OHRP: Univ. of Arkansas Isn’t Following Revised Common Rule
The University of Arkansas at Little Rock (UALR) still hasn’t changed its institutional review board (IRB) policies and procedures to comply with the 2018 revised Common Rule, according to the HHS Office for Human Research Protections (OHRP). “Instead, UALR indicated that their researchers and IRB members would need to visit the OHRP website, contact the IRB, or visit UALR’s Blackboard site for further information about complying with the 2018 regulatory requirements,” OHRP said in an Oct. 7 determination letter to UALR. The letter posted on the agency’s website summarizes OHRP’s previous correspondence with UALR, which occurred twice this year. UALR has a policy to “continually, and at least annually, assess the adequacy of existent policies and the need for new policies as the field of research ethics and human participant protection evolves,” OHRP said, quoting UALR. “At least once every four years, in the fall semester, the IRB will implement a process to review all of its policies and procedures” and “will adopt and implement the revisions” at the end of the four-year cycle.
UALR should have been following the revised Common Rule as of January 2019 but OHRP “determined that UALR does not have IRB written procedures that the IRB can follow to ensure adequate review and compliance with the 2018 regulatory requirements,” the agency wrote. “For example, UALR’s existing IRB written procedures do not include the 2018 additional requirements for informed consent.” OHRP asked UALR to provide the agency with “IRB written procedures that reflect the 2018 regulatory requirements. These procedures should include sufficient detail to ensure that the IRB is reviewing human subjects research in a way that is compliant with the 2018 regulatory requirements, for research subject to those regulations.” OHRP asked UALR to send the new policies by Nov. 10.
