On September 2, 2015, HHS issued the long-awaited Notice of Proposed Rulemaking (NPRM) on revisions to the rules governing federally-funded research involving individuals, commonly referred to as the Common Rule (Subpart A of 45 CFR Part 46). The Common Rule has been in place since 1991 and is followed by 18 federal agencies. The NPRM sets forth a number of proposed revisions in an effort to help align the Common Rule with advancements in science and the changing nature of research since the Common Rule was originally promulgated more than 20 years ago. The NPRM was published in the Federal Register on September 8, 2015 and is available here. Comments are due by December 7, 2015.
The Common Rule was originally released when single-site investigations at universities, colleges, and medical institutions were the norm as opposed to the current shift toward more collaborative and multi-site studies. The NPRM incorporates feedback that HHS received from interested stakeholders in response to its Advance Notice of Proposed Rulemaking published in theFederal Register on July 26, 2011 (available here). Central to the NPRM are the proposed changes related to strengthening human subjects’ ability to make informed decisions. Among the more significant proposals, the NPRM:
- Updates the informed consent process to be more user-friendly by requiring, for example, that the consent forms provide the most important research details and emphasize key information relevant to a person’s decision to participate in the study;
- Requires the use of an informed consent to secondary research with a biospecimen whereby a person gives consent to future unspecified research uses of specimens, such as blood samples, even if the investigator is unable to identify whose biospecimen it is (the proposal allows for a broad consent for future, unspecified research studies);
- Enhances the oversight system by requiring the level of review to align more consistently to the seriousness of the risks and harm associated with the research study and exempting and excluding certain studies from institutional review board (IRB) oversight that are inherently low-risk;
- Increases privacy safeguards to help reduce the potential for violations of privacy and confidentiality;
- Mandates that U.S. institutions participating in cooperative research use a single IRB for the portion of research that is conducted within the United States (with limited exceptions);
- Enhances oversight of research reviewed by unaffiliated IRBs (that is, by IRBs not operated by or affiliated with an assurance-holding institution) and proposes, in certain instances, to hold them directly accountable for compliance with the Common Rule;
- Applies the scope of the NPRM to extend to all clinical trials involving human participants from a Common Rule agency, regardless of funding source, if they are conducted in a U.S. institution that receives federal funding for non-exempt human subjects research.
HHS explains in its press release that the NPRM “proposes to modernize the current regulations by enhancing the ability of individuals to make informed decisions about participating in research, while reducing unnecessary burdens by streamlining the regulator requirements for low risk research.”