HHS announces proposal to update rules governing research on study participants: Proposed changes enhance protections for individuals involved in research, while modernizing rules and improving efficiency.
HHS 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.
Press Release: http://www.hhs.gov/news/press/2015pres/09/20150902b.html