Collaborative/multi-site research is research conducted in conjunction with an institution not affilated with Binghamton University. When Binghamton University researchers plan to conduct collaborative or multi-site research, determining which IRB should complete the review process will depend on a variety of factors including, but not limited to: funding requirements, the extent of IRB oversight required relative to the participant risks; the nature of the research to be conducted by each institution; and which other institutional IRBs are involved.
- Collaborative Research - Occurs when non-Binghamton investigators come to Binghamton to work on a Binghamton study (i.e. help with consenting subjects, assisting with administering study interventions), or conduct some aspect of the research elsewhere (i.e. accessing subjects' identifiable information).
- Multi-Site Research - Occurs when Binghamton University is serving as one of several participating sites running a full protocol (each institution enrolling subjects and carrying out the protocol at its own site).
Use the Engagement Determination Checklist to determine if a site is considered "engaged" in the research and what the next steps are.
What is an Authorization Agreement?
When multiple institutions are engaged in a research study involving human participants, an IRB Authorization Agreement permits one institution's IRB to cede review (the “Relying IRB”) to another institution's IRB (the “IRB of Record”). In doing so, only one IRB reviews and approves the human subject research activities for both institutions; avoiding duplicative review and regulatory oversight. A reliance agreement may be required when you are collaborating with researchers external to Binghamton who are engaged in non-exempt human subjects research.
Institutions may use different descriptive terms for an authorization agreement including: reliance agreement, cooperative agreement, institutional authorization agreement (IAA), or memorandum of understanding (MOU). MOUs are generally entered into when addressing issues pertaining to coverage of an entire research program, whereas reliance agreements are more common and generally used to cover a single study protocol.
Steps for requesting an authorization agreement
If you believe an authorization agreement makes sense for a study that you are involved in, and your co-investigators from the other institution(s) agree, you should initially contact the Binghamton IRB office to confirm that your proposed approach will work (607-777-3818 or firstname.lastname@example.org). Once it is confirmed that an authorization agreement is needed, next steps depend upon whether you propose that Binghamton or an external IRB serve as the IRB of record:
When Binghamton is to Cede IRB Review (act as the Relying Institution)
To request that your collaborator's institution be named as the IRB of Record:
- Fill out and submit the "Application for External Institution to Serve as IRB of Record" to email@example.com. Include as an email attachment a protocol summary or the human subjects section of the grant application.
- Only once institutional signoff has been provided by Binghamton University may you submit your study to the external IRB for approval. Note that institutional signoff to submit may be in advance of the reliance agreement being fully executed.
- The Binghamton University IRB will conduct a local context review and will work directly with the external IRB to execute the reliance agreement.
- Once a reliance agreement has been fully executed the Binghamton investigator will be notified directly by the IRB staff. Note that tudy procedures may only comence once the agreement is fully executed AND the external IRB has approved the research.
When Binghamton is the IRB of Record (External Institution(s) Cede Review):
To propose that the Binghamton University IRB serve as the IRB of record for a multi-site or collaborative project:
- Confirm with your collaborators from the other participating institutions that their IRB(s) do not request to serve as the IRB of record. Some institutions will require an application be submitted for a determination to be made.
- Fill out and submit the "Application for Binghamton University to Serve as the IRB of Record" to firstname.lastname@example.org.
- Once confirmation has been recieved that the external institution will cede review and Binghamton will serve as the IRB of record, submit the study as usual in PACS.
Note: When submitting the study in PACS, you will need to list the external study team members and provide proof of CITI training.