A Taxonomy of Value in Clinical Research

Medical research that involves human subjects presents what appears to be an intractable ethical problem: patients are exposed to risks in order to create valuable knowledge. A central goal of research is to produce knowledge that is important, fruitful, or that will have value. Indeed, federal regulations require that research risks be reasonable in proportion to potential benefits, and in proportion to the importance of the knowledge to be gained (45 CFR 46.111(a)(z)). Moreover, one reason that subjects participate inresearch is to produce knowledge that will benefit others

Human Experiments and National Security: The Need to Clarify Policy

On September 4, 2001, press reports indicated that the Defense Intelligence Agency of the U.S. Department of Defense (DOD) planned to reproduce a strain of anthrax virus suspected of being held in Russian laboratories. According to the same reports, the Central Intelligence Agency (CIA), under the auspices of Project Clear Vision, is engaged in building replicas of bomblets believed to have been developed by the former Soviet Union. These small bombs were designed to disperse biological agents, including anthrax. Government attorneys were said to be confident that, because these projects were designed to develop defensive measures, they were not in violation of the 1972 Biological and Toxin Weapons Convention

Juicing the Brain: Research to limit mental fatigue among soldiers may foster controversial ways to enhance any person\u27s brain

The article discusses the drugs being used to enhance performance and to limit mental fatigue among soldiers and its repercussions. It is a known fact that amphetamines such as Dexedrine are commonly prescribed to keep pilots alert even though questions have been raised about safety. The air force is considering alternatives to amphetamines, in particular a medication that has also gained the attention of long-distance business travelers, modafinil and the ampakines

The Triumph of Autonomy in Bioethics and Commercialism in American Healthcare

Justifying his proposal for health savings accounts, which would allow individuals to set aside tax-free dollars against future healthcare needs, President Bush has said that Health savings accounts all aim at empowering people to make decisions for themselves. Who could disagree with such a sentiment? Although bioethicists may be among those who express skepticism that personal health savings accounts will be part of the needed fix of our healthcare financing system, self determination has long been part of their mantra. Indeed, the field of bioethics played an important role in advancing this idea in the medical world when physician paternalism was regnant. Has its popularity caused it to become so vapid as to be ripe for misuse

DARPA On Your Mind

Think your brain is being controlled or disrupted by the Pentagon? You risk being called a nut, but the notion is not so far-fetched. Current research at the intersection of neuroscience and national security might one day produce weapons that literally boggle (or, if desired, enhance) the mind. This would give us unprecedented war-fighting superiority as well as a set of ethical dilemmas that could make genetically-modified-organism issues pale in comparison

Bioethics Inside the Beltway: IRBs Under the Microscope

The spring and summer of 1998 were seasons in the sun for institutional review board (IRB) aficionados. Rarely have the arcana of the local human subjects review panels been treated to so much attention in both the executive and the legislative branches of government, not only at the federal but also at the state level. And it looks as if the attention will continue for some time. The spate of interest is due to a series of coincidences: a powerful House of Representatives subcommittee held hearings after its chairman learned about the IRB system during a previous session on research in underdeveloped communities; the Department of Health and Human Services\u27s Inspector General (DHHS-IG) released a report on IRBs; the National Institutes of Health (NIH) Office of Extramural Research completed a report on clinical trial monitoring; the National Bioethics Advisory Commission (NBAC) readied a report on research involving persons with mental disorders; the states of Maryland and New York completed studies of research with subjects who lack decision-making capacity; and advocacy groups protested a psychiatric research project involving inner city children

Neuroethics: an agenda for neuroscience and society

The last decades of the twentieth century saw the rise of modern genetics. Now, many regard the initial decades of the twenty-first century as an era that promises explosive growth in our knowledge of the brain. Just as ethical issues have been a part of discourse in genetics from the outset, we are now paying attention to ethics in neuroscience. But whereas the ethics of genetics was in many ways a new conversation, the philosophical discussion of mental function and behaviour is an ancient tradition that both informs and complicates the emerging field of neuroethics

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