Compelling Circumstances

Conflicted Investigators – Questions Compelling Circumstances Review

 

The COI Committee has established a precedent that prohibits an investigator with a significant financial conflict from acting as PI on research that is related to that conflict.

There are three options available related faculty member's role in [insert name of project and sponsor]:

1.      Conflicted faculty member to discontinue outside activity.

2.       Conflicted faculty member to step down as PI of this study in favor of another Duke faculty member who does not have a conflict of interest; or

3.       Present compelling circumstances to the COI Committee as to why conflicted faculty member should be allowed to continue to serve as PI.

If faculty member choose option three, the compelling circumstances presentation is required.

Presentation should include the following:

 

Compelling Circumstances Presentation – 5 to 7 minutes (All studies)

1.       BACKGROUND: Briefly describe your relationship with the sponsor, the research study, and your role on the study. Examples of things to address: 

  • To the extent known, what are the potential financial gains in the immediate and long-term future in the event the research is successful?
  • To what degree is your outside relationship related to the research?
  • What steps can you propose for effective oversight and management of the financial interest?

2.       Explain why you are uniquely qualified to be the local PI as compared to un-conflicted Duke faculty.

3.       Describe the process for data monitoring and analysis. Is this performed by conflicted personnel or is this done independently?

For human studies, please also address the following:

  • Are the experimental aspects of the study high risk, moderate risk, etc.?
  • Do you screen the subjects?
  • Do you recruit subjects?
  • Do you consent the subjects? If it is you, you need to provide strong rationale to support this.
  • Duke is one of how many sites?
  • How many subjects are projected to be enrolled at Duke; what is the total N?
  • Do you participate in analysis of the data?
  • Is Duke uniquely qualified (by special facilities or equipment, unique patient population, qualifications of investigators, etc.) to conduct the research and safeguard the research subjects?