The Department of Health and Human Services (HHS) recently announced plans to significantly update the regulations protecting human research subjects. 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.

The proposed changes are designed to improve informed consent practices to better protect those who are involved in research, while simultaneously easing oversight and administrative requirements for scientists. Revisions will also address new standards for digital privacy and security, as well as extend the scope of the policy to cover all clinical trials, regardless of funding source, conducted at a US institution that receives federal funding for non-exempt human subjects research.

The agency will decide how to proceed with the changes after the 90-day public comment period end on December 7th.

Last updated: September 14, 2015