Guidance for Use of a Single IRB
This page is meant to provide guidance on how to conduct the same protocol at multiple institutions under a single IRB. It should help study teams prepare a single IRB submission.
DF/HCC Consortium Trials (DFCI IRB)
The Dana-Farber Cancer Institute (DFCI) IRB is the designated single IRB for Oncology trials for Dana-Farber/Harvard Cancer Center (DF/HCC) member institutions which include:
- Beth-Israel Deaconess Medical Center (BIDMC)
- Boston Children’s Hospital (BCH)
- Brigham and Women’s Hospital (BWH)
- Dana-Farber Cancer Institute (DFCI)
- Massachusetts General Hospital
In certain circumstances the DFCI IRB may act as the IRB of record for DF/HCC lead, Multi-Center studies. Please contact OHRS to determine if the DFCI IRB is able to serve as the IRB of record for these studies at OHRSCentral_IRB@dfci.harvard.edu.
National Cancer Institute Central IRB (NCI CIRB)
The National Cancer Institute Central IRB (NCI CIRB) serves as the IRB of record for NCI funded network (cooperative group) trials.
The DF/HCC has a master reliance agreement with the NCI CIRB. If you are going to use the NCI CIRB, you may skip to Step 3, "Before you initiate a protocol with a Single IRB."
Other External IRBs including Academic Medical Center and Independent IRBs
On a case by case basis, the DFCI IRB may agree to allow investigators reliance on an external IRB to serve as the IRB of record for research conducted by a DF/HCC site.
In order to choose a different type of External Single IRB, please follow the steps provided starting with Reliance agreement. Whenever possible, the SMART IRB reliance platform should be used to enter into these 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.
Please contact the Office for Human Research Studies Director for more information about setting up a new Reliance Agreement.
Requesting to Rely on a Single IRB
To request to rely on a 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.