Significant change to the Common Rule proposed in the NPRM: Extend application of Common Rule
After years of debate and speculation, sixteen federal agencies have collaborated on a notice of proposed rulemaking (NPRM) with the stated purpose of modernizing, strengthening, and making more effective the federal policy for the protection of human subjects. While the NPRM does not tackle as many issues as the Advanced Notice of Proposed Rulemaking (ANPRM) of July 2011, it nevertheless proposes a number of bold moves to streamline the clinical trial process. The U.S. Department of Health and Human Services has identified eight of the proposed changes as “most significant.” The following is the eigth of these significant changes and a brief description prepared by Quorum Review’s regulatory attorneys:
Change proposed in the NPRM
Extend the scope of the policy to cover all clinical trials, regardless of funding source, conducted at a U.S. institution that receives federal funding for non-exempt human subjects research.
Quorum’s description of the proposed change
The NPRM would extend Common Rule protections to any clinical trials conducted at an institution that receives federal support for human subject research. This change would extend the Common Rule to almost all human subjects research in the United States. The purpose of the extension is to ensure human subjects protection in clinical trials that otherwise would not be covered by federal research ethics regulations.
The NPRM states that this may not change common practice at many institutions. Although the Federal Wide Assurance (FWA) mandates the Common Rule be applied only to federally-funded research projects, the Office for Human Research Protection (OHRP) estimates that twenty-five percent of institutions with an active FWA formally extend the Common Rule to all research regardless of funding. Comments from the community also indicate that most institutions voluntarily follow the Common Rule for all research activities although they have not formally committed to do so.
Read all the changes
Click here to read all of the significant changes to the Common Rule proposed in the NPRM.