The protection of human subjects in biomedical research relies on two principal mechanisms: assessing and comparing the risks and potential benefits of proposed research, and obtaining potential subjects' informed consent. While these have been discussed extensively in the literature, no attention has been paid to whether the processes should be different when the objective of an experimental biomedical intervention is to improve individual appearance, performance, or capability rather than to prevent, cure, or mitigate disease . This essay examines this question (...) in order to ensure that subjects in biomedical enhancement research receive adequate protection. (shrink)

: Protection of human subjects from investigators' conflicts of interest is critical to the integrity of clinical investigation. Personal financial conflicts of interest are addressed by university policies, professional society guidelines, publication standards, and government regulation, but "intrinsic conflicts of interest"—conflicts of interest inherent in all clinical research—have received relatively less attention. Such conflicts arise in all clinical research endeavors as a result of the tension among professionals' responsibilities to their research and to their patients and both academic and financial (...) incentives. These conflicts should be disclosed to research subjects and managed as assiduously as are financial conflicts of interest. (shrink)

Purpose: This review identifies the prominent topics in the literature pertaining to the ethical, legal, and social issues raised by research investigating personalized genomic medicine. Methods: The abstracts of 953 articles extracted from scholarly databases and published during a 5-year period were reviewed. A total of 299 articles met our research criteria and were organized thematically to assess the representation of ELSI issues for stakeholders, health specialties, journals, and empirical studies. Results: ELSI analyses were published in both scientific and ethics (...) journals. Investigational research comprised 45% of the literature reviewed and the remaining 55% comprised normative analyses. Traditional ELSI concerns dominated the discourse including discussions about disclosure of research results. In fact, there was a dramatic increase in the number of articles focused on the disclosure of research results and incidental findings to research participants. Few papers focused on particular disorders, the use of racial categories in research, international communities, or special populations. Conclusion: Considering that strategies in personalized medicine increasingly target individuals’ unique health conditions, environments, and ancestries, further analysis is needed on how ELSI scholarship can better serve the increasingly global, interdisciplinary, and diverse PGM research community. (shrink)

There are two critical steps in determining whether a medical experiment involving human subjects can be conducted in an ethical manner: assessing risks and potential benefits and obtaining potential subjects’ informed consent. Although an extensive literature on both of these aspects exists, virtually nothing has been written about human experimentation for which the objective is not to prevent, cure, or mitigate a disease or condition, but to enhance human capabilities. One exception is a 2004 article by Rebecca Dresser on preimplantation (...) genetic modification — one of the most controversial enhancement technologies — in which she states, “Under existing research ethics principles, it would be unethical for investigators to perform modifications exposing embryos expected to develop into healthy children to significant risk in exchange for a possible physical or mental enhancement.” But Dresser does not explain why such an experiment would be unethical under existing principles, and her conclusion is not self-evident. (shrink)

: All three main articles in the issues of the Kennedy Institute of Ethics Journal endorse the view that genetic enhancement should be permitted, including human germ-line genetic enhancement. However, unregulated, wealth-based access to genetic enhancement in general, and germ-line enhancement in particular, would create intolerable risks for society. Although there are a number of practical problems raised by proposals to regulate or restrict access to genetic enhancement, which will make it difficult if not impossible to muster support for any (...) effective restrictions until we begin to experience the societal problems that genetic enhancement will create, it is important to consider now what restrictions would be appropriate, how they would be imposed, and what changes would be needed in existing laws and institutions to facilitate them. Without this type of groundwork, there is no way society will be in a position to act in time. (shrink)

The United States, along with other nations and international organizations, has developed an elaborate system of ethical norms and legal rules to govern biomedical research using human subjects. These policies govern research that might provide direct health benefits to participants and research in which there is no prospect for participant health benefits. There has been little discussion, however, about how well these rules would apply to research designed to improve participants’ capabilities or characteristics beyond the goal of good health. When (...) mentioned at all in the literature, this so-called enhancement research, as opposed to research aimed at diagnosing, preventing, curing, or treating illnesses or medical conditions, is usually dismissed without explanation. (shrink)

