Bioethics

Bioethics in the United States

Bioethics and the Law

There are many definitions of bioethics, including “the systematic study of the moral dimensions – including moral vision, decisions, conduct, and policies – of the life sciences and health care, employing a variety of ethical methodologies in an interdisciplinary setting.” 1 There are also differing opinions of when bioethics was “born” or “developed” in the United States.2 The earliest date for which an argument could be made is 1847, the year the American Medical Association (AMA) published the first edition of its Code of Medical Ethics.3 Based on the work of English physician Thomas Percival,4 the AMA Code was instrumental in transforming a loose, unstructured, and largely unregulated craft into a learned profession based on scientific principles and devoted to the service of patients and society.5

Another possible starting date for bioethics is exactly one century later, 1947, In that year, following the trial and conviction of 20 Nazi doctors and three medical administrators for their role in fiendish medical experiments on concentration camp prisoners, the Nuremberg Code was published.6 The Nuremberg Code established the ethical requirements for biomedical research on human subjects. By today’s standards, the Code is vague and not demanding. Yet, if marked a formal, international declaration of the limits of experimentation. The Code’s widely cited first principle is that no research may be conducted without the informed consent of the subject. “The voluntary consent of the human subject is absolutely essential.”7 The Nuremberg Code provided the ethical justification and intellectual impetus for regulation of research in the United States and throughout much of the world.

Another possible beginning date for bioethics is 1970, when the term “bioethics” was first used in print. An article by University of Wisconsin oncologist Van Rensselaer Potter was titled “Bioethics, the Science of Survival.”8 Potter published the first bioethics book the following year, Bioethics: Bridge to the Future.9 Andre Hellegers also is credited with using the term bioethics at this time in connection with the newly-established Kennedy Institute at Georgetown University, the nation’s first bioethics institute.10 (…)

During the 1970s, as bioethics emerged, the law relied on bioethics for guidance and supplied a decisional framework in return. Bioethics concepts, such as autonomy and respect for persons, were embraced by the law. Legal concepts, such as procedural due process and freedom of speech and inquiry, were embraced by bioethics. Over time, the relationship between bioethics and law has strengthened and each field continues to have important effects on the other.

The connection between bioethics and law in the United States, and no doubt in other countries as well, raises several challenges, not all of which have been adequately addressed. In contemplating the future of bioethics and law, at least the following three issues should be considered.

First, law usually does not change as quickly as science or even societal values. Because law frequently lags behind these other areas, individuals working in the law need to be careful that today’s law is not addressing the scientific or bioethics problems of yesterday. Laws need to be reassessed continually and, if necessary, revised to reflect current conditions.

Second, the law’s emphasis on procedural regularity is essential to criminal law and other areas of the law. When similar procedures are applied to science, technology, and health care, however, the result sometimes can be slow, formalistic, burdensome, and expensive processes that interfere with scientific research, clinical care, and other important interests. Accordingly, laws and procedures regulating biomedical research and health care should be designed carefully and with due consideration for their consequences.

Third, law and bioethics have similar – but not identical – aims. In matters such as privacy, conflicts of interest, and respect for persons, the law usually sets minimum standards of what must be done. By contrast, codes of ethics of health professionals and scholarship in bioethics generally set loftier goals of what ought to be done. As legal requirements enter more areas of the health sciences and professions, it is important that minimum legal standards of conduct not replace more demanding ethical standards.

Author: Mark A. ROTHSTEIN

Former Bioethics Commissions

This is a list of all former U.S. national bioethics commissions with all of their reports:

[2001-2009] President’s Council on Bioethics (PCBE)

Created by President George W. Bush in 2001, the Council was charged with advising the President on bioethical issues that may emerge as a consequence of advances in biomedical science and technology. It expired in 2009.

