January 19, 2017
Health Care Alert
Health Care Alert
Author(s): Gabrielle B. Goldstein
On January 18, 2017, the U.S. Department of Health and Human Services (HHS), along with 15 other federal agencies, issued a final rule (Final Rule) amending the federal regulations pertaining to human subjects research often called the “Common Rule.” The Final Rule will be effective on January 19, 2018, except for certain provisions pertaining to Cooperative Research, which will have a compliance date of January 20, 2020.
The overarching goals of the Final Rule are to strengthen protections for people who participate in biomedical research, and to facilitate research by streamlining administrative requirements. Given its broad reach, the Final Rule will have wide-ranging implications for clinical research sponsors, investigators, research sites, institutional review boards (IRBs) and research participants.
HHS acknowledges in the Final Rule that the research environment has changed dramatically since the Common Rule regulations went into effect in 1991, and that these changes in the institutional landscape necessitate modifications to the regulations. While clinical research once occurred almost entirely at universities and medical institutions, it is now increasingly undertaken in community and other non-academic and non-institutional settings. Further, while research was once generally confined to a single site, studies are now increasingly multi-site. The explosion of medical technology development, the genomics revolution and “big data” have also contributed to the changing dynamics within the research field.
The Final Rule is the culmination of significant agency interest in revisions over the past few years. On July 26, 2011, HHS published an Advance Notice of Proposed Rulemaking (ANPRM) to request comments for how to revise the Common Rule; a Notice of Proposed Rulemaking (NPRM) was then issued on September 8, 2015. HHS states that it has taken public comments on both the ANPRM and the NPRM into account in preparing the Final Rule.
The NPRM advanced a number of proposed changes to the Common Rule that were critically received in public comments. As a result of further consultation and consideration, certain proposals have not been finalized in the Final Rule. Among others, these include the following:
The Final Rule does include a number of significant changes to the Common Rule. Among others, these include the following:
The Final Rule is available here.
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