CLINICAL RESEARCH OFFICE
FWA number: FWA00000280
The San Francisco Veterans Affairs Health Care System (SFVAHCS) has an institutional affiliation with UCSF and provides opportunities for collaborative research. The UCSF IRB is the primary 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.
Consideration should be taken to reduce COVID-19 transmission risk to research subjects and research staff as much as possible. Remote study procedures can and should be utilized when feasible. This may include, but is not limited to: obtaining consent remotely, remote study visits, and/or use of web-based surveys or mobile apps for data collection. Please refer to guidance documents below for more information, and to the CDC website for COVID-19 updates.
For COVID-19-related new studies, prior to submission to the VA Research and Development Committee (R&DC), submit a brief description of the research to [email protected] and forward a copy of ORD’s response to [email protected].
To restart in-person research visits at SFVA, you must obtain approval from Dr. Jennifer Mitchell, VA Deputy ACOS for Research ([email protected]).
Additional COVID-19 VA research guidance:
- ORD Covid-19 SharePoint site (accessible only behind VA firewall)
- ORD Policies and Guidance
- Bulletin No. 427 VA Research & Development Guidance for Securely Obtaining Informed Consent
- VA Video Communication Technology Research Memorandum—April 7, 2020
- ORD Human Subject Protection Issues Related to COVID-19 Frequently Asked Questions—April 6, 2020
- VA COVID-19 Research Biorepositories/Biobanks—May 1, 2020
- ORD Guidance on VA Employee Participation in VA-Conducted COVID-19 Research Studies—September 24, 2020
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 or staff at the VA, or use VA personnel, facilities or medical records, you must secure prior approval of the SFVAHCS Research & Development Committee (R&DC).
VHA Directive 1200.05
VHA Directive 1200.05 (new revision published January 8, 2021) 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.
Special considerations may be found in the following sections:
- 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 (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
Also refer to ORPP&E’s Policy and Guidance FAQs.
What to do if VA is an administrative site only
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.
Quality Improvement Projects
Per VHA Program Guide 1200.21, activities—including some involving collection of PHI/PII—do not constitute research if they are not designed to produce information that expands the knowledge base of a scientific discipline (or other scholarly field). This includes projects focused on quality improvement, program administration, and/or program evaluation that are not designed to answer a research question nor includes a hypothesis designed to contribute to generalizable scientific knowledge. Use the Research vs. Operations Decision Tool and Research or QA Chart to determine if the project meets the definition of research.
Quality improvement projects do not require IRB approval, therefore do not submit an IRB application in iRIS. If you need written determination that the project is not research (e.g., for publication), submit the QI vs Research Determination Checklist to [email protected].
Please also consult with Education Service, Chief of Quality Management Service and your service chief for any additional approvals that may be needed to proceed with your project.
Advertising non-VA studies at SFVA
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 is not required. Complete this form and return it to the VA Clinical Research Office ([email protected]) prior to advertising non-VA studies at SFVA.
If SFVAHCS and any other Federal or Federally-funded institutions are engaged in a non-exempt research study which has been approved or transitioned to follow the 2018 Requirements of the Common Rule, the cooperative research provisions may apply. Per these provisions, the use of a single IRB (sIRB) or ORD-approved sIRB exception is required.
When collaborating with other sites, take into consideration the single IRB requirement early in the grant writing stage, before submitting the project for IRB approval. If one or more other VA sites are engaged in your research study, first consider using VA Central IRB as your IRB of record. Contact [email protected] or visit the VA Central IRB website for more information.
If using a commercial IRB, refer to Commercial IRB submission guidance.
VA employment or WOC status required
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].
Mandatory VA-specific training for research staff
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.
Additional training (not required)
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.
The VA distinguishes between projects and protocols. A projects is a cohesive body of work, usually tied to one major funding source, and is reviewed for safety before any research may begin. Projects may contain one or more Protocols (i.e., IRB, BUA, IACUC).
IRB protocol approval and VA R&D Committee project approval are required for human subjects research. Protocol approval is not required for projects that are not considered human subjects research (e.g., QA/QI projects).
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)—new requirement as of March 22, 2021
- 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.
- Research Protocol Safety Survey (RPSS)—Refer to instructions for completing the RPSS.
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)
- Phone scripts
- Recruitment materials
- Interview, survey or focus group questions
- Request for Non-Veteran Approval form, if enrolling non-Veteran subjects
- Assessments, measures, questionnaires (excluding standardized/validated questionnaires, such as the PHQ-9)
- Tables, charts, diagrams referenced in the IRB Application – paste these items into a Word document(s) and reference the attachment in the relevant application section(s).
- Sponsor’s or multicenter protocol
- Scientific protocol for greater-than-minimal-risk-studies that don’t have a sponsor’s or multicenter protocol
- IRB approval letters and/or letters of support from collaborating or cooperating sites
- Single IRB exception approval - only required if there are collaborating engaged VA sites and/or other collaborating engaged sites which are Federal entities or Federally-funded.
- 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.
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.
