p. 34-45 in Human Genome Research and Society
Proceedings of the Second International Bioethics Seminar in Fukui, 20-21 March, 1992.

Editors: Norio Fujiki, M.D. & Darryl R.J. Macer, Ph.D.

Copyright 1992, Eubios Ethics Institute All commercial rights reserved. The copyrights for the employees of the US Government, are subject to other copyright arrangements. This publication may be reproduced for limited educational or academic use, however please enquire with Eubios Ethics Institute.

Bioethics in the United States of America: Who Decides?

Michael S. Yesley,
Coordinator, Program on the Ethical, Legal and Social Implications of the Human Genome Project, United States Department of Energy, USA

As an attorney, I am interested in the process by which bioethics decisions are made as well as the actual decisions that are reached. The process commonly is one of "shared decision-making," that is, decision making at several levels, beginning with the government and ending with the individual. After the government has defined a scope of permissible activity, the research or health care institution may further limit what activities are permitted. Finally, the individual patient, or, if the patient is incompetent, the patient's legal representative decides whether or not to participate in the activity.

I should add that this is a general description of the process in the United States. In Japan, there is an additional level at which decisions are made, or perhaps a level that is substituted for a decision by the individual, and that is a decision on behalf of the individual by his or her family.

Where is the scientist in this process? I have not forgotten the scientist. It is he or she who initiates the process by proposing to conduct novel activities intended to help the individual patient and to add to the body of knowledge. Because these activities - particularly in molecular medicine - are novel or may present unknown risks to the patient, society does not leave the decision entirely to the scientist, but establishes a process in which many share in making the decision whether to proceed, after the scientist has proposed an activity.

Because bioethics in general, and bioethics related to genetics in particular, evolves through this process of decision- making at several levels, I propose to briefly trace the process, to see how it works in several areas of bioethics, in order to provide a perspective on the way in which ethical decisions related to genetics are or will be made.

Before discussing this process, however, I would like to briefly outline a set of principles formulated by the National Commission for the Protection of Human subjects, with which I was associated 15 years ago. These principles are as much descriptive of the process of bioethics as they are prescriptive, that is, the process customarily takes these principles into account, and it would be unwise to fail to do so.

The principles, as enunciated in the Commission's so-called "Belmont Report," are respect for persons, beneficence, and justice. To say just a few words about each, respect for persons has two aspects: respecting the autonomy of individuals by requiring their informed consent if they are competent and, if they are incompetent, providing protection by requiring the consent of those who act on their behalf. It appears to me that the involvement of the family in Japan is roughly equivalent to the involvement of the family in the United States when the patient is incompetent. In a way, you treat patients generally as incompetent, not out of disrespect, but because you rely on the family to determine the patient's best interests.

In order for the patient or the family to make the decision, three elements of informed consent are necessary: sufficient information must be provided, the information must be understood by the patient or family, and the decision whether to participate in the research or course of treatment must be voluntary.

The principle of beneficence may be expressed as the traditional "Do no harm" plus a utilitarian ethic of maximizing possible benefits and minimizing possible harms. Justice requires fairness in the distribution of health care and the selection of research subjects. Those who share the risks should also share the benefits.

Turning to the broadest level of bioethics decision making - the government, we note the three branches in the United States: the legislature, that is, Congress, the judiciary, most significantly the Supreme Court, and the Executive Branch, which administers the laws passed by Congress within the statutory and constitutional limits enunciated by the courts.

Congress may act in several ways, most notably by the appropriation of funds and the imposition of controls. An example of bioethics by appropriation is the decision to fund the Human Genome Project - certainly a matter of scientific policy but also a determination that public moneys should be allocated to this effort in order to gain a public good.

Among the controls imposed by Congress that have bioethics aspects are the requirement that human experimentation must be reviewed by an institutional review board, the recent Patient Self-Determination Act that requires hospitals to inform all incoming patients of their right to direct that they be allowed to die under certain circumstances, and the Americans with Disabilities Act, also recent, which prohibits discrimination against those who are disabled. I should note that the requirement that human experimentation be reviewed is a good example of shared decision making: the federal government requires the review, the research institution conducts the review, and, if the research is approved, the subject decides whether or not to participate. I should also note that the Patient Self-Determination Act may be superfluous in a country such as Japan, where the determination is made by the patient's family.

