As science learns more about how the brain works, and fails to work, the possibility for developing “cognition enhancers” becomes more plausible. And the demand for drugs that can help us think faster, remember more, and focus more keenly has already been demonstrated by the market success of drugs like Ritalin, which tames the attention span, and Prozac, which ups the competitive edge. The new drug Aricept, which improves memory, most likely will join them. Whether such drugs are good for (...) individuals, or for society, is an open question, one that demands far more public discussion. (shrink)

Slowing the aging process would be one of the most dramatic and momentous ways of enhancing human beings. It is also one that mainstream science is on the brink of pursuing. The state of the science, together with its possible impact, make it an important example for how to think about research into all enhancement technologies.

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)

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)

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)

: 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)

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)

: 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)

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)

“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)

In lieu of an abstract, here is a brief excerpt of the content:LettersMaxwell J. Mehlman, Susan R. Massey, Ronald M. Green, and Fred RosnerPhysicians and the Allocation of Scarce ResourcesMadam: We read with interest Dr. Pellegrino's commentary on our article in the December 1994 issue of the Kennedy Institute of Ethics Journal, and commend him for pointing out so well the different ways that law and ethics approach the issue of physician allocation of scarce resources.We wish to make one clarification. (...) Dr. Pellegrino states that we propose that fiduciary duties be abolished. Quite the contrary, our position is that fiduciary obligations are essential to the maintenance of trust—which we believe to be an efficient as well as an ethical element of the patient-provider relationship. If fiduciary duties are undercut, as we pointed out they are by the Oregon Medicaid legislation, then some other method of promoting trust must be established, and, as we point out in the article, it is difficult to identify what that method could be.Maxwell J. MehlmanandSusan R. MasseyThe Law Medicine CenterArter & HaddenCase Western Reserve UniversityCleveland, OHSchool of LawCleveland, OHReport of the Human Embryo Research PanelMadam: In the December 1994 issue of the Kennedy Institute of Ethics Journal, I reported on the controversy surrounding the work of the NIH Human Embryo Research Panel and the conclusions reached in its report, which was formally presented to NIH Director Harold Varmus on September 27, 1994. At that time, the report was to be reviewed by the Advisory Committee to the Director (ACD) until its next meeting in early December. I am writing to update your readers on the fate of the Panel's report.On the morning of December 2, 1994, following a previous afternoon of animated discussion, the ACD unanimously accepted the Report of the Human Embryo Research Panel. Panel members and members of the NIH staff who were present and had worked for nearly a year on the Report were gratified by this vote of confidence and by the strong support of NIH Director Harold Varmus.We had little time to enjoy this success. Within a matter of hours, the White House issued a press release in which President Clinton thanked the committee for its work and then, in a remark overruling one of the key recommendations in our report, stated: "I do not believe that federal funds should be used to support the creation of human embryos for research purposes, and I have directed that NIH not allocate any resources for such research." [End Page 83]As a Panel member and active participant in that day's events, my initial response was one of shock. I was particularly distressed that the President and his advisors chose a moment so late in the process to make their views known. Why had we worked for months, I asked, without a word of concern from the White House? Although Panel members were guided primarily by our perceptions of the ethical and scientific issues involved, some were close to the political realities of Washington and would have introduced these concerns into the Panel's deliberations.Within a matter of days, my own sense of outrage had diminished. First of all, it was clear that whatever the personal sources of the President's objections to the Panel's recommendations, this high level political intervention was inevitable. Less than a month before, on November 8, with the election of a majority House and Senate, the political environment for embryo research had changed dramatically. The previous June, 32 congressmen, most of them members of a minority Republican party, had signed a letter protesting the Panel's work. Now, one of the signers of that letter, Newt Gingrich, was destined to be Speaker of the House.Second, it became clear that the damage was not total. The President has forbidden NIH to support work involving the deliberate creation of embryos for research. Without exception, members of the Panel had come to the conclusion that some development of "research embryos" must be permitted to reduce the risks of new assisted reproductive technologies, to enhance scientific knowledge, and to develop new therapies for a range of serious diseases. All these... (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.

What if science enabled us to live an extended lifespan? Well, not us, but people in the future, and perhaps not everybody in the future, at least not at first. Should we allow and encourage science to develop this capability, or should we try to prevent or inhibit it? John Davis's book New Methuselahs: The Ethics of Life Extension is a thorough exploration of these questions. He presents the arguments for and against developing this capacity, and he considers three perspectives: (...) those of individuals who will be able to extend their lives (the Haves), individuals who will not because they can't afford to (the Have‐nots), and individuals who will not extend their lives because they are opposed to doing so (the Will‐nots). Davis is a philosopher, and the bulk of this book is for the cognoscenti. (shrink)

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)

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.