NIH CLINICAL TRIAL SUPPORT

Effective January 25, 2018, NIH requires that all applications involving one or more “clinical trials” be submitted through a Funding Opportunity Announcement (FOA) or request for proposal (RFP) specifically designed for clinical trials. The Brown HRPP is available to support you in determining whether your proposed research meets the definition of an NIH Clinical Trial. Learn more about the NIH Clinical Trial definition, the available NIH resources, the support the Brown HRPP is able to provide, and access a list of FAQs here.

NIH Single IRB Mandate

The NIH single IRB (sIRB) mandate is now in effect.  The Brown HRPP is available to work with investigators on application of this mandate, and has created a new page with information about interpretation and implementation of this NIH requirement. Please contact HRPP staff early in the process to discuss plans for establishing an sIRB.

REVISED REGULATIONS DELAYED

On the evening of Wednesday, January 17, 2018, the U.S. Department of Health and Human Services and 15 other federal departments issued an interim final rule to delay the implementation of the revised Federal Policy for the Protection of Human Subjects (the “Common Rule”) for six months, until July 19, 2018, to provide regulated entities additional time to make the necessary preparations to implement the revised regulations. This delay impacts both the effective date and compliance date of the revised regulations. This means that we are not permitted to apply the new exemption categories, eliminate continuing review for lower-risk studies, and omit the review of the grant proposal against the IRB protocol. 

What's next? 

Federal departments and agencies listed in the interim final rule are in the process of developing a notice of proposed rule-making (NPRM) seeking public comment on a proposal for further delay in the required implementation of the revised Common Rule (for example, until January 21, 2019). If such an NPRM is published, after consideration of the public comments, the federal departments and agencies will determine whether a final rule to further delay the revised Common Rule will be issued.