IRB Reliance Agreements
UVa researchers are often engaged in non- exempt human subject research that may involve collaborators and/or human subjects at other institutions. In accordance with 45CFR46.114, UVa may rely upon the review of another qualified IRB. This is done through an IRB Reliance Agreement, also referred to as an IRB Authorization Agreement. The scope of the Reliance Agreement may be limited to a specific protocol on a case-by-case basis or to any group of protocols agreed upon by both parties.
The decision to rely on another IRB raises several issues to consider.
For IRBs/Institutions: Use of reliance agreements varies across institutions and is often dependent on the research protocol. It is recommended to inquire with each institution involved whether they will consider using a reliance agreement.
For Researchers: Agreements avoid duplicate IRB review across institutions, but do not lessen researchers’ oversight across those sites. The Reviewing Site’s PI must act as overall PI, collecting all regulatory information from all sites and informing the Reviewing IRB. The Relying Site’s PI must communicate all regulatory information from their site to the Reviewing Site’s PI and IRB.
Extent of reliance agreement: Agreements only cover IRB review: Institutional (ancillary) reviews (ancillary non-IRB reviews such as pharmacy reviews, radiation safety committee reviews, clinical trial agreement reviews, etc.) still need to be conducted at each institution
New Reliance Agreements to Rely on Non- UVa-IRB
IRB of Record: A reviewing IRB that assumes IRB responsibilities for another organization
IRB Reliance Agreement: A formal, written agreement in which the reviewing IRB agrees to serve as the IRB of Record for a Relying Organization. Also known as IRB Authorization Agreement
Relying Site: A relying Site is the site that has entered into an IRB Reliance Agreement with another site’s IRB to serve as the IRB of Record.
Non-Exempt Human Subject Research- any human subject research that does not meet the Exempt criteria in 45CFR46.
Engagement of Organizations in Non-Exempt Human Subject Research: An organization is considered engaged in human research when its employees or agents, for the purposes the research project obtain 1) data about the subjects of the research through intervention or interaction with them; 2) identifiable private information about the subjects of the research; 3) informed consent of human subjects for the research; OR 4) a direct federal award to conduct human subject research, even when all activities involving human subjects are carried out by subcontractors (i.e. employees or agents of another organization).
HHS Guidance: Engagement in Human Subjects Research
Requests for a new reliance agreement to rely on another IRB for review are considered on a case-by-case basis.
There are several different scenarios when this would apply:
1. A UVa student, employee/ faculty member wishes to work on a protocol that has or will be approved by an outside IRB and the subjects will not be enrolled at UVa.
NOTE: A Determination of UVa Agent Form may also be applicable in this situation-
The following steps must be taken:
- The UVa researcher will collect the most recent IRB approval along with the current protocol and consent(s) and other relevant documents from the offsite institution.
- The UVa researcher will submit a IRB Reliance Agreement Request Form- non - UVA IRB as IRB of Record to the IRB office.
- IRB staff will then provide an IRB Reliance Agreement to the study team.
- The UVa researcher will submit the complete packet of documents including the signed IRB Reliance Agreement to the IRB for review and approval.
- The IRB-HSR will review the documents and submit the documents to the Office of the VP for Research.
- If approved the IRB Reliance Agreement will be signed by the UVa Signatory Official (Associate VP for Research) and returned to the IRB-HSR.
- The IRB will send the original of the form to the UVa researcher and keep a copy in their files.
- The UVa researcher should forward the original to the outside IRB and keep a copy for their records.
- If funding for the project is coming through UVa, the IRB-HSR may determine if any additional documentation is required from local IRB (e.g. continuation approvals, unanticipated problem reports).
2. Continued Access of an Investigational Drug, Device or Biologic outside of a Clinical Trial
Researchers wishing to open a continued access protocol may use a non- UVa IRB as the IRB of record for the protocol. Continued access is for patients at UVa who need continued access to an investigational drug/device or biologic outside of a clinical trial. If Western IRB will be the IRB of Record, see steps to follow under Alternative IRB of Record. If Western IRB will not be the CIRB see the information below.
For additional information from the FDA on Continued Access protocols see Additional Information from FDA on Continued Access
3. Use of a Non-UVa IRB for a Multi-site Protocol
UVa will review the request to rely on a non- UVa IRB for a multi-site protocol on a case by case basis. Before beginning any submission, contact the IRB-HSR Director to discuss the option of relying on a non- UVa IRB. If the use of the non-UVa IRB is agreed upon, the study team will submit an IRB Reliance Agreement Request Form Non-UVA IRB as IRB of Record to the IRB-HSR. The researchers will then proceed to - Protocol Builder to create a submission to the IRB-HSR. Even though the UVa IRB-HSR will not serve as the IRB of record, they are responsible for verifying that other compliance and educational requirements are met.
For more information or questions about IRB Reliance Agreements, contact the IRB-HSR Director at 924-9634.
New Reliance Agreements for an Outside Institution to Rely on the IRB-HSR as the IRB of Record for a Multi-Site Study
Requests for a new reliance agreement to allow another institution or independent investigator to rely on the IRB-HSR for IRB review are considered on a case-by-case basis. Complete and submit the IRB Reliance Request Form- IRB-HSR as IRB of Record to the IRB-HSR. The IRB-HSR staff will contact you with questions regarding your request.
For more information or questions, contact the IRB-HSR Director at 924-9634.
IRB Reliance Agreements- Frequently Asked Questions