Dear Dr. Palladino:

Thank you for the December 13, 2022, April 27, 2023, and February 29, 2024, reports in response to our October 18, 2022, and January 11, 2024, requests that Stockton University (hereinafter referred to as “Stockton”) evaluate allegations of noncompliance with Department of Health and Human Services (HHS) 2018 Requirements for the protection of human research subjects (Subpart A, 45 CFR part 46) (hereinafter referred to as the “2018 Requirements”). In our January 11, 2024, letter we made the following determinations:

• Stockton did not have IRB written procedures that the IRB could follow to ensure compliance with the 2018 Requirements, as required by the 2018 Requirements at 45 CFR 46.108(a)(3).
• Stockton’s minutes of IRB meetings lacked sufficient detail as required by the 2018 Requirements at 45 CFR 46.115(a)(2).
• For certain convened meetings of Stockton’s IRB, a member whose primary concerns are in a nonscientific area was not present, as required by the 2018 Requirements at 45 CFR 46.108(b).
• For two HHS-supported research studies that involved the collection of identifiable private information, the informed consent documents reviewed and approved by Stockton’s IRB did not include information as required by the 2018 Requirements at 45 CFR 46.116(b)(9).
• Stockton’s IRB did not have procedures for keeping all IRB members advised of research proposals that have been approved under an expedited procedure, as required by the 2018 Requirements at 45 CFR 46.110(c).

Per Stockton’s February 29, 2024, report in which Stockton provided details and revised documents in response to our determination letter, we acknowledge that Stockton implemented corrective actions that adequately address the determinations identified in our January 11, 2024, letter. Both our January 11, 2024, letter and Stockton’s February 29, 2024, report describe Stockton’s corrective actions responding to the determinations, such as:

• revised Stockton’s IRB written procedures to include sufficient operational detail to ensure compliance with section 46.108(a)(3) of the 2018 Requirements,
• re-reviewed the studies in which quorum was not maintained,
• IRB review of revised consent forms in accordance with the 2018 Requirements, and
• developed and implemented standard templates for IRB agendas and meeting minutes, including information on proposals approved under the expedited review process, an IRB member reviewer worksheet, a consent element checklist, and a consent template.

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 your institution’s continued commitment to the protection of human research participants. 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. Amber Gihorski, Human Protections Administrator, Stockton
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