Issue: 59 Food and Drug Law Journal 45-78 (2004).
The conduct of clinical trials, once the exclusive province of the academic research institution, has made significant inroads into the private practice setting over the past several years, and private practice physicians increasingly find themselves balancing the best interests of the patient against the potential financial conflicts of interest that arise in the research setting. The private practice physician who engages in clinical trials must juggle his duty as a clinician, which first and foremost must be to safeguard the patient’s health and welfare, against his duty as a researcher, which, by its nature, subordinates the best interests of the patient to the interests of the research study. This article examines the potential conflict that arises when clinical trials are imported into the private practice setting and the effect that this might have on the doctor-patient relationship. After looking at the history of informed consent and financial conflicts of interest in both the private practice and research settings, this article offers a number of safeguards to ensure that adequate disclosure of any potential financial conflicts of interest that might affect the physician’s judgment is provided to the patient in order to protect his or her deliberative autonomy.