events occurring during the current reporting period and may be best addressed by the Research Service.Go to Part ANumber 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: FORMTEXT ?????Number in #1 that were NOT initially approved by the R&DC before research was initiated: FORMTEXT ?????Note: For answers greater than zero for item #1a, provide details in the text box below or provide the ORO case number if previously reported to ORO: Click or tap here to enter text.Number in #1 that required at least one continuing review during this period: FORMTEXT ?????Number in #1b not receiving required continuing review performed during this period: FORMTEXT ?????Note: For answers greater than zero in Item #1c, provide details in the text box below or provide the ORO case number if previously reported to ORO: Click or tap here to enter text.HUMAN RESEARCH PROTECTION PROGRAMNote:? Questions 2-3 are not based on RCO audits and pertain only to events occurring during the current reporting period and may be best addressed by the Research Service.Number of protocols suspended or terminated early by the IRB (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:Do not include suspensions/terminations due to approval lapses or other administrative issues. Do not include suspensions due to the COVID-19 administrative hold. FORMTEXT ?????Note: For answers greater than zero in Items #2, provide details in the text box below or provide the ORO case number(s) if previously reported to ORO: Click or tap here to enter text. Number of events determined by the IRB to constitute serious and/or continuing 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.) FORMTEXT ?????Note: For answers greater than zero in Items #3, provide details in the text box below or provide the ORO case number(s) if previously reported to ORO: Click or tap here to enter rmed Consent AuditsNote:? Questions #4-12e are based on RCO Informed Consent (IC) Audits for this reporting period.?All active human subject protocols must receive an IC audit at least once per reporting period, EVEN IF NO INFORMED CONSENT DOCUMENTS WERE SIGNED, with the exception of protocols that have previously received at least one IC audit where the research is permanently closed to enrollment and all subjects have completed all research activities and the research remains active only for long-term follow-up of subject or the remaining research activities are limited to data analysis. ?For protocols not requiring review of Informed Consent Documents (ICDs), an audit of administrative information, including Continuing Review (CR) status, must have occurred. ?All ICDs and HIPAA Authorizations audited this reporting period will be reported in this section.Number of human subject protocols active (open to enrollment or closed to enrollment but still involving data collection or data analysis) at any time during this reporting period:(Include the Million Veteran Program (MVP) and All-of-Us in protocol count) FORMTEXT ??????MVP is currently active at siteNumber of Veterans enrolled in the MVP during the reporting period:Number of Veterans whose MVP ICD and HIPAA Authorization were audited: FORMTEXT ????? FORMTEXT ??????All-of-Us is currently active at siteNumber of protocols in #4 for which the risk level was greater than minimal risk: FORMTEXT ?????Number of protocols in #4:That were exempt from IRB oversight: FORMTEXT ?????That were nonexempt from IRB oversight: FORMTEXT ?????Note: Items #6a+bb should equal Item #4 in most cases. ?Explain any discrepancies in the text box below: Click or tap here to enter text.With informed consent waived per 38 CFR 16.116(This is the number of protocols for which the IRB has granted a waiver of informed consent for the study) FORMTEXT ?????With documentation of ICD AND HIPAA authorization waived per 38 CFR 16.117(c) and HIPAA Privacy Rule (45 CFR sec. 164.512(i))(This is the number of protocols for which the IRB has granted a waiver of documentation of informed consent and HIPAA authorization for the study.) FORMTEXT ?????NOTE: In the text box below, please include any additional details you wish to provide regarding protocols with documentation of ICD and HIPAA authorization:Click or tap here to enter text.Number of protocols in #4 receiving informed consent audits for the current reporting period: FORMTEXT ?????Number of protocols in #7 subject to the 2018 Common Rule: FORMTEXT ?????Number of protocols in #7 subject to the Pre-2018 Common Rule: FORMTEXT ?????Number of protocols in #4 meeting the criteria for not requiring an IC audit and that did NOT receive an IC audit:Note: RCOs are required to conduct an IC audit on all active human subjects protocols with the exception of protocols