Research at the SFVAMC

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Research at the SFVAMC
When is VA Approval Required?
How to Apply to the VA and Required Forms
Study Application Guidance

Special Considerations for Conducting Clinical Research at the SFVAMC
Contact Information

 

Research at the SFVAMC

The San Francisco Veterans Affairs Medical Center (SFVAMC or VAMC) has an institutional affiliation with UCSF and provides researchers access to additional research opportunities. The UCSF IRB is the IRB of record for the SFVAMC, but there are additional requirements to obtain permission to conduct research at the VAMC. While SFVAMC and UCSF are affiliated institutions, they are separate legal entities.

National VA Policy: VHA Handbook 1200.05 is the national policy that describes the requirements for the protection of human subjects in VA research. Please review this policy if you are interested in engaging VA in your research project.

When is VA Approval Required?

VA research is research that is conducted by VA investigators (serving on compensated, WOC, or IPA appointments) while on VA time. If you wish to enroll patients at the VA, or use VA personnel, facilities or medical records, you must secure prior approval of the VA Research & Development Committee (R&DC).

If your research is limited to UCSF or another site, and all work is done on your UCSF time and using only UCSF resources, your study does not need VA approval.

Note: If you only wish to inform VA patients about a non-VA study by posting/distributing recruitment materials on the premises of a VA facility, R&DC approval may not be required. Please consult the VA Clinical Research Office to discuss how this can be approved by the facility.

How to Apply to the VA and Required Forms

Check “SF VA Medical Center (SFVAMC)” under “Sites” on the IRB Application and ensure that all VA-specific sections of the Application are completed. If you are not affiliated with the SFVAMC, you will need to identify a SFVAMC-approved PI who will be responsible for the conduct of the work at the VA.

The VA distinguishes between projects (a cohesive body of work usually tied to one major funding source) and protocols. Ensure that you submit the necessary forms for each, as you need protocol (i.e., IRB and VA Clinical Research Workgroup) approval before VA R&D Committee project approval will be granted. You cannot begin a new research project without a signed ACOS/R&D letter giving you authorization to do so.

SFVAMC Forms (for all new PROJECTS):

SFVAMC Forms (for all new PROTOCOLS):

SFVAMC Forms (if applicable for a given protocol):

Use the SFVAMC-approved PI’s name in the template header field

You may include the UCSF PI name, if different, in other areas of the VA consent form.

Include the VA treatment and compensation for research-related injury paragraph

This paragraph must be used verbatim in the VA consent form: 

If you are injured as a result of a VA procedure in this study, VA will ensure that treatment is made available at a VA medical facility. If you are eligible for veteran’s benefits, the costs of such treatment will be covered by the Department of Veterans Affairs. If you are not eligible for veteran’s benefits, the costs of treatment may be billed to you or your insurer just like any other medical costs, or covered by the Department of Veterans’ Affairs or the University of California, depending on a number of factors. The Department of Veterans Affairs and the University do not normally provide any other form of compensation for injury. For further information about this, call the VA Regional Counsel at (415) 750-2288 or the office of the UCSF Committee on Human Research at (415) 476-1814.

When a sponsor's indemnification policy is involved, the statement is as follows:

If you are injured as a result of a VA procedure in this study, VA will ensure that treatment is made available at a VA medical facility. If you are eligible for veteran’s benefits, the costs of such treatment will be covered by the Department of Veterans Affairs. If you are not eligible for veteran’s benefits, the costs of treatment may be billed to you or your insurer just like any other medical costs, or covered by the Department of Veterans’ Affairs or the University of California or the study sponsor [sponsor name], depending on a number of factors. The Department of Veterans Affairs, the University and the sponsor do not normally provide any other form of compensation for injury. For further information about this, call the VA Regional Counsel at (415) 750-2288 or the office of the UCSF Committee on Human Research at (415) 476-1814.

