Protocol-Specific Conflict Management Stipulations

Conflict Types

For conflicts with Ohio State investigators and research that is reviewed by an Ohio State IRB (single or multi-site)

• A protocol-specific Conflict Management Plan (CMP) is developed by the Conflict Approval Committee (CAC) and provided to an Ohio State IRB with relevant submission materials to satisfy the FCOI SOP which states the IRB has “full and final authority for implementing the decision concerning the role of the conflicted researcher in the research protocol.” Submit the CMP to the IRB and address all relevant stipulations as soon as the CMP is finalized.
  • The CMP may be added to an open Initial, Continuing Review, or Amendment submission if the conflict is identified prior to review.
    • If the CMP is not final and you wish to continue with Initial or Continuing IRB review, the conflicted individual must be removed from the study and added back later via an Amendment once the CMP is finalized.
    • If a CMP is finalized when there is no open submission, it must be submitted with all stipulations addressed via an Amendment as soon as possible.
• External investigators covered under an Individual Investigator Agreement (IIA) are considered Ohio State investigators for these purposes.
• Best practices for human subjects research relevant stipulations:
  • If the CMP requires that financial interests are disclosed to participants in consent forms: Include the recommended language early in the body of the form. While there is no specific call-out in the templates, it is best practice to ensure that participants are informed sooner rather than later.
  • If the CMP requires that conflicted investigators not participate in the recruitment or consent process: Recruitment and consent is a continual and fluid process, and it is difficult to define where recruitment ends, and consent begins. To best comply with this stipulation, you may:
    • Inform the potential participant that the study exists
    • Advise the potential participant of your conflict
    • Explain that because of the conflict your nurse practitioner (or other non-conflicted individual also involved in their clinical care) will provide additional details including other treatment options, risks, benefits, etc. and answer any questions.
  • If the CMP prevents the conflicted investigator from being the sole determinant of reportable adverse events: While this stipulation is particularly relevant to post-approval activities, be mindful of reporting requirements to the IRB (per policy and guidance) and to the sponsor.

For conflicts with external investigators and research that is reviewed by an Ohio State IRB

• The relying site’s local context form must disclose the conflict. The relying site’s conflict review committee will draft the CMP and provide to the Ohio State study team with relevant submission materials that the Ohio State IRB must review and approve. As noted above, stipulations are implemented within the submission materials, as applicable (e.g., disclosure in consent).
• SMART IRB and Ohio State IRB Authorization Agreement (IAA) default language stipulates that the relying institution retains Conflict of Interest (COI) analyses, disclosure, and management and provides the resulting determinations, prohibitions, management plans, and any updates to Ohio State. The Ohio State IRB then has the right to impose additional prohibitions or conflict management requirements.
• Exceptions are rare, but possible, and the IAA will include these details. Exceptions most commonly occur when the relying site does not have a mechanism in place for assessing potential COIs. For example, Ohio State could take on the responsibility of assessing and managing potential COIs for a relying site.

For conflicts with Ohio State investigators and research that is ceded to an external IRB

• The CMP is included with the initial application for ceded review and stipulations are addressed accordingly. The reviewing IRB reviews the CMP and can impose additional stipulations as needed. If a CMP is finalized after the initial review is ceded, the ERIK Research Compliance team will provide the CMP to the Responsible Research Practices staff who will archive the CMP with the study materials. An amendment to submit the CMP for Ohio State IRB record keeping is not required; however, study teams must submit the plan and any revised submission materials to the reviewing IRB.

General guidance for non-conflicted study team members who are responsible for assuming recruitment and consent activities

• Consult Ohio State HRPP Policies, Recruiting Methods, Recruitment Materials, and Participant Compensation and Informed Consent Process and the Elements of Informed Consent.
• Key to both recruitment and consent considerations are the requirements to minimize the possibility of coercion and undue influence. The regulations at 45 CFR 46.116 state that “An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.” The U.S. Department of Health and Human Services (HHS) provides related guidance in Informed Consent FAQs, pointing specifically to the subtle undue influence that may arise between a patient who may feel obligated to participate in research when their physician is also an investigator.
• FDA-regulated research is governed by additional requirements. FDA guidance documents for Recruiting Study Subjects and Informed Consent have been incorporated into Ohio State policies. In short, there can be no claim (direct or implied) that the research provides specific treatment, will improve the participant’s condition, or is FDA approved; that the product is safe, effective, equal to, or better than existing treatment or in any way inconsistent with FDA labeling; or that the research is “free medical treatment” as opposed to meaning that individuals will not be charged for participation. Additionally, the product cannot be described as “new” without explanation that it is investigational.

Notes

Language in this guidance is specific to the current Buck-IRB submission system and will be revised upon transition to Huron. This guidance is specific to Ohio State policies. Any additional internal processes associated with the study must also be followed and documented. Please reach out to the contacts below for questions related to how those processes may best align with these policies as well as federal regulations.

Contacts

• Reach out to Nicola Hettler (hettler.6@osu.edu) with any questions regarding submitting your CMP for Ohio State IRB review or addressing CMP stipulations. For ceded studies, contact Melanie Howell (howell.488@osu.edu).
• Reach out to conflictinfo@osu.edu with any questions regarding your conflict or CMP.
• Schedule a consultation with Responsible Research Practices staff for any other help preparing IRB submissions or understanding Ohio State policies or review procedures.

Article ID: 79
Created: December 3, 2024
Last Updated: December 3, 2024

Online URL: https://ohiostateresearch.knowledgebase.co/article/protocol-specific-conflict-management-stipulations-79.html