Single IRB Implementation in VAs
January 20, 2020 was the compliance date of the cooperative research provisions in 38 CFR§16.114 of the 2018 Requirements. As of January 20, 2020, all VA Non-Exempt Human Subjects Research approved or transitioned to follow the 2018 Requirements of the Common Rule must use a single IRB unless an exception applies to the research activity if more than one institution is engaged in the research and any of the following applies to the multi-site research:
Please note: The cooperative research provisions (also commonly referred to as the “single IRB” requirement) only applies to those institutions that follow the 2018 Requirement. For example, if VA was conducting an industry-funded clinical trial with 14 universities, 3 VA Facilities, and 2 Department of Defense (DoD) Facilities with no other federal support or funding involved, the VA and DoD Facilities are required to use a single IRB unless an exception applies.
Determining Whether the §.114 Cooperative Research Provision Applies
Requesting Change in IRB Arrangements
- ORD policy requires that the VA Medical Center Director request approval from the Chief Research and Development Officer (CRADO) approval when the VA facility wants to establish a new HRPP, change its IRB(s) of Record, or wants its internal IRB to serve as an IRB of Record for a non-VA entity if allowed by ORD policy.
- VA Facilities wishing to change IRB arrangements for a single or multiple studies must submit the ORD application form: Institutional Review Board (IRB) Reliance Request Form.
- The form must be submitted by the VA Medical Center Director via email to the IRB Reliance and SIRB Exceptions email box at (IRBRelianceandSIRBExceptions@va.gov).
- Any additional individuals the form must be submitted to are included in the directions on the application.
Please note The Institutional Review Board (IRB) Reliance Request Form cannot be used by VA Facilities requesting to start a research program. A dialogue with both ORO and ORD is required before any documentation is sent by a VA Facility wishing to start or re-initiate a research program.
Requesting an Exception from the Single IRB Requirement for Cooperative Non-Exempt Human Subjects Studies
- ORD supports use of a single IRB when possible, but ORD also recognizes that mandating use of a single IRB in all cases is not logical or feasible. The §.114 cooperative research provision also recognizes that use of a single IRB is not always required.
- VHA Facilities wishing to request an exception from the single requirement for an applicable study must
- Submit a request to the IRB Reliance and SIRB Exceptions email box at (IRBRelianceandSIRBExceptions@va.gov) using the spreadsheet: Prospective CHNE Research Exceptions Request. The request must be sent to ORD by the ORD funding service, ACOS/R&D, AO/R&D, VA Human Research Protections Administrator, or the VA Facility’s IRB Administrator.
- The email subject line should reference that it is a request for single IRB exception with the name of the study and the VA Principal Investigator.
Example: Request for sIRB exception: Comparison of X vs. Y, A. Investigator, M.D.
- Requests will be reviewed by ORD with an expected response time no later than 10 business days.
Requesting Change in Institutional Review Board (IRB) Arrangements: Commercial IRB
- VHA Directive 1200.05 (Paragraph 5.f(8)(a) was amended on March 3, 2020 permitting VA Facilities to use commercial IRBs for cooperative (multi-site) research activities as approved by ORD. Only commercial IRBs vetted and approved by ORD can be used by VA Facilities in which ORD has executed an agreement with the commercial IRB(s).
- ORD policy requires that the VA Medical Center Director request approval from the Chief Research and Development Officer (CRADO) when the VA facility wants to establish a new Human Research Protection Program (HRPP), change its IRB(s) of Record, or wants its internal IRB to serve as an IRB of Record for a non-VA entity if allowed by ORD policy. This applies to any change or addition in a VA Facility’s HRPP, including use of commercial IRBs.
- VA FACILITIES MUST NOT CONTACT ANY COMMERICIAL IRBs DIRECTLY TO ENTER INTO THEIR OWN SEPARATE CONTRACTS. THIS IS PROHIBITED BY ORD.
- You will be asked to identify a VA Facility Liaison to be a contact between the commercial IRB and your VA Facility. The role is similar to the VA Site Liaison for the VA Central IRB.
