The U.S. Department of Health and Human Services and 16 other federal agencies have issued a final rule updating the Federal Policy for the Protection of Human Subjects (the “Common Rule”), which provides regulatory safeguards for individuals who participate in research.
The Revised Common Rule will take effect January 21, 2019. The major regulatory changes are related to human subject research exemption determinations, continuing review, limited Institutional Review Board (IRB) review, informed consent, and use of a Single IRB-of-Record (sIRB). Some of these changes will reduce the burden on both researchers and institutional compliance obligations; however, the regulations also introduce new requirements and some added responsibilities. As a result, there will be anticipated delays to the human subjects research review process at Portland State University in early 2019 during the transition to the new regulations.
Implementation of Changes at PSU:
In order to transition from the current set of regulations to the Revised Common Rule, PSU’s Office of Research Integrity (ORI) will not be accepting new Human Research Protocol Applications or Amendments to existing protocols from January 5-13, 2019.
New Projects – not yet submitted
Human Research Protocol Applications will be accepted on existing forms for review under the current regulations through Friday, January 4, 2019. Applications must be received by ORI prior to 3 p.m. to be considered for review under the existing Common Rule. Human Research Protocol Applications and templates for review under the new regulations will be available and posted on the PSU Human Subjects Protection Program website on Monday, January 14.
New projects – currently under review
The ORI and IRB will continue to review applications received prior to January 4 under the existing regulations. If an approval or exempt determination is not in place prior to January 21, 2019, the applications will need to be reviewed under the new regulations. In those cases, researchers will work with ORI to address any required adjustments to IRB materials needed to achieve compliance with the revised regulations.
Existing projects – already approved
The Revised Common Rule changes will not immediately affect existing studies approved or determined exempt prior to January 21, 2019. Those studies will remain governed by the pre-2018 Common Rule regulations, which means any amendments to and continuing review of these studies will continue under the existing Common Rule requirements, unless they are transitioned to the Revised Common Rule on a case-by-case basis.
Who can I contact to find out more information?
Please visit the PSU IRB website, which will be updated as more information becomes available. If researchers have any questions about the upcoming changes to the IRB regulations, contact the Office of Research Integrity at hsrrc@pdx.edu or call 503-725-4288.
