Industry, academia, investigator: managing the relationships.

Financial self-interests in medical research are again the subject of increasing public and government concern. Proposed new statutes and regulations would prescribe research conduct and oversight, as well as faculty behavior, in ways that would represent an unprecedented interposition of federal authority into areas of traditional university autonomy. Overly zealous regulation could also interdict a fruitful product development pathway of enormous benefit to public health. Yet, the universities and their academic medical centers have failed to respond sufficiently or credibly to the profound transformation of their research culture in the past two decades, which has witnessed a dramatic increase in the privatization of historically public biomedical research, and in the financial self-interests of investigators and institutions in the research they conduct. The author reviews the history of federal regulation of individual conflicts of interest in biomedical research, and examines the always-complex relationships and expectations of research universities with industry and society. While university oversight of individual conflicts of interest demands strengthening, the issues are long debated and well understood. In contrast, the financial interest of institutions in the medical research they conduct is recent, more complicated, poorly understood, and highly sensitive, involving investment decisions that lie at the heart of university autonomy. The author argues that institutions and professional societies must promulgate and enforce transparent standards of conduct, and strengthen oversight and management of financial self-interests, to avoid burdensome federal intervention and corrosive public skepticism. He concludes by reporting three promising responses from academia and major medical journals.