American medicine has long sought to control the standard of care that physicians are expected to provide to their patients. One effort to insulate the standard of care from external interference, called a “safe harbors” approach, would enable physicians to avoid liability for malpractice if they adhered to medical practice guidelines. The idea is to eliminate the “battle of experts” and reduce defensive medicine by requiring judges and juries to accept guidelines as conclusive evidence of the standard of care. Yet (...) current efforts to improve the guideline development process, including the use of evidence-based guidelines, are unlikely to be able to overcome the shortcomings that led a similar safe harbors initiative to fail in the early 1990s. Moreover, there is no adequate justification for conferring this degree of self-regulatory power on the medical profession. (shrink)

The idea that physicians should accept recommendations from learned colleagues on how to practice medicine is probably as old as medicine itself, but beginning around 1990, it took on new urgency in the face of rising health care costs, widespread, unjustifiable variation in practice patterns, concerns about medical errors and quality of care, and what some perceived to be perverse effects of the malpractice system. One solution put forward was practice guidelines, which the Institute of Medicine defined as systematically developed (...) statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. (shrink)

A widely accepted framework governs biomedical research and the practice of medicine in the civilian sector, but no such framework exists to guide the military in how it should treat its own personnel. Civilian bioethical principles are unsuitable because of fundamental differences between civilian and military core values. This paper proposes a framework for military bioethics. It begins by describing core military values, articulating how they differ from civilian goals and values, and explaining how these differences limit the ability of (...) civilian bioethical principles to govern military biomedicine. The paper then puts forward a set of more appropriate principles for the military and discusses how these principles apply in three main areas of controversy within military bioethics: the use of military personnel as research subjects; the deployment use of biomedical agents; and the obligations of military physicians toward their own troops. (shrink)

The ability of patients to trust physicians to act in their best interests is a critical aspect of a welfare-maximizing relationship. This commentary discusses physician trustworthiness within the framework of the Affordable Care Act and considers steps to reinforce trustworthy behavior.

Patients with insufficient financial resources place physicians in a conflict of interest between the patients' needs and the financial interests of the physician, other patients, and society. Not only must physicians act ethically, but they must avoid liability for violating their legal duties to their patients. The traditional rules of contract and malpractice law that govern the patient-physician relationship do not provide satisfactory guidelines. Better answers are found in the rules of fiduciary law, but only with regard to direct conflicts (...) between patients and physicians and only at the risk of reducing patient access to care. Certain types of legislative action can resolve these conflicts by altering the traditional legal rules, but care must be taken to preserve patient-physician trust, which the legal rules were designed to enhance. (shrink)

Opponents of reproductive choice are attempting to limit reproductive decisions based on certain underlying reasons. This commentary explores the rationales for these limitations and the objections to them. It concludes that reasoned-based limitations are unsupportable and unenforceable.

“Wrongful birth” is a controversial malpractice action, which has arisen in the past two decades, secondary to an expanding knowledge of human genetics and the constitutionally protected access to abortion. Under the wrongful birth claim, parents of a child with a congenital illness or abnormality may bring suit against a physician who allegedly failed to provide appropriate prenatal counseling or information. Typically, the parents claim that they were inadequately warned of a potential problem in their child, and that this paucity (...) of timely information prevented them from avoiding the pregnancy or from obtaining an abortion. While these cases have arisen in a variety of clinical circumstances, a characteristic example is the obstetrician who fails to offer amniocentesis to a woman of advanced maternal age who subsequently gives birth to a child with Down syndrome. Since the parents were prevented from learning of the abnormality and therefore exercising the option to terminate the pregnancy, they may claim damages for themselves for the wrongful birth of the infant. (shrink)

“Wrongful birth” is a controversial malpractice action, which has arisen in the past two decades, secondary to an expanding knowledge of human genetics and the constitutionally protected access to abortion. Under the wrongful birth claim, parents of a child with a congenital illness or abnormality may bring suit against a physician who allegedly failed to provide appropriate prenatal counseling or information. Typically, the parents claim that they were inadequately warned of a potential problem in their child, and that this paucity (...) of timely information prevented them from avoiding the pregnancy or from obtaining an abortion. While these cases have arisen in a variety of clinical circumstances, a characteristic example is the obstetrician who fails to offer amniocentesis to a woman of advanced maternal age who subsequently gives birth to a child with Down syndrome. Since the parents were prevented from learning of the abnormality and therefore exercising the option to terminate the pregnancy, they may claim damages for themselves for the wrongful birth of the infant. (shrink)