The Common Rule – or the 'Federal Policy for the Protection of Human Subjects' – is a human subjects biomedical and behavioral ethics rule that sets the ethical standards by which all government–funded research in the U.S. are held, and which are upheld by most academic institutions and researchers regardless of the funding source. The Common Rule includes the regulations that govern Institutional Review Boards (IRBs), informed consent requirements, and protections for vulnerable populations such as children, pregnant women, newborns, and fetuses. In short, these are the policies that determine how you are consented when participating in trials and research, what types of research are considered to be ethical, and how biomedical samples acquired from patients can be used and stored.
The existing regulations were first adopted by the Department of Health and Human Services (HHS) in 1981 and then fully implemented by other federal agencies in 1991. Despite a rapidly changing biomedical and research landscape, very few changes had been made to the original Common Rule until September 8, 2015 when the Office of Human Research Protections within HHS released a proposed revision. The proposed rule attempts to reduce the burden placed on IRBs, address the length of the informed consent process, and match the level of research oversight with the level of risk associated with the research endeavor.
Of particular interest to our Duchenne community are the proposed revisions to the rule that would impact the requirements for consent and use of biospecimens in research and secondary research, as well as those impacting newborn screening programs and public health infrastructure. PPMD has been engaged with a number of coalition efforts working to evaluate the proposed revisions to the Common Rule and joined with the March of Dimes in submitting a comment reflecting the interests of one such coalition [click here to download our coalition comment]. In addition, PPMD submitted a comment reflecting the priorities of our Duchenne community [click here to download PPMD's comment].