Research at the SF VA Healthcare System

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Research at the SFVAHCS
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 SFVAHCS
 

CLINICAL RESEARCH OFFICE

San Francisco VA Health Care System
4150 Clement Street (CRO 151)
Building 210, Room 100
Telephone: (415) 221-4810 extension 26425
Fax: (415) 750-6906
 

Research at the SFVAHCS

The San Francisco Veterans Affairs Health Care System (SFVAHCS) has an institutional affiliation with UCSF and provides researchers access to additional research opportunities. The UCSF IRB is the IRB of record for SFVAHCS, but there are additional requirements to obtain permission to conduct research at the VA. While SFVAHCS 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 Intergovernmental Personnel Agreement 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 SFVAHCS Research & Development Committee (R&DC). 

Please complete this form for UCSF research projects where SFVAHCS is an administrative site only (i.e., no VA patients or employees are enrolled, no identifiable data or specimens are used at SFVAHCS, no VA funding is used, local VA resources such as SFVAHCS property, office/lab, computer, server, email are used, VA time is used. 

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 (SF VAMC)” under UCSF and Affiliated Sites on the IRB Application and ensure that all VA-specific sections of the Application are completed. If you ​are not affiliated with SFVAHCS, you will need to identify a SFVAHCS-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 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.

SFVAHCS Forms (for all new PROJECTS):

SFVAHCS Forms (if applicable for a given protocol):

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

If you are experiencing a medical emergency, please call 9-1-1. If you incur an injury or illness as a result of being in this study, the Department of Veterans Affairs (VA) will ensure that treatment is made available at a VA medical facility or non-VA facility, as appropriate. If you were following study instructions, the costs of such treatment will be covered by the VA or the study sponsor (if applicable). If you were NOT following study instructions, the costs of such treatment may be covered by the VA or the study sponsor (if applicable) or may be billed to you or your insurer just like any other medical costs, depending on a number of factors. The VA and a study sponsor do not normally provide any other form of compensation for injury or illness. For further information about this, call the study team at the number(s) provided.

When to use a VA consent form 

Examples of when a VA consent document must be used:

  • 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 the VA consent form for VA-funded studies even when informed consent is obtained at UCSF or other outside (non-VA) site.
  • An individual from whom you are obtaining consent was identified by reviewing VA records (medical or research) and/or screened for study eligibility at VA but sent to UCSF for all subsequent study procedures.  Note the participant may need to sign both VA and UCSF consents. 
  • Study procedures are conducted at both the VA and UCSF—participant signs a VA consent and a UCSF consent (if such is required by UCSF).
  • VA or NCIRE employees (on their VA or NCIRE time) go to UCSF to obtain informed consent from UCSF patients for VA studies.
  • You (or your study staff) are on your VA time when you obtain informed consent from an individual on UCSF premises.
  • The participant typically receives care at UCSF, but you are seeing him/her at the VA for a study procedure (included obtaining informed consent).
  • Informed consent is obtained at VA or on VA-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 VA, NCIRE, UCSF, or elsewhere. (Please note: Any individual who obtains informed consent on VA premises MUST be VA-employed or have WOC status.)

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

  • VA clinician informs Veteran patient of a UCSF-based treatment study, then refers patient directly to UCSF study team and consent process is conducted at UCSF.
  • All data is UCSF data (obtained either through direct interaction or records review) and the role of VA 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.

 

  • Authorization for Use & Release of Protected Health Information for Research Form (HIPAA form): This VA form must be used for VA research subjects for which written HIPAA authorization is required. SFVAHCS Privacy Officer must review and approve the VA HIPAA form for each study prior to implementation (this also applies to modifications to the HIPAA). Upload this form in Other Study Documents in iRIS—DO NOT upload in Consent Document section. If you have questions, please contact the VA Privacy Officer at v21SFCPOstaff@va.gov.
  • VHA Handbook 1200.05 Privacy Officer duties (section 22) states: 

    If a study includes information covered under 38 U.S.C. 7332 (DRUG, ALCOHOL, HIV AND SICKLE CELL ANEMIA INFORMATION) that will be disclosed outside of VA, the study must include written assurance from the VA researcher, e.g. within the protocol, that the purpose of the data is to conduct scientific research and that no personnel involved in the study will identify, directly or indirectly, any individual patient or subject in any report of such research, e.g. manuscript or publication.

