US HHS revises rules on patient participation in medical research

The US Department of Health and Human Services yesterday announced proposed revisions to the regulations that govern research on individuals who participate in research.

The current regulations that protect individuals who participate in research, which have been in place since 1991, are followed by 18 federal agencies and are often referred to as the Common Rule. They 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. 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.

In July 2011, HHS issued an Advance Notice of Proposed Rulemaking to seek the public’s input on updating the Common Rule. The Notice of Proposed Rulemaking (NPRM) issued yesterday reflects that input and requests comments for HHS to consider as it drafts the final rule.