Under the Financial Conflict of Interest in Research Policy, an investigator may appeal:
- A determination that a financial conflict of interest in research exists with a specific research project
- A step in a management plan
- A determination of non-compliance
Appealing a Determination of a Financial Conflict of Interest in Research or a Step in a Management Plan
Within 14 days of receiving the draft management plan, the investigator sends an appeal request by email to the Associate Director of Conflicts of Interest and Export Controls. The request must identify the investigator’s position, the decision being challenged (either the determination or a step in the management plan), and one of the following grounds for appeal:
Procedural error: Failure to comply with the Financial Conflict of Interest in Research Policy and standard operating procedures and such procedural error more than likely would have changed the outcome of the decision. Appeals based on procedural error may include claims that a decisionmaker had a conflict of interest or bias that affected the outcome of the matter.
Unreasonable outcome: The decision that an activity constitutes a conflict, the decision that the outside relationship must be severed, or the management plan is unduly burdensome based on the evidence provided.
New information: New information not previously known to the investigator would more than likely change the decision.
- The Associate Director shares the appeal with the Conflict of Interest in Research Committee (COIRC). The COIRC hears the appeal at the next monthly meeting and makes a final determination. Absent extenuating circumstances, the COIRC will issue a decision within forty-five (45) days of receipt of the appeal.
- Within 5 days of the COIRC’s final determination, the Associate Director notifies the investigator of the final determination. The Conflict of Interest Office may notify the sponsor, if/as required.
Appealing a Determination of Non-compliance
Within 60 days of receiving information relating to an investigator’s potential non-compliance with the Financial Conflict of Interest in Research Policy, the Associate Director of Conflicts of Interest and Export Controls works with the Conflict of Interest in Research Committee (COIRC) to gather necessary information to make a non-compliance determination. If, based on the information gathered, the COIRC determines non-compliance did occur, the Associate Director notifies the investigator.
Identification of non-compliance can happen through various channels, such as a self-report, report by a supervisor or unit leadership, report received by the ethics hotline, or report received by Employee and Labor Relations.
Gathering necessary information to determine non-compliance may include conferring with Employee and Labor Relations, Office of the General Counsel, the investigator, the investigator’s supervisor, the investigator’s unit leadership, and/or others who may have relevant information.
The investigator has 14 days from receipt of the notification of non-compliance to submit an appeal by email to the Associate Director of Conflicts of Interest and Export Controls. The appeal request must identify the investigator’s position on the issue and one of the following grounds for appeal:
Procedural error: Failure to comply with the Financial Conflict of Interest in Research Policy and standard operating procedures and such procedural error more than likely would have changed the outcome of the decision. Appeals based on procedural error may include claims that a decisionmaker had a conflict of interest or bias that affected the outcome of the matter.
Unreasonable outcome: The decision that an activity constitutes a conflict, the decision that the outside relationship must be severed, or the management plan is unduly burdensome based on the evidence provided.
New information: New information not previously known to the investigator would more than likely change the decision.
- Within 45 days of receiving the appeal, the Associate Director and the COIRC review the appeal and gather additional information if/as needed. The COIRC then presents the appeal and its recommendation to the Associate Vice President of Research Integrity.
- Concurrently, within 7 days of receiving the appeal, the COIRC identifies interim measures the investigator must implement in the research to preserve the objectivity of the research and/or protection of human subjects until the appeals process is complete.
- The Associate Vice President of Research Integrity has 5 days from receipt of the appeal to make a final determination of non-compliance and notify the investigator.
The COIRC then completes a retrospective review following the process described in non-compliance.