A variety of cases of scientific misconduct have been documented since the 1980s among biological scientists. These cases have focused the attention of the public and scientific community on this behavior and made it the centerpiece of the concern about ethics in the biological sciences. In contrast, the ethics movement in clinical medicine, which arose in the 1960s, was not basically directed at the problems of wrong-doing. Instead it concentrated on the difficult ethical choices that had to be made In the practice of medicine.

In this essay, I discuss the two movements. The attention given to misconduct In the biological sciences has become excessive and diverts its ethics movement from exploring and teaching about the difficult ethical decisions scientists must make in weighing obligations to self, science, and society. A more balanced and selective approach to developing an ethical framework in the biological sciences is needed.

I have been a member of the Loyola University of Chicago, Medical Center Institutional Review Board (IRB) for 12 years and Chair for the last 4 years. The Medical Center Campus is a full-service academic medical center, providing tertiary and primary care to Chicago and its western suburbs. The campus houses a 520bed hospital, outpatient facilities, a cancer center, the graduate medical sciences, a nursing school, and the Loyola University Stritch School of Medicine.

The mission of the Indian Health Service (IHS) affects what research is done and how It is reviewed and managed and in turn affects the forms and process used to obtain informed consent. Consent forms must be Informative and understandable to American Indian and Alaska Native (AI/AN) potential volunteers; the process used to obtain informed consent must minimize any institutional pressure to participate. The IHS Institutional Review Boards (IRBs) developed seven research Model Volunteer Consent Forms (available from the author).

Throughout the world, research ethics committees are relied on to prevent unethical research and protect research subjects. Given that reliance, the composition of committees and the manner in which decisions are arrived at by committee members is of critical importance. There have been Instances in which an inadequate review process has resulted in serious harm to research subjects. Deficient committee review was identified as one of the factors In a study in New Zealand which resulted in the suffering and death of many women diagnosed with carcinoma in situ.

There is significant evidence that the health needs of women and minorities have been neglected by a medical research community whose agendas and protocols tend to focus on more advantaged segments of society. In response, the National Institutes of Health (NIH) and Food and Drug Administration (FDA) in the United States have recently issued new policies aimed at increasing the utilization of women in clinical studies. As well, the U.S. Congress passed the NIH Revitalization Act of 1993, which specifically mandates increased inclusion of women and racial and ethnic groups in clinical studies. On the face of it, such gender and race-specific policies would appear to be morally problematic because traditionally ethics opposes the use of sex or race as legitimate criteria for distributions of benefits or burdens in social policies. Hence, these policies pose some significant moral questions. Feminist ethics provides us with a framework for evaluating such policies because of its readiness to recognize that socially and politically significant factors such as sex and race are morally relevant in setting public policy. Of course, feminist ethics does not simply endorse all appeals to sex and race but only the policies in which attention to such factors will contribute to social justice. In this essay, I Identify some of the Important ethical questions that a feminist ethics perspective raises about research policies devised to promote the Inclusion of women in clinical studies.

As research into Alzheimer's disease and other dementing disorders becomes more complex, risky, invasive, and commonplace, the need intensifies for discussion of the ethics of involving persons with dementia in research, specifically research of greater than minimal risk and of no expected direct benefit to the subject. (It is beyond the scope of this paper to consider the ethical issues related to research involvement of cognitively impaired children or children or adults with intermittent and/or reversible cognitive or psychiatric impairments. For such discussions, refer to the references in notes 1–6.) Reviewing such studies pushes our traditional analysis tools to their limits. Simply balancing and prioritizing the basic ethical principles of respect for persons, beneficence, and justice that serves us well in reviewing the vast majority of studies is inadequate when reviewing research of such ethical complexities as studies with marked risks and no expectation of direct benefit to subjects unable to consent or withdraw. Moving up to the level of theory, placing these principles within the commonly applied frameworks of consequentialism, deontology, or virtue ethics bring us no closer to reducing the tensions such research creates between upholding individual autonomy and advancing society's need to learn how to treat and cure these devastating diseases. What is needed is the introduction of more contemporary moral analyses. Specifically, we need to become more inclusive of the diversity of values perspectives of our general citizenry. In more theoretical terms, we ought to elevate to a more central role a communitarian perspective and a feminist ethics emphasis on relationships and context as we rush to keep in step, ethically, with this rapidly expanding area of medical inquiry.

In a research proposal recently submitted to one of the research ethics committees in Wales, children suffering from otitis media, or ‘glue ear’ as it is more familiarly known, were to be tested for allergic reactions to a number of substances using skin-prick tests. Small lancets would be used to pierce the skin of the forearm, allowing the penetration of traces of the allergenic reagent. The size of the subsequent inflamed area of skin would be measured. To demonstrate the expected correlation between glue ear and an allergic reaction, it would be necessary to see whether other children who did not suffer from glue ear also had the same reactions. If they did not, of course, then some causal association between the reaction and the disease condition could be inferred and investigated, with the hope of improving the treatment of the disease itself.

Medical research with children has been the subject of ongoing debate. The reason for controversy is clear. As with research on adults, one must strike a balance between two goals – promoting the health of children through advances in scientific knowledge and protecting child research subjects from exploitation and harm. However, because of their age and relative immaturity, children cannot protect their own interests as well as adult subjects can. Yet as they progress toward adulthood, increasing care must be taken to involve children in decisions that affect them, even to the extent of allowing them to make choices that may have serious and long-term consequences.

Virtually all persons who have had a hand in shaping the concept of ethics committees in this country accept the principle that the individuals making up the ethics committee should represent different interests, backgrounds, and viewpoints. In other words, ethics committees are intended mainly to represent the interests of the communities they serve. However, ethics committees often also serve hospitals that are religiously based and who, not unreasonably, may insist on affirming their own institutional morality and their own peculiar way of looking at some problems. Deep-seated ethical quandaries, especially in shaping policy, are often unavoidable.

Japan has no law recognizing the condition of brain death as the standard for determining that an individual has died. Instead, it is customary medical practice to declare a person dead when three conditions have been met: cessation of heart beat, cessation of respiration, and opening of the pupils. Of the developed nations, only Japan and Israel do not recognize brain death as the death of the human person.

The Research Center for Surgery (RCS) in Moscow is recognized as one of the largest and most prestigious surgical institutions in Russia. In this 400-bed facility more than 3,000 surgical procedures are performed annually, including heart, liver, and pancreas interventions and the reimplantation of limbs. The main focus of the research program at the RCS is on the transplantation of organs and reconstructive surgery. All procedures are free of charge to the patient.

As the concept of universal access to healthcare comes to America, an ethical paradox emerges. “Access” is the code word for being assured that sick people without financial resources get appropriate medical care. There is an ethical imperative to provide care for the sick – whether paying or not – and this value ought to give direction to any reformed system.