Application Process for Use of a Commercial IRB Approved by ORD:
- The VA Facility (Not the Investigator) must send an email that includes the Medical Center Director to the IRBRelianceandSIRBExceptions@va.gov with the subject line: “Commercial IRB Reliance Request”
- The email must include the following information:
- Name of the Commercial IRB
- Name of the VA Nonprofit Corporation (NPC)
- Statement indicating whether your VA Facility has been selected by the sponsor for a study that is using the commercial IRB (time-sensitive)
- Verification that the industry sponsor or federal agency is directly contracting for use of the commercial IRB
*If the request for reliance on a commercial IRB is time-sensitive (e.g. the sponsor requires the VA
Facility to enroll the first participant within one week of site selection), email and/or call:
Note: Do not submit an Institutional Review Board (IRB) Reliance Request Form to ORD for a commercial IRB reliance request.
- When the commercial IRB reliance request is received and if ORD has negotiated an agreement with the commercial IRB, ORD and ORO will send your VA Facility instructions to complete the following templates:
a. Commercial IRB Authorization Agreement (only fields to complete are the name of the VA facility, Federalwide Assurance (FWA) number, and the signatures and dates of the signatories); and
b. Local template for standard operating procedures (SOPs) to modify for use of the commercial IRB
Note: Submit each as soon as you have completed them to ORD and ORO.
- ORD will send you a letter approving or not approving the use of the commercial IRB. If approved, ORO will inform your VA Facility when the SOP is complete.
VA Facility Commercial IRB Endorsement Letter Requirement
“Verification of Preliminary Privacy and ISSO Reviews – Update 9-11-2020
NOTE: Please inform ORD and the VHA Privacy and Privacy Compliance Assurance Offices of any delays in the conduct of preliminary privacy reviews that may result in the VA Facility being removed from the study as a study site by emailing: VHAPrivIssues@va.gov,VHAPCS@va.gov and IRBRelianceandSIRBExceptions@va.gov. Please identify and contact the facility Information System Security Manager (ISSM) Point of Contact (POC) available on the ISSO PO Locator (VA network access only) if delays are occurring in the conduct of local facility ISSO reviews that may result in the VA Facility being removed from the study as a study site. For any research related information security protocol review questions/concerns, please contact the OIS-Research Support Division (RSD) by emailing: OISISPSSSSRSDInformationSecuritySupport@va.gov. Information is contained within the update on 2 options to facilitate the preliminary privacy and ISSO reviews, including accessing the platforms used by the ORD-approved commercial IRBs. ORD has approved the use of Sterling IRB as on 09-24-2020; instructions on how VA Facility POs and ISSOs can request access to each ORD-approved commercial IRB is included in the list of ORD-approved commercial IRBs.”
Current List of Commercial IRBs Approved by ORD for VA Facilities as of September 25, 2020
To set up an account with Advarra to use CIRBI, please follow the CIRBI Quick Steps instructions. For additional assistance contact the Advarra CIRBI helpdesk between 8am - 8am ET send an email to CIRBI@advarra.com or call 1-866-99CIRBI (1-866-992-4724).
2. Sterling IRB
To set up an account with Sterling to use the SilverLink portal, please follow the SilverLink Quick Start Guide. For questions regarding the SilverLink portal, please email Software Support at email@example.com. For questions regarding the initial submission process, please contact Debby Hybart (firstname.lastname@example.org) in the Site Support Department. For additional information about Sterling IRB visit https://sterlingirb.com/.
3. Western Institutional Review Board (WIRB)-Copernicus Group (WCG)
To set up an account with WIRB, please follow the instructions located on the VAIRRS Share Point site(VA network access only). Review the IRBNet GovCloud Training Energizer - Submitting to WIRB as WIRB uses IRBNet. If the VA facility is live on VAIRRS (IRBNet), the VA Facility Privacy Officer and ISSO may already have an account. The VA investigator or study team member with full access to the project should be able to "share" the project with the VA Facility Privacy Officer and ISSO. For additional assistance contact WIRB at VAreliance@wirb.com.
VA Specific Requirements for Informed Consent and HIPAA Authorizations for Commercial IRB Submission
Any IRB reviewing VA research must follow VA's requirements. The table with language for VA informed consent and VA HIPAA authorizations was provided to commercial IRBs approved by the VHA Office of Research and Development to review and approve VA research. VA Facilities are to include VA informed consent language into the commercial IRB informed consent document, where applicable. It is the responsibility of the VA Facilities to include the language prior to uploading their local VA Facility informed consent documents and HIPAA authorizations as part of the application process.
Table of VA Specific Requirements for Informed Consent and HIPAA Authorizations for Commercial IRB Submission 09-14-2020