Research at the SFVAMC

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.

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.

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.

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.

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.

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).

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.

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.

• Examples and Reporting Guide for Apparently Serious or Continuing Noncompliance in VA Human Research
• Decision Chart for Reporting Local Deaths, SAEs, and Serious Problems Involving Risk in Research

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.

• 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).