Revisions to federal human research regulations delayed

MRI brain scan

Revised federal regulations that apply to UO investigators conducting research involving human subjects have been delayed until Jan. 21, 2019.

The revisions had been scheduled to take effect in July, but a final rule announced by the U.S. Department of Health and Human Services and 16 other federal departments delayed the general compliance date by six months. The regulations, which govern federally funded research involving human subjects, are referred to as the “Common Rule.”

UO researchers with studies reviewed and approved prior to Jan. 21 must continue to comply with the current Common Rule regulations, officials in UO’s Research Compliance Services division said.

“We will continue to update the UO research community on how the Common Rule revisions will affect human subjects research and approval processes at UO,” said Sheryl Johnson, director of research compliance services.

The UO’s Research Compliance Services office is examining the new final rule, which includes options for institutions to adopt three “burden-reducing provisions” of the revised requirements during the six-month delay period. Researchers who have new protocols or protocol revisions between July 19, 2018, and Jan. 21, 2019, should contact Research Compliance Services at researchcompliance@uoregon.edu or 541-346-2510 to discuss their options.

“Our office is committed to streamlining administrative processes,” said David Conover, vice president for research and innovation. “Should we determine that the compliance burden can be reduced by applying the exception, we will be ready to accommodate our researchers.” 

The June 19 announcement is the second time the compliance date for the revised guidelines has been delayed by federal agencies. In December 2017, federal agencies announced that the implementation date for the Common Rule would be delayed from January 2018 to July 2018.

The Common Rule revisions fall under the purview of the Research Compliance Services unit, which is part of the Office of the Vice President for Research and Innovation. The unit supports the UO community and the rights and welfare of participants in human research through regulatory compliance and best practices.

UO researchers are encouraged to visit the UO’s Revised Common Rule website for detailed information and regular updates on the 2018 Common Rule implementation. The office is holding special office hours every Thursday from 2-4 p.m., dedicated specifically to talking with researchers about the revised Common Rule and implications for their research.

Research Compliance Services is located in Suite 500 of the Physicians and Surgeons Building North, Sacred Heart Medical Center, University District, 677 E. 12th Ave. Inquiries can be directed to researchcompliance@uoregon.edu or 541-346-2510.