Carol A. Tauer

International policy failures: cloning and stem-cell research.

In late 2003, two international bodies were unable to resolve disagreements that involved bioethical issues. First, the United Nations General Assembly failed to pass a treaty on reproductive cloning because of insistence by some countries that the treaty include a ban on cloning for research. In view of the importance of enacting prohibition of reproductive cloning, the two issues should be separated and each argued on its own merits. Relevant objections to separation of the two issues can be refuted. Second, the European Union (EU) failed to agree on conditions for funding stem-cell research because of the diversity of views and policies of the countries of the EU. Because a stalemate was reached, funding decisions in the next programme cycle will be made on an ad hoc basis. Scientists will not have information they need to plan research programmes, suggesting that clear guidelines, even if restrictive, are preferable to vague unpublicised criteria.

Overseeing research on therapeutic cloning: a private ethics board responds to its critics.

Advanced Cell Technologys Ethics Advisory Board has been called window dressing for a corporate marketing plan. But the scientists and managers have paid attention, and the lawyers have gone along.

Testing Drugs in Pediatric Populations: The FDA Mandate

On November 27, 1998 the Food and Drug Administration (FDA) issued a new rule requiring that drugs and biological products be tested in pediatric populations. Since voluntary testing in pediatric populations had not resulted in a significant increase in pediatric labeling of drugs, stronger measures were needed to ensure that infants and children would receive the benefits of properly tested drugs and biologies. The mandate for pediatric testing raises a core ethical question: How should the need for validated treatments that benefit children as a group be weighed against the obligation to protect individual child subjects of research? The preamble to the new rule claims that adherence to Department of Health and Human Services (DHHS) and American Academy of Pediatrics (AAP) guidelines will provide adequate protection to individual subjects. Yet the special protections provided to children in these guidelines are not required by the new FDA rule, and have never been obligatory for research that is regulat...

Human growth hormone. A case study in treatment priorities.

One of the most commonly cited examples of enhancement genetic engineering is insertion of the growth hormone (GH) gene into a medically normal child. At this time, insertion of the gene itself is not planned. However, the modification of height, which is possible through administration of biochemical GH, raises the same questions about therapeutic versus enhancement uses of genetics. While insertion of the gene is a more drastic measure and probably carries more risks, the question of appropriate limits on use of the GH drug raises similar ethical and policy questions.

AIDS: human rights and public health.

This paper considers human rights and acquired immunodeficiency syndrome (AIDS) focusing on the distinctive approaches of France and Great Britain in medical and civil rights and relating significant aspects of their responses to that of the US. As regards the issue of confidentiality or the personal control of private information the US is characterized as the least sensitive mandating national reporting of AIDS in contrast to Great Britain where reporting is voluntary and medical records are less accessible. Both countries allow exceptions either to protect a 3rd party or for the sake of the common good unlike France where the sacredness of medical confidences are compared to religion. These policies impact on research. Great Britain and France have maintained a more paternalistic view of the role of the physician in the area of informed consent and the right to know than the US. Drug trials with volunteers are common practice in the US although repugnant in France. While the US encourages testing for HIV the British question the value of testing and the French advocate it only for blood donors. Mass education and counseling programs are backed by the British government while France has been reluctant to openly discuss the disease. The US investment in sex education is described as restrained. Frances lags behind in quarantine and other restrictive policies. However a common thread in laws about AIDS among US states Great Britain and Sweden is some explicit provision for an imminent threat to the health of others. Great Britain does not enunciate the rights of individuals in a constitution or other fundamental document rather a mutual atmosphere of respect and trust exists between the government and the individual. France on the other hand has a forceful and detailed declaration of rights which is reflected in her resistence to collect epidemiological data. The US policy lies somewhere between Great Britain and France. Though the rights of homosexuals are protected in some jurisdictions of the US there is no general protection as exists for minorities.

Ethically questionable research with children: the fenfluramine study.

Since the National Commission for the Protection of Human Subjects enunciated three principles governing human experimentation in the Belmont Report (National Commission, 1979), the principles of beneficence, respect for persons, and justice have been central in research ethics in the United States. As defined in the report, beneficence includes the obligation not to harm, as well as the duty to balance benefits (to society and to research subjects), against possible harms to subjects. Respect for persons, in the case of adults who are able to make their own decisions, primarily requires respect for autonomy, an abstract notion that is expressed through the practice of informed consent. Respect for those who are unable to make their own decisions requires that they be protected by those who have a duty to care for them. Permission for research participation must be obtained from the person(s) responsible for their care, a parent or guardian in the case of a child, in order to protect the child’s health and welfare. Justice requires that selection of subjects be done in an equitable manner, with no subgroup of the popu-

Just don't tell my husband.

A physician must honor a patients request to keep the information about her desire to have a tubal ligation from her husband, but the physician and patient should discuss the possible ramifications of concealing the procedure. Virtual Mentor is a monthly bioethics journal published by the American Medical Association.

Bringing Embryos into Existence for Research Purposes

The new reproductive technologies provide a new context for asking questions about existence, number, and identity. Procedures such as in vitro fertilization (IVF) make it possible for new human life to be created in the laboratory under the supervision of scientists, rather than through sexual intercourse. In this situation, decisions must be made as to how many oocytes will be fertilized, how many zygotes (fertilized eggs) will be supported in their continued development, which cleavage-stage embryos will be transferred to a woman, and what will be the fate of the others. Each step of the process involves decisions about the existence, number, and identity of future persons.

Abortion: Embodiment and Prenatal Development

The prenatal development of the human fetus is the process by which the fetus becomes embodied in a specifically human way. Because of the significance of the prenatal period for future well-being, prenatal development has been studied extensively by scientists and clinicians. Yet much is still uncertain, even from a scientific point of view. In particular, the first days after fertilization, including the beginnings of cell differentiation, hold numerous unresolved questions. A second crucial aspect of embodiment, the process of neural system development, has been described in detail in terms of its stages. But scientists do not agree on the significance of these stages in relation to the fetus’s integration, sentience, and consciousness.

Essential Ethical Considerations for Public Policy on Assisted Reproduction

The title of this chapter, “Essential Ethical Considerations” rather than “The Essential Ethical Considerations,” indicates that there is no single, monolithic set of ethical considerations. Different religious groups have their own sets of ethical criteria, as do various cultural groupings. Even individuals differ as to the ethical concerns they view as important or even relevant. Every ethical issue can be examined from a variety of perspectives, each with its own set of ethical considerations.