that have previously received at least one IC audit where the research is permanently closed to enrollment and all subjects have completed all research activities and the research remains active only for long-term follow-up of subject or the remaining research activities are limited to data analysis. FORMTEXT ?????Total number of protocols receiving an informed consent audit (#7) that required IRB continuing review: FORMTEXT ?????Number of protocols in #9 with a lapse in IRB continuing review: FORMTEXT ?????Number of protocols in #9a for which research activities occurred during lapse:(Do not count activities occurring during the approval lapse period that were authorized by the IRB to continue as in the best interests of already-enrolled subjects.) FORMTEXT ?????Note: For answers greater than zero in Item #9b, please provide details in the text box below or provide the ORO case number if previously reported to ORO:Click or tap here to enter text.Total number of informed consent documents audited in all protocols: FORMTEXT ?????Number of individual ICDs audited found to have no deficiencies:(This is the number of ICDs with "N"?in the wrong version, unapproved ICD and ICD from another study?columns, and "Y" 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.) FORMTEXT ?????Number of missing ICDs: (This is the number of entries with “No” under “ICD or Copy Found”; Missing ICDs should NOT be included in counts for other deficiencies below) FORMTEXT ?????Note: For answers greater than zero in Item #10b, please provide details in the text box below or provide the ORO case number if previously reported to ORO. Click or tap here to enter text.Number of ICDs with wrong version used:(This is the number of entries with “Yes” under “Wrong Version ICD Used”) FORMTEXT ?????Number of ICDs from another study used:(This is the number of entries with “Yes” under “ICD from another study used”) FORMTEXT ?????Number of unapproved ICDs used: (This is the number of entries with “Yes” under “Unapproved ICD used”) FORMTEXT ?????Note: For answers greater than zero in Items #10d and/or 10e, please provide details in the text box below or provide the ORO case number if previously reported to ORO: Click or tap here to enter text.Number of ICDs without a subject (or Legally Authorized Representative ) signature:(This is the number of entries with “No” under “Subject Signature Present”): FORMTEXT ?????Note: For answers greater than zero in Item #10f, please provide details in the text box below or provide the ORO case number if previously reported to ORO: Click or tap here to enter text.Number of ICDs without a subject date:This is the number of entries with “No” under “Date of Subject Signature Present”) FORMTEXT ?????Number of ICDs audited subject to the 2018 Common Rule Requirements: FORMTEXT ?????Number of ICDs in #11 without the required key information up front:(This is the number entries with “No” under “Key Info Provided Up Front”) FORMTEXT ?????Number of ICDs in #11 from protocols involving identifiable information or biospecimens:(This is the number of entries with “Yes” under “Identifiable Info/Biospecimens Collected”) FORMTEXT ?????Number of ICDs in #11b without the required statement on future use of identifiable information or biospecimens:(This is the number of entries with “No” under “Information or Biospecimen Statement on Future Use”) FORMTEXT ?????Number of ICDs in #11 requiring Broad Consent:(This is the number of ICDs with "Y" or "N" under "Broad Consent Signed" and excludes all "N/A" entries). FORMTEXT ?????Number of ICDs in #11d with for which broad consent was required but not obtained:Note: For answers greater than zero in Item #11e, please provide details in the text box below or provide the ORO case number if previously reported to ORO: Click or tap here to enter text.Number HIPAA Authorizations Required: FORMTEXT ?????Number of HIPAA Authorizations not obtained (i.e. no HIPAA Authorization or copy that could be located): (This is the number of HIPAA authorizations with “No” under HIPAA Authorization Obtained FORMTEXT ?????Number of HIPAA authorizations without a subject signature:(This is the number of HIPAA authorizations with “No” under “HIPAA Authorization Signature Present”; Do not include those authorizations previously counted as not obtained) FORMTEXT ?????Number of HIPAA authorizations without a subject date:(This is the number of HPAA authorizations with "No" under "HIPAA Authorization Date Present; Do not include those authorizations previously counted as not obtained or missing a signature (i.e., if a HIPAA authorization is missing a signature and a date, only count that HIPAA authorization as missing a subject signature)) FORMTEXT ?????Note: For answers greater than zero in Items #12a – c, provide details in the text box below or provide the ORO case number if previously reported to ORO: Click or tap here to enter text.Number of HIPAA authorizations that required use of VA Form 10-0493 (i.e., HIPAA authorizations not combined with the ICD): (This is the number of entries with "No" under "ICD and HIPAA Combined”; VA Form 10-0493 is required for all protocols approved between March 12, 2015 and January 20, 2019 and protocols approved on or after January 21, 2019 utilizing a separate HIPAA Authorization document) FORMTEXT ?????Number of HIPAA authorizations not using VA Form 10-0493 as required:(This is the number of entries with "No" under "VA Form 10-0493 Used if Separate HIPAA Authorizations") FORMTEXT ?????Notes for ICD Section: Click or tap here to enter text.HRPP Regulatory AuditsNote:? Questions #13-25c are based on RCO?Regulatory Audits?conducted for the current?reporting periodTotal number of human subjects protocols receiving an HRPP regulatory audit for this period: FORMTEXT ?????Number of audited protocols in #13 that were greater than minimal risk: FORMTEXT ?????Number of protocols in #13a (greater than minimal risk protocols) that received initial approval by expedited review: FORMTEXT ?????Note: For answers greater than zero for #13b, please provide details in the text box below or provide the ORO case number if previously reported to ORO:Click or tap here to enter text.Number of protocols audited in #13 initiated without required IRB approval: FORMTEXT ?????Number of protocols in #14a completed without required IRB approval: FORMTEXT ?????Number of protocols audited in #13 initiated without required R&DC approval: FORMTEXT ?????Number of protocols in #14c completed without required R&DC approval: FORMTEXT ?????Note: For answers greater than zero in items #14a-14d, provide details in the text box below or provide the ORO case number if previously reported to ORO:Click or tap here to enter text. Number of human subject protocols audited in #13 involving international research: FORMTEXT ?????Number of protocols in #15 that did not have documentation of facility Director approval (or CRADO approval as applicable): FORMTEXT ?????Note: For answers greater than zero in Item #15a, provide details in the text box below or provide the ORO case number if previously reported to ORO:Click or tap here to enter text. Number of human subject protocols audited in #13 involving children: FORMTEXT ?????Number of protocols in #16 that did not have documentation of facility Director approval (or CRADO approval as applicable): FORMTEXT ?????Note: For answers greater than zero in Item #16a, provide details in the text box below or provide the ORO case number if previously reported to ORO: Click or tap here to enter text. Number of human subject protocols audited in #13 involving prisoners: FORMTEXT ?????Number of protocols in #17 that did not have documentation of CRADO approval: FORMTEXT ?????Note: For answers greater than zero in Item #17a, provide details in the text box below or provide the ORO case number if previously reported to ORO:Click or tap here to enter text.Number of protocols audited in #13 subject to the 2018 Common Rule requirements: FORMTEXT ?????Number of protocols in #18 that were IRB-exempt: FORMTEXT ?????Number of protocols in #18a with exempt category not documented:(This is the number of protocols with “No” under “Exempt Category Documented”) FORMTEXT ?????Number of protocols in #18a with incorrect exempt category:(This is the number of protocols with “No” under “Exempt Category Matches Regulatory Description”) FORMTEXT ?????Note: For answers greater than zero in items #18b or #18c, provide details in the text box below or provide the ORO case number if previously reported to ORO:Click or tap here to enter text.Number of protocols in #18a requiring limited IRB review:(This is the number of protocols with “Yes” under “Required Limited IRB Review”) FORMTEXT ?????Number of protocols in #18d not receiving required limited IRB review:(This is the number of protocols with “No” under “Limited IRB Review Received”) FORMTEXT ?????Note: For answers greater than zero in item #18e, provide details in the text box below or provide the ORO case number if previously reported to ORO:Click or tap here to enter text.Number of protocols in #18a involving direct interaction with human subjects without provision for providing subjects required information:(This is the number of protocols with “No” under “Did the study documents include provisions for giving the subjects the information outlined in VHA Directive 1200.05(2) § 10.c.”) FORMTEXT ?????Note: For answers greater than zero