Goodbye to All That: The End to Moderate Protectionism in Human Subjects Research

Federal policies on human research subjects have undergone a progressive transformation. In the early decades of the twentieth century, federal policies largely relied on the discretion of investigators to decide when and how to conduct research. This approach gradually gave way to policies that augmented investigator discretion with externally imposed protections. We may now be entering an era of even more stringent external protections. Whether the new policies effectively absolve investigators of personal responsibility for conducting ethical research, and whether it is wise to do so, remains to be seen

Critical Issues Concerning Research Involving Decisionally Impaired Persons

This is a working paper prepared by staff to the Human Subjects Subcommittee of the National Bioethics Advisory Commission (NBAC). At the request of the subcommittee, the paper attempts to set out the critical issues facing the commissioners concerning the recruitment and participation in clinical research of those who are decisionally impaired

Acid Brothers: Henry Beecher, Timothy Leary, and the psychedelic of the century

Henry Knowles Beecher, an icon of human research ethics, and Timothy Francis Leary, a guru of the counterculture, are bound together in history by the synthetic hallucinogen lysergic acid diethylamide (LSD). Both were associated with Harvard University during a critical period in their careers and of drastic social change. To all appearances the first was a paragon of the establishment and a constructive if complex hero, the second a rebel and a criminal, a rogue and a scoundrel. Although there is no evidence they ever met, Beecher’s indirect struggle with Leary over control of the 20th century’s most celebrated psychedelic was at the very heart of his views about the legitimate, responsible investigator.That struggle also proves to be a revealing bellwether of the increasingly formalized scrutiny of human experiments that was then taking shape

Protectionism in Research Involving Human Subjects

In the ethics of human subjects research, protectionism is the doctrine that human beings should be protected from the risks of participation in research. Evidently, unless one believes that scientific progress always trumps the interests of human subjects, protectionism per se is hardly a controversial view. Controversy enters mainly when several nuanced interpretations of the doctrine are distinguished with an eye toward its application to actual research projects

Making Sense of Consensus: Responses to Engelhardt, Hester, Kuczewski, Trotter, and Zoloth

It has been a pleasure to read these papers and to contemplate their importance for what I believe to be a useful and provocative prism though which to view the field of bioethics: the nature of moral consensus. In my own most extended contribution to this literature, Deciding Together, I did not attempt to prescribe so much as to understand the role of moral consensus in the practice of bioethics. At the end of the book, I expressed the hope that it might help trigger an examination of bioethics and moral consensus. Though a few others shared my interest at that time (in particular Tris Engelhardt, for whose early encouragement I remain deeply grateful), with this set of stimulating papers the conversation has finally begun in earnest

A molecularly detailed Na V 1.5 model reveals a new Class I antiarrhythmic target

Antiarrhythmic treatment strategies remain suboptimal due to our inability to predict how drug interactions with ion channels will affect the ability of the tissues to initiate and sustain an arrhythmia. We built a multiscale molecular model of the N