The comment period for the Notice of Proposed Rule Making (NPRM) regarding proposed changes to the Human Subjects Protection “Common Rule” issued by 16 federal departments and agencies in September has been extended an additional 30 days to January 6, 2016. Only the U.S. Department of Health and Human Services (HHS) has received any comments on the NPRM to date. Most of these comments are brief requests for more time to review the changes, given the sheer volume and impact of the proposals. More substantive comments were submitted by prominent research organizations, including the American Society for Investigative Pathology, Dana-Farber Cancer Institute, the Federation of American Societies for Experimental Biology, the American Society of Microbiology, and others, expressing concern that redefining “Human Subject” to include biospecimens may stifle research breakthroughs by requiring significant expenditures of time and resources, often creating a disproportional impact on small community and minority-serving institutions. Many comments were also submitted by individuals impacted by rare cancers, voicing similar concern that including biospecimens as “Human Subjects” would make accessing research materials and treatment breakthroughs that much more unlikely.
It is encouraging that industry leaders and community members have started evaluating the NPRM and its effect on clinical research. The deadline extension likely will result in additional meaningful discussion that will allow HHS and other federal departments to craft a final rule that meets the NPRM’s stated goal to “modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects.”