Revisions to Human Subjects Regulations

What is the new Final Rule?

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

What changed?

  • New definitions, including clinical trials, "written/in writing" to include electronic formats, legally authorized representative
  • Informed consent changes, including the addition of a summary of key information at the beginning of the consent form
  • Inclusion of items that are not deemed "human subjects research"
  • Changes to exempt categories
  • Requirements for single IRBs for multi-site research

Important information for KU researchers

  • New regulations were implemented starting Jan. 21, 2019.
  • HRPP still requires submissions in eCompliance for all human subjects research activities.
  • CITI human subjects training was updated to reflect the regulatory changes.

Questions or additional training?

Contact the HRPP office at 785-864-7385 or email