FCOI Guidance on Research Involving Human Participants

Guidelines for Involving Human Participants

When submitting the required COI report through RASS-COI, consider the following questions:

• Does the research you participate in involve human participants? 
• Do you have a financial relationship with a company or organization that is funding your research, directly involved in your research, or otherwise might benefit from your research?

Consistent with University Policy 1.7, in the event that a conflict of interest exists that is related to human participant research, a conflict management plan (CMP) must be put into place, and must include additional protections for human participants. The Cornell Institutional Review Board (IRB), which is responsible for ensuring that the interests of research participants are protected, has the final authority in determining the conditions under which such research is allowable. In such cases, at minimum, the restrictions listed below must be implemented in order for research to be potentially approved by the IRB. In exceptional cases, the FCOI Committee and the IRB may elect to waive some of these restrictions if they believe that these conditions will not be in the best interests of the human participants:

• The conflicted researcher may not serve as the principal investigator (PI) for the research. Another individual who does not report to the researcher and does not have a financial interest in the company must serve as the PI.
• The researcher may not be involved in the informed consent or data/sample collection processes with participants.
• In some instances, including clinical trials, the data may need to go through an independent review by a third party approved by the FCOI Committee.
• During the informed consent process, participants must be informed of the researcher’s relationship with the entity and, if relevant, of the steps that are being taken to protect their interests and the integrity of the research.

The CMP must be put into place before conflicted research personnel can participate in the design or conduct of the research, enrollment of participants, or analysis of the results. For new projects, the IRB protocol will only be approved once the CMP has been implemented. For previously-approved projects where a new conflict has arisen, the protocol’s IRB approval will be paused until the CMP has been implemented. Failure to abide by the terms laid out in a CMP may result in sanctions for non-compliance with Cornell policy. 

If you have questions, please write to the COI and IRB offices via coi@cornell.edu and irbhp@cornell.edu.