Compelling Circumstances

TEMPLATE VERSION- to be revised as needed

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]: edit as needed to the situation

  1. Discontinue your outside activity.
  2. Designate an un-conflicted PI, or 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 you should be allowed to be the PI or continue to serve as PI.

If you choose option three, the compelling circumstances presentation, please let me know if you will be able to present your case at the next COI Committee meeting on [insert date and time] , [insert location]. Please let me know as soon as possible if you wish you choose this option.

Here is some information that you should be prepared with for the presentation:

 

Compelling Circumstances Presentation – 5 to 7 minutes (All studies)- edit questions as needed to the situation

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

    1. To the extent known, what are the potential financial gains in the immediate and long-term future in the event the research is successful?
    2. To what degree is your outside relationship related to the research?
    3. Are there any steps that you can propose for effective oversight and management of the financial interest (in other words, in your opinion, how might the potential for bias be mitigated)?
  2. Could another laboratory, whether at Duke or outside of Duke, possibly do the work? If not, why not?
    1. If so, could your laboratory perform better work? (e.g., more accurately, more efficiently). If yes, please describe why you believe this to be true, is there any evidence to support your position or is it just your opinion?
    2. If not, why do you believe the work should be performed at your laboratory rather than by an un-conflicted group? Provide details to support your position.
  3. Explain why you are uniquely qualified to be the local PI as compared to un-conflicted Duke faculty.
  4. 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:

    1. Are the experimental aspects of the study high risk, moderate risk, etc.?
    2. Do you screen the subjects?
    3. Do you recruit subjects?
    4. Do you consent the subjects? If it is you, you need to provide strong rationale to support this.
    5. Duke is one of how many sites?
    6. How many subjects are projected to be enrolled at Duke; what is the total N?
    7. Do you participate in analysis of the data?
    8. **Remove if the project is a multi-site**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?