Human Research Protection Program

HITECH Act

Conflicts of Interest

Research and the pursuit of new knowledge are considered one of the core missions of Yale University. To advance these missions, Yale is committed to ensuring that research activities are conducted properly and consistently with the principles of openness, trust, and respect for the autonomy of human subjects. Toward that end and consistent with federal regulations, Yale has formulated policies and procedures to ensure that financial and non-financial relationships with sponsors or other external entities related to the conduct or review of research do not adversely affect the rights and welfare of research volunteers or the integrity of the research.

Yale Research Community Obligations

Yale’s research community must be sensitive to the potential impacts of financial and non-financial relationships with sponsors or other external entities on the conduct or review of research and the protection of human research participants.

A conflict of interest arises when:

  • There is a divergence between an individual’s private interests, or the interests of the individual’s immediate family, and his or her professional obligations to the research.

Conflicts frequently arise due to investments or the transfer of knowledge gained through research and scholarship, such as consulting or the commercialization of technologies derived from research. While it may be appropriate for an individual to be compensated for these activities, it is never appropriate for the individual’s research-related actions or decisions to be influenced by the possibility of personal gain.

Conflicts of interest have the potential to affect, or may appear to affect:

  • The professional objectivity in the conduct of the research.
  • The ethics of the individual researcher.
  • The actions of Yale or its IRBs as institutions of public trust.

Disclosure, Management, Reduction and Elimination of Conflicts of Interest

Research team members and the IRB must work collaboratively ensure that conflicts that would otherwise compromise the protection of human research participants or the integrity of the research are managed, minimized or eliminated.

Research team members must therefore disclose to the Yale IRB any interest related to the research that is under review by the IRB. Such disclosures must be made at the time the initial protocol is submitted and at the time a request for continuing review or re-approval is submitted. Disclosures must also be made at any time conflicts related to the specific protocol are added or increased.

IRB Members are required to disclose their interests at least annually to the IRB Chair and are required to excuse themselves from deliberation of any protocol in which they have an interest.

Policies and forms