Field Research Programs The most obvious reason for the differentiation AOs in different facilities is the size of that center’s research program. It is useful to understand that research programs at VA Medical Centers vary in size and affiliation. For some large research programs, there are mirror components that are comparable to the support components of the Medical Center: Small A Research Program with no Budget Analyst <100 projects Usually uses the affiliate IRB and/or Medium A Research Program with a Budget Analyst, Procurement Technician, and one or more Committee Coordinators (usually Program Specialists) 100-300 projects has its own IRB and IACUC Large A Research Program with a Budget Analyst and many staff in support of research administration functions 300+ projects May use the affiliate IRB and/or IACUC, and its affiliate is a large research university At facilities with a large research program, the AO is usually knowledgeable of – but delegates – many of the duties for which they are responsible. The AO is equivalent to an Operations Manager (or, perhaps, the conductor of an extremely diverse orchestra). At facilities with smaller research programs, the AO must be a jack-of-all-trades, and does many different tasks to support a smaller number of research projects. However, whether there are 10 projects or 500 projects, the regulations apply just the same. At facilities with a moderate amount of research studies, AOs can delegate more than counterparts at facilities with smaller programs, but they also perform more of the actual tasks than someone at a facility with a larger program. trial
Use of Schedule B Vs. Title 38 Medical Support Authority Schedule B Authority Title 38 Medical Support Authority Can be used for excepted appointments Yes Yes Required GS GS11 or greater Any GS level Individuals must have specialized technical, scientific, or professional skills Yes Yes Can be used for administrative positions No No Must be linked to a specific research project Yes Yes Can be used for full-time appointments Technically yes, but due to limited number of this authority is reserved for part-time and intermittent appointees Yes For part-time or intermittent appointments Yes, can appoint for up to 3 years with multiple renewals. Can pay benefits Yes, but can only appoint for 1 year, with no renewals and no benefits Total number of appointees is capped nationwide Yes No Requires approval from ORD for initial appointment *** Yes No
Biomed Refresher 1 – Research (ID: 983) Biomed Refresher 1 – Genetics Research (ID: 984) Biomed Refresher 1 – Populations in Research Requiring Additional Considerations Protections (ID: 985) Biomed Refresher 2 – Regulations and Process (ID: 512) Biomed Refresher 2 – Informed Consent (ID: 514) Biomed Refresher 2 – SBR Methodologies in Biomedical Research (ID: 515) Biomed Refresher 2 – Research (ID: 516) Biomed Refresher 2 – Genetics Research (ID: 518) Biomed Refresher 2 – Populations in Research Requiring Additional Considerations Protections (ID: 519) Biomed Refresher 3 – Genetics Research (ID: Biomed Refresher 3 – History and Ethical Principles –Belmont Principles (ID: 12640) Biomed Refresher 3 – Populations in Research Requiring Additional Considerations Protections (ID: 12643) Biomed Refresher 3 – Regulations and Process –IRB Authority and Composition (ID: Biomed Refresher 3 – Regulations and Process –IRB Responsibilities (ID: 12645) Biomed Refresher 3 – Informed Consent (ID: 1003) Biomed Refresher 3 – SBR Methodologies in Biomedical Research (ID: 1004) SBE Refresher 1 – Defining Research with Human Subjects (ID: 15029) SBE Refresher 1 – Assessing Risk (ID: 15034) SBE Refresher 1 – History and Ethical Principles (ID: 936) SBE Refresher 1 – Federal Regulations for Protecting Research Subjects (ID: 937) SBE Refresher 1 – Informed Consent (ID: 938) SBE Refresher 2 – Assessing Risk (ID: 12624) SBE Refresher 2 – History and Ethical Principles (ID: 12702) SBE Refresher 2 – Defining Research with Human Subjects (ID: 15038) SBE Refresher 2 – Federal Regulations for Protecting Research Subjects (ID: 15040) SBE Refresher 2 – Informed Consent (ID: 12620)
