Conflict of Interest Committee
Applying for an Exception to a Management Plan
If you wish to seek an exception to the full management plan prohibition against serving as the Principal Investigator (PI) or key personnel on a human subjects research protocol, write the COI Committee through its staff. The letter should explaining the compelling circumstances that require you to actively participate in the study. The letter should provide details on:
- The nature of the research, including whether the study:
- Is part of a multicenter clinical trial
- Tests a technology you developed
- Tests one of the company's products for regulatory approval
or another purpose (e.g., pilot testing a new version of software,
validating a new laboratory test). Identify any other purpose.
- The stage of your research activities, including whether:
- Subject enrollment has been completed
- Study treatments or interventions have been completed
- The protocol is only open for data analysis or long-term
follow-up
- The companies or business entities that:
- sponsor the research,
- are involved in the research other than as a study sponsor (e.g. perform special tests for the protocol), or
- may be affected significantly by the research project.
Identify any roles these companies or business entities have related
to the project.
- Your unique qualifications, by virtue of expertise or experience,
requiring your continued role(s) in this research protocol.
- Why, without your participation, the research could not otherwise be conducted as safely or effectively and the extent to which your participation is necessary in each of the following activities.
- Study design
- Subject recruitment and enrollment
- Determination of subject eligibility
- Data collection
- Conduct of study procedures (e.g. administration of protocol treatments, performance of laboratory tests)
- Data safety and monitoring
- Data analysis
- Publication
- After you have submitted your letter requesting an exception to the prohibition against serving as the Principal Investigator (PI) or key personnel on a human subjects research protocol to the COI Committee, a COI Committee member may contact you to discuss your request.