Dear Dr. Drale,

Thank you for your November 8, 2022 response to our October 7, 2022 determination letter requesting that University of Arkansas at Little Rock (UALR) provide OHRP with their revised Institutional Review Board (IRB) written procedures that reflect the 2018 Requirements (45 CFR part 46, subpart A, as amended, also referred to as “the Common Rule”¹) including sufficient detail to ensure that IRB review of human subjects research is compliant with those regulations.

When OHRP opened this investigation, it was in response to allegations that UALR’s IRB written procedures were not updated to reflect the 2018 Requirements and, according to the Federalwide Assurance (FWA) on file with OHRP, UALR had elected to apply the Common Rule to all research regardless of funding.

Based on your responses and the information you provided to our February 2, 2022 inquiry letter, it appears that UALR was engaged in research subject to the 2018 Requirements, and the IRB was responsible for reviewing at least some of that research. OHRP requested an explanation why UALR had not revised its IRB written procedures to reflect the 2018 Requirements when implementation was required by January 20, 2019. Further, OHRP asked UALR to explain how, in the absence of IRB written procedures that align with the 2018 Requirements, the IRB and UALR researchers knew what the 2018 Requirements were and how to adhere to them when reviewing and conducting human subjects research.

In OHRP’s October 7, 2022 letter, we determined that UALR did not have satisfactory IRB written procedures that the IRB can follow to ensure adequate review and compliance with the 2018 Requirements as required by 45 CFR 46.108(a)(3)(i) (e.g., conducting initial and continuing review of research and for reporting findings and actions to the investigator and the institution). For example, the existing IRB written procedures provided by UALR that were dated May 2018 did not include the 2018 Requirements’ additional informed consent provisions.

As part of UALR’s November 8, 2022 response, UALR notified OHRP that it had modified their FWA to no longer extend to all research engaged regardless of funding.

OHRP noted that UALR’s revised written procedures (“Research Protection Program (RPP) Policies and Procedures” dated May 2022) include all the required written procedures that are relevant to the research portfolio currently reviewed by UALR’s IRB, which appears to include largely research that qualifies for exempt or expedited review under the 2018 Requirements. For example, UALR’s written procedures were revised to specify the additional basic element of informed consent required under the 2018 Requirements at 45 CFR 46.116(b)(9), the three additional elements of informed consent, when appropriate, required under 45 CFR 46.116(c)(7), (8), & (9), and examples of activities deemed not to be research as defined by 45 CFR 46.102(l). Furthermore, we note that UALR is not currently engaged in any HHS-supported research.   

In the future, if UALR expects to engage in HHS-supported non-exempt human subjects research, or any research involving limited IRB review, the IRB written procedures must be revised to reflect all the 2018 Requirements before the UALR IRB reviews such research.

For additional guidance on requirements for written procedures, please see: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/institutional-issues/institutional-review-board-written-procedures/index.html. While this guidance was published in 2018, it is still relevant to research covered by the 2018 Requirements.

In light of UALR’s current research portfolio, OHRP determines that the corrective actions taken by UALR adequately address OHRP’s determinations. At this time, there should be no need for further involvement by our office in this matter. Please notify us if you identify new information which might alter this determination.

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, Food and Drug Administration (FDA)
Dr. Michelle Bulls, Director, OPERA, Office of Extramural Research, National Institutes of Health (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 
Center for Devices and Radiological Health (CDRH) IRB: BIMO-CDRH@fda.hhs.gov 
Center for Biologics Evaluation and Research (CBER): CBERBIMONotification@fda.hhs.gov 
Office of Regulatory Affairs (ORA): orabimoinspectionpoc@fda.hhs.gov   
Center for Drug Evaluation and Research (CDER): BIMO-CDEROSI@fda.hhs.gov

Endnotes

¹  The Common Rule, codified by HHS at subpart A of 45 CFR part 46, was revised by a final rule published in the Federal Register on January 19, 2017 (82 FR 7149), and subsequently amended by an interim final rule published in the Federal Register on January 22, 2018 (83 FR 2885) and a final rule published on June 19, 2018 (83 FR 28497). The revised Common Rule is defined in the regulatory text as the “2018 Requirements.”