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E T H I C S F O R U M
by James L. Fozard, NIA, John J. O'Shea, NIAMS,
and Joan P. Schwartz,
NINDS (for the Committeee on Scientifics Conduct and Ethics)
CONFLICT OF INTEREST
IN PEER REVIEW:
WHERE NIH GUIDELINES LEAVE OFF
The NIH guidelines for study section members explicitly enjoin a reviewer from participating in the review of grant proposals by professional collaborators, rivals, or organizations in which she or he has a financial interest. Moreover, the NIH Guidelines for the Conduct of Research in the Intramural Research Program state that the material to be reviewed must be held confidential and not be used for the reviewers personal gain until it has been made public. Finally, the review should be based on the quality of data and logic presented, not on personal knowledge that is not available to the author or public. Most journals and granting agencies have similar guidelines and requirements.
A Hypothetical Case
However instructive they may be, there are gaps in existing guidelines on how to avoid conflicts of interest. A fictitious case study on Peer Review, used in NHGRI intramural ethics training and soon to be presented in other intramural programs, illustrates some aspects of conflict of interest that arent covered explicitly by the guidelines. For further discussion, see this Web site:
Don, a full professor and respected scientist, participated in an NIH study section. Among the grants he reviewed was one by a scientist working in the same field. His review of this grant led Don to recognizeafter the study section meetingthat his approach to research on a similar problem required major changes. Specifically, he realized that his postdoctoral fellows research project was headed toward a dead end. In addition, Don was involved in a company doing similar research.
What should Don do? What should any of us do who have experienced any of the issues mentioned in the hypothetical case? In a very lively discussion of the case held by members of the NIH Committee on Scientific Conduct and Ethics, it became clear that the case reflected what we characterized as the inherent conflict of interest created by the peer review system. Reviewers are selected because of their expertise in a specific area of science. They should agree to serve because they want to be good citizens, but in reality they also benefit from hearing about good science and innovative ideas. If there were absolutely nothing to gain from serving on a study section or reviewing manuscripts for a journal, and it was purely an act of altruism, it would undoubtedly be much more difficult to get scientists to agree to serve as reviewers.
From the outset, then, being a reviewer involves a balancing act: achieving the proper balance between applying the expertise that brought you to the study section in the first place and maintaining complete objectivity in evaluating research related to your own. Obviously, a direct competitor would be ruled out as a reviewer, but where is that fine line to be drawn?
Dons case involved a delayed recognition of conflict of interest the relevance to our own work of something we review is recognized only after the formal review process has been completed. One might react as follows: "On the basis of what I learned, I should change procedures, or do a different control in order to get the result I expect" or "This persons plan makes me more confident about what is going on in my lab."
One consequence of recognizing a conflict of interest after the fact may be the problem of competition among ethical goals created by the delayed knowledge gained by the reviewer. Again, one might ask, "Is it more important to maintain strict confidentiality or to give a hint to my postdoc that will improve or redirect his project?" Everyone agrees that providing proper guidance to fellows is an essential function of a mentor. If a mentor has information that substantially affects the success of a postdocs research, how should his/her mentoring responsibilities be weighed relative to obligations to maintain confidentiality?
Furthermore, this knowledge could save precious resources in the laboratory or institute, and we as NIH scientists have an obligation to U.S. taxpayers. If we learn that we are bound to fail with a given approach, is it appropriate to waste a fellows time and government money on it? Is there a greater standard of confidentiality when the issue involves a for-profit organization, because information generated in NIH labs must be made equally available to all?
Strategies to Avoid Inherent Conflicts of Interest
So what should we do with confidential information that we know can help us in our work? Committee members unanimously agreed that one cannot use this knowledge to help friends or to hurt competitorsor use the confidential information to give oneself or ones lab an unfair advantage. Most importantly, credit needs to be given to the person from whom the information came.
Several possible approaches came up in the discussion by the Committee. First, there is a time element to be considered. If the grant has been funded or the paper is published, credit can be given openly. Frequently these days, abstracts of papers, or abstracts from grant applications, are published on a Web site; some abstracts appear before the publication. Such information is no longer confidential, and citing it is perfectly reasonable. However, could one invite the individual to present a seminar, since he or she is likely to be a scientific colleague? If he/she voluntarily divulged the information in question, it would no longer be confidential and you could use it and credit the scientist. Or does that make use of the confidential information you have obtained, in a more subtle way? Alternatively, could one guide the postdoc without breaking confidentiality, by suggesting that ambiguous studies be rerun with additional controls, or that certain papers be reread and reconsidered? Finally, it was unanimously agreed that the wall of confidentiality was even higher when a for-profit organization was involved.
In all ethical dilemmas, such as the ones that may arise in peer review, we should deal openly with the issues. This means discussing the general problem, without violating confidentiality, with colleagues, supervisors, editors, the NIH Ombuds, etc. We should not assume that we can be objective when the stakes are high, and our own success or failure is involved; we need to turn to our colleagues for a reality check.
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