Today, the Department of Health and Human Services (HHS) along with 15 other federal agencies and departments officially opened for comment their proposed regulations to update the Federal Policy for the Protection of Human Subjects, often referred to as the “Common Rule.” The Common Rule is a uniform federal policy for the protection of human subjects, originally issued in 1991. The central premise of the Common Rule is that people who participate as subjects are selected equitably and give their voluntary written consent, and that the proposed research be reviewed by an Independent Review Board (IRB) that ensures risks to subjects are minimized compared to anticipated benefits. The proposal seeks to make far-reaching updates to the Rule, and is open for public comment through December 7, 2015.
See the Notice of Proposed Rulemaking here.
The current regulations “were developed at a time when research was predominantly conducted at universities, colleges and medical institutions, and each study generally took place at a single site,” states HHS. “The expansion of research into new scientific disciplines, such as genomics, along with an increase in multisite studies and significant advances in technology, has highlighted the need to update the regulatory framework. Notably, a more participatory model of research has also emerged, with individuals looking for more active engagement with the research enterprise.”
Their proposal, HHS notes is designed 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 regulatory requirements for low-risk research.”
Changes proposed in Rule include:
- Strengthened informed consent provisions to ensure that individuals have a clearer understanding of the study’s scope, including its risks and benefits, as well as alternatives to participating in the study.
- Requirements for administrative or IRB review that would align better with the risks of the proposed research, thus increasing efficiency.
- New data security and information protection standards that would reduce the potential for violations of privacy and confidentiality.
- Requirements for written consent for use of an individual’s biological samples, for example, blood or urine, for research with the option to consent to their future use for unspecified studies. This provision has sparked commentary from stakeholders who are concerned that requiring explicit consent for research done with de-identified samples could add a layer of time-consuming consent procedures to important research. “Researchers now can use leftover samples by simply stripping them of any personal identifying information,” states Modern Healthcare.
- Requirement, in most cases, to use a single institutional review board for multisite research studies. “Clinical trials are now frequently conducted at multiple sites, with research protocols often reviewed by individual ethics committees at each place,” explains Heidi Ledford writing for Nature, International Weekly Journal of Science. “As a result, it can take a year or more to gain approval for a large, multi-centre trial. The proposed revisions would streamline this process by authorizing a single ethics review for such studies.”
- The proposed rule would apply to all clinical trials, regardless of funding source, if they are conducted in a U.S. institution that receives funding for research involving human participants from a Common Rule agency.
The proposed rule has many important and far reaching provisions. Thus, it is important for stakeholders to respond by December 7 with comments.
View the HHS announcement here.