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THE COMMITTEE ON HUMAN RESEARCH
WORKING WITH THE VETERANS AFFAIRS
MEDICAL CENTER (VAMC)
| US
Department of Veterans Affairs Medical Center San Francisco
(SF VAMC) |
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The San Francisco Veterans Affairs Medical Center (SFVAMC or VAMC) is an affiliated campus of the University of California, San Francisco (UCSF) and provides researchers access to additional research opportunities. It is important to remember, however, that the VAMC is a separate federal institution and does have its own rules for conducting research. The UCSF Committee on Human Research (CHR) is the Institutional Review Board (IRB) of record for the SFVAMC, but there are additional requirements to obtain permission to conduct research at the VAMC. We encourage you to contact the VAMC Clinical Research Office early in the submission process to ensure the VA issues are addressed in a timely manner.
When is VA Approval required? If the VA is engaged in human subjects research (if you are planning to enroll patients at the VA, or are using VA personnel or resources) you must secure approval of the VA Research & Development Committee in addition to CHR approval. Similarly, if you are interested in advertising for participants at the VA your study must be reviewed for authorization to advertise at our campus.
How to Apply to the VA:
If you are affiliated with the VAMC: Submit all CHR materials (correspondence, applications, modifications, incident reports, SAE reports, etc.) to CHR through the VA Clinical Research Office.
If you are not affiliated with the VAMC: You will need to identify a SFVAMC-approved PI who will be responsible for the conduct of the work at the VA. We understand that your office may file directly with CHR, but it is important to send two copies of all submissions to the Clinical Research Office at the VA at the same time you file your materials with CHR to avoid unnecessary delays. Both offices work closely together, but it is the researcher’s responsibility to ensure the VA Clinical Research Office receives all materials in a timely manner.
For more information, please contact the Clinical Research Office.
If I have a dual appointment, do I need VA Approval? That depends on the project. If you have been awarded funds through NCIRE or the VA, or are engaged in research at the VA (see above) then you must secure and maintain approval at the VA.
If your research is limited to UCSF or another site and all work is done on your UCSF time, using UCSF resources then your study would not need approval at the VA.
Can I add the VA as a site later? Yes. The VA Clinical Research Office will need a complete CHR application packet, together with the modification submission and any required VA documents (see below) . Depending upon the nature of the research we may need a VA consent form and HIPAA Authorization as well as VA specific documents.
Contact the Clinical
Research Office if you are contemplating
adding the VAMC as a site for your research. The telephone number
is (415) 221-4810, extension 6670.
SFVAMC Forms: Research at the VA has several additional forms that are required with all applications. These include:
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VA Renewal Supplement: VA Studies in which the VA is a research site must complete and enclose the VA Supplement with all Major Modifications / Renewals. This must be signed by the VA site PI if there is a different PI at the VA and UCSF.
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Authorization for Use & Release of Protected Health Information for Research Form (HIPAA form): The VA cannot accept the UCSF HIPAA Authorization; this form should be filled out as completely as possible and submitted with your application and any renewals. Please remember that the FDA will have the right to review any research involving FDA-regulated materials. Please also remember that you must disclose how long you intend to access PHI.
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VA Investigational Drug Information Report (10-9012): Study medications and comparators must be reported to pharmacy on this form. The document indicates who may write for research medications as well as safety information that may not be available in published drug references.
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Initial Billing Form: In some cases researchers need support from clinical services within the medical center (e.g., laboratory, radiology, or in-patient stays). When these services are provided solely for research, it is expected that the medical center will be reimbursed from research funds. This form should be completed to identify any procedures that will be completed at the SFVAMC and exceed routine clinical care of the patient. If there are none, the box at the upper right must be completed to represent this. An initial billing form, signed by the VA PI is required for every study.
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Certification of Data Security: Each new application will require a Certification form, signed by the VA PI to certify how the study data will be managed. The form is also part of a VA supplement for renewal and is required at least annually. All research at the VA is reviewed by the Information Security Officer and the Privacy Officer for compliance with federal information technology (IT) and privacy rules.
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Pink Sheet: The Request for R&D Approval, known as the ‘pink sheet,’ is the VA’s internal application for research and must be completed for every new submission. It must be signed by the VA PI and list all personnel involved in research at the VA.
