While the University must be vigilant in review and oversight of all activities and relationships giving rise to real or apparent conflicts of interest, the issues inherent in human subjects research demand a higher level of accountability and oversight. Fundamentally, an investigator who has a real or perceived conflict of interest related to human subjects research under their direction may not conduct such research, except in compelling circumstances. *
In the event of “compelling circumstances” a covered individual who has a real or perceived conflict of interest in human subjects research under their direction may be permitted to conduct the research. Whether the circumstances are deemed compelling will depend in each case upon the nature of the science, the nature of the conflict of interest, how closely the conflict of interest is related to the research, the degree to which the conflict of interest, specifically any significant financial interests attributable to the real or perceived conflict of interest may be affected by the research, the degree of risk to the human subjects, the extent to which the Investigator is uniquely qualified to perform the research study, and the extent to which the conflict of interest is amenable to effective oversight and management.
Upon submitting a study protocol to the IRB, the principal investigator and all covered individuals involved in the study must ensure that their current conflict of interest disclosure and any necessary management plan(s) are up to date and certify, on the IRB application form, that any necessary management plan(s) have been considered and properly incorporated into the conduct of the proposed human subjects research. The IRB is authorized to access the Conflicts of Interest (COI) disclosure forms for all covered individuals involved in the study protocol. The IRB possess final authority as to whether human subjects research may proceed irrespective of the independent supervisory authorization of a COI disclosure and management plan.
Primary Considerations for IRB Approval
In instances where a conflict of interest involving human subjects research is determined allowable by the IRB, the following constituents should be informed of the real or perceived conflict of interest:
- Research subjects and other interested parties
- Research sponsors
- External regulatory authorities (e.g. the state or federal agencies or as required by statute)
- Editors of any publication to which an Investigator submits a manuscript
concerning the research and in any substantive public communication of the
research results, whether written or oral
Compelling Circumstances are those facts that convince the reviewer that an Investigator who has a Significant Financial Interest should be permitted to conduct human subjects research, taking into account the following factors:
- the nature of the research,
- the magnitude of the Significant Financial Interest and the degree to which it is related to the research,
- the extent to which the Significant Financial Interest could be directly and substantially affected by the research,
- the degree of the risk to the human subjects involved that is inherent in the research protocol,
- the extent to which the Investigator is uniquely qualified to perform a research study with important public benefit, and
- the extent to which the interest is amenable to effective oversight and management.
Note: An environmental scan of many institutional websites, with particular gratitude to the University of Georgia’s site, was instrumental in the development of this guidance and promulgation of policy.