Correspondence

Nonfinancial Conflicts of Interest in Research

N Engl J Med 2002; 347:2173December 26, 2002

Article

To the Editor:

In his provocative article on nonfinancial conflicts of interest in research, Dr. Levinsky (Sept. 5 issue)1 wisely focuses on the ultimate danger of intrinsic conflicts of interest — that of harm to patients or healthy volunteers who participate in research.

The doctrine of informed consent embodies the ethical norm that research subjects have a right to be apprised of all reasonably foreseeable risks of their participation in research and to undertake those risks, if at all, completely voluntarily. Some commentators have recently endorsed the notion that financial conflicts of interest that are not already prohibited should be disclosed to subjects.2-6 We would go farther and propose that intrinsic conflicts be disclosed as part of the informed-consent process. This disclosure would demonstrate the seriousness of the investigators' and institutions' commitment to the safety and autonomy of research subjects. It is true that providing subjects with additional information of this nature might be cumbersome and even disruptive. Even so, we think that if subjects were informed generally about the nature of academic self-interest and encouraged to ask about issues specific to the research project that they were being invited to participate in, the informed-consent process could still run smoothly. More important, disclosure should be an integral component of any sincere and intellectually honest effort to ameliorate the problem of intrinsic conflicts of interest.

Sharmon Sollitto, J.D.
Case Western Reserve University School of Law, Cleveland, OH 44106

Stuart Youngner, M.D.
Case Western Reserve University School of Medicine, Cleveland, OH 44106

Michael M. Lederman, M.D.
Case Western Reserve University Hospitals of Cleveland, Cleveland, OH 44106

6 References

1. 1

   Levinsky NG. Nonfinancial conflicts of interest. N Engl J Med 2002;347:759-761
   Full Text | Web of Science | Medline

2. 2

   McCrary SV, Anderson CB, Jakovljevic J, et al. A national survey of policies on disclosure of conflicts of interest in biomedical research. N Engl J Med 2000;343:1621-1626
   Full Text | Web of Science | Medline

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   Cho M, Shohara R, Schissel A, Rennie D. Policies on faculty conflicts of interest at US universities. JAMA 2000;284:2203-2208
   CrossRef | Web of Science | Medline

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   Morin K, Rakatansky H, Riddick FA Jr, et al. Managing conflicts of interest in the conduct of clinical trials. JAMA 2002;287:78-84
   CrossRef | Web of Science | Medline

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   Coyle SL. Physician-industry relations. 1. Individual physicians. Ann Intern Med 2002;136:396-402
   Web of Science | Medline

6. 6

   Ethical and policy issues in research involving human participants: report and recommendations. Bethesda, Md.: National Bioethics Advisory Commission, August 2001:60.