DUHS IRB Members are responsible for making known any potential or perceived conflict of interest (COI) concerning protocols reviewed by the IRB. If you hold any of the following roles or relationships to a study undergoing IRB review, then you are considered to have a potential or perceived conflict:
- Principal Investigator
- Co-Principal Investigator or other key personnel
- Investigator receiving funding from the study, as listed in the study budget
- In a supervisory role over the PI of the study,
- Involved in research utilizing a competing technology such that the ability to render an objective assessment is compromised; or
- Family member of PI (spouse or child) or otherwise involved in a close personal relationship with a member of the study team.
- You have a relationship, financial or otherwise, with the sponsor of the study.
You are also considered to have a conflict when you or a member of your immediate family has any of the following:
- Involvement in the design, conduct, or reporting of the research with the following exception:
- An IRB member who is listed on an IRB protocol as a member of the study’s Key Personnel but whose study activities are limited to (i) the performance of commercial services for the investigator (or performing other genuinely non-collaborative services meriting neither professional recognition nor publication privileges), while (ii) adhering to commonly recognized professional standards for maintaining privacy and confidentiality, is not considered to have a conflicting interest on this basis.
- Ownership interest, stock options, or other financial interest related to the research unless it meets four tests:
- The value of the interest does not exceed $5,000 when aggregated for the immediate family.
- The interest is publicly traded on a stock exchange.
- The value of the interest does not exceed 5% interest in any one single entity when aggregated for the immediate family.
- No arrangement has been entered into where the value of the ownership interests will be affected by the outcome of the research.
- Compensation related to the research unless it meets two tests:
- The value of the compensation does not exceed $5,000 in the past year when aggregated for the immediate family.
- No arrangement has been entered into where the amount of compensation will be affected by the outcome of the research.
- Proprietary interest related to the research including, but not limited to, a patent, trademark, copyright or licensing agreement.
- Board or executive relationship related to the research, regardless of compensation.
- Any other reason for which you believe that you cannot provide an independent review.
What To Do If You Think You Have a Conflict
- If you are assigned a protocol to review and you have a potential conflict with the protocol, tell your Board Specialist immediately. As you are reviewing the agenda before the meeting, please tell your Board Specialist if you have a conflict with an item on the agenda, so the conflict can be noted on the agenda and the Board Specialist will know ahead of time that you will need to leave the room during the deliberation and vote on that item.
- At the start of an IRB meeting, and prior to the beginning of the Board’s discussion of the protocol under review, if you realize then that you have a conflict, please identify any conflicting interests relating to any protocol on that day’s agenda. You may remain in the room for the general discussion of the protocol, but must leave the meeting room before the Board’s deliberation and vote. Your absence from the room will be recorded in the minutes of the meeting.