    38 U.S.C. Section 7332 makes all VA records that strictly confidential contain the identity, diagnosis, prognosis or treatment of VA patients or subjects for drug abuse, alcoholism or alcohol abuse, infection with human immunodeficiency virus (HIV/AIDS), or Sickle Cell Anemia. This statute applies to information whether or not it is recorded in a document or a Department record.

    PARTICIPATION OF NON-VETERANS AS RESEARCH SUBJECTS [section 24(f)] Investigators must follow VHA Handbook 1605.04, Notice of Privacy Practices, to provide notice of privacy practices and acknowledgement for any non-Veteran enrolled in the approved protocol. 
  • VA Investigational Drug Information Report (10-9012): This form is required for studies involving investigational drugs. An investigational drug is defined as a new chemical compound, which has not been approved by the FDA, or an approved drug that is being studied for an approved or unapproved use, dose, dosage form, administration schedule, or under an IND application, in a clinical investigation. The 10-9012 must indicate who may prescribe the research medications and include any safety information that may not be available in published references. Please ensure this form is signed by VA PI, IRB Chair, and R&D Chair.
  • VA Form 10-9012 is not required if package insert is available (i.e., for studies involving approved drug(s) being used according to its/their approved labeling). Authorized prescribers should be described as such in the key study personnel section of the Study Application

Study Application Guidance

Unless the research is conducted at VA only, then the following sections of the IRB Application MUST dintinguist the VA vs non-VA research elements:

Inclusion/Exclusion Criteria

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

Qualifications of Key Study Personnel

Clearly distinguish VA personnel from non-VA in the qualifications of Key Study Personnel section. If the personnel will not have access to identifiable VA data, include in this section.

Study Procedures

Identify all research-related procedures to be conducted at VA.  If any procedures are not being done at VA or any study populations are not included at the VA, describe in the Procedures section.  If the same applies at all sites, clearly indicate that.

Recruitment

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

Confidentiality

Describe how VA data/specimens will be stored (e.g., de-identified, coded or identifiable), where (e.g., VA server, UCSF server, sponsor), and who will have access to the data. Specify whether non-VA personnel will have access to identifiable VA information. If you plan to transmit VA data outside the VA, describe how the data will be transferred (e.g., encrypted email) AND whether VA data will be combined with non-VA data. This information must also be included on the VA consent and VA HIPAA forms. Note that VA must retain the complete record (original or copy) of all data obtained in VA research.

 

 

Include the following verbatim: VA research records will be kept in accordance with VA Records Control Schedule (RCS 10-1).

Research Records Storage. Refer to VHA Records Control Schedule (RCS 10-1) Section 8300.6 Research Investigator Files for research records maintenance. Contact the Research Office for assistance for off-site record storage.

 

Special Considerations for Conducting Clinical Research at the SFVAHCS

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 VAHCS Clinical Research Office for assistance in interpretation of these policies.

Research pharmacy requirements

All investigational drugs and devices used at the SFVAHCS MUST be shipped directly to the VA 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. 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 SFVAHCS, the following additional 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 drug(s) if applicable.
    • Copies of all correspondence addressed to the Researcher from the FDA specific to the investigational drugs or devices if applicable.
  • Inform the chief of pharmacy service, the research pharmacy when applicable, and the IRB in writing when a study involving investigational drugs or devices 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 paid by the VA or have completed a federal background check and have Worker Without Compensation (WOC) status. These personnel must be registered in the VA Research and Development Information System (RDIS) which is only accessible behind the VA firewall.

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

All research staff, including residents and fellows, must complete the following trainings which are specific to the VA (UCSF training is not sufficient):

  • CITI Training in the protection of Human Subjects—CITI account must be affiliated with VA San Francisco, CA-662. This training must be renewed every three years. Review the CITI FAQs for more information.
  • VA Privacy and HIPAA: Available online at www.tms.va.gov.  For TMS access, please contact the VA Clinical Research Office.
  • The Scope of Practice (in RDIS) 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 indicated in the Scope of Practice along with the level of access requested (read-only or read/write).

VA Privileges required for Research Personnel

Licensed practitioners 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 SFVAHCS.

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 business 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, please email VA Privacy Office at v21sfcpostaff@va.gov or call 415-750-2135. For data security incidents please email VA Information Security Office at (find email group),
  • If the privacy or data incident also involves UCSF participants, contact the UCSF Privacy Office, 415-353-2750
  • 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).