All personnel engaged 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.

The VA PI (or designee) must complete a Scope of Practice for each RDIS user listing designated research duties. If users require access to the VA’s electronic medical record (CPRS) as part of their research duties, this must be indicated in the scope and the user must be listed in key study personnel on the IRB Study Application. It is the PI’s responsibility to ensure the new personnel are listed on the IRB Study Application either in real time or that the request to add new personnel is combined with the next future IRB submission. 

For assistance with RDIS or with obtaining a VA laptop and other VA equipment for research personnel, email the VA onboarding team at [email protected].

IRB approvals may be delayed if key study personnel listed in the Study Application are not up-to-date on the following VA research training at the time of submission:

• CITI (VA Human Subjects Protection)—CITI account must be affiliated with VA San Francisco, CA-662. This training must be renewed every three years. Review the VA ORD website and CITI FAQs for more information.
• VA Privacy & HIPAA and VA Privacy & Information Security and Rules of Behavior must be updated annually via the VA TMS website. All researchers accessing identifiable VA data must complete these trainings. For assistance with TMS accounts or training requirements, contact [email protected].

Trainings are specific to the VA. UCSF training may not be substituted.

VA Office of Research Protections, Policy, and Education (ORPP&E) webinar archive may be accessed here. It is highly recommended that VA research personnel review the topics listed and listen to any webinars that may pertain to your VA research activities.

OHRP provides Human Research Protection Training that includes foundational knowledge on protecting human subjects in research funded by the U.S. Department of Health and Human Services (HHS). The training is developed for the broad research community including IRBs, investigators and key personnel, and anyone interested in the Common Rule. Access is free.

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.

Log into iRIS and submit the appropriate submission packet (Initial Review or Modification Form, if adding SFVAHCS as a site) with a complete description of study procedures on the Study Application.

Attach all required VA forms to your IRB submission:

• VA Form 10-250 Privacy Checklist - complete Page 1 only
• Enterprise Research Data Security Plan (ERDSP)—This link is only accessible behind the VA firewall. The VA PI or designee must sign.
• Request for R&D Approval (aka 'pink sheet')—List all protocols attached to the funding source. You must obtain your Service Chief’s signature on this form. After VA PI signature, you must obtain your VA Service Chief’s signature on this form.
• Research Protocol Safety Survey (RPSS)—Refer to instructions for completing the RPSS. The VA PI must sign.

Failure to attach the above required documents may result in delays in review and approval.

Attach the following study documents, if applicable. 

Consent Documents section: 

• VA consent form(s) 
• Information sheet
• Verbal consent script

Other Study Documents section

• VA HIPAA (VA Form 10-0493)
• Non-consent phone scripts
• Request for Non-Veteran Approval form, if enrolling non-Veteran subjects in research that involves VA outpatient or VA hospital treatment
• Single IRB exception approval letter: only required for non-exempt studies if there are collaborating engaged VA sites and/or other collaborating engaged sites which are Federal entities or Federally-funded
• Proactive calling approval letter issued by ORD
• Any other related materials

Once your protocol documents are submitted to the IRB, VA Research Office personnel will facilitate R&DC approval. You may not begin a new research project without IRB and R&D Committee approval. When your project is approved, you will receive a signed ACOS/R&D memo giving you authorization to begin your project.

If enrolling non-Veterans in VA research, include explicit justification. Refer to Non-Veteran Research Subjects section.

• If the UCSF PI is not affiliated with VA, indicate who will serve as the VA PI.
• Clearly distinguish VA from non-VA personnel.
• Identify personnel who will interact with VA subjects and/or have access to identifiable VA data (not required if the study is conducted at VA only)
• Identify authorized study drug prescribers, if applicable.

• Describe all study 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 this section.
• Include all remote study procedures, if applicable.

• Distinguish which recruitment methods will occur at the VA and which methods will NOT be conducted at the VA.
• If there are multiple subject populations (e.g., Veterans and non-Veterans), distinguish how each group will be recruited.
• Proactive calling (sometimes referred to as “cold calling”) may be permitted in certain circumstances. Click here to request ORD approval for proactive calling. 

1. For VA studies, include the Required VA records retention language: VA research records will be retained and disposed in accordance with the VHA Records Control Schedule (RCS 10-1). 

2. Describe:

• How VA data/specimens will be stored (e.g., de-identified, coded or identifiable). If biospecimens are collected and/or stored at SFVA, specify whether the specimens will be labeled with identifiable, coded or de-identified information.
• Where data will be stored (e.g., VA server, UCSF server), and
• Who will have access to the data.

3. If the study involves collection or use of sensitive VA data (specifically drug abuse, alcoholism/alcohol abuse, HIV, or sickle cell anemia), include 38 USC 7332 language

4. Specify whether non-VA personnel will have access to identifiable VA information.

5. 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 the complete record (original or copy) of all data obtained in VA research must be retained at VA.

The following language regarding VA treatment and compensation for research-related injury must be included verbatim in VA consent forms for greater than minimal risk studies:

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.

NOTE: If the greater than minimal risk study is conducted at both UCSF and VA, include both VA and UCSF treatment and compensation for injury wording. 

• 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 and consented 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 (as required by the IRB).
• 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 study procedures are conducted at the VA.
• 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.)

