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Research at the SFVAHCS
HRPP COVID-19 Information
When is VA Approval Required?
Required Education and Training
Submission Process
Study Application Guidance
Consent Forms
VA Privacy and Information Security Requirements
Non-Veteran Research Subjects
VA Research Pharmacy
VA Radiation Safety Committee Forms
Research Compliance
CLINICAL RESEARCH OFFICE
HRPP Team
FWA number: FWA00000280
Research at the SFVAHCS
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.
HRPP COVID-19 Information
NOTE: If you are making a change in study procedures for safety reasons anticipated to be temporary due to COVID-19 (example: cancelling non-essential study visits or temporarily changing from in person to telephone visits), then a modification is not required prior to implementing. If changes in study procedures are permanent, a modification to the study protocol is required.
Contact the VA Office of Research & Development (ORD) with any questions, ideas, or comments about VA research and COVID-19 at [email protected].gov. First check the COVID-19 FAQs on ORD’s website.
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].
You must get approval from the VA Deputy ACOS for Research to restart in-person research visits at SFVA. For more information, contact Dr. Jennifer Mitchell ([email protected]).
Additional COVID-19 VA research guidance
ORD Covid-19 SharePoint site (accessible only behind VA firewall)
VA remote consent and data collection guidance - April 15, 2020 (PDF)
Requesting Use of DocuSign for COVID-19 Studies—September 3, 2020 The Office of Research and Development has been given a limited supply of DocuSign "envelopes" for use though the ATO approved DocuSign Cloud. The use of DocuSign is currently limited to COVID studies intending to recruit >100 subjects until ORD can secure a contract for additional envelopes and more support staff can be trained.
To request the use of DocuSign for your COVID research involving more than 100 subjects, complete the request form and email to [email protected] with the subject "DocuSign Request". Additional instructions will follow pending the review of your request. Review of request is currently within 1 business day. Failure to complete the form or improperly address the email will delay review.
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 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 March 3, 2020) 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 (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
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.
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 may not be required. Consult the VA Clinical Research Office ([email protected]) to discuss how use of non-VA study advertisements can be approved.
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, the cooperative research provisions may apply. Per these provisions, the use of a single IRB (sIRB) or ORD-approved sIRB exception is required.
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
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. Access to the VA’s electronic medical record (CPRS) must be indicated in the scope along with the level of access requested (read-only or read/write).
For assistance with RDIS accounts or with obtaining a VA laptop and other VA equipment, email the VA onboarding team at [email protected].
Mandatory
VA-specific training for research staff
All research staff, including residents and fellows, must complete the following training:
- 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 and HIPAA & VA Privacy and 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.
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
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.
Submission Process
The VA distinguishes between projects--a cohesive body of work usually tied to one major funding source—and protocols. 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).
You may not begin a new research project without R&D approval. When your project is approved, you will receive a signed ACOS/R&D memo giving you authorization to begin your project.
- Complete description of study procedures on the Study Application
- VA Form 10-250 Privacy Checklist, if accessing VA data or specimens
- Detailed description of data storage methods and location of data storage
- Request for R&D Approval (aka 'pink sheet')
- Research Protocol Safety Survey (RPSS)
- VA consent form(s) or script(s)
- VA HIPAA (VA Form 10-0493)
- Recruitment materials
- Interview, survey or focus group questions
- Request for Non-Veteran Approval form, if enrolling non-Veteran subjects
- Assessments, measures, questionnaires
- OGE Conflict of Interest Form
- Any other related materials
- 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.
Study Application Guidance
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 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.
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.
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VA Consent Forms
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.
When to use a VA consent form
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.
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.
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.
VA Privacy and Information Security Requirements
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 (Page 1) of this form and upload in the Other Study Documents section of your iRIS submission. Include all relevant information in the Study Application for consistency.
The VA 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 HIPAA (Authorization for Use & Release of Protected Health Information for Research Form 10-0493):
This pdf works best with Internet Explorer. The VA HIPAA 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 Informed Consent section. If you have questions, contact the VA Privacy Officer at [email protected].
Required VA records retention language
For all VA studies, 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).
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 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.
Reporting Privacy and Information Security Incidents
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.For privacy incidents, email the VA Privacy Office at [email protected] or call 415-750-2135. For 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, 415-353-2750.
Non-Veteran Research Subjects
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.
VA 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 VA Notice of Privacy Practices 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).
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 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 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
Research Audits
Informed consent audits are completed by the VA Research Compliance Officer 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 Handbook 1058.01 (revised October 22, 2020) for specific examples. 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 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: 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.
Monitoring Visits
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.