Special considerations for conducting clinical research at the SFVAMC:
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The VAMC grants PI status independent of UCSF: Having permission to conduct research at UCSF does not grant permission to oversee research at the VAMC. Please contact the CRO for details on how to receive VA PI status.
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There is a separate approval process at the VAMC: Even if you have CHR approval for your study, you must have the study reviewed and approved by the VA’s Subcommittee for Clinical Research and the R&D Committee. The committee oversees all research activity involving human subjects, including adverse events, modifications and applications for continuing review. To facilitate review, materials should be submitted through the VA’s Clinical Research Office or simultaneously with submission to CHR.
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Research Pharmacy: All research medications MUST be shipped to the Research pharmacy, and not to the PI or study staff. Medications are maintained at all times under the control of the pharmacy. If your research needs do not permit participants to obtain medications directly from the pharmacy, this should be addressed in your application and approved prior to initiating the procedure. The pharmacy charges researchers a modest fee for its services; researchers are encouraged to discuss dispensing issues and fees with the research pharmacist before the budget is finalized.
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Recruiting for subjects at the VA requires approval of the VA R&D Committee. Posters and other advertisements for studies that do not have VA approval are not allowed on the campus. If you are interested in recruiting, please contact the Clinical Research Office for guidance.
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Legally Authorized Representatives/Surrogate Consent: VA rules regarding who may serve as a legally authorized representative to give consent for enrollment in research and for surrogate consent procedures differ from California rules. Consult the Clinical Research Office for more information, and be sure to complete the VAMC section of the CHR Surrogate Consent Application Supplement.
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There are training, credentialing and documentation requirements for all persons working with human subjects, human tissue or human subjects’ data at the VAMC. This includes residents and fellows. In addition to an individual’s CV and documentation of any professional license(s), the required modules currently are:
- CITI Training in the protection of Human Subjects and Good Clinical Practices (www.citiprogram.org) - select the VA (station 662). Review the CITI FAQs for more information.
- The following trainings are online at https://www.lms.va.gov/plateau/user/logout.do. If you have any trouble accessing these modules please call the CRO at the number below:
- Privacy Training (aka HIPAA): Not the same class as taken at UCSF.
- Cyber Security
- Privacy and Security in VA Research
- Office of General Counsel Ethical Behavior Training, at http://www.usoge.gov/pages/about_oge/ethics_program.html After reading this module, notify us via e-mail to henry.holdt@va.gov
- Scope of Practice outlining delegated research duties to research team members. This may only be signed by the VA PI, as the person responsible for the conduct of research at the VA.
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VA Privileges are required for Research Personnel: Just as in clinical practice, individuals working in research must be appropriately credentialed and privileged at the VA to perform restricted procedures. Physicians, nurses, psychiatrists, etc. must have appropriate privileges from the VA’s Professional Standards Board or Nurse Credentialing Committee prior to working on research at the VA. Individuals who are not privileged at the SFVAMC may not prescribe research medications at the SFVAMC.
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VA employment or “WOC” Status: All personnel working in research at the VA must be paid by the VA, or must have completed a federal background check and have Worker Without Compensation (WOC) status. This applies to personnel paid by NICRE, UCSF and/or volunteers.
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Some research is not appropriate for the VAMC, or may need significant additional approvals (e.g., research involving minors or international research).
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Adverse Events / Incident Reports / Unanticipated Problems: If you need to report these events to CHR, a copy must be provided for or sent to the SFVAMC Clinical Research Office at the time of submission to CHR – even if the event affected only a UCSF participant. The VA has additional reporting requirements and we monitor for patterns that may suggest a reassessment of the study under our quality improvement program.
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Monitoring of Research: The VA requires that all outside monitors who come to the VA to oversee your research check in with the Clinical Research Office and file a brief report before they leave. It is the PI’s obligation to ensure that monitors register with Police Services for a badge and check in with the Clinical Research Office at each visit.
For more information, please contact the Clinical Research Office:
CLINICAL RESEARCH OFFICE
San Francisco VA Medical Center
Building 203, Room 1A-14
Telephone: (415) 221-4810 x6670
Fax: (415) 379-5636
Packages may be delivered to:
Clinical Research Office
San Francisco VA Medical Center
4150 Clement Street, MS 151CRO
San Francisco, CA 94121 |