• VA clinician informs Veteran patient of a UCSF 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 VA is serving as an administrative site (e.g., the role of VA is limited to data analysis).
• A prospective participant contacts a researcher about a UCSF study and discloses that he/she happens to be a Veteran.

This form must be completed and attached to all initial submissions as well as to any modification that result in changes to: data collection/use/storage/transmission/disposition, VA informed consent, VA HIPAA Authorization form, Data Use Agreement (DUA), or when the modification impacts waiver of HIPAA Authorization.

Complete the Study Information section (Page 1 only) of the VA Form 10-250 and upload in the Other Study Documents section of your iRIS submission. Include all relevant information in the Study Application for consistency.

Unless it’s determined that Privacy Officer review is not required, the VA Privacy Officer will email a signed copy of the form to the study team documenting the final privacy review. Please visit this website for more information about VA Privacy requirements (only accessible behind VA firewall).

Authorization for Use & Release of Protected Health Information for Research Form 10-0493. Please download the file and open it in Adobe prior to editing. The VA HIPAA form must be used when written HIPAA authorization is required for a VA study. SFVAHCS Privacy Officer must review and approve the VA HIPAA form for each study prior to implementation (this applies to new and revised versions of the HIPAA). If you have questions, contact the VA Privacy Officer at [email protected].

Attach the HIPAA form to your IRB submission in the Other Study Documents section—DO NOT upload in the Consent Documents section.

For all VA studies, include the following statement verbatim in the Confidentiality section of the Study Application: VA research records will be retained and disposed in accordance with the VHA Records Control Schedule (RCS 10-1).

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

38 U.S.C. Section 7332 makes all VA records that contain the identity, diagnosis, prognosis or treatment of VA patients or research subjects for drug abuse, alcoholism or alcohol abuse, infection with human immunodeficiency virus (HIV/AIDS), or Sickle Cell Anemia strictly confidential. This statute applies to information regardless of whether it is recorded in a document or a Department record.

If a study collects or uses individually identifiable patient health information covered under 38 U.S.C. 7332 (DRUG, ALCOHOL, HIV AND SICKLE CELL ANEMIA INFORMATION), include the following statement verbatim in the Study Application:

This study includes collection of information covered under 38 U.S.C. 7332 (drug, alcohol, HIV and/or sickle cell information). The purpose of the data is to conduct scientific research. 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.

For VA Information Systems Security Officer requirements, refer to Confidentiality section of the Study Application table. For additional guidance, refer to ORPP&E’s Research Information Security & Cybersecurity Toolkit.

If VA staff will obtain VA patients’ contact information from the VA medical record and provide it to UCSF staff (e.g., for recruitment into a non-VA study), this is considered an external disclosure which requires the VA patient’s signed authorization. This disclosure of identifiable information must be documented using VA Form 10-5345 (Release of Information Form).

The 10-5345 must be collected by the VA employee and sent to HIMS for scanning into the patients’ medical records. Information may be pre-filled for the patient (except for the section related to authorizing disclosure of 7332-protected information), then the patient must review and sign it.  Electronic signatures are not accepted.  The 10-5345 must be filled out completely to be valid. If you plan to pre-fill the form for patients, the Privacy Officer must review the form prior to use.  Email the pre-filled form to [email protected] for review.

To report privacy incidents, email the VA Privacy Office at [email protected] or call 415-750-2135. To report data security incidents, email the VA Information Security Office at [email protected].

If the privacy or data incident also involves UCSF participants, contact the UCSF Privacy Office at 415-353-2750.

When requesting a Certificate of Confidentiality, you may find more details about how to respond to the specific sections of the request here. Further questions should be directed to the NIH CoC Coordinator at [email protected]

Informed consent audits are completed by the VA Research Compliance Officer (RCO) annually. Regulatory audits are conducted every three years depending on IRB status of study. Contact the VA RCO, Rakesh Singh ([email protected]), for more information.

For essential documents templates and good clinical practice documentation guidance, refer to the VA Site Monitoring, Auditing and Resource Team (SMART) website.

Research guidance and templates are also available on the ORPP&E website.

The VA has a shorter timeline (5 business days) and different definitions than UCSF for reporting certain categories of post-approval events. See VHA Directive 1058.01 (revised October 22, 2020) for specific examples. Note that reporting requirements for research subject deaths are shorter than 5 business days—see 1058.01 for more information related to reporting requirements.

Please consult with the VA Research Office 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 of Noncompliance in VA Human Subjects Research that ORO Typically Considers to Meet the Definition of Serious or Continuing Noncompliance (March 8, 2021)

Decision Chart: Reporting Human Deaths, Unanticipated Problems and Accident, Injury, Illness or Exposure in VA Research (March 12, 2021)

Note: 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.

Refer to VA ORO Publications and Guidance for more information.

All outside monitors visiting SFVA must register with VA Police Services for a badge. Monitors must also email the Clinical Research Office at [email protected] and provide a brief report at the conclusion of the visit.

For information related to remote monitoring visits, refer to remote monitoring guidance. 

There are additional requirements in VHA Handbooks 1058.01, 1200.01,1605.1, and 6500 and SFVAMC MCM 11-19. The full list of VHA Publications may be found here.  Contact the SFVAHCS Clinical Research Office for assistance in interpretation of these policies.