Research Regulations Get Updated

An increase in multisite studies and advances in technology have highlighted the need to update regulatory framework.

Federal Practitioner. 2015 October;32(10):e11

October 9, 2015|Federal Practitioner

Times have changed, and the “Common Rule”—regulations that protect people who participate in research—is being revised.

The regulations, in place since 1991, are followed by 18 federal agencies. The regulations were developed at a time when research was conducted mostly at single sites, usually at universities and medical institutions. Now, however, an increase in multisite studies and advances in technology have “highlighted the need to update the regulatory framework,” according to HHS.

The Notice of Proposed Rulemaking (NPRM) is an effort to reinforce and modernize the regulations. For example, the NPRM advocates strengthening informed consent provisions to make sure individuals have a clearer understanding of the study’s scope, including its risks and benefits, as well as alternatives to participating in the study. The proposal also covers changes in review, such as requiring a single institutional review board, in most cases, for multisite research studies.

HHS is taking public comments on the NPRM through December 7, 2015.