in item #18f, provide details in the text box below:Click or tap here to enter text.Number of protocols audited in #13 that required IRB continuing review (per 1200.05(2)): FORMTEXT ?????Number of protocols audited in #13 not requiring IRB continuing review per 1200.05(2) but continuing review was required by the IRB: FORMTEXT ?????Number in #20 with rationale for IRB-required continuing review not documented: FORMTEXT ?????Note: For answers greater than zero in item #20a, provide details in the text box below:Click or tap here to enter text.Number of protocols in #19 or 20 with a lapse of IRB continuing review: FORMTEXT ?????Number in #21 for which research activities occurred during lapse:(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.) FORMTEXT ?????Note: For answers greater than zero in Item #21a, provide details in the text box below or provide the ORO case number if previously reported to ORO:Click or tap here to enter text.Number of human protocols audited in #13 subject to the single IRB requirement: FORMTEXT ?????Number of protocols in #22 (protocols subject to the single IRB requirement) without a valid reliance agreement or a valid exception FORMTEXT ?????Note: For answers greater than zero in item #22a, provide details in the text box below:Click or tap here to enter text.For those protocols?receiving an HRPP regulatory audit (#13), what was the total number of LOCAL adverse events (AEs) or unanticipated problems involving risks to subjects or others (UPIRTSOs) that were determined by the IRB to be serious, unanticipated, and related or possibly related to the research: FORMTEXT ?????Number of serious adverse events (SAEs)/UPIRTSOs in #23 not reported to the IRB within the required time period: FORMTEXT ?????Number of SAEs/UPIRTSOs in #23 not reviewed and categorized by the IRB within required time period: FORMTEXT ?????Note: For answers greater than zero in Item #23a or #23b, provide details in the text box below or provide the ORO case number if previously reported to ORO:Click or tap here to enter text.Total number of research personnel records audited as part of the HRPP regulatory audits in #13: FORMTEXT ?????Number of research personnel records in #24 with lapse in required human research training:(This is the number of records with “N” under “All Human Research Training Current”) FORMTEXT ?????Number of research personnel records in #24 without initial training:(This is the number of records with “N” under “Initial Human Research Training Completed”) FORMTEXT ?????Note: For answers greater than zero in Item #24b, provide details in the text box below or provide the ORO case number if previously reported to ORO:Click or tap here to enter text.Total number of subject records reviewed as part of the HRPP regulatory audits in #13 for this period:(Subject records review can be found on page 6 of the HRPP audit tool) FORMTEXT ?????Number of subjects in #25 with research initiated prior to consent: (This is the number of subject records with an “N” under “Documentation that consent obtained prior to initiation of study procedures”) FORMTEXT ?????Note: For answers greater than zero in Item #25a, provide details in the text box below or provide the ORO case number if previously reported to ORO:Click or tap here to enter text.Number of subject records in #25 for which application of Incl/Exclusion criteria were audited:(Auditing of inclusion/exclusion criteria is only required for research involving intervention or interaction with subjects determined to be more than minimal risk by the IRB) FORMTEXT ?????Number of subjects in #25b included in research without satisfying inclusion/exclusion criteria:(This is the number of subject records with a “Y” under “Subject included in research not meeting inclusion/exclusion criteria") FORMTEXT ?????Note: For answers greater than zero in Item #25c, provide details in the text box below or provide the ORO case number if previously reported to ORO:Click or tap here to enter text.Notes for?HRPP/IRB Section:Click or tap here to enter text.ANIMAL CARE AND USE PROGRAM AND IACUCNote:??If your program does not have an ACUP, skip questions #26-33b.?Questions #26-28 are not based on RCO audits and pertain only to events occurring during the current reporting period and may be best addressed by the Research Service.Total number of animal protocols active (open) at any time during this reporting period: FORMTEXT ?????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: FORMTEXT ?????Note: ?If not yet reported to ORO, provide details for suspensions including species and associated corrective actions (if applicable)?in the text box below. If previously reported to ORO, provide the ORO case number (if an ORO case Number is provided, no additional information is necessary):Click or tap here to enter text. Number of events determined by the IACUC to constitute serious and/or continuing noncompliance.