General Guidance for Single IRB Submissions

This page is meant to help study teams prepare a Single IRB (also known as Central IRB) submission.
 

Reliance Agreements

An Institutional Review Board (IRB) Reliance Agreement, also known as an IRB Authorization Agreement, is a written agreement between organizations collaborating in non-exempt human subjects’ research outlining each organization’s responsibilities in the oversight of research.  An IRB reliance agreement identifies the IRB of record for overseeing the project.

A Reliance Agreement may be an individual agreement for one trial or be a master agreement that would cover many studies.  There following master reliance agreements are currently exist for DF/HCC research:

  • The Dana-Farber Cancer Institute (DFCI) IRB is the designated single IRB for DF/HCC consortium cancer trials.
  • National Cancer Institute Central IRB (NCI CIRB)

Please contact the Office for Human Research Studies Director for more information about setting up a new Reliance Agreement. 


Requesting to Rely on an External Single IRB

To request to rely on an External Single IRB the following form will need to be submitted through OHRS Submit. Please note, you can skip this step if you are relying on the NCI Central IRB.

For reliance on an external academic medical center IRBs, DF/HCC investigators are required to use the SMART IRB common reliance agreement platform.

SMART IRB - Participating Institutions

Before you initiate a protocol with a Single IRB - Action Items

Please contact the following departments prior to submitting the study to the external sIRB and to OHRS.

Submitting your New Project to OHRS

Please see the following guidance document that describes the process.

When you are ready, please submit the appropriate documents below through OHRS Submit.

Maintaining a Single IRB Study

OHRS has developed several Single IRB-specific submission forms (e.g., amendment forms, continuing review forms). As only an administrative review is being performed by OHRS, please use these forms for Single IRB submissions.


Additional Resources