New Federal Regulations for Human Subjects Research

A page from federal policy

Office for Research Protections     |     Institutional Review Board (IRB)

Updates to the Federal Policy for the Protection of Human Subjects, known as the “Common Rule," became effective January 21, 2019.

Studies that receive initial IRB approval on or after January 21 are subject to the new federal requirements, known as the "2018 Requirements." This includes initial studies submitted to the IRB prior to the date but not yet approved by then. Studies approved before January 21, 2019 will continue to be subject to the old regulations, known as the "Pre-2018 Requirements."

As a result of the new regulations, some of which will reduce administrative burden, investigators will see changes to the documents in CATS IRB and IRB policies and review. Researchers submitting a new study should be sure to use the new, updated protocol templates and consent form templates. These can be found in the "Templates" tab of the Library in CATS IRB. For assistance in choosing the correct template and consent form documents, see the Investigator Manual.

CATS IRB documents have also been updated to include information to help investigators comply with both the new regulations and the "Pre-2018 Requirements." If changes are needed to your research (e.g., to the consent process and/or protocol) to comply with the 2018 requirements, the IRB will provide you with instructions and feedback in their request for clarifications.  The IRB will also include relevant instructions in IRB determination letters to help you understand which rules apply and key requirements, such as whether the research is subject to continuing review by the IRB or if an administratve review form is required in lieu of a continuing review report.  If you have a question whether the 2018 Requirements or the Pre-2018 Requirements apply to a study, ask your IRB Analyst.

Among other changes, the 2018 Requirements effective January 21, 2019 include:

  • The addition of select activities defined as “not human research and do not require IRB review”
  • Changes to the consent form and consent process, including a "key information" section for consent forms over a certain length
  • New exempt categories
  • Changes to the continuing review requirements

Additional changes regarding the use of a single IRB will be effective January 19, 2020.

Currently, the new regulations do not apply to FDA-regulated research or research funded by the Department of Justice. 

To learn more, investigators can attend an educational session on the 2018 Requirements and visit the Office for Research Protections website dedicated to the changes: