Dear Ms. Levy,

Thank you for the December 13, 2022, and April 27, 2023 reports in response to our October 18, 2022 request that Stockton University 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). Based on our review of your responses, OHRP makes the following determinations:

Determinations

1. The complainant alleged that the current version of the Stockton University IRB “Guidelines and Regulations” does not contain any of the information required under the 2018 Requirements at 45 CFR 46.108 that requires institutions to establish and follow IRB written procedures.

   Based on our review of Stockton University’s current written procedures, we noted that there were few references to the 2018 Requirements, aside from reporting requirements. However, we acknowledge your report dated December 13, 2022 that specifies Stockton University’s IRB and human subjects researchers do not have written procedures with sufficient detail to comply with §46.108 for the 2018 Requirements for human subjects research (HSR). Stockton University further recognizes that their “lack of comprehensive written procedures and updated guidance documents inhibits Stockton University’s IRB and researchers working with human subjects from applying the 2018 Requirements when reviewing and conducting human subjects research.”

   Further, section 46.108(a)(3)(i) of the 2018 Requirements requires that an IRB establish and follow written procedures for conducting initial and continuing review of research, and this requirement encompasses the procedures for taking minutes of IRB meetings at which initial and continuing reviews occur. See 45 CFR 46.115(a)(2).

   We have determined that Stockton University does not have IRB written procedures that the IRB can follow to ensure adequate review and compliance with the 2018 Requirements under 45 CFR 46.108(a)(3).

   Corrective Action: Based on the responses provided, Stockton University has hired an HSR consulting firm to provide guidance and support in developing IRB written procedures and other written guidance including forms, checklists, consent templates, and reviewer worksheets. Further, Stockton University notified OHRP on April 27, 2023, that they were finalizing their draft written procedures.

   Required Action: Please provide OHRP with the revised IRB written procedures that include sufficient operational detail to ensure compliance with section 46.108(a)(3) of the 2018 Requirements. Further, please explain the process the IRB uses to ensure approved research satisfies all criteria (45 CFR 46.111) required for approval of research.

2. HHS 2018 Requirements at 45 CFR 46.115(a)(2) require that minutes of IRB meetings be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions, including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution. Specifically, the IRB meeting minutes that we reviewed lack the following:

   • documented attendance at IRB meetings
   • sufficient information to indicate that quorum was met and maintained during the meeting
   • documentation of the vote on IRB actions, including the number of members voting for, against, and abstaining
   • the basis for requiring changes in or disapproving research
   • a written summary of the discussion of controverted issues and their resolution

   Based on the items noted above, we have determined that Stockton University’s minutes of IRB meetings do not comply with the 2018 Requirements at 45 CFR 46.115(a)(2).

   Corrective Action: Based on your responses, Stockton University will develop a standard template for IRB agendas and minutes with guidance from an HSR consulting firm and will develop clear and sufficient standard operating procedures to ensure that systems and staff are in place to effectively use the standardized template. We noted that Stockton’s responses acknowledged these deficiencies.

   Required Action: Please provide OHRP with the status of the implementation of this corrective action. For additional guidance on requirements for minutes of IRB meetings, please see: https://www.hhs.gov/ohrp/minutes-institutional-review-board-irb-meetings-guidance-institutions-and-irbs.html-0. While this guidance was published in 2017, it is still relevant to research covered by the 2018 Requirements.

3. HHS 2018 Requirements at 45 CFR 46.108(b) require that, except when an expedited review procedure is used, research be reviewed at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in a nonscientific area (hereinafter referred to as “nonscientist”).

   Based on the responses provided, Stockton University stated that the “IRB currently consists of 12 members. We have ensured that there are at least six members present, but we do not take and monitor attendance throughout the meeting […] our records indicate that we have held convened meetings without a nonscientist present.”

   We have determined that the IRB failed to meet this requirement for certain IRB meetings. Thus, any actions taken at meetings that required a quorum would not be in compliance with the HHS 2018 Requirements at 45 CFR 46.108(b). We have emphasized that should the quorum fail during a meeting (e.g., those with conflicts being excused, early departures, or absence of a nonscientist member), the IRB may not take further actions or votes that require a quorum unless the quorum is restored.

   Corrective Action: Based on the responses provided, Stockton University is working with an HSR consulting firm to determine whether re-review of open research studies is necessary and that should a need for a re-review be indicated, they will work with the HSR consulting firm to develop a method for re-reviewing open research using updated standard operating procedures, templates, checklists, and forms.

   Required Action: Please provide Stockton University’s plan to ensure that HHS-supported, active nonexempt human subjects research that was not eligible for expedited review and reviewed at a convened IRB meeting that did not meet or maintain quorum requirements are identified and then re-reviewed at a convened IRB meeting. Please include in the plan a list of applicable studies and when they will be re-reviewed.

4. HHS 2018 Requirements at 45 CFR 46.116(a) and (b) require that when seeking informed consent specific information shall be provided to each subject unless the IRB approves a consent procedure that omits some, or alters, some or all of the required basic elements of informed consent provided in accordance with 45 CFR 46.116 (e) or (f).

   Based on the responses provided and our review of the consent forms for the two HHS-supported research studies listed below, Stockton University identified that required elements of informed consent were not included in part, due to deficiencies in the informed consent checklist and example consent forms provided to investigators.

   The purpose of protocol 2022.126 is to assess an exercise and nutrition program that can be used to promote active and healthy lifestyles for adults ages 55 and older. The purpose of protocol 2022.127 is to learn about health, nutrition, and physical activities in individuals with intellectual and developmental disabilities through interviews. For these protocols, we have determined that the informed consent documents reviewed and approved by the IRB failed to include relevant information meeting the regulatory criterion for the basic element required by 2018 Requirements at 45 CFR 46.116(b)(9): For research that involves the collection of identifiable private information or identifiable biospecimens, either a statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or a statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

   Corrective Action: Based on the responses provided, Stockton University planned to contact investigators by December 31, 2022, to request immediate updates to their consent forms and a plan for providing the updated information to current participants. All consent forms for HHS-supported studies were anticipated to be updated to comply with the 2018 requirements by January 15, 2023. Stockton University will develop a standard template for informed consent forms with guidance from an HSR consulting firm.

   Required Action: Please provide OHRP with the status of the implementation of this corrective action.

5. The 2018 Requirements at 45 CFR part 46.110(c) require that each IRB that uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals that have been approved under the procedure.

   Based on the responses provided, OHRP has determined that Stockton University’s IRB does not have procedures for keeping all IRB members advised of research proposals that have been approved under an expedited procedure in contravention of this regulatory requirement.

   Required Action: Please explain how the IRB members will be advised of research proposals that have been approved under an expedited review procedure.

Additional corrective actions implemented by Stockton University

OHRP acknowledges that Stockton University is working diligently to support and stabilize its Human Research Protections Program (HRPP) and IRB, including the following:

• Stockton University has appointed a new Institutional Official (IO) who has completed several trainings to increase institutional knowledge related to IO responsibilities and human subjects protections.
• Stockton University has worked with an HSR consulting firm to determine an appropriate infrastructure for their Office of Research and Sponsored Programs (ORSP), as it relates to their HRPP. The HSR consulting firm has provided a template for Standard Operating Procedures (SOP) to Stockton University and is providing support and guidance as they develop their operating procedures specific to their institutional context.
• Stockton University has launched and successfully completed a search for a new Executive Director (ED) of the ORSP. The new ED has prior experience as an IRB administrator and has experience in grant management thus adding a wealth of knowledge to the institution.
• Per recommendations by the HSR consulting firm, Stockton University has acquired approval for an Associate Director (AD) of the ORSP line, who will also serve as an institutional compliance officer. The search for this position was underway at the time of the update in April of 2023.
• Stockton University has hired an IRB Administrator, with previous IRB knowledge, who has completed numerous trainings to help increase their institutional knowledge of human subjects protections and IRB operations. Stockton University intends for the IRB Administrator to attend a future conference and to complete additional core training to support an increase in institutional knowledge.
• Stockton University has provided release time for the IRB Chair to develop the SOP for the IRB. The SOP manual is currently being finalized.
• Stockton University has secured funding and acquired access to a new electronic IRB system.
• Stockton University is currently collaborating with multiple institutions to secure Reliance Agreements, particularly for any clinical-based research.

Please provide us with responses to the above determinations by March 7th, 2024, including a corrective action plan for each of our determinations. Feel free to contact me if you would like guidance in developing a corrective action plan.

This letter is not intended to be an all-inclusive list of deficiencies related to the IRB’s procedures or the review and approval by the IRB of protocols and informed consent documents. It is the institution’s responsibility to ensure adherence to each requirement of the relevant HHS regulations.

We appreciate your institution’s continued commitment to the protection of human research subjects.

Sincerely,

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

cc:
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