On Sept. 8, 2015, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rule Making (NPRM) to seek input on changes to the Federal Policy for the Protection of Human Subjects, otherwise known as the “Common Rule” as set forth under 45 CFR Part 46, Subpart A. From the NPRM, it appeared as though human subject protections would be considerably tightened and that conducting research, especially with biospecimens, was going to be an administrative nightmare. Alas, it was not so. On Jan. 19, 2017, HHS and 15 other federal agencies issued a Final Rule to update the Common Rule. Revisions to the Common Rule are intended to enhance protections for research participants and minimize the administrative and regulatory burden for researchers by providing flexibility in the ever-changing human subjects research landscape. The majority of the Final Rule is expected to go into effect Jan. 19, 2018.
This summary features an overview of the notable changes required by the Final Rule, and the implications for clinical research sponsors, researchers, research sites, institutional review boards (IRBs), and research participants. Such parties should be aware of the changes discussed in the Final Rule and the necessary steps to ensure compliance.
To read the full alert, please click the PDF above.