(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.) FORMTEXT ?????Note: For answers greater than zero in Items #28, provide details in the text box below or provide the ORO case number(s) if previously reported to ORO:Click or tap here to enter text.Animal Welfare AuditsNote: Questions #29-33b are based on RCO Regulatory audits conducted for this reporting period.Total number of protocols receiving animal welfare regulatory audits during the reporting year: FORMTEXT ?????Number of protocols audited in #29 involving DEA controlled substances: FORMTEXT ?????Number of protocols in #30 conducted at the VA: FORMTEXT ?????Number of protocols in #30a with DEA controlled substances not obtained through the VA pharmacy:(This is the number of protocols with "No" under "Controlled substances are obtained through the VA Pharmacy") FORMTEXT ?????Note: For answers greater than zero in Item #30b, provide details in the text box below or provide the ORO case number if previously reported to ORO:Click or tap here to enter text.Number of protocols in #30a with controlled substances not properly stored:(This is the number of protocols with “No” under “Controlled substances stored in a double-locked cabinet and accessible only to authorized personnel”) FORMTEXT ?????Note: For answers greater than zero in Item #30c, provide details in the text box below or provide the ORO case number if previously reported to ORO:Click or tap here to enter text.Number of protocols initiated or completed prior to approval by appropriate oversight committeesNumber of protocols audited in #29 initiated prior to IACUC approval: FORMTEXT ?????Number of protocols in #31a completed prior to IACUC approval: FORMTEXT ?????Number of protocols audited in #29 initiated prior to R&DC approval: FORMTEXT ?????Number of protocols in #31c completed prior to R&DC approval: FORMTEXT ?????Note: If not yet reported to ORO, provide details for research initiated or completed prior to committee approval in the text box below. If previously reported to ORO, provide the ORO case number (if an ORO case Number is provided, no additional information is necessary):Click or tap here to enter text.Number of protocols audited in #29 that required at least one IACUC annual review: FORMTEXT ?????Number of protocols in #32 with a lapse in annual review: FORMTEXT ?????Number of protocols audited in #29 that required a triennial review: FORMTEXT ?????Number of protocols in #32b with a lapse(s) in triennial review: FORMTEXT ?????Number of protocols in #32c in which research activities continued during the lapse in triennial review: FORMTEXT ?????Note: If not yet reported to ORO, provide details for lapses in triennial reviews including species information in the text box below. If previously reported to ORO, provide the ORO case number (if an ORO case Number is provided, no additional information is necessary):Click or tap here to enter text.Total number of research personnel records audited as part of the animal welfare audits in #29: FORMTEXT ?????Total number of research personnel records in #33 with lapse in required continuing animal welfare training:(This is the number of records with “N” under “All Animal Welfare Training Current”) FORMTEXT ?????Number of research personnel records in #33 without initial animal welfare training:(This is the number of records with “N” under “Initial Animal Welfare Training Completed”) FORMTEXT ?????Note: For answers greater than zero in Item #33b, provide details in the text box below or provide the ORO case number if previously reported to ORO:Click or tap here to enter text.Notes for?ACUP/IACUC Section:Click or tap here to enter text.RESEARCH SAFETY AND SECURITY PROGRAM AND SRSNote:??If your program does not have research involving biological, chemical, physical, or radiation hazards, skip questions #34-44b.Questions #34-36 are not based on RCO audits and pertain only to events occurring during the current reporting period and may be best addressed by the Research Service.Total number of safety protocols active (open) at any time during this reporting period: FORMTEXT ?????Number of protocols in #34 with no IRB or IACUC approval components (i.e. only basic science, bench, or wet lab protocols): FORMTEXT ?????Number of protocols in #34 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: FORMTEXT ?????Note:? If not yet reported to ORO, provide details for suspensions in the text box below.? If previously reported to ORO, provide the ORO case number (if an ORO case Number is provided, no additional information is necessary):Click or tap here to enter text.Number of events determined by the SRS to constitute serious and/or continuing noncompliance.