Patient Outcomes Research Teams (PORTS): Managing Conflict of Interest

of commitment¹ occur ubiquitously and unavoidably in professional life where the ''coin of the realm'' is some admixture of influence and power as manifested in personal prestige and career advancement, commitment to teaching, and furtherance of the activities of a research program, a university department, or the university itself. These professional conflicts of interest need not be conscious decisions on the part of the investigator; nevertheless, intellectual attachment or commitment to a particular scientific theory may pose some possible conflicts. All such interests may affect professional judgment and actions and thus constitute broader concerns than simply financial conflicts of interest.

Several definitions of conflict of interest reviewed by the committee placed particular weight on the financial aspects of such conflicts. ² The committee took particular note of definitions of conflicts of interest that also addressed nonfinancial conflicts. The American Medical Association's Councils on Scientific Affairs and on Ethical and Judicial Affairs (1990) derived their definition of conflict of interest from Webster's Third New International Dictionary: a "conflict between private interests and official responsibilities of a person in a position of trust." This definition stresses private versus public interests where there is fiduciary responsibility. Similarly, the Association of Academic Health Centers (AAHC, 1990:7) offers the following: "A potential or actual conflict of interest exists when legal obligations or widely recognized professional norms are likely to be compromised by a person's other interests, particularly if those interests are not disclosed." This definition expands upon fiduciary responsibility by including legal and professional responsibilities, and it further implies that nondisclosure exacerbates the effect of a conflict of interest.

As faculty members, most university researchers have a primary responsibility to the interests of the university (teaching, research, and possibly patient care). Conflicts of commitment arise when consulting arrangements or other outside ties, such as involvement with professional societies and participation on review panels, interfere with obligations to the university or receive undue benefit from investigators' research.

For instance, at the workshop convened by the IOM committee, one participant suggested that conflicts of interest are "any interests, mainly any financial interests, that mitigate a researcher's desire to tell the truth about what he has found in his research." The definition of conflict of interest used by the National Research Council also stresses financial aspects: "any financial or other interest which . . . (1) could impair the individual's objectivity or (2) could create an unfair competitive advantage for any person or organization" (National Research Council, 1989:5–6). Likewise, the Harvard Medical Center recently approved guidelines that refer specifically to financial interests and relate them to faculty research. The relevant section says, in part: "[C]onflicts arise from a faculty member's opportunities to benefit financially either from the outcome of his or her research or from the legitimate activities conducted in the course of his responsibilities as a faculty member."

Table of Contents

Front Matter R1-R12

Summary 1-8

1 Introduction 9-12

2 Patient Outcomes Research Teams 13-26

3 Conflict of Interest 27-46

4 Sources of Special Concern about Conflicts of Interest in PORTS 47-60

5 Managing Conflicts of Interest: General Models and Approaches 61-68

6 Points to Consider 69-92

References 93-98

Appendix A Agenda and Summary of IOM Invitational Workshop 99-103

Appendix B Workshop Participants 104-109

Appendix C Scenarios and Rapporteur Summaries 110-124

Appendix D Background Papers and Presentations 125-170