I. Introduction: Relational Duties And Regulatory Duties
Money seems to have supplanted state power as the principal concern of biomedical research ethics. Each year brings new illustrations of the tension between financial flows and the moral and legal duties of academic researchers1:
* A young man dies after university-based physicians with a commercial stake in a novel gene therapy ignore warning signs when enrolling research subjects to test the procedure.2
* A pharmaceutical company pressures a university to which it has promised a large gift to demote a researcher who had published research casting the company's products in a negative light.3
* A pharmaceutical company attempts to prevent a university researcher from reporting that, contrary to expectations, its proprietary formulation of a human hormone is not superior to cheaper generics.4
* Another pharmaceutical company pressures the university researchers with whom it has contracts not to publish findings that antidepressant drugs are ineffective and may increase the risk of suicide.5
* A prominent health care provider conducts clinical trials on a new use of a Food and Drug Administration (FDA)-approved radiofrequency ablation device in which the health care provider itself, its physician-CEO, and others had invested. The health care provider publishes its results in peer-reviewed journals, and treats over 1,000 patients with the device "off-label."6
These are serious situations that demand a response from the scientific establishment, the health care professions, and the government. Poorly conducted or managed research can harm research subjects, bias research outcomes, delay dissemination of useful research products, and threaten public trust in, and support of, science.
This Article challenges the legal and ethical language of the response that is occurring and the implications of that language - not the underlying need for current action or future vigilance. Criticism of financial relationships involving biomedical research has been widespread, with individuals, professional associations, and government entities universally labeling them "conflicts of interest." In 2004, the U.S. Department of Health and Human Services issued a detailed guidance document regarding financial conflicts of interest in medical research.7 The guidance includes points for consideration by research institutions, institutional review boards (IRBs), and individual researchers in constituting themselves and with respect to the design and review of specific research protocols. Measures recommended to manage a financial interest include reducing or eliminating the interest, disclosing it to prospective subjects, separating financial from research decisions, independently monitoring research, and modifying the roles for particular individuals or the location of certain activities. In response to such mandates, or as a result of collective professional deliberation, academic research organizations have directed their IRBs to examine research proposals for conflicts of interest, and have chartered conflicts of interest committees to monitor individual and institutional behavior. In general, these bodies are expected to know a conflict of interest when they see one.
The current discussion of research conflicts builds on prior controversies over the commercialization of medicine, most recently involving managed care. In addition to reviewing the medical necessity of treatment, health insurers in the 1980s and 1990s began structuring financial incentives for physicians to promote cost-consciousness in the choice of treatment. Although health policy commentators generally accept the need for fairly allocating scarce resources among needy patients, vesting rationing authority in private insurance companies, which were often commercial enterprises, did not sit easily with the medical profession or the public. Many regarded capitated payment, even seen in its best light, as promoting a population-based medical ethic that was incompatible with the bond between individual physicians and patients that characterized traditional medical ethics. …