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Conflict resolution is tricky, but when regulations are violated and conflicts arise, they are even more challenging. We will use this case scenario to practice conflict management.
This time you’ll be acting as the research director of a large academic medical center. You have administrative responsibility over your organization’s entire research portfolio. In response to the Office of the Inspector General’s (OIG) Work Plan, you launch an internal investigation to ensure that your organization’s policies and procedures are in compliance with federal regulations regarding NIH funding for research grants. You identify an investigator who has failed to adequately disclose a significant financial conflict of interest that would likely result in a loss of objectivity in the research conducted with the allocated federal funds. You have heard from team members that the investigator refuses to acknowledge the conflict and will not complete the needed steps to disclose and adequately manage the conflict.
Write a 2-3 page outline of the steps you will take when addressing the investigator as you try to resolve the conflict. Use course material to support your plan and steps. Skim the items from the OIG and the NIH (in your required readings list) for context and background as you work on the application exercise for this module.
🔴 Struggling with where to start this assignment? Follow this guide to tackle your assignment easily!
Outline for Addressing the Investigator’s Financial Conflict of Interest
I. Introduction (1 Paragraph)
- Introduce the scenario and the importance of maintaining research integrity in federally funded projects.
- State the purpose of the outline: To resolve a conflict arising from non-disclosure of financial interests while ensuring compliance with NIH regulations and OIG guidelines.
- Emphasize the impact of unresolved conflicts on research credibility and federal funding.
II. Step 1: Initial Assessment and Documentation
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Review Federal Regulations & Institutional Policies
- Refer to NIH Financial Conflict of Interest (FCOI) regulations (42 CFR Part 50, Subpart F).
- Consult OIG compliance guidelines to determine violations.
- Ensure alignment with the institution’s Conflict of Interest (COI) policy.
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Gather and Document Evidence
- Compile all relevant records, including grant applications, financial disclosures, and internal reports.
- Document reports from team members regarding the investigator’s refusal to acknowledge the issue.
III. Step 2: Private Discussion with the Investigator
- Schedule a confidential meeting to address the issue directly.
- Present findings objectively, highlighting the undisclosed conflict.
- Explain the implications of non-disclosure:
- Regulatory violations leading to loss of federal funding.
- Institutional penalties and potential damage to the investigator’s career.
- Ethical concerns and the need for transparency in research.
- Allow the investigator to respond and address concerns.
IV. Step 3: Formal Compliance Measures
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If the investigator refuses to comply, escalate the issue:
- Involve the Institutional Review Board (IRB) and Conflict of Interest Committee.
- Issue a formal written notice requiring immediate corrective action.
- Outline possible disciplinary actions (e.g., suspension from grants, research restrictions).
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Require a Conflict Management Plan:
- The investigator must fully disclose financial interests.
- Implement a monitoring strategy (e.g., appoint an independent reviewer for research oversight).
V. Step 4: Institutional Reporting & Compliance Follow-Up
- Report findings to NIH and OIG if required under federal guidelines.
- Ensure ongoing monitoring of the investigator’s compliance.
- Conduct training sessions to reinforce ethical research practices.
VI. Conclusion (1 Paragraph)
- Summarize the importance of addressing conflicts proactively.
- Reiterate the goal of maintaining research integrity while resolving disputes professionally.
- Emphasize long-term compliance and institutional reputation in federally funded research.
🔹 Final Tips for Success
✔ Use course materials and official NIH/OIG regulations to support each step.
✔ Keep the outline structured, logical, and clear.
✔ Cite sources in APA format if required.
This outline ensures a strategic, ethical, and regulatory-compliant approach to conflict resolution. 🚀 Now, start drafting your paper! 😊