Congress may act in another way when it is not certain what to do about a bioethics or other issue: it may establish an advisory commission to study the issue and then make recommendations for legislation or regulation. In this way, bioethics decision making is shared even further, by the members of the advisory commission. Among the advisory commissions that have operated in the United States are the national commission that focused on guidelines for research with human subjects, the president's commission that made recommendations on the definition of death and other issues, and the so-called ELSI Working Group - not actually a commission - that is providing advice on the ethical, legal and social implications of the Human Genome Project. (More about ELSI, later.)

Turning to the judiciary, particularly the United States Supreme Court, I would note - without discussion - the decisions regarding abortion, a judicial area that continues to change, and the right-to-die decision involving Nancy Cruzan, an unfortunate young woman who was maintained in an irreversible comatose condition for several years after a car accident. The Cruzan decision is another instance of shared decision making, in which the courts decided the level of evidence that would be required to be presented by Nancy's family to indicate what Nancy herself would have chosen if she were able to contemplate her condition. The Cruzan decision might be unnecessary in Japan, where the family is expected to make that decision for the patient.

In discussing the role of the judiciary, I should note that the courts of our states also make bioethics decisions. For example, a state court decided that "custody" of IVF-fertilized cryo-preserved ova would be shared by a divorced couple, and that the former wife could not make a unilateral decision to have the ova implanted in her. The state courts also make decisions about "wrongful birth" and "wrongful life" - the former being the claim of the parents for the costs of raising a child whose genetic disorder a physician failed to diagnose. "Wrongful life" is the claim of the child itself for the damage of having been born in a genetically impaired condition. As a matter of law, the state courts generally allow parents' claims for "wrongful birth" on the grounds that the costs could have been avoided if there had been a correct diagnosis. But the courts disallow the child's "wrongful life" claim on the grounds that there is no damage from being born - even in an impaired condition - as opposed to not being born at all.

The state courts have also been called upon to decide disputes over surrogate motherhood. In the famous case of "Baby M" four years ago, a state court decided that a contract to be artificially inseminated and then give up the child to its genetic father and his wife was unenforceable because it violated the equal rights of the natural (surrogate) mother concerning her child. But the court also found that it was in the best interests of the child to be raised by the natural father and his wife, who were awarded custody subject to liberal visitation rights of the natural mother.

In a more recent case, however, where an IVF embryo was implanted in the surrogate mother, the contract for her to carry and deliver the child, then surrender her maternal rights to the child's genetic parents was enforced. The crucial difference from the Baby M case was this surrogate mother's lack of a genetic relationship with the infant.

Two other recent state court bioethics decisions did not involve reproduction. One involved the unauthorized use of a patient's tissue - the court decided the patient did not have a property right in tissue taken for treatment purposes, but that the researcher had violated the patient's right to give or withhold his consent to the use of his tissue for research. In another case, the father of illegitimate 3-year-old twins who lived with their mother was denied a court order that the twins submit to bone marrow harvesting against the wishes of their mother to donate to a half-brother suffering from leukemia.

Bioethics decisions are also made by agencies of the executive branch of government. For example, the Public Health Service prohibits federally-funded fetal research, on the grounds that the prospect of such research might influence women to have abortions. In response to this decision by the executive branch, Congress recently voted to end the ban on fetal research, and two medical societies are establishing a national board to develop voluntary guidelines for privately funded fetal research. It's unclear at present who will decide this issue finally.

Another agency - the Centers for Disease Control - is dealing with the question of whether to require that health care providers be tested for AIDS, in the aftermath of the dentist who infected 5 patients.

Many agencies are involved in issues related to genetics, including the Food and Drug Administration, the Recombinant DNA Advisory Committee, and the ELSI activities that I mentioned before. Most of these agencies are involved not only in issues of safety and efficacy, but also of the social acceptability of genetic research activities and, in the case of ELSI, the broad social implications of advances in genetic knowledge.

The ELSI effort is actually composed of several activities. There is a working group of seven advisers who meet three times a year, and also a multi-million dollar program to provide grants for academic research and public educational activities related to the ethical, legal, and social implications of the Human Genome Project. Although these activities have been in process for two years, I would characterize most of them as efforts to learn more about such issues as employment and insurance discrimination, privacy rights including the right not to know, and the integration of genetics into health care delivery. After this information has been developed, we will be in a better position to determine who decides the appropriate course of action for society in the genetic age.

In closing, I would like to acknowledge the challenge of decision-making on an international level. The increasing interdependence of nations and potential impact of the Human Genome Project on the human species have led to calls for an international ELSI policy. However, cultural and economic differences among nations will greatly complicate any effort to achieve a uniform policy for all. Perhaps the experience of the United States, a culturally and economically diverse nation, can provide a model for international approaches.

