October 7, 2022 - University of Arkansas at Little Rock

Dear Dr. Drale,

Thank you for your August 5, 2022, and February 28, 2022 responses to our July 6, 2022, and February 2, 2022 requests that the University of Arkansas at Little Rock (UALR) investigate allegations of noncompliance with Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR part 46). Based on review of your response, we make the following determinations:

Determinations:

1. The complainant alleged that the most recent version of the UALR “Research Protection Program (RPP) Policies and Procedures” is dated May 15, 2018 and does not appear to meet the current regulations. Specifically, these written procedures do not reflect the 2018 regulatory requirements at 45 CFR part 46, subpart A (also referred to as the “Common Rule”), that went into effect on January 20, 2019.
   
   Based on your responses and the information you provided, it appears that UALR is engaged in research subject to the 2018 regulatory requirements, and the IRB is responsible for reviewing at least some of that research. OHRP asked UALR to explain why UALR had not revised their IRB written procedures to reflect the 2018 regulatory requirements when implementation was required by January 20, 2019. Further, we asked UALR to explain how, in the absence of IRB written procedures that align with the 2018 regulatory requirements, the IRB and UALR researchers knew what the 2018 regulatory requirements were and how to adhere to them when reviewing and conducting human subjects research.
   
   We noted the following from your response:
   1. “Policy 2.13 of UA Little Rock’s IRB Research Protection Program Policies and Procedures provides that “[i]t is the IRB’s 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. At least once every four years, in the fall semester, the IRB will implement a process to review all of its policies and procedures.”
   2. “…At the conclusion of [the four-year review cycle] process, the IRB will adopt and implement the revisions.”

OHRP noted that IRB written procedures provided by UALR did not include any 2018 regulatory requirements. Instead, UALR indicated that their researchers and IRB members would need to visit the OHRP website, contact the IRB, or visit UALRs Blackboard site for further information about complying with the 2018 regulatory requirements.

We have 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 per 45 CFR 46.108(a)(3)(i). For example, UALR’s existing IRB written procedures do not include the 2018 additional requirements for informed consent.

Required Actions: Please provide OHRP with UALR’s 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.

At this time, OHRP requests that UALR respond to the required actions listed above by November 10, 2022. Please notify us if you identify new information which might alter the nature of these requests.

We appreciate the continued commitment of your institution to the protection of human research subjects. Please do not hesitate to contact me should you have any questions.

Sincerely,

Crystal M. Kelly, MPH
Compliance Analyst
Division of Compliance Oversight

cc:
Ms. Angela Willis, Human Protections Administrator, UALR
Ms. Winifred Meeker-O’Connell, Director, Office of Clinical Policy, FDA
Dr. Quynh-Van Tran, Center for Drug Evaluation and Research, FDA
Dr. David Glasgow, Office of Regulatory Affairs, FDA
Dr. Michelle Bulls, Director, OPERA, Office of Extramural Research, NIH
Dr. Pamela Kearney, Director, Division of Human Subjects Research, Office of Extramural Research, NIH
Dr. Adam Berger, Director, Division of Clinical and Healthcare Research Policy, Office of Science Policy, NIH
Ms. Lydia Kline, Team Lead, Clinical Research Policy, Division of Clinical and Healthcare Research Policy, Office of Science Policy, NIH