Personnel Engaged in Animal Research Working with the VA CITI module, every 3 years Species-specific CITI modules, as applicable to their work – every 3 years members must take the CITI Essentials for IACUC members – every 3 years Additional optional training models can be under the Animal Research tab on the ORD webpage. For IACUC members, the CVMO Office has put together a compilations of various training scenarios that are excellent. Personnel Engaged in Laboratory Research Laboratory safety training as determined by policy. This may be either by computerized course training or in-person training or both Specialized training for radioisotopes or other hazard as determined by local policy. Training Required of all Working in VA Research VA Privacy and Information Security Awareness and Rules of Behavior VHA Privacy and HIPAA Government Ethics Prevention of Workplace Harassment/No FEAR Active Threat Training VA Core Values Training (iCARE Recommitment) Local sites may require additional training modules for designated employ
AAALAC VISN contractors to review: Safety Security Others EPA You will probably have facility groups that want to perform inspections or walk-throughs: Annual Workplace Evaluation (AWE) Environmental Rounds Safety ISO IT or IRM Controlled Substance Space Hardly a week will go by during which you are not coordinating, or participating, in some type of research program review. You may need to help coordinate the submission of documents for the review. These would include minutes, agendas, SOPs, and reports. You may need to help set the agenda for the inspection and coordinate the people needed to be in attendance. In some instances, you will be asked to help with hotel reservations, meals/restaurant locations, and transportation for the visiting inspection staff. Remember, you are not alone! There are many other people who are responsible for the success and compliance of the research program. As the AO, you have an enormous role in this – but, the ACOS/R&D, RCO, and committees are responsible entities, as well. SECTION 22 – IBC Registration and Annual Reporting Institutional Biosafety Committee If your research program is engaged in research involving recombinant DNA then you will need to have committee oversight from an Institutional Biosafety Committee (IBC) which is registered with the Office of Biotechnology Affairs (OBA) at the NIH. Some facilities have their safety committees function as the IBC. The IBC will need to have and follow an SOP for how to function and document its activities. You may use the affiliate’s IBC if your MOU with the affiliate university allows for it. The research program will need to name a Biological Safety Officer (BSO), who will be a member of the IBC. The BSO will also be responsible for performing periodic inspections of areas involving rDNA research to ensure that lab standards are rigorously followed.
Key Issues to Address When Terminating Human Subject Studies at a VA Facility with a Human Research Protection Program VHA Office of Research and Development, March 25, 2016 Category Issue Comment 1. Timeline Define the date for the projected closure of the Human Research Protection Program (HRPP) Intervals vary anywhere between 60 days to 1 year, with the usual range being between 3 to 9 months. 2. Notification of any relying HRPPs Any HRPP relying upon the VA Facility’s IRB of Record and/or Research and Development Committee must be informed immediately as this directly impacts the relying VA Facility’s HRPP. 3. Categorization of studies: (a) which studies are non-human subjects, exempt, or human subjects (b) funded (ORD, other federal funding, industry) (c) collaborative (d) Repositories – data or biospecimen Different studies will have different issues involving termination and/or transition. If there are any studies with CRADAs, the termination clauses of those CRADAs need to be reviewed. For data and biorepositories, effort should be made to transfer those studies as permitted within the approved protocol and the applicable informed consent and HIPAA authorization. 4. Subject status: Determine which studies have subjects which are currently receiving any interactions, interventions, and/or follow-up monitoring. Subject safety is the priority for terminating and/or transitioning any subjects study. Determinations must be made for any notifications that must be made for subjects in any currently active human subjects studies. 5. Transfer of studies: Determine if any of the studies will or can be transferred to another institution It is unknown whether any of the studies will or can be transferred to other VA facilities. Category Issue Comment
