Revisions to Human Subjects Regulations

On October 7, 2017, HHS proposed a one year delay of the implementation of the Final Rule, which is currently under review by the Office of Management and Budget. If there is a delay, more information will be posted on this site.

You can find resources on the changes of the new regulations by using CITI Program's free resources.

What is changing?

  • 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

What is the new Final Rule?

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 “ 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:

The Final Rule and additional related information can be accessed at:

Important Information for KU Researchers:

  • New regulations will be implemented starting on January 19, 2018
  • HRPP will still require submissions in eCompliance for all human subjects research activities
  • HRPP will inform researchers of changes through email, departments, and use of this website. If the regulations are not delayed, trainings will be offered to departments when requested.
  • HRPP is currently developing new policies and guidance. New consent form templates will be provided that includes the new regulatory requirements.
  • Pay attention to future emails from HRPP, or visit HRPP's webiste--we will include more information and guidance as it is available.

What to do if you have questions or want additional training?

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

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