Items for Consideration

Conflict of Interest

The term "conflict of interest" in science refers to situations in which financial or other personal considerations may compromise, or have the appearance of compromising, an investigator's professional judgment in conducting or reporting research. The bias such conflicts may conceivably impart not only affects collection, analysis, and interpretation of data, but also the hiring of staff, procurement of specimens, sharing of results, choice of protocol, and the use of statistical methods. Conflicts of interest are particularly important to consider in biomedical and behavioral research because of the impact such conflicts can have on human health. The conduct and review of research must be managed carefully to ensure that neither individual nor institutional financial interests result in danger to subjects. The integrity and objectivity of the conduct and review of human subject research must be beyond reproach.

The PNNL definition of conflict of interest for human subject research is, "Any financial incentive or personal interest which could cause a researcher or IRB member to lose their objectivity (or create the appearance thereof) in the conduct or review of research, which in turn, may compromise the validity and integrity of the conduct or review of that research and/or negatively impact the public's trust in human subject protection at the Pacific Northwest National Laboratory."

Persons covered by the PNNL policy for reporting conflict of interest include primary research staff and IRB members, consultants and staff and the immediate family member of any of the above, including their spouse, domestic partner, children or dependents.

The mere appearance of a conflict may be just as serious and potentially damaging as an actual financial conflict. Reports of conflicts based on appearances can undermine public trust in ways that may not be adequately restored even when mitigating facts of a situation are brought to light. Apparent conflicts, therefore, should be evaluated and managed with the same vigor as known conflicts.

Conflict of interest may exist for researchers, IRB members and the institutions they represent, as well. 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.

Research Staff

All research staff is required to comply with PNNL standards for financial conflict of interest found in SBMS, Conflict of Interest ( Restricted Access to content restricted access). For example:

A staff member may not hold a significant indirect (e.g., by a member of one's immediate family) financial or management interest in another organization that Battelle does, or reasonable expects to do, business with or an organization that is a competitor of Battelle.
A staff member may not be a principal or significant investor in an organization that does, or is reasonably expected to, conduct business transactions with any Battelle component or that competes, directly or indirectly, with any Battelle component or any Battelle client.

Investigators describe financial or personal conflicts of interest in their applications for IRB review. They may also discuss potential conflicts of interest with the IRB Chair or PM prior to completing the application. In either case, the IRB Chair will inform the investigator when a conflicting interest exists that the IRB believes may cause the investigator to lose their objectivity (or create the appearance thereof) in the conduct of that research. Where the IRB determines that a conflict exists, it will table approval until the conflict has been eliminated or resolved. The IRB may take the following action(s):

Require modifications to the protocol.
Require documentation that the conflict of interest has been eliminated or resolved.
Require assignment of a different investigator.
If the conflict cannot be resolved, deny approval.

In most instances, modifications or changes to mitigate a conflict of interest must be approved by a convened IRB. The convened IRB may, at the time or original review, authorize the IRB Administrative Team to approve minor modifications under expedited review. The investigator and IRB members will be copied on the results of that review.

Conflict of Interest in SBMS ( Restricted Access to content restricted access). The IRB application form includes a section on conflict of interest. When a conflict of interest exists, the application will be tabled until the conflict has been resolved.

IRB Members, Staff and Consultants

See "The Institutional Review Board" section of this web site for details related to conflict of interest for IRB members, staff and consultants.

Institutional Conflict of Interest

The Department of Energy (DOE) has uniform contract procedures for avoiding and mitigating organizational conflicts of interest in its Management and Operations (M&O) contracts for its national laboratories. At PNNL, it is included as clause I-65 of Contract No. DE-AC05-76RLO1830, incorporating DOE Acquisition Regulation (DEAR) clause 952-209-72 (see "Conflict of Interest - Department of Energy Laboratories" (.pdf 136kb)). Also see, "The Battelle Way – Battelle Standards of Business Ethics and Conduct."