When to use a VA consent form (examples)

Examples of when a VA consent document must be used:

  • VA-funded study in which informed consent is obtained at UCSF or other outside (non-VA) site.
  • Every participant takes part in some study procedures at SFVAMC and some study procedures at UCSF —participant signs a VA consent document and a UCSF consent document (if such is required by UCSF), with each document conforming to its respective institutional standards.
  • SFVAMC or NCIRE employees (on their SFVAMC or NCIRE time) go to UCSF to obtain informed consent from UCSF patients.
  • Informed consent is obtained at SFVAMC or on SFVAMC-leased property – regardless of:
    • participant’s Veteran status
    • the location(s) at which study procedures will be performed, or
    • whether the individual obtaining informed consent is employed by SFVAMC, NCIRE, UCSF, or elsewhere. (Please note: Any individual who obtains informed consent on SFVAMC premises MUST be VA-employed or have WOC status.)

Examples of when a VA consent document must NOT be used:

  • Clinician at SFVAMC informs Veteran patient of a UCSF-based treatment study, patient directly contacts UCSF study team and visits UCSF to complete consent process.
  • All data is UCSF data (obtained either through direct interaction or records review) and the role of SFVAMC is limited to data analysis.
  • Upon seeing a flyer recruiting for a UCSF-based study, a prospective participant contacts the UCSF study team and incidentally discloses that he/she happens to be a Veteran.

More examples:

  • If you (or your study staff) are on your SFVAMC time when you obtain informed consent from an individual on UCSF premises, you must use a VA consent form.
  • If you (or your study staff) are on your UCSF time when you obtain consent from an individual on UCSF premises, then you must not use a VA consent form.
  • If the participant typically receives care at UCSF, but you are seeing him/her at SFVAMC for a study procedure (included obtaining informed consent), then you must use a VA consent form.
  • If the study for which you are obtaining informed consent has VA funding of any type (including, but not limited to Career Development Awards, Merit Review Awards, Cooperative Studies Program) you must use a VA consent form for all participants, even those at UCSF.
  • If an individual from whom you are obtaining consent was identified/recruited by reviewing VA records (medical or research) and/or screened for study eligibility at VA but sent to UCSF for all subsequent study procedures, he/she may need to sign both VA and UCSF consents – but he/she definitely must sign a VA consent form.

Study Application Guidance

Include the information below in the IRB application. The following sections of the IRB Application MUST distinguish the VA vs. non-VA research elements when applicable:

Inclusion/Exclusion Criteria

VHA Handbook 1200.05 requires explicit justification for including non-veterans in VA research that involves outpatient or VA hospital treatment (e.g. research occurring at VA facilities). Include this information in the inclusion criteria of the IRB Application.

Key Study Personnel

Identify all VA personnel in the Key Personnel or Procedures section.

Study Procedures

Identify all VA research-related procedures. If any procedures are not being done or any study populations are not included at the VA, clearly identify those in the Procedures section.

Recruitment

Indicate what recruitment methods will be unique to the VA and/or any elements that will NOT be conducted at the VA.

Confidentiality

Indicate how the VA data will be stored (i.e. de-identified, coded or identifiable), and who will have access to the data-including specifying whether non-VA personnel will have access to identifiable information. If you plan to transmit VA data outside the VA (e.g., UCSF), please indicate how you will do so (e.g., encrypted media) AND whether VA data will be combined with non-VA data.

 

Special Considerations for Conducting Clinical Research at the SFVAMC

Review VHA Handbook 1200.05 for specific requirements for conducting human research at the VA

In particular, please review and become familiar with the following paragraphs of VHA Handbook 1200.05 (version date November 12, 2014):

13 – Collaborative Research
15 – General Requirements for Informed Consent
16 – Documentation of Informed Consent
17 – Research Involving Pregnant Women, Human Fetuses, and Neonates as Subjects
18 – Research Involving Prisoners
20 – Subjects Lacking Decision-Making Capacity
23 – HIPAA Authorization
28 – Student and Other Trainee Research
29 – Investigator's Responsibilities

There are additional requirements in VHA Handbooks 1058.01, 1200.01,1605.1, and 6500 and SFVAMC MCM 11-19. Contact the SF VAMC Clinical Research Office for assistance in interpretation of these policies.

