1. What is a reliance agreement and what is its purpose?
A reliance agreement is a document signed by two or more institutions engaged in human subjects research. Once executed (i.e. signed by the appropriate signatory authority at each institution), this document permits one or more of the institutions to defer IRB oversight to another IRB for the duration of the study or group of studies defined in the agreement.
2. What is the first step to initiate a reliance agreement for OUHSC to defer IRB oversight to an outside IRB?
Submit the Request to Use an External IRB Form to the OUHSC HRPP Office. Attach to this form the protocol, the external IRB’s template reliance agreement, and any other supporting document.
Additional supporting documents may include an outside IRB approval letter, a cover letter explaining the single IRB arrangement, a letter of acknowledgment, etc.
3. How will I know if my request to use an external IRB is accepted by the University?
The HRPP Office will notify you via email when the University concurs with the proposed single IRB arrangement. After you receive notification of University acceptance, you may proceed to work with the external IRB on the reliance agreement.
See the Defer IRB Oversight to an External IRB flowchart for the steps that follow University concurrence.
4. What do I do if an outside institution wants OUHSC IRB to serve as the IRB of record?
Complete the full study application in iRIS. Indicate the non-OU site(s) involvement in the appropriate sections of the application (Non-OU Collaborator(s) and Non-OU Site(s) sections). The protocol should explain the research activities that will be completed by each key study personnel. If data will be transferred from one site to another, the time at which this occurs and the state of the data must be described in the protocol.
5. How will I know if the University accepts my request for OUHSC IRB to serve as the reviewing IRB?
The HRPP Office will notify you via email when the University accepts the proposed single IRB arrangement. After you receive notification of University acceptance, you may proceed to work with the external IRB on the reliance agreement.
See the OUHSC to be Reviewing IRB flowchart for the steps that follow University concurrence.
6. Since only sites engaged in the research enter a reliance agreement, how do I determine whether a site is engaged in the research?
Not every collaborative research study requires a reliance agreement. Only sites that are engaged in research enter a reliance agreement.
An institution is engaged in human subjects research when its employees or agents for the purposes of the research project obtain:
- An award through a grant, contract or cooperative agreement directly from HHS;
- Data about the subjects of the research through intervention or interaction with them;
- Identifiable private information about the subjects of the research;
- The informed consent of human subjects for the research.
Please see OHRP's Guidance on Engagement of Institutions in Human Subjects Research (2008) for more information and examples of such engagement.
7. If the non-OU researcher is engaged in the research but their site does not have an IRB, will OUHSC still serve as the reviewing IRB?
If the non-OU researcher engaged in the research comes from an institution that does not have an IRB, a reliance agreement between OUHSC and the outside site will not be initiated. Instead, an individual investigator agreement (IIA) is initiated between OUHSC and the individual engaged in the research.
To initiate an individual investigator agreement:
- Add the non-OU researcher to the application in iRIS.
- Update all applicable sections of the application.
- Attach the non-OU researcher's CV or resume and their CITI or equivalent education certification.
- Attach an updated protocol that clearly describes the non-OU researcher's role and research activities in the study.
- Proceed to step two when you receive notification from the IRB to proceed with the Individual Investigator Agreement.
- Download the HRPP Individual Investigator agreement template, available here and in the Help section of iRIS.
- Complete the template. Leave the portion to be completed by OUHSC blank. Send the agreement to ORA to sign.
- Attach the executed agreement to stipulations in iRIS. The Outcome approval letter generated in iRIS will document the IRB's acceptance of the IIA.