Updates Announced for Federal Guidelines Regarding Human Subject Research


The U.S. Department of Health and Human Services has issued updated guidelines for research involving human subjects.

These new guidelines, referred to as the Revised Common Rule (RCR), went into effect on Jan. 19. The RCR updates terminology and reduces some of the regulatory burden on Institutional Review Boards (IRBs) and investigators by revising criteria and procedures for exempt and expedited reviews. It also adds a new category of review, named “limited review,” and changes the required elements of informed consent documents to better protect human research subjects.

Previously approved research will not be affected by these changes, and investigators are expected to comply with approved research protocols and contact the IRB with any questions.

Southeast’s IRB is working to update documents to reflect these new guidelines. Investigators who completed CITI training modules for human subjects research after Jan. 21 do not need to complete further training on the Revised Common Rule, as these modules have been updated with the new regulations. Investigators who completed CITI training modules for human subjects research prior to Jan. 21 are encouraged, but not required at this time, to complete the newly available Revised Common Rule supplemental course. Instructions for adding the course are available on the IRB website.

For more details, see the informational material provided by CITI at https://about.citiprogram.org/en/final-rule-resources/#overview, or contact Jennifer Bengtson, chair of Southeast’s IRB, at jbengtson@semo.edu or Pam Vargas, director of Research and Sponsored Programs, at pvargas@semo.edu.