Faculty Bibliography

Doctors use their judgment and experience all the time to recommend things to patients that regulatory bodies have not approved or that their peers might think inadvisable: "Yes, there are risks involved, but I don't wear a helmet when I ride my motorcycle, and I understand if you don't want to, either." Especially when they speak on TV. Because lives hang in the balance, medical speech is held to a higher standard

In November, Ebola was still a major public-health threat in West Africa, with thousands of new cases; many deaths, including local doctors, nurses, and gravediggers; economies in shambles; and orphans all over the place. But America's moral vision didn't extend beyond its borders, and Americans' attention spans had maxed out after about a month of coverage. Here, Caplan cites some lessons to be learned from Ebola

STUDY OBJECTIVE: Frequent emergency department (ED) users with severe alcohol use disorders are often excluded from research, in part because assessing capacity to provide consent is challenging. We aim to assess the feasibility of using the University of California, San Diego Brief Assessment of Capacity to Consent, a 5-minute, easy-to-use, validated instrument, to screen for capacity to consent for research in frequent ED users with severe alcohol use disorders. METHODS: We prospectively enrolled a convenience sample of 20 adults to assess their capacity to provide consent for participation in 30-minute mixed-methods interviews using the 10-question University of California, San Diego Brief Assessment of Capacity to Consent. Participants were identified through an administrative database, had greater than 4 annual ED visits for 2 years, and had severe alcohol use disorders. The study was conducted with institutional review board approval from March to July 2013 in an urban, public, university ED receiving approximately 120,000 visits per year. Blood alcohol concentration and demographic data were extracted from the medical record. RESULTS: We completed assessments for 19 of 20 participants. One was removed because of agitation. Sixteen of 19 participants passed each question and were deemed capable of providing informed consent. Interventions to improve understanding (prompting and material review) were required for 15 of 19 participants. The mean duration to describe the study and perform the assessment was 10.4 minutes (SD 3 minutes). The mean blood alcohol concentration was 211.5 mg/dL (SD 137.4 mg/dL). The 3 patients unable to demonstrate capacity had blood alcohol concentrations of 226 and 348 mg/dL, with 1 not obtained. CONCLUSION: This pilot study supports the feasibility of using the University of California, San Diego Brief Assessment of Capacity to Consent to assess capacity of frequent ED users with severe alcohol use disorders to participate in research. Blood alcohol concentration was not correlated with capacity.

The media, his colleagues and public health folks seem willing to give the leader of the House a pass on his tanning obsession. Because tanning, especially indoor tanning, is a major cause of cancer and death in America and around the world

How did bioethics manage to grow, flourish and ultimately do so well from a very unpromising birth in the 1970s? Many explanations have been advanced. Some ascribe the field's growth to a puzzling, voluntary abnegation of moral authority by medicine to non-physicians. Some think bioethics survived by selling out to the biomedical establishment-public and private. This transaction involved bestowing moral approbation on all manner of biomedicine's doings for a seat at a well-stocked funding table. Some see a sort of clever intellectual bamboozlement at work wherein bioethicists pitched a moral elixir of objective expertise that the morally needy but unsophisticated in medicine and the biological sciences were eager to swallow. While each of these reasons has its defenders, I think the main reason that bioethics did well was that it did good. By using the media to move into the public arena, the field engaged the public imagination, provoked dialogue and debate, and contributed to policy changes that benefitted patients and healthcare providers.

There are competing ethical concerns when it comes to designing any clinical research study. Clinical trials of possible treatments for Ebola virus are no exception. If anything, the competing ethical concerns are exacerbated in trying to find answers to a deadly, rapidly spreading, infectious disease. The primary goal of current research is to identify experimental therapies that can cure Ebola or cure it with reasonable probability in infected individuals. Pursuit of that goal must be methodologically sound, practical and consistent with prevailing norms governing human subjects research. Some maintain that only randomized controlled trials (RCTs) with a placebo or standard-of-care arm can meet these conditions. We maintain that there are alternative trial designs that can do so as well and that sometimes these are preferable to RCTs.