Revisions to the Federal Policy for the Protection of Human Subjects

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

Most of these provisions will go into effect on January 19, 2018, with the exception of the requirements for cooperative research which go into effect on January 20, 2020. Until then, the current regulations remain in place.  In addition, this revised regulation is subject to additional review by the federal government which could result in changes.

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.