Reports created:

Human Cloning and Human Dignity: An Ethical Inquiry (July 2002)
Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003)
Being Human: Readings from the President’s Council on Bioethics (December 2003)
Monitoring Stem Cell Research (January 2004)
Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004)
White Paper: Alternative Sources of Pluripotent Cells (May 2005)
Taking Care: Ethical Caregiving in Our Aging Society (September 2005)
Human Dignity and Bioethics:Essays Commissioned by the President’s Council on Bioethics (March 2008)
The Changing Moral Focus of Newborn Screening: An Ethical Analysis by the President’s Council on Bioethics (December 2008)
Controversies in the Determination of Death: A White Paper by the President’s Council on Bioethics (December 2008)

[1996-2001] National Bioethics Advisory Commission (NBAC)

The NBAC was established by Executive Order 12975 (October 3, 1995), Amendment (September 16, 1996), Amendment (May 16, 1997), Amendment (September 15, 1999) and the NBAC Charter (October 20, 1999). The Charter of the National Bioethics Advisory Commission expired on October 3, 2001.

This commission met for the first time in 1996, a year after it was created by Executive Order.

Reports:

Cloning Human Beings
Volume 1: Report and Recommendations (June 1997)
Volume 2: Commissioned Papers
Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity
Volume 1: Final Report (December 1998)
Volume 2: Commissioned Papers (March 1999)
Research Involving Human Biological Materials: Ethical Issues and Policy Guidance
Volume 1: Report and Recommendations of the NBAC (August 1999)
Volume 2: Commissioned Papers (January 2000)
Ethical Issues in Human Stem Cell Research
Volume 1: Report and Recommendations of the NBAC (September 1999)
Volume 2: Commissioned Papers (January 2000)
Volume 3: Religious Perspectives (June 2000)
1998-1999 Biennial Report
Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries (April 2001)
Ethical and Policy Issues in Research Involving Human Participants, Volume I (August 2001)
Ethical and Policy Issues in Research Involving Human Participants, Volume II (August 2001)

[1994-1995] Advisory Committee on Human Radiation Experiments

Created in January 1994 and dissolved in October 1995, the 14-member Committee was charged with investigating and reporting on the use of human beings as subjects of federally funded research using ionizing radiation. To maximize public access as required under the Federal Advisory Committee Act, the Committee created for the first time a gopher site on the World Wide Web, which is now under the National Security Agency Archives at gwu.edu/~nsarchiv/radiation/.

Reports:

Interim Report (1994)
Final Report (1995)

[1994] Human Embryo Research Panel (National Institutes of Health)

This panel was formed by the National Institutes of Health in January 1994. The group classified human embryo research into three categories: acceptable, needing additional review, and unacceptable. It also drafted guidelines for the review and conduct of acceptable research. The Advisory Committee to the Director of NIH unanimously approved the report, but President Clinton issued a statement saying, “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.”

Reports:

Volume 1 (September 1994)
Volume 2 (September 1994)

[1989-ongoing as of 2010] NIH-DOE Joint Working Group on Ethical, Legal and Social Implications (ELSI) of Human Genome Research

ELSI is the largest bioethics initiative funded by the government, where a percentage of the research budgets within the U.S. Dept. of Energy and the U.S. Dept. of Health and Human Services is set aside to study the ethical, legal and social implications of research on the human genome. Begun in 1989, a joint working group between the two departments analyzes critical issues and provides guidance. Currently ELSI focuses on four priority areas: (1) the use and interpretation of genetic information; (2) clinical integration of genetic technologies; (3) issues surrounding genetics research; and (4) public and professional education and training on those issues.

[1988-1990] Biomedical Ethical Advisory Committee

The 14 initial members of this Committee were selected by the Biomedical Ethics Board, which was made up of six senators and six members of Congress. The group functioned only briefly from late 1988 to early 1989 and had two meetings before its parent group became politically deadlocked due to abortion politics, its appropriations were frozen, and finally its term expired in 1990.

