Revisions to Human Subjects Regulations

A delay to the new human subject regulations was announced. The new effective date is January 21, 2019.

 

You can find resources that outline the revisions to the regulations by visiting CITI Program's page.

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 “...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:

  • If there is not a further delay, new regulations will be implemented starting on January 21, 2019.
  • 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
  • In January 2019, CITI human subjects training will be updated to reflect the changes to the regulations.
  • 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 irb@ku.edu.