NIH issued a notice last week regarding the changes in effect as of January 21st:
NIH Implementation of the Final Rule on the Federal Policy for the Protection of Human Subjects (Common Rule) (NOT-OD-19-050) National Institutes of Health
We received questions with regard to this part of the notice:
NIH will no longer require IRB review and approval of the entire grant application or contract proposal. Instead, the IRB must review and approve the research (e.g. a research protocol) for all NIH-supported non-exempt human subjects research studies. Recipients must provide certification to NIH that the IRB has reviewed and approved the research (e.g. research protocol).
Please note that Tufts business process of submitting the confirmation of the IRB approval to NIH during the Just In Time (JIT) will not change. The investigator should partner with their local research administrator to provide Pre-Award with the confirmation of the IRB approval for their human subjects research and to confirm that the activities in the grant are covered under the approved protocol.