[1988] Human Fetal Tissue Transplantation Research Panel

The National Institutes of Health created this 21 member advisory panel, composed of medical researchers, clergy, ethicists, lawyers, and politicians, to deliberate over federal support of therapeutic transplantation research using human tissue obtained from aborted fetuses. The group existed from the spring to the fall of 1988. In its December report, the panel in a majority vote of 19 to 2 recommended continuing the funding for such research if guidelines were established to keep abortion separate from the research. Despite the recommendation, the moratorium on such research that went into place as this topic was debated was extended from a temporary one to an indefinite one.

Report of the Human Fetal Tissue Transplantation Research Panel (1988)

[1978-1983] President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research

This Congressionally mandated group was formed in 1978, succeeding the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. It worked independently from January 1980 to March 1983.

Reports:

Defining Death (1981)
Protecting Human Subjects (1981)
Whistleblowing in Biomedical Research (1981)
IRB Guidebook (1981)
Compensating for Research Injuries (1982) Volume 2: Appendices
Splicing Life: The Social and Ethical Issues of Genetic Engineering with Human Beings (1982 )
Making Health Care Decisions (1982)
Deciding to Forego Life-Sustaining Treatment (1983)
Implementing Human Research Regulations (1983)
Screening and Counseling for Genetic Conditions: The Ethical, Social, and Legal Implications of Genetic Screening, Counseling, and Education Programs (1983)
Securing Access to Health Care (1983)
Summing Up (1983)

[1978-1979] Ethics Advisory Board (EAB)

This group began in 1978 under the auspices of the Department of Health, Education and Welfare. Its pronouncement on human embryo research in 1979 followed by the EAB dissolution began a 15-year moratorium on such research.

HEW Support of Research Involving Human In Vitro Fertilization and Embryo Transfer: Report and Conclusions (1979)
[1974-1978] National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

The first public national body to shape bioethics policy in the U.S., this commission was created by Congress in 1974 and was under the Dept. of Health, Education and Welfare (now known as the Dept. of Health and Human Services) until 1978.

Reports:

Research on the Fetus (1975)
Research Involving Prisoners (1976)
Research Involving Children (1977)
Psychosurgery: Report and Recommendations (March 1977)
Disclosure of Research Information Under the Freedom of Information Act (April 1977)
Research Involving Those Institutionalized as Mentally Infirm (1978)
Ethical Guidelines for the Delivery of Health Services by DHEW (1978)
Appendix to Ethical Guidelines for the Delivery of Health Services by DHEW (1978)
Institutional Review Boards (1978)
Implications of Advances in Biomedical and Behavioral Research (1978)
The Belmont Report: Ethical Principles and Guidelines for Protection of Human Subjects of Biomedical and Behavioral Research (1978)
The Belmont Report: History, 25th Anniversary, Oral Archives

Bioethics, Sexual Behaviour and the Law

Resources

Notes

1. Reich Warren Thomas. Encyclopedia of Bioethics. I. New York: Macmillan; 1995. Introduction; p. xxi.
2. Jonsen Albert R. The Birth of Bioethics. New York and Oxford: Oxford University Press; 1998.
3. Code of Medical Ethics of the American Medical Association. 1847.
4. Pereival’s initial code was written in 1794. His 1803 version. Code of Medical Ethics, was the first publication to use the term “medical ethics.”
5. See Starr Paul. The Social Transformation of American Medicine. New York: Basic Books; 1984.
6. See Weindling Paul Julian. Nazi Medicine and the Nuremberg Trials: From Medical War Crimes to Informed Consent. New York: Palgrave Macmillan; 2006.
7. Nuremberg Code, available at http://ohsr.od.nih.gov/guidelines/nuremberg.html.
8. Van Rensselaer Potter. Bioethics: The Science of Survival, 14 Perspectives in Biol, & Med. Vol. 127. 1970.
9. Van Rensselaer Potter. In: Bioethics: Bridge to die Future. Swanson Carl P., editor. Englewood Cliffs. NJ: Prentice-Hall; 1971.
10. Jensen, supra note 2, at 27.

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