Revisions to Human Subjects Regulations

Sixteen Federal Departments and Agencies (including The U.S. Department of Health and Human Services) have issued a revision to the Federal Policy for the Protection of Human Subjects. HHS states that the change “...is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.”

HHS released a Press Release about the final rule that can be accessed at: https://www.hhs.gov/about/news/2017/01/18/final-rule-enhances-protections-research-participants-modernizes-oversight-system.html.

The Final Rule and additional related information can be accessed at: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html.

Important Information for KU Researchers:

  • New regulations allow a 1 year implementation (3 year implementation for Single IRB)
  • HRPP will inform you of the changes through newsletters and available trainings as soon as a timeline has been determined within our office.
  • No changes are required from KU researchers at this time. We are aware of the changes, and new policies and guidance will be drafted.
  • Pay attention to future emails from HRPP, or visit HRPP's webiste--we will include more information and guidance as it is available.
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