HRP recently sought clarification from NIH and OHRP regarding the process for organizations to request exceptions from the revised Common Rule requirement for single IRB for cooperative research. While NIH was previously able to grant exceptions from its own single IRB policy, it is unable to grant exceptions to the revised Common Rule requirement.  HHS interprets the regulatory text (see excerpt below) to mean that exceptions not based in law may only be granted at the Department or Agency Head level. 45 CFR 46.114(b)(2) The following research is not subject to this provision: (i) Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or (ii) Research for...