HHS Final Rule Protects Research Participants and Modernizes Oversight

In January, the U.S. Department of Health and Human Services (HHS), along with 15 other agencies, finalized a rule whose provisions safeguard individuals who participate in research, most of which will go into effect in 2018. The finalized rule updates regulations that have been in place since 1991, often referred to as the “common rule,” that were developed when research was conducted predominantly at universities and medical institutions. Elements of the finalized rule include:

• The requirement for consent forms to provide potential research subjects with a better understanding of a project’s scope, including its risks and benefits, so participants can make a more fully informed decision about whether to take part;
• The requirement to use a single institutional review board (IRB) for multi-institutional research studies, but allowing for broad groups of studies, rather than just specific studies, to be removed from the requirement;
• For studies on stored identifiable data or identifiable biospecimens, researchers have the option of relying on broad consent obtained for future research rather than seeking IRB approval to waive the consent requirement (consistent with the current rule, researchers will not have to obtain consent for studies on nonidentified stored data or biospecimens);
• The establishment of new exempt categories of research based on the level of risk they pose to participants;
• Removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects; and
• The requirement that consent forms for certain federally funded clinical trials be posted on a public website.