Note that if the UCSF Principal Investigator is not affiliated with SFVAHCS, a SFVAHCS-approved PI who will be responsible for the conduct of the work at the VA must be identified. For information about applying for VA PI status, contact [email protected].
If enrolling non-Veterans in VA research, include explicit justification. Refer to Non-Veteran Research Subjects section.
Note that the complete record (original or copy) of all data obtained in VA research must be retained at VA.
All VA studies must use the VA consent form template (VA Form 10-1086). All consent forms and verbal consent scripts must contain the required elements of consent as described in VHA Directive 1200.05. When drafting your consent form(s), refer to UCSF consent form guidelines and suggested wording. You may also refer to the VA Informed Consent checklist.
Greater than minimal risk studies
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.
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 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.)
Examples of when a VA consent document must NOT be used:
- 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.
As of March 22, 2021, DocuSign may be used to obtain signatures on VA consent forms and the VA HIPAA Authorization Form. ORD has purchased a supply of envelopes to be used in research studies requiring documentation of informed consent. All requests are considered but studies requiring the creation of <100 envelopes (100 subjects) will need to provide justification. Inpatient studies are generally not appropriate for DocuSign and study teams should consider the use of iMedConsentTM for inpatient studies or studies where all study subjects will present to a facility with CPRS access.
Requesting Use of VA DocuSign
If ORD approves your request to use VA DocuSign
- Review DocuSign Post-Approval Instructions (only accessible behind VA firewall).
- Submit a Modification Form for your study in iRIS.
- On the IRB Study Application:
- Clearly indicate that VA DocuSign will be used with VA subjects only.
- In the CONSENT METHODS item, select “Sign an electronic consent form using DocuSign (signed consent)”
- In the CONSENT PROCESS section, describe the procedures for obtaining consent remotely. You may refer to ORD’s DocuSign SOP (see Post-Approval Instructions) for guidance.
- Attach a PDF copy of the approval correspondence from ORD.
- Attach 1) email script and 2) consent phone script as needed -- see email script template and phone script template.
NOTE: Do not list VA DocuSign in the Disclosure section of the VA HIPAA form.
After IRB approval is granted, questions should be directed to [email protected].
Enterprise Research Data Security Plan (ERDSP)—new requirement for SFVA studies reviewed/approved after March 22, 2021
This form must be completed and attached to all initial submissions and to any modifications that affect the study's data and security plan.
ORD has mandated that Information Security Officers use the ERDSP to facilitate protocol reviews. Note once you select the Purpose of Submission, the form will branch out with questions and will continue to branch based on your responses. Refer to ERDSP Guide and FAQs for further information, or contact [email protected].
If you plan to share VA research data (electronic and/or hard copy) with another VA or non-VA entity/institution, refer to the VA Data Transfer Methods Table for VA-approved methods for secure data transfer.
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).
This pdf works best with Internet Explorer. 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.
Required VA records retention language
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.
Required 38 USC 7332 language
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.
Reporting Privacy and Information Security Incidents
If the privacy or data incident also involves UCSF participants, contact the UCSF Privacy Office at 415-353-2750.
Certificates of Confidentiality
For general information about Certificates of Confidentiality, refer to the UCSF IRB website: https://irb.ucsf.edu/certificate-confidentiality-nih.
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]
Non-Veteran subjects include students, fellows, clinical staff, caregivers or any other research subject who is not a Veteran. In addition to IRB approval, you must obtain R&D approval before enrolling non-Veterans (by obtaining consent, written or verbal). Complete the Request for Non-Veteran Approval Form and attach in Other Study Documents section of the IRB submission.
Required Study Application Language
If a study involves consenting non-Veterans, 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 relevant to the Veteran population. The approximate number of non-Veterans to be enrolled in VA research is ______.
In the Study Application, include any of the following language applicable to the study:
[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.
VHA Notice of Privacy Practices for Non-Veterans
Non-Veteran participants who receive treatment at SFVA as part of their participation in VA research must be provided the VHA Notice of Privacy Practices (NoPP) in accordance with VHA Handbook 1605.04. In some circumstances (i.e., if a medical record is created), the non-Veteran participant must sign VA Form 10-0483 (Acknowledgment of the Notice of Privacy Practices) and the form must be scanned into the non-Veteran’s medical record.
The VA form 10-9012 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&DC Chair.
VA Form 10-9012 is not required if a package insert is available (for studies involving approved drugs used according to FDA-approved labeling). Identify authorized study drug prescribers listed on the 10-9012 in the qualifications of key study personnel section of the Study Application.
Research pharmacy requirements
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 must 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 ([email protected]) before the budget is finalized.
When the study is conducted at SFVAHCS, the following additional obligations must be met by the researcher:
- The research pharmacy must be provided:
- 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 related to the investigational drugs or devices.
- 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.
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
- Radiation Exposure Form for Skin Dose Calculation and Reporting form
- Copy of the IRB Study Application
- Clinical Investigation Plan (Protocol)
- Informed Consent Form
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.
Adverse Events/Incident Reports/Unanticipated Problems
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.
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.
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.
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.
Click here for information related to remote monitoring visits.
Additional VA Research Guidance
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.