|
The CIRB facilitated review process can streamline local IRB reviews for national multi-center cancer treatment trials. Under the facilitated review process local IRBs enrolled in the CIRB can download CIRB reviews from a confidential webpage and decide whether or not to use the CIRB's
review for a particular protocol. This facilitated review can
take place rapidly.
Once an investigator at an institution decides to submit the
study for IRB review, the local IRB Chair (or a designated
subcommittee) performs a "facilitated review" using the CIRB
documents. If there are no concerns about local context, the
Chair (or subcommittee) can decide to accept the CIRB review,
in lieu of a full board review. In this case, the CIRB becomes
the IRB of record for the particular study and performs all
future continuing reviews, amendment reviews and reviews of
serious adverse events for the life of the study. The Chair
(or subcommittee) retains the option not to accept the CIRB
review and can choose to conduct a full board review.
A major benefit for local IRBs participating in the CIRB will
be a reduction in their review workload while still retaining
their authority to accept or reject a "facilitated review" on
a protocol-by-protocol basis. Likewise, due to the
"facilitated review" process, patients and investigators will
benefit from the resulting rapid opening and greater
availability of new trials.
|