Research pharmacy requirements

All research medications and investigational devices used at the SFVAMC MUST be shipped to the Research pharmacy, and not to the PI or study staff. 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.

When the study is conducted at the SFVAMC, the following additional reporting obligations must be met by the researcher:

  • Ensure the local Pharmacy Service or Research Service Investigational Pharmacy receives:
    • A copy of VA Form 10-9012 (if applicable).
    • A copy of the consent document for each participating participant with all appropriate signatures.
    • Copies of sponsor-related correspondence specific to the drugs as appropriate.
    • Copies of all correspondence addressed to the Researcher from the FDA specific to the investigational drugs as appropriate.
  • Inform the chief, pharmacy service, the research pharmacy when applicable, and the IRB in writing when a study involving investigational drugs has been suspended, terminated, or closed.
  • Comply with all documentation requirements and make relevant records accessible to the investigational drug pharmacist when requested.

VA employment or “WOC” status required

All personnel working in research at the VA, including volunteers, must be registered in the VA Research and Development Information System (only accessible behind the VA firewall) and paid by the VA or have completed a federal background check and have Worker Without Compensation (WOC) status.

VA-specific training mandatory for research staff, including residents and fellows

All research staff, including residents and fellows, must be trained and their credentials and study privileges must be documented. The trainings are specific to the VA (UCSF training is not sufficient) and include:

  • CITI Training in the protection of Human Subjects — select the VA (station 662). Review the CITI FAQs for more information. This training must be renewed every three years for the VA.
  • Privacy and HIPAA: Available online at www.tms.va.gov. For TMS access, contact Ed Cayabyab (415-221-4810 x3396).
  • The Scope of Practice lists research duties delegated to research team members, and may be signed only by the VA PI. Access to the VA’s electronic medical record (CPRS) must be requested separately, and the level of access requested (read-only, for those who must access medical records or test results, or co-signer required, for those who obtain informed consent) must be documented in the Scope. Both requests must be submitted through the VA’s Research and Development Information System (RDIS — only accessible behind the VA firewall).

VA Privileges required for Research Personnel

Physicians, nurses, psychiatrists, etc. must have appropriate privileges from the VA’s Professional Standards Board or Nurse Credentialing Committee prior to working on research or prescribing research medications at the SFVAMC.

Adverse Events/Incident Reports/Unanticipated Problems: VA has a shorter timeline (5 days) and different definitions for reporting

The VA has a shorter timeline (5 days) and different definitions than UCSF for reporting certain categories of post-approval events. See VHA Handbook 1058.01 for specific examples. Please consult with the VA and review the following VA decision charts to determine if your adverse event report or protocol violation or incident needs to be reported to the IRB.

Note: The VA requirements dictate that some types of apparent serious or continuing noncompliance be reviewed at a convened IRB meeting for determination of whether they constitute actual serious or continuing noncompliance. See section 6.f in VHA Handbook 1058.01.

Reporting privacy/information security incidents

  • For privacy incidents, call 415-750-2135. For data security incidents, report to the SF VAMC ISO (see the ISO Sharepoint site for more information).
  • If the privacy or data incident also involves UCSF participants, also contact the UCSF Privacy Office, 415-353-2750 (in addition to the SF VAMC ISO).
  • Monitoring of research: All outside monitors must register with Police Services for a badge, check in with the Clinical Research Office and file a brief report before they leave.
  • Some research is restricted by the VAMC (e.g., research involving prisoners).

Contact Information

For more information, please contact the Clinical Research Office:

CLINICAL RESEARCH OFFICE
San Francisco VA Medical Center
Building 210, Room 100
Telephone: -415-221-4810 x6425* — If you are calling from outside SFVAMC, dial a "2" before the 4-digit extension.
Fax: 415-750-6906

Packages may be delivered to:
Clinical Research Office
San Francisco VA Medical Center
4150 Clement Street, MS 151CRO
San Francisco, CA 94121