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 “...is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.”
- Slides from KU's Final Rule information session (PDF)
- HHS news release about the Final Rule
- The Final Rule and additional related information
- CITI Program's Final Rule page
- 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.