HHS Issues Final Rule on Protecting Human Subjects in Research

The U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule to update regulations regarding the use of human subjects in research (known as the Common Rule) in an effort to strengthen protections for people who volunteer to participate in research, while ensuring the oversight system does not add administrative burdens.

“We are very hopeful that these changes and all the others that reduce unnecessary administrative burdens will be beneficial to both researchers and research participants,” said Jerry Menikoff, MD, director of the Office for Human Research Protections at HHS. The new ruling reflects changes that have occurred in the two decades since the Common Rule’s implementation, including evolving technologies, larger-scale studies, and an even more diverse population of study participants.

Some highlights of the final rule include:

  • Consent forms must provide potential research participants with an upfront and better understanding of a project’s scope, including the purpose of the research, risks and benefits, and appropriate alternative treatments, so they can make a more fully informed decision about participation.
  • A single institutional review board (IRB) is required for multi-institutional research studies (in most cases).
  • For studies on stored identifiable data or identifiable biospecimens, researchers can rely on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement.
  • New exempt categories of research based on the level of risk the research poses to participants were established.
  • The requirement to conduct continuing review of ongoing research studies has been removed in certain instances where such review does little to protect participants.
  • Consent forms for certain federally-funded clinical trials must be posted on a public website.

Most of these provisions go into effect in 2018.

In September 2015, HHS published a Notice of Proposed Rulemaking (NPRM) and received 2,100 comments; in response, the final rule contains significant changes from the proposed rule, including:

  • The final rule does not require that research involving non-identified biospecimens be subject to the Common Rule, and it does not require that consent be obtained to conduct such research.
  • To the extent that some of the NPRM proposals relied on tools or standards that had not yet been proposed, the final rule either does not adopt those proposals or includes revisions to eliminate such reliance (e.g., a template to be used for broad consent forms and a decision tool to be used for making exemption determinations).
  • The final rule does not expand the policy to cover clinical trials that are not federally funded.
  • The final rule does not adopt the NPRM’s proposed concept of “excluded” activities. Generally, activities proposed to be excluded are now described as not satisfying the definition of what constitutes research under the regulations or are classified as exempt.
  • The final rule does not include the proposed standardized privacy safeguards for identifiable private information and identifiable biospecimens.

To read the final rule, visit federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-the-protection-of-human-subjects.

Source: U.S. Department of Health and Human Services press release, January 18, 2017.