The U.S. Department of Health and Human Services (HHS) and 15 other federal agencies published a Final Rule to update regulations that safeguard individuals who participate in research. The new rule strengthens protections for people who volunteer to participate in research, while ensuring that the oversight system does not add inappropriate administrative burdens, particularly to low-risk research, and also allows more flexibility in keeping with today’s dynamic research environment.
The regulations, which have been in place since 1991, are often referred to as the “Common Rule.” They were developed at a time when research was conducted predominantly at universities and medical institutions, and each study generally took place at a single site. Since then, research with human participants has grown in scale and become more diverse and data has become digital. In September 2015, HHS and the other Common Rule agencies published a Notice of Proposed Rulemaking (NPRM), which drew more than 2,100 comments.
Some of the notable elements in the final 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 they can make a more fully informed decision about whether to participate.
- Requirements, in many cases, to use a single institutional review board (IRB) for multi-institutional research studies. The proposal from the NPRM has been modified, however, to add substantial increased flexibility in now allowing broad groups of studies (instead of just specific studies) to be removed from this requirement.
- For studies on stored identifiable data or identifiable biospecimens, researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement. As under the current rule, researchers will still not have to obtain consent for studies on non-identified stored data or biospecimens.
- The establishment of new exempt categories of research based on the level of risk they pose to participants. For example, to reduce unnecessary regulatory burden and allow IRBs to focus their attention on higher risk studies, there is a new exemption for secondary research involving identifiable private information if the research is regulated by and participants protected under the HIPAA rules.
- Removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.
- Requirement that consent forms for certain federally funded clinical trials be posted on a public website.
Also see the2017 NEJM Editorial – Perspective from the Office for Human Research Protections (OHRP)
The Final Rule will be effective January 19, 2018, with the exception of cooperative research (single IRB review) which will not be effective until January 20, 2020.