Conflict of Interest

Several types of conflict of interest come up in connection with human subjects review.

Conflict of interest may arise either for researchers or Human Subjects Review Committee members; for either group, the conflict may arise either from financial or from other reasons. Because of the range and potential complexity of conflict of interest issues, it is not possible to provide an exhaustive treatment of them here; the following points, however, should clarify the nature of the concerns involved.

Researchers

Financial conflict of interest:

University of Washington policy and procedures about financial conflict of interest are described in Grants and Contracts Information Memorandum GIM 10, "Significant financial Interest Disclosure Policy".

The Human Subjects Review Committee application form includes a question asking specifically whether there is any financial conflict of interest on the part of any of the researchers or co-investigators involved in the research activity being reviewed. When there is such a conflict of interest, an application will not undergo review until the Human Subjects Review Committee has been notified by the University that the conflict has been resolved successfully within the requirements of federal and state law and University policy.

Non-financial conflict of interest
Researchers may find themselves in non-financial conflicts of interest when conducting research. This can occur in situations that may lead to undue pressure or coercion on subjects during the recruitment, consent, or data collection activities. For example, suppose a researcher were to recruit his or her students or employees as subjects in a research activity. These (prospective) subjects might feel that their status as students or employees could be affected negatively if they refused to participate in the study. Therefore, unless there is a compelling scientific reason, the Human Subjects Review Committees will not allow researchers to recruit subjects with whom they have a supervisory or evaluative relationship.

A similar problem may arise when practitioners seek to recruit their own clients into research studies. In these cases, the Human Subjects Review Committee will evaluate whether it is possible for the researcher-practitioner to recruit subjects from outside his or her practice. If this is not possible, then the Committees will assist the researcher in creating recruitment and consenting procedures that minimize the risk that subjects will feel pressured into participating in the research. For example, instead of recruiting subjects face-to-face, a researcher-practitioner may post a flyer in the clinic office inviting interested clients to contact the researcher to learn more about participating in the study. Alternatively, the practitioner-researcher may delegate the recruitment and consenting procedures to a person who is not involved in the client’s care.

Human Subjects Review Committee members

The foregoing financial and personal conflicts may also arise for members of Human Subjects Review Committees. The federal regulations under which the University’s Human Subjects Review Committees operate (45 CFR 46.107(e)) states, "No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB."

The University of Washington Human Subjects Review Committees interpret this regulation in a broad way to include not only financial conflict of interest, but personal conflict of interest as well. It is the responsibility of members to bring to the attention of the Committee if they are in a conflict of interest situation. The Committee determines on a case-by-case basis whether the member in question may be present for the discussion of the application in question. This decision is based on the type of conflict and the kind of information that a member has about the application. For example, suppose the researcher is a protégé of the member who, therefore, determines that he or she is "too close" to the researcher to render an independent judgment about the safety and ethics of the research. But suppose that the member is also the only one in the group who is able to explain the project and assist the Committee in appropriately framing questions for the researcher. In this situation, the member may be asked to remain for the discussion, but to absent him or herself from the vote. In no case may the member in conflict be present for the vote.