Multi-Site and Collaborative Research

Collaborative/multi-site research is research conducted in conjunction with an institution not affilated with 绿帽社. When 绿帽社 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-绿帽社 investigators come to 绿帽社 to work on a 绿帽社 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 绿帽社 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  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 鈥淩elying IRB鈥) to another institution's IRB (the 鈥淚RB of Record鈥). 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 绿帽社 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 绿帽社 IRB office to confirm that your proposed approach will work (607-777-3818 or hsrrc@binghamton.edu). Once it is confirmed that an authorization agreement is needed, next steps depend upon whether you propose that 绿帽社 or an external IRB serve as the IRB of record:

When 绿帽社 is to Cede IRB Review (act as the Relying Institution)

To request that your collaborator's institution be named as the IRB of Record:

  1. Fill out and submit the "" to hsrrc@binghamton.edu. Include as an email attachment a protocol summary or the human subjects section of the grant application.
  2. Only once institutional signoff has been provided by 绿帽社 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.
  3. The 绿帽社 IRB will conduct a local context review and will work directly with the external IRB to execute the reliance agreement. 
  4. Once a reliance agreement has been fully executed the 绿帽社 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 绿帽社 is the IRB of Record (External Institution(s) Cede Review):

To propose that the 绿帽社 IRB serve as the IRB of record for a multi-site or collaborative project:

  1. 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.
  2. Fill out and submit the "" to hsrrc@binghamton.edu. 
  3. Once confirmation has been recieved that the external institution will cede review and 绿帽社 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.