Research at the SFVAHCS
When is VA Approval Required?
How to Apply to the VA and Required Forms
Study Application Guidance
CLINICAL RESEARCH OFFICE
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 for research conducted at the VA. While SFVAHCS and UCSF are affiliated institutions, they are separate legal entities.
National VA Policy (new revision published March 3, 2020): VHA Directive 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.
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. SFVA is considered an administrative site when local VA resources such as SFVAHCS property, office, computer, server, or email are used, and/or VA time is used, but:
- no VA patients or employees are enrolled,
- no identifiable data or specimens are collected from or used at SFVAHCS, and
- no VA funding 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.
On the IRB Study Application, check “SF VA Medical Center (SF VAMC)” under UCSF and Affiliated Sites 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):
- Request for R&D Approval (aka ‘pink sheet’): List all the protocols attached to this funding source. You must obtain your Service Chief’s signature. The Research Office will obtain the ACOS signature once the project has been approved.
- Research Protocol Safety Survey (RPSS): Used to identify which VA research subcommittees or workgroups must review and approve the project. Refer to instructions for completing the RPSS.
SFVAHCS Forms (if applicable for a given protocol):
- Consent form 10-1086 template: This document contains only the header and footer. For content, refer to UCSF consent form guidelines and suggested wording. All consent forms and verbal consent scripts must contain the required elements of consent as described in VHA Directive 1200.05. You may use the VA Informed Consent checklist as a guide.
Please include the following in the VA consent form:
SFVAHCS-approved PI’s name in the template header field:
If different from the VA PI, you may include the UCSF PI name in the text of the VA consent form.
All consent forms must include a person to contact in case of research-related injury, and a statement that VA will provide treatment for research-related injury in accordance with VA regulations.
- If the study is greater than minimal risk, include the following VA treatment and compensation for research-related injury paragraph (updated March 2018).
For greater than minimal risk studies, 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 Form 10-250 (required by VHA Directive 1605.03) For all initial review submissions and modifications adding SFVA as a site, complete the ‘Study Information’ section and attach Form 10-250 in ‘Other Study Documents.’ Include all relevant elements throughout the study application for consistency. The Privacy Officer will use the form to conduct required privacy reviews. The Privacy Officer will email signed version 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).
- VA Radiation Safety Committee Forms: If using radiation in your study, once the initial review submission has been submitted in iRIS, email the following forms and documents to [email protected].
- Application form—Application for the Use of X-rays in Human Research and/or Application for Radionuclide Utilization in Human Use Research
- IRB Study Application Form
- Clinical Investigation Plan (Protocol)
- Radiation Exposure Form for Skin Dose Calculation and Reporting form
- Informed Consent Form
- For more information, please visit the Radiation Safety Committee (accessible behind the VA firewall only) website or email Victor, [email protected].
- Authorization for Use & Release of Protected Health Information for Research Form (HIPAA form): (Please open this document on Internet Explorer) This VA form must be used when written HIPAA authorization is required. 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). Upload the HIPAA 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 [email protected].
- VHA Directive 1605.01 Privacy Officer duties (Page 42) states:
38 U.S.C. Section 7332 makes all VA records that 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 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.
PARTICIPATION OF NON-VETERANS AS RESEARCH SUBJECTS The following guidance applies to Non-Veteran participants receiving clinical care or treatment as part of the research. The following language must be included in the IRB Study Application when the study population includes non-Veteran subjects:
Please add the following language in the Inclusion Criteria section of the Study Application:
The recruitment of non-Veterans in VA research is not for the sake of convenience for this study. The objective and justification for enrolling non-Veterans in VA research is:_________________. (for example, there are not enough Veterans available to reach the sample size needed to draw meaningful conclusions). Although non-Veterans subjects will be recruited in VA research, we believe the results will be generalizable to the Veteran population. The approximate number of non-Veterans to be enrolled in VA research is ______.
Non-Veteran participants enrolled in VA research must be provided the VA Notice of Privacy Practices in accordance with VHA Handbook 1605.04. In some circumstances, the non-Veteran participant is required to sign VA Form 10-0483 (Acknowledgment of the Notice of Privacy Practices). For additional guidance, click here or contact the VA Privacy Office at [email protected].
Include any of the following language applicable to the study involving non-Veteran subjects:
[Required for greater than minimal risk studies] For VA research related injuries: For any non-Veteran injured because of participation in a VA research activity for this study, immediate care will be provided as described in the VA research consent form.
For a multisite study only: In this study it is/is not anticipated that any VA inpatient care will be needed however, we made arrangements with the study site(s) for the provision of care if needed. Study funds will be reserved to accommodate the enrollment of non-Veterans in VA research.
For a DOD/VA joint study: Active duty military personnel will be recruited for enrollment in VA research and agreements are in place that all VA research related injuries of active duty personnel enrolled in this protocol will be treated (either inpatient or outpatient) by the DOD. In the event that an active duty subject is within a VA medical facility when emergent care is needed, the emergency treatment will occur within VA until the subject is stabilized and then the active duty subject will be transferred to the nearest DOD medical facility that is capable of caring for the injury/problem.
- VA Investigational Drug Information Report (10-9012): TThis 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 (for studies involving approved drug(s) being used according to FDA-approved labeling). Identify authorized prescribers in the key study personnel section of the Study Application.
Unless the research is conducted at VA only, the following sections of the IRB Application MUST distinguish the VA vs non-VA research elements:
- Inclusion/Exclusion Criteria
- Qualifications of Key Study Personnel
- Study Procedures
VHA Directive 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.
Clearly distinguish VA personnel from non-VA in the Qualifications of Key Study Personnel section. Describe whether personnel will have access to identifiable VA data.
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 this section.
Distinguish which recruitment methods will be unique to the VA and which methods will NOT be conducted at the VA.
Describe how VA data/specimens will be stored (e.g., de-identified, coded or identifiable), where data will be stored (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 the complete record (original or copy) of all data obtained in VA research must be retained at VA.
Include the following 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).
Research Records Storage. 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 record storage.
In particular, please review the following paragraphs of VHA Directive 1200.05 (amended March 3, 2020):
- 5g -- VA Investigators' Responsibilities
- 15 – Collaborative Research
- 17 – General Requirements for Informed Consent (refer to VA Informed Consent Checklist)
- 18 – Documentation of Informed Consent
- 19 – Research Involving Pregnant Women, Human Fetuses, and Neonates as Subjects (also refer to ORD Memo: Restriction on Use of Fetal Tissue for all VHA Research Studies, dated August 28, 2019)
- 20 – Research Involving Prisoners (restricted by the VA)
- 23 – HIPAA Authorization
There are additional requirements in VHA Handbooks 1058.01, 1200.01,1605.1, and 6500 and SFVAMC MCM 11-19. Contact the SFVAHCS Clinical Research Office for assistance in interpretation of these policies.
All investigational drugs and devices used at the SFVAHCS MUST be shipped directly to the VA Research pharmacy, 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 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, 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 research pharmacist when requested.
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.
All research staff, including residents and fellows, must complete the following trainings which are specific to the VA (UCSF training may not be substituted):
- 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 VA TMS training website. 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).
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.
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.
- 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.
Please also refer to VA ORO Memo: Clarification of the VHA Office of Research Oversight’s (ORO) Requirements for the Review of Reportable Events Involving Exempt Human Subjects Research, dated August 7, 2019.
- Monitoring of research: All outside monitors must register with VA Police Services for a badge, check in with the Clinical Research Office and file a brief report before they leave.