In the United States, we have identified broad principles, such as the Bill of Rights, and broad boundaries of acceptable activity to which nearly all can agree. On a less lofty level than the Constitution, the principles enunciated in the Belmont Report have achieved general acceptance among those who conduct or review human experimentation. However, the detailed rules or mode of implementation of broad principles often varies from one state to another in our "laboratory of the states" or from one institutional review board to another, according to different values and preferences for administration. This latitude is built into the system there is no need to achieve complete uniformity. In this fashion, decision making is shared at different levels of government and between the government, private institutions and individuals.

Perhaps this simple model is appropriate for international approaches to the ethical issues raised by increases in genetic information. It is probably not feasible to produce a detailed set of guidelines to which all nations can subscribe. But, again, there is no need for complete uniformity. We can profitably aim for international agreement on broad principles to guide the development and use of genetic information - to protect human rights and assure access to health care, and to guard the future of the human species - while preserving decision making responsibilities of different nations that will accommodate their unique cultural and economic requirements.

Outline of key issues

I. Introduction

A. Why survey bioethics?

1. Existing policy and institutions that deal with ethical issues in medicine and research provide a starting point and possible mechanisms to resolve the ethical, legal and social issues (ELSI) of medical genetics

B. Why focus on "who decides"?

1. Much of bioethics is procedural: determining who has authority to make a decision and under what circumstances

2. Mapping the areas of decision making reserved to government and those left to private institutions and individuals provides a framework for analysis and comparison

C. Scope of bioethics

1. Ethical, legal and social issues related to health care and research with human subjects: generally, whether, or under what conditions, an activity will be permitted:
a. Societal acceptability
b. Risk-benefit comparison
c. Informed consent

2. Who decides? Examples:

a. Government limits the circumstances in which women may select abortion
b. Government may establish conditions for an individual or others to decide when to terminate the individual's life support
c. Government requires research institutions to establish the conditions under which subjects decide whether to participate in human experimentation
d. Ultimate issue is the scope of individuals' autonomy

3. Genetics and bioethics
a. Human Genome Project (HGP) itself raises issues about opportunity costs and the impact on biology of funding the HGP
b. Uses of knowledge and technology from HGP raise issues about:
i. Discrimination
ii. Privacy
iii. Health services
iv. Eugenics

D. Nature of bioethics

1. Herein, main focus on public policy and private decision making, not a philosophical perspective, with emphasis on medical genetics

E. Sources of bioethics

1. Public policy making: federal and state governments
a. Legislation
b. Regulation implementing legislation
c. Litigation

i. Governmental enforcement of policy, private challenges to governmental policy, and disputes between individuals that involve public policy in determining who wins
ii. "Formulation of public policy within the common law system takes place on a case-by-case, trial-and-error basis in the context of particular disputes in which the issues are presented to the courts by adversary parties." (Green, Mechanisms for Public Policy Decision-Making)
2. Private decision making: institutions and individuals
a. To the extent authorized, or not preempted, by government, bioethics decisions are made by private institutions and individuals

3. Academic and advocacy efforts
a. Philosopher's most important role is to assure the right questions are asked, not to provide the answers
b. Ethics begins with facts; principles may assist the analysis of facts; advocacy and analysis are strongest when dealing with facts

F. Principles of bioethics

1. One approach: "Belmont Report":
a. Respect for persons
i. Autonomy through informed consent
A] Information
B] Comprehension
C] Voluntariness
ii. Protection of those unable to exercise autonomy
b. Beneficence
i. Do no harm
ii. Maximize possible benefits and minimize possible harms
c. Justice
i. Fairness in the distribution of health care and selection of research subjects

II. Public Policy

A. Federal government

1. Congress: legislation

a. Appropriate funds
i. Abortion not federally funded unless mother's life endangered (upheld by Supreme Court in Harris v. McRae,1980)
ii. Human Genome Project
iii. National health insurance?

b. Impose requirements
i. Human experimentation must be reviewed by an Institutional Review Board (IRB) before subjects are invited to participate (National Research Act, 1974)
ii. Hospitals must inform incoming patients about their "right to die" (Patient Self-Determination Act, 1990)
iii.Employers must not discriminate on basis of disability (Americans with Disabilities Act (ADA), 1990) (applicable to carrier or pre- onset genetic condition?)