(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.) FORMTEXT ?????Note: For answers greater than zero in Items #36, provide details in the text box below or provide the ORO case number(s) if previously reported to ORO:Click or tap here to enter text.Research Safety AuditsNote: ?Questions #37-44b are based on RCO Regulatory audits conducted for this reporting period. Number of protocols receiving a Research Safety regulatory audit during the reporting period: FORMTEXT ?????Number of protocols audited in #37 conducted completely or partially at an off-site location: FORMTEXT ?????Number of protocols in #38 with "No" in "off-site waiver approved": FORMTEXT ?????Number of protocols audited in #37 involving chemical hazards: FORMTEXT ?????Number of protocols in #39 without required semi-annual laboratory chemical inventory review:(This is the number of protocols with "No" in "was the laboratory chemical inventory reviewed semi-annually”) FORMTEXT ?????Number of protocols audited in #37 involving radioisotopes or radiation sources: FORMTEXT ?????Number of protocols in #40 without required review by the Radiation Safety Officer or Research Safety Coordinator:(This is the number of protocols with "No" in "protocol reviewed by the Radiation Safety Officer or Research Safety Coordinator") FORMTEXT ?????Number of protocols audited in #37 initiated prior to SRS approval: FORMTEXT ?????Number of protocols in #41a completed prior to SRS approval: FORMTEXT ?????Number of protocols in #37 without appropriate written notification of outcome of SRS review:(This is the number of protocols with “No” in “investigator appropriately notified in writing or electronically of the outcome of the IBC’s review”) FORMTEXT ?????Number of protocols audited in #37 initiated without required R&DC approval: FORMTEXT ?????Number of protocols in #41d completed without required R&DC approval: FORMTEXT ?????Note: If not yet reported to ORO, provide details for research initiated or completed prior to committee approval in the text box below. If previously reported to ORO, provide the ORO case number (if an ORO case Number is provided, no additional information is necessary):Click or tap here to enter text. FORMTEXT ?????Number of protocols audited in #37 involving use of non-exempt rDNA requiring IBC approval: FORMTEXT ?????Number of protocols in #42 initiated prior to IBC approval: FORMTEXT ?????Number of protocols in #42a completed prior to IBC approval: FORMTEXT ?????Number of protocols in #42 without appropriate notification of IBC review:(This is the number of protocols with “No” in “investigator appropriately notified in writing or electronically of the outcome of the IBC’s review”) FORMTEXT ?????Note: If not yet reported to ORO, provide details for research initiated or completed prior to IBC approval in the text box below. If previously reported to ORO, provide the ORO case number (if an ORO case Number is provided, no additional information is necessary):Click or tap here to enter text.Number of audited protocols in #37 that required at least one SRS annual review: FORMTEXT ?????Number of protocols in #43 with a lapse in SRS annual review: FORMTEXT ?????Number of protocols in #43a in which research activities continued during the lapse: FORMTEXT ?????Note: ?Provide details for lapses in required annual reviews. Please note whether the finding has already been reported to ORO and any ORO case numbers if known (if you provide the ORO case Number, no additional information is necessary):Click or tap here to enter text.Total number of research personnel records audited as part of the research safety audits in #37: FORMTEXT ?????Total number of research personnel records in #44 with lapse in required continuing research safety training:(This is the number of research personnel records with an “N” under “All Safety Training Current”) FORMTEXT ?????Number of research personnel records in #44 without initial research safety training:(This is the number of personnel records with a “N” under “Initial Safety Training Completed”) FORMTEXT ?????Note: For answers greater than zero in Item #44b, provide details in the text box below or provide the ORO case number if previously reported to ORO:Click or tap here to enter text.Notes for?RSSP/SRS Section:Click or tap here to enter text.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.Medical Facility Director: Enter Medical Facility Director’s Name.For submission, please email this document to oroida@. ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download