Academic medical centers and drug manufacturers have traditionally occupied very distinct positions with regard to public trust. As collaborations among medical researchers and pharmaceutical companies expand, however, worries about the aggressive pursuit of profit that has tarnished the reputation of the pharmaceutical industry may be transferred to medical institutions and clinical investigators, suggesting to some that biomedical research is more about increasing profit than promoting public health. Consequently, when medical institutions forge research collaborations with industry they should be mindful of (...) the potential for these relationships to erode public confidence in the integrity of clinical research.Recent events have heightened concerns about the financing of clinical research. These include the widely publicized deaths of several research volunteers, scandals at the nation's largest funder of biomedical research, and evidence of fabricated research findings in prominent medical journals. These unfortunate events have prompted many to re-examine strategies for managing industry relationships and the financial conflicts of interest they may create. (shrink)

Informed consent requirements for medical research have expanded over the past half-century. The Declaration of Helsinki now includes an explicit positive obligation to inform subjects about funding sources. This is problematic in a number of ways and seems to oblige researchers to disclose information irrelevant to most consent decisions. It is argued here that such a problematic obligation involves an “informational fallacy.” The aim in the second part of the paper is to provide a better approach to making sense of (...) how a failure to inform about funding sources wrongs subjects: by making appeals to obligations to refrain from misleading by omission. This alternative approach—grounded in a general obligation to refrain from misleading, an obligation that is independent of informed consent—provides a basis for a norm that protects subjects’ interests, without the informational fallacy. The approach developed here avoids the problems identified with the currently specified general obligation to inform about funding sources. (shrink)

Disclosure is a common response to conflicts of interest; it is intended to expose the conflict to scrutiny and enable it to be appropriately managed. For disclosure to be effective the receiver of the disclosure needs to be able to use the information to assess how the conflict may impact on their interests and then implement a suitable response. The act of disclosure also creates an expectation of self-regulation, as the person with the conflicting interests will be mindful of their (...) own potential biases and aware that their decisions may be monitored. This article discusses some of the problems of relying on disclosure as a solution to address conflicts of interest in research, including the added complexities around institutional conflicts of interest. The case of Dan Markingson illustrates these issues and highlights the vulnerable position relying on disclosure as a solution leaves research participants in. (shrink)

Ethicists widely accept the notion that scientists have moral responsibilities to benefit society at large. The dissemination of scientific information to the public and its political representatives is central to many of the ways in which scientists serve society. Unfortunately, the task of providing information can often give rise to moral quandaries when scientific experts participate in politically charged debates over issues that are fraught with uncertainty. This paper develops a theoretical framework for an “ethics of expertise” (EOE) based on (...) the notion that scientists have responsibilities to provide information in a way that promotes autonomous decision-making on the part of the public and its representatives. Moreover, insofar as the principle of informed consent has developed in biomedical ethics as a way for physicians to promote autonomous decision-making on the part of their patients, this paper suggests that the informed-consent concept may suggest a set of criteria and guidelines that can help scientists to fulfill their similar ethical responsibilities to the public. In order to illustrate how the resulting EOE could provide practical guidance for scientific experts, the paper examines a case study involving the dissemination of information about the low-dose biological effects of toxic chemicals and carcinogens. (shrink)