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." We would be
happy to assist you if you would like to prepare a comment on the
NPRM during the extended comment period.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
