- Research at the SFVAHCS
- HRPP COVID-19 Information
- When is VA Approval Required?
- Required Education and Training
- IRB and R&D Submission Process
- Study Application Guidance
- Consent Forms
- VA Docusign
- VA Privacy and Information Security Requirements
- Restrictions on VA Research Subject Payments
- Non-Veteran Research Subjects
- VA Research Pharmacy
- VA Radiation Safety Committee Forms
- Research Compliance
- Quick Links
CLINICAL RESEARCH OFFICE
FWA number: FWA00000280
Research at the SFVAHCS
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.
HRPP COVID-19 Information
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.
Additional COVID-19 VA research guidance
- ORD Covid-19 SharePoint site (accessible only behind VA firewall)
- ORD Policies and Guidance
- SFVA remote consent and data collection guidance - May 18, 2021
- Bulletin No. 427 VA Research & Development Guidance for Securely Obtaining Informed Consent - December 22, 2020
- 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
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 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 (QI) projects do not require IRB approval, therefore do not submit an IRB application in iRIS. To determine if your proposed VA project is QI or Operations, go to the VA Electronic Determination Aid (VAEDA) website tool and fill out the checklist. Please submit the results to HRPP at [email protected]. If you need written determination that the project is not research (e.g., for publication), contact [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.
Those who work only on QI projects are not required to complete VA CITI Human Subjects Protection training.
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.
Cooperative Research Provisions and Single IRB Implementation at VA
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 SFVA Commercial IRB submission guidance for our facility. The following forms from ORD will aid in ensuring your ICF and/or HIPAA documents are in compliance:
- VA ICD Requirements When Using an Independent Commercial IRB
- VA HIPAA Authorization Requirements for and Independent Commercial IRB
- Checklist for VA Facilities Using Independent Commercial IRB’s (ICD & Combined ICD/HIPAA)
For more information about cooperative research provisions requirements, refer to the ORPP&E website or email the VA Research Office at [email protected].
Required Education and Training
IRB and R&D Submission Process
The VA distinguishes between projects and protocols. A project 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).
Study Application Guidance
Review the following for information that must be included in the IRB Study Application. Failure to include this information may result in delays in approval.
If SFVA is engaged in the research, 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].
VA Consent Forms
VA consent forms are the consent document used to obtain informed consent from participants in VA-approved research, including but not limited to research conducted at VA, using VA employees and time, funded by VA, etc. Please see the “When to use a VA consent form” section below for more information.
All VA consent forms and verbal consent scripts must contain:
- The required elements of consent as described in VHA Directive 1200.05
- VA treatment and compensation for research-related injury wording, if applicable.
- All 2018 Common Rule required language.
When drafting your consent form(s), refer to UCSF consent form guidelines and suggested wording and the VA Informed Consent checklist. You may use the VA consent form header (VA Form 10-1086) if desired, though use of the 10-1086 is not required.
NOTE: You may include the Person Obtaining Consent signature block on VA consent forms if desired, however this is no longer a VA requirement.
When to use a VA consent form
VA Docusign
DocuSign may be used to obtain signatures on VA forms (VA consent, VA HIPAA Authorization Form and other VA forms requiring subject signature). 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.
Requesting Use of VA DocuSign
For more information, visit instructions for requesting the use of VA DocuSign. Please also refer to the SFVA remote consent and data collection guidance.
If approved 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 to recruit VA subjects only.
- In CONSENT METHODS item, select “Sign an electronic consent form using DocuSign (signed consent)”
- In CONSENT PROCESS section, describe the procedures for obtaining consent remotely.
- 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].
VA Privacy and Information Security Requirements
Enterprise Research Data Security Plan (ERDSP)
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 (accessible only behind the VA firewall) to facilitate protocol reviews. 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.
Research Subject Payments
SFVAHCS subjects may not be paid for participation in research when the research is integrated with the patient’s medical care and makes no special demands on the patient.
Payment is permissible in the following circumstances:
- When the research is not directly intended to enhance the diagnosis or treatment of the medical condition for which the subject is being treated, and when the standard of practice in affiliated non-VA institutions is to pay subjects.
- If subjects at a collaborating non-VA institution are being paid for the same participation, in the same study, at the same rate proposed.
- In comparable situations when, in the opinion of the IRB, payment of subjects is appropriate.
- When the subject incurs transportation expense that would not be incurred in the normal course of treatment which are not reimbursed by another mechanism.
Non-Veteran Research Subjects
Per VA Directive 1200.01, non-Veterans may be entered into a VA-approved research study that involves VA outpatient or VA hospital treatment, but only when there are insufficient Veteran patients suitable for the study. 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.
VHA Notice of Privacy Practices for Non-Veterans
Some non-Veteran research participants must be provided the VHA Notice of Privacy Practices (NoPP) in accordance with VHA Handbook 1605.04. VHA health care facilities must provide the Notice of Privacy Practices when a non-Veteran patient attends their first research visit associated with an episode of care. Only pharmacy medication pick-up, laboratory appointments and Tuberculosis screening, are not considered episodes of care.
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.
If you must provide the NoPP or obtain the VA Form 10-0483, note this in the Study Application.
For additional guidance, click here or contact the VA Privacy Office at [email protected]
VA Research Pharmacy
VA Investigational Drug Information Report (10-9012)
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 in a clinical investigation for an approved or unapproved use, dose, dosage form, administration schedule, or under an IND application.
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 the VA PI, IRB Chair, and R&DC Chair. The study IRB approval letter may be used in lieu of the actual signature of the IRB chair if it is attached to the VA Form 10-9012.
Per VHA Handbook 1108.04, 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.
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
- Radiation Exposure Form for Skin Dose Calculation and Reporting form
- Copy of the IRB Study Application
- Clinical Investigation Plan (Protocol)
- Informed Consent Form
For more information, visit the Radiation Safety Committee website (accessible behind the VA firewall only) or email [email protected].
Research Compliance
Quick Links
- RDIS
- ORD Policies and Guidance
- Office of Research Oversight (ORO) Publications and Guidance
- ORPP&E Policy and Guidance FAQs
- ORPP&E Communication Page for VHA Researchers. Items included on this page:
- DocuSign
- FERSS
- Proactive Calling
- Qualtrics Requests