ORD Acquisition Specialist; Centralized Agreements Coordinator; Credit Card Holder Gregory Johnson 202-443-5627 Patents and Royalty distribution; Support to Program 820 Lyvonne Lawson 202-443-5629 Program 825; MVP Program; Central Office Interagency Agreements Matt Verna 202-443-5644 Program 821 and 829 Sara Clark 202-443-5673 *Phone numbers may change. E-mail addresses are more reliable. Appendix B – SF-52, Request for Personnel Action Appendix C – SF-50, Notification of Personnel Action Appendix D – VHA DIRECTIVES AND HANDBOOKS (As of August 22, 2017) A good web page with links to policies, handbooks, contact lists, etc., can be found . Directives Number Title (Link) 1200 1200.02 1200.18 1203 1205 1206 Handbooks
Appendix G – Research Calendar (Example: As of August 1, 2017) Broad category Discipline Regulatory item Point of Contact Latest approval/ Review Review Schedule Renewal Due Date/ Expiration Regulatory visits Animal research AAALAC AO/ Veterinarian Every 5 years Regulatory visits Safety Annual AWE rounds AO/ Research Safety Annually Regulatory visits Compliance ORO RCO AO/RCO Regulatory visits All ORO Comprehensive Review AO/RCO Every 5 External reports/doc/approvals Animal Research OLAW Assurances IACUC Jun-16 External reports/doc/approvals Animal Research Semi-Annual Inspection Report IACUC Chair/ Veterinarian June and Dec External reports/doc/approvals Animal Research Annual USDA Report Supervisor Every Dec External reports/doc/approvals Animal Research VMU Central Office Report supervisor Every Dec External reports/doc/approvals Subjects FWA IRB Coordinator Update as Needed External reports/doc/approvals Human Subjects IRB Membership Listing IRB Coordinator Update as Needed External Meetings VISN Oversight VISN Research Roundtable Assistant Quarterly External Agreements MOU VA Central IRB MOU R&DC/CIRB coordinator Annual R&DC May External Agreements MOU Affiliate IACUC MOU IACUC/ACOS Annual R&DC May External Agreements MOU Affiliate Data Security MOU ACOS/AO Annual R&DC May External Agreements MOU Affiliate Safety MOU ACOS/AO Annual R&DC May External Agreements MOU Non-Profit MOU PREF ED/ACOS Annual R&DC May External Agreements MOU Cytometry Core MOU AO/ACOS/IFI Annual R&DC May
Annual Review and R&DC Evaluation Animal Research Annual IACUC Evaluation R&DC Chair/ Coordinator Annually Annual Review and R&DC Evaluation AO/ACOS Annual review of WOC/VA Appointment Roster R&DC Coordinator Annually Annual review and R&DC eval Human Sub Annual IRB Evaluation R&DC chair/coord Annually Annual review and R&DC eval Human Sub Annual Central IRB eval R&DC chair/coord every year Annual review and R&DC eval Safety Annual SRS eval R&DC chair/coord year Annual review and R&DC eval R&D Annual subcommittee eval by R&DC R&DC chair/coord every year Annual review and R&DC eval R&D ACOS QA review of DUA/DTA ACOS/AO every year Annual review and R&DC eval R&D ACOS QA review for minutes ACOS/AO every year Annual review and R&DC eval R&D ACOS QA review of VA/DoD agreements ACOS/AO every year Quarterly review and R&DC eval R&D Quarterly FCOI eval R&DC chair/coord/AO quarterly Quarterly review and R&DC eval R&D Quarterly Space comm eval R&DC chair/coord/AO quarterly Internal document Human Sub HRPP IRB SOP IRB coord yearly review Internal document R&D Research MCM AO yearly review Internal document Safety Chemical Hygiene Plan Research Safety yearly review Internal process Safety Hazardous Chemical inventory + attestation from PIs AO Internal process Safety Semi-annual Bldg XX walk-through by SRS SRS Chair/coord every 6 mon Internal process Safety Annual Emergency and Disaster Preparedness Plan RSO every year Internal process Safety Annual Safety/Security Drills (access, chemical, security) Police, Safety year Internal process Safety Quarterly EOC rounds Research Safety quarterly Internal process Safety Review of weekly Bldg XX access AO weekly + monthly Internal process Safety Weekly RSO walkthrough with monthly report at SRS Research Safety weekly + monthly Internal process Safety SRS review of Research Bldg access AO/SRS coord Internal Process Safety Annual Review of off-site VA research AO/ACOS Annual