Important Updates to Common Rule for Clinical Trials

Male clincian placing material on slide under microscope

U.S. Department of Health and Human Services (DHHS) and 15 other federal agencies on January 18 issued a final rule to update the Federal Policy for the Protection of Human Subjects, which had been in place since 1991. The Common Rule, as Federal Policy for the Protection of Human Subjects is know, provides safeguards to individuals who participate in research. The changes to the Common Rule will be effective in January 2018.

“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,” said the press release from HHS. “It also allows more flexibility in keeping with today’s dynamic research environment.”                             

Key elements in the final rule issued include:

  • A new requirement that the informed consent process provide the participant with a better understanding of the project’s scope, by beginning with a presentation of key information, including risks and benefits, so that the participant is able to make a more fully formed decision whether to participate.
  • Requirement to use a single IRB for multicenter research studies.
  • Removal of continuing review requirement in instances where such review does little to protect subjects.
  • The establishment of new exempt categories of research based on level of risk for participants, in order to reduce unnecessary regulatory burden.
  • The option for researchers to utilize broad consent for future research of identifiable biospecimens as an alternative to seeking IRB approval to waive the consent requirement.

The new rule also includes expanded and updated definitions for terms, including clinical trial, human subject, Vulnerable Subject, and identifiable biospecimens.

Please note that these new changes to the Common Rule do not go into effect until January 2018, so forthcoming communications will elaborate on how MedStar will adhere to these new standards.  Also, the recent executive orders that put a moratorium on new federal regulations may effect this new Common Rule, so we at MedStar will continue to monitor the situation.

To view the final rule in the Federal Register, click here.

Please contact the MHRI Office of Research Integrity at [email protected] or the MHRI's compliance director, Kate Cohen at [email protected], if you have questions.