SOP 042: Conflicts of Interest

Purpose

This SOP describes the process to identify, evaluate, manage, and minimize or eliminate the organization’s proprietary interests, financial investments or holdings, and the personal financial interests of key organizational leaders when such interests could conflict with the organization’s obligations to protect research participants, maintain the integrity of research, and ensure the credibility of the human research protections program.

Procedures for Identifying and Reporting Potential Organizational Conflicts

1. The initial review of human subjects research applications require that investigators disclose whether any WVU principal or co-investigator, has a financial interest that would reasonably appear to be affected by the research. Such financial interests involving key organizational leaders, or other potential organizational conflicts of interest, are forwarded to the WVU Conflict of Interest Office for review and approval. The Conflict of Interest website guides researchers in disclosing the above referenced potential conflicts of interest during a research project’s initial review and approval process.
2. Principal investigators and co-investigators must submit a Conflict of Interest in Research Disclosure regardless of whether they have a Significant Financial Interest for Research to report. Disclosure requirements, review of conflict of interest in research, and COI-specific policies can be found in the Conflict of Interest Office’s Governance, Ethics, Conflicts of Interest, and Outside Consulting Arrangements Policy . Principal investigators and Co-investigators complete the COI process within the electronic IRB submission system.

References

WVU Policies:
Conflict of Interest Office’s Governance, Ethics, Conflicts of Interest, and Outside Consulting Arrangements Policy

Federal Regulations:
42 CFR 50, Subpart F
45 CFR 94

AAHRPP:
Standard I-6