Financial conflicts of interest in human subjects research: Proposals for a more effective regulatory scheme

Washington and Lee Law Review, Winter 2003 by Jordan, Karen A

I. Introduction

Human participants' need for protection in research received substantial attention in the late 1960s and early 1970s because of public disclosure of abuses in research.1 After substantial study, the National Commission for Protection in Human Subjects of Biomedical and Behavioral Research (NCPHS) made numerous substantive and procedural recommendations for a process that would help ensure that research projects involving human participants were appropriately designed and carried out.2 In response, the federal government enacted regulations that require institutions to assure federal agencies that their researchers will obtain both approval of research procedures by an institutional review board (IRB) before commencing the research project and written informed consent from research participants throughout the project.3 Those regulations were well received, and, as one commentator has noted, "everything seemed settled" by the 1980s.4

However, the environment for biomedical/biotechnology research involving human participants has changed in the last two decades and the discussion of how to improve the process of protecting human research participants has again moved to the forefront of the debate.5 Indeed, a flurry of activity by federal regulators, the research community and scholars has recently taken place as concerns stemming from the changing research environment have come to light.6 The changes in the research environment include more competition for research money and an increased commercialization of research. Together, the changes have resulted in a more entrepreneurial approach to research and development of innovative medical treatments, techniques, drugs, and devices such as surgical or diagnostic instruments.

An entrepreneurial approach to research means that scientists conduct research with an emphasis on commercial applications and generating revenue for the institution as well as for individual researchers.7 Through cooperative arrangements with for-profit businesses and industries, university research is more quickly transferred into the private market, and institutions and researchers share in the profits. The approach leads to an environment that is competitive, fast-paced, and laced with more tangible financial conflicts of interest arising at multiple points throughout the research process. The existence of financial conflicts of interest is not unique to the biomedical/biotechnology research arenas. But, because biomedical/biotechnology research more often involves human participants, financial conflicts of interest in this arena and the incentives they create must meet a higher level of scrutiny.8

Importantly, the entrepreneurial factor is present within the community of academic medical centers, where the majority of biomedical/biotechnology research has traditionally occurred, as well as in the growing for-profit experimentation industry. The for-profit experimentation industry, involving "human experimentation corporations" that aggressively recruit research participants and use independent for-profit IRBs, presents unique and pressing regulatory problems.9 However, this Article addresses the entrepreneurial factor within academic medical centers. In particular, this Article focuses on the increasing concern about conflicts of interest arising from financial arrangements between commercial entities and university-based research centers and their researchers.

Financial conflicts of interest within the academic research environment present a more difficult regulatory dilemma because of the general integrity of the academic community. Regulatory agencies historically have trusted the academic research community to oversee the research process and to ensure protection for human research participants. The increasing use of the research process to generate profits for universities and their researchers does not mean that the academic community can no longer be trusted. However, it does mean that universities and their researchers are operating under significant conflicts of interest more frequently than they previously had. Accordingly, the key federal agencies overseeing research involving human participants-the Department of Health and Human Services and the Food and Drug Administration-have an obligation to the public to preserve complete integrity and objectivity in research involving human participants, as well as the perception of complete integrity and objectivity.

The federal agencies have recognized this need and initiated discussions with the academic research community. A consensus exists among agencies and universities that something should be done to temper any potential negative consequences flowing from the rampant financial conflicts of interest facing researchers and institutions. However, little consensus has emerged as to the proper way to address the problem. This Article hopes to advance the discussion. The Article first reviews the problem of financial conflicts of interest and the inadequacies of the current regulatory regime in relation to that problem. The Article then outlines some of the emerging initiatives at the federal and institutional levels. Finally, the Article identifies deficiencies in those initiatives and offers suggestions for more comprehensive and effective regulatory intervention.