UPDATE: Implementation Delayed - Revisions to the Federal Policy for the Protection of Human Subjects

UPDATE: The U.S. Department of Health and Human Services and 15 other federal departments and agencies have announced an Interim Final Rule (IFR) that delays by six months the effective date and general compliance date of the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule) originally published in the Federal Register on January 19, 2017 (82 FR 7149).  Most provisions in the revised Common Rule were scheduled to go into effect on January 19, 2018. The IFR delays the effective date and general compliance date to July 19, 2018, providing regulated entities additional time to prepare to implement these revisions.The IFR is available at https://www.gpo.gov/fdsys/pkg/FR-2018-01-22/html/2018-00997.htm

In January 2017, final revisions to the Federal Policy for the Protection of Human Subjects were issued by the U.S. Department of Health and Human Services and 15 other federal agencies.

Major changes include:

  • New requirements regarding information that must be given to prospective research subjects as part of the informed consent process
  • Allows the use of broad consent (i.e., seeking prospective consent to unspecified future research) from a subject for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens
  • Establishes new exempt categories; under some of the new categories, exempt research would be required to undergo limited IRB review
  • Removes the requirement to conduct continuing review of ongoing research for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing study data or involve only observational follow up in conjunction with standard clinical care
  • Creates a requirements for U.S. based institutions engaged in cooperative research to use a single IRB for that portion of research that takes place within the U.S., with certain exceptions

Until the provisions go into effect, the current regulations remain in place. 

The revised regulation is available at: https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/html/2017-01058.htm

As implementation proceeds, more information will be provided.