Revisions to federal human research rules to take effect

Treadmill testing

UO research compliance administrators are preparing for revisions to federal research regulations that are set to take hold later this month.

The regulations, which govern federally funded research involving human subjects, are referred to as the “Common Rule” and will affect UO investigators and research staff members who conduct research involving human subjects when they go into effect Jan. 21.

Research Compliance Services, the UO’s central research integrity office, is working in collaboration with members of the Institutional Review Board to update policies, forms and guidance. The unit has a dedicated Revised Common Rule website, and is offering several information and education sessions to help researchers and research staff understand the revised regulations, which are being adopted by the U.S. Department of Health and Human Services and 16 other federal departments.

“We are continuing to update the UO research community on what these changes will mean for them,” said Sheryl Johnson, director of Research Compliance Services. “We want investigators and their staff members to know that they are not alone and that we are here to help.”

That help is available in several forms, Johnson said. Resources include upcoming overview and Q&A info sessions that will give a high-level perspective of the changes and provide answers on how the UO will implement the changes and how the changes will affect existing research and newly reviewed studies.

Sessions are scheduled for the following dates and locations:

  • Tuesday, Jan. 15, noon to 1:30 p.m., Diamond Lake Room, Erb Memorial Union
  • Friday, Jan. 18, 10 to 11:30 a.m., Lease Crutcher Lewis Room, Erb Memorial Union
  • Thursday, Jan. 24, noon to 1:30 p.m., Mount Hood Room, PeaceHealth North, 677 E. 12th Ave.

Because the new regulations will create new exempt categories and modify some existing categories, each information session will be immediately followed by a one-hour session on exempt research under the revised Common Rule.

Faculty and staff members can register for these sessions through MyTrack. Students can register by contacting Research Compliance Services at 541-346-2510 or researchcompliance@uoregon.edu.

Additionally, Research Compliance Services is holding special office hours to discuss the revised regulations every Thursday from 2 to 4 p.m. in the consulation room at PeaceHealth North, 677 E. 12th Avenue,. The sessions are dedicated specifically to talking with researchers about the revised Common Rule and implications for their research.

Administrators will also be available to answer revised Common Rule questions during standard office hours in the same location, Tuesdays from 10 a.m. to noon and Wednesdays from 2 to 4 p.m.

UO researchers are encouraged to visit the UO’s Revised Common Rule website for detailed information and regular updates. 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.