E-Newsletter - March 2019

REGULATORY COLUMN | NIH Single IRB (sIRB) Implementation - Effective March 1, 2019

As part of the effort of the NIH to reduce redundancy and help streamline the IRB review process to more expeditiously initiate clinical studies, the NIH has issued a new policy for all NIH-funded research. To achieve this goal the NIH has mandated the use of a single IRB (sIRB) to be utilized for the review of all NIH-funded clinical studies. The NCI CIRB serves as that sIRB for all NCTN or NCORP multi-site clinical studies.
Effective March 1, 2019, all NCTN or NCORP sites must be a member of the NCI CIRB.
Here is how your site will be affected.
Studies activated prior to March 1, 2019
Sites that have been using a local IRB as their IRB of record for any NCTN studies they activated prior to March 1, 2019, do not need to transfer them. Those studies can remain with their local IRB unless the site has a compelling reason to transfer it to the CIRB, i.e., the site no longer maintains a local IRB.
Any sites that utilize a local IRB as their IRB of record for any NCTN studies activated prior to March 1, 2019, will need to register that IRB with CTSU. Sites are not mandated to switch NCTN studies previously reviewed by a local IRB to the CIRB but they must register their site with the CIRB. Sites that do not register their NCTN studies with the CIRB will not be able to continue enrolling study subjects after March 1, 2019, since any new patient registrations will be blocked by CTSU.

Studies activated after March 1, 2019
Any site activating/enrolling on a new NCTN/ NCORP study after March 2019, must use the CIRB as their IRB of record. Each signatory site will be responsible for signing a Reliance Agreement (which will cover all affiliate sites under their signatory agreement) with the CIRB.
Each signatory site will be responsible for filing their Reliance Agreement with CTSU. The signatory Agreement is available on the CIRB website. Upon completion, submit this document to the CIRB, not to the Alliance.
Foreign sites participating in NIH-funded, multi-site studies will not be expected to follow this policy.
Click here for a flow chart that better illustrates the implementation of this new policy.




For other articles in this issue of the Alliance E-News newsletter, see below.