The Revised Rule (aka “2018 Requirements”) that took effect on January 21, 2019 requires that all federally funded research that involves multiple institutions must have only one IRB provide review. Also known as “Single IRB” (or “sIRB” – a cool new IRB word, by the way), this requirement follows the NIH’s implementation of a similar policy way back in 2018. With the NIH policy, only those studies funded by NIH and meeting the definition of a “clinical trial” required sIRB review. This current requirement applies to all federally funded “Cooperative Research”. This is different because cooperative research does not need to be a clinical trial; the research only needs to involve more than one institution.
There are some exceptions (insert a sigh of relief here). The following types of studies DO NOT need to follow the sIRB requirement (as stated by the Feds):
- Cooperative research conducted or supported by HHS agencies other than the National Institutes of Health (NIH), if an IRB initially approved the research before January 20, 2020.
Cooperative research conducted or supported by NIH if either:
- the NIH single IRB policy does not apply, and the research was initially approved by an IRB before January 20, 2020, or
- NIH excepted the research from its single IRB policy before January 20, 2020.