CHANGES TO HUMAN SUBJECTS PROTECTIONS ‘COMMON RULE’ DELAYED BY INTERIM FEDERAL RULE

Laboratory

Photo by Pixabay.

JANUARY-FEBRUARY 2018 |

Originally, changes to the Federal Policy for the Protection of Human Subjects (known as the Common Rule) were expected to take effect on Jan. 19, 2018. However, on Jan. 17, 2018, the U.S. Department of Health and Human Services communicated that these proposed changes are delayed to allow federal agencies and research institutions additional time to implement the requirements. The effective date is now July 19, 2018, though further delay until Jan. 21, 2019 is possible.

What does this mean for researchers?

  1. Federally-funded research with human subjects considered non-exempt by the Purdue Institutional Review Board (IRB) will continue to require annual review. Studies not funded by federal sources will be notified of future continuing review requirements by the IRB. Please continue to notify the IRB of any changes to the funding source of a protocol.
  1. Clarifications and additions to the categories of exempted research were anticipated, including the new definition of Benign Behavioral Interventions. However, at this time the six categories of exempt research remain unchanged. The IRB cannot introduce these new categories prior to the new Common Rule effective date.

The Purdue Human Research Protection Program (HRPP) will continue with actions permissible under the Common Rule to support the intent of the delayed regulation. HRPP will continue to monitor changes and will update information received on our website (http://www.irb.purdue.edu) as it becomes available.

Writer: Ianthe “Cookie” Bryant-Gawthrop, director, Research Regulatory Affairs and Human Research Protection Program (ibg@purdue.edu)