c. Establish advisory mechanisms (in executive branch)
i. Bioethics commissions and ELSI programs
ii. Why create an advisory commission? "In areas of sharply conflicting values, an advisory commission may be the best mechanism for generating broadly acceptable solutions. Given a diverse, representative membership, resources for the gathering of information, and sufficient time and commitment to conduct deliberations, a commission can achieve a moderate consensus that is sensitive and responsive to a wide range of interests and concerns." (Yesley, The Use of an Advisory Commission)

2. Supreme Court (and lower federal courts): judicial review
a. State abortion statutes
i. Roe v. Wade (1973)
A] Constitutional right of privacy protects woman's decision to abort but is qualified by state's interests in protecting health of the woman and potentiality of life
B] After first trimester, state may regulate abortion to protect maternal health, e.g., by designating type of facility
C] After viability, state may protect fetal life by barring abortion except when necessary to preserve the health or life of the mother
ii. Webster v. Reproductive Health Services (1989)
A] State may require physician to determine whether fetus of 20 or more weeks gestational age is viable (instead of leaving decision to physician)
B] Constitutional privacy is a "liberty interest" (contrasted with "limited fundamental constitutional right" in Roe)
iii. Supreme Court may overturn or further limit Roe in pending Pennsylvania appeal

b. Federal regulation of family-planning services ("gag rule")
i. Rust v. Sullivan (1991): government may prohibit federally funded agency from discussing abortion as a method of family planning

c. State evidence requirements regarding "right to die"
i. Cruzan v. Director, Missouri Health Department (1990)
A] Competent person has constitutionally protected right ("liberty interest") to refuse life-saving food and water
B] State may impose heightened evidentiary requirement for determining wishes of incompetent

d. State sodomy statute
i. Bowers v. Hardwick (1986)
A] Majority (5-4): there is no constitutional right to engage in homosexual sodomy
B] Dissent: the right to privacy is at issue in this case, not the "right to engage in homosexual sodomy"

e. Rationing of health care
i. Ellis v. Patterson (8th Cir. Court of Appeals, 1988): state is not required to fund organ transplants under Medicaid

3. Executive branch: administration and regulation

a. Departments and agencies
i. Department of Health and Human Services
A] Public Health Service
1] Bans discussion of abortion in federally funded family- planning clinics (regulation approved by Supreme Court in Rust)
2] Bans federally funded fetal research
a] Congress has voted to end this ban
b] Medical societies are establishing national board to develop voluntary guidelines for fetal research

B] Office for Protection from Research Risks
1] Coordinates Federal Common Rule on human research, implemented by local IRBs
2] No specific guidance yet concerning genetic research, for example, should at-risk relatives who have not requested information be advised of their status?

C] Centers for Disease Control
1] AIDS screening of health care providers?

D] Recombinant DNA Advisory Committee
1] Reviews human gene transfer protocols

E] National Center for Human Genome Research
1] ELSI program

ii. Department of Energy, Office of Health and Environmental Research
A] ELSI program

iii. Department of Defense, Armed Forces Institute of Pathology
A] DNA databank of all members of armed forces

b. Advisory commissions

i. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-78)
A] Recommendations to protect human research subjects, especially those with reduced or no capacity to give informed consent
B] Basic ethical principles ("Belmont Report")
C] Implemented in Federal Common Rule and special regulations for fetal research, research with children, and research with prisoners

ii. President's Commission for the Study of Ethical Problems in Medicine and Research (1980-83)
A] Recommendations on definition of death, genetic testing, research with human subjects, etc.

c. ELSI activities
i. NIH-DOE ELSI Working Group
A] Genetic discrimination
1] Employment: comments on ADA regulations
2] Insurance: task force
B] Genetic privacy
1] Right not to know and to prevent access by others
2] Collaboration of grants and commissioned papers
C] Genetics in health care
1] Cystic fibrosis pilot studies

ii. ELSI grants and contracts (DOE and NIH)
A] Research: empirical and analytic
B] Education: formal classroom and TV documentary
C] Conferences and workshops: outreach and professional

B. State legislatures and courts: "laboratory of the states"

1. Reproduction
a. Right to fertilized ova: Davis v. Davis (Tennessee, 1990)
i. After divorce, who controls IVF-fertilized frozen ova?
ii. Trial court awarded former wife "custody" of ova for implantation
iii. Appellate court ruled the award of custody violated the former husband's right not to beget a child where no pregnancy has occurred, ordered that the former husband and wife have equal voice over disposition of the ova

b. Abortion
i. Some control was returned to the states in Webster and more control will be returned to the extent Roe is overturned in the pending Pennsylvania appeal

c. "Wrongful birth" and "wrongful life"
i. Genetic counseling and treatment generally are not regulated except professionally and through litigation
ii. "Wrongful birth" claims of parents to recover medical expenses of misdiagnosed, genetically afflicted child are usually recognized by state courts, because the expenses could have been avoided by not conceiving or abortion
iii."Wrongful life" claims of the afflicted child are generally not recognized, because there is no injury in being born afflicted when the alternative was not to be born at all

d. Surrogate motherhood
i. Genetic surrogate mother: Matter of Baby M (New Jersey,1988)
A] Should a contract to be artificially inseminated, carry and deliver the child, then surrender maternal rights in exchange for $10,000 be enforced against surrogate mother who sought to keep the child?
B] Court found contract unenforceable because it violated the equal rights of the natural mother concerning her child and ignored the child's best interests
C] But the natural father and his wife were found more suitable to raise the child and awarded custody, with liberal visitation rights for the natural mother
D] Although the contract is unenforceable, surrogacy is permitted in U.S. (unlike most other countries) Japanese couples have hired surrogacy services in U.S.

ii.Gestational surrogate mother: Johnson v. Calvert (California, 1990)
A] Where IVF embryo was implanted in surrogate mother,the court enforced a contract to carry and deliver the child, then surrender maternal rights to the genetic parents in exchange for $10,000
e. Newborn screening
i. Nearly every state provides by law for newborn screening, most states allow objection to screening, very few provide for informed consent
ii. DNA databanks as potential sources of genetic information

2. Informed consent
a. Court-ordered Caesarean: In Re A.C. (District of Columbia,1990)
i. Who shall determine the medical treatment of a patient near death and pregnant with a viable fetus? How shall this decision be made if the patient cannot make it?
ii. The patient shall decide what is to be done, on behalf of herself and the fetus, and if she is unable to do so, the court should use substituted judgment procedure to determine what the patient would do if competent

b. Unauthorized use of tissue: Moore v. Regents of Univ. of California (California, 1990)
i. Patient claimed the use of his cells without permission for medical research and potential economic gain was: (1) a breach of disclosure obligations, and (2) a theft of his property
ii. For informed consent, physician must disclose research or economic interests that may affect professional judgment and are unrelated to the patient's health claim upheld
iii.For public policy considerations, unauthorized use of the cells was not a theft claim rejected

c. Compelled donation of bone marrow: Curran v. Bosze (Illinois, 1990)
i. Father sought court order that his illegitimate three-year-old twins submit to bone marrow harvesting against the wishes of their mother, who was the primary caretaker, to donate to their half brother suffering from leukemia
ii. Parent may consent to donation only when it would be in the child's best interest, which would require emotional support from those caring for child and existing, close relationship between donor and recipient
iii.Ayala family in California satisfied these conditions, but with a complication: the infant donor was conceived for that purpose

3. Right to die
a. Incompetent patient
i. All states authorize general durable power of attorney
ii. Many states also authorize living will and appointment of proxy to make health care decisions
iii.Other evidence of intent and substituted judgment
A] New Jersey: Matters of Quinlan (1976), Conroy (1985), and Farrell (1987)
B] Missouri's stringent evidence rules were approved by the Supreme Court in Cruzan

b. Competent patient
i. Bouvia v. Superior Court (California, 1986)
A] Court upheld quadriplegic patient's right to removal of nasogastric tube that was inserted and maintained against her will for the purpose of keeping her alive
B] "If there is ever a time when we ought to be able to get the 'government off our backs' it is when we face death - either by choice or otherwise." (concurring opinion)

4. Criminal prosecution

a. Removal of life support: Barber v. Superior Court (California, 1983)
i. Court overturned murder prosecution because the doctors' removal of life support at the request of the family of a patient in a permanent vegetative state was not an unlawful failure to perform a legal duty
b. Assisted suicide
c. Fetus endangerment
d. DNA identification and databanks

III.Institutional Decision making

A. Research institutions
1. IRB approval is pre-condition of human experimentation
a. risk-benefit analysis
b. informed consent

B. Hospitals

1. Bioethics Committees consider ending life support, Do Not Resuscitate orders, etc.
a. general policies
b. specific cases

C. Professional groups and organizations

1. Asilomar conference
2. American Society of Human Genetics Statement on CF Screening
3. National Advisory Board of Ethics in Reproduction

D. Commercial organizations: employers and insurers

1. Office of Technology Assessment reports on employment screening
2. Information on insurance practices is mostly anecdotal to date

E. Commercial organizations: biotechnology industry
1