Conflicts of interest: conceptual and normative issues.

Growing university-industry ties, particularly in biomedical areas, naturally raise concerns about conflicts of interest. Such conflicts are essentially problems in business and professional ethics. As of the fall of 1995, all institutions seeking funding from either the Public Health Service or the National Science Foundation have been required to maintain and enforce a written policy on conflicts of interest. The PHS and the NSF also require the disclosure of "significant" financial interests that might affect the research. Although the PHS and NSF requirements may prove helpful, they are not sufficient for monitoring the full range of serious conflicts of interest that can arise in university-industry relations. The PHS and the NSF are basically concerned with potential bias in the design, conduct, and reporting of research. Their disclosure requirements are restricted to financial considerations of $10,000 or more. However, bias in research can result from conflicts of interest when much less is at stake financially. Furthermore, it can arise at both individual and institutional levels. This article attempts to provide a conceptual and normative analysis of conflicts of interest that better enables us to understand the subtleties that can be involved. This article is one of three in this issue of Academic Medicine that deal with issues of conflict of interest in university-industry research relationships. These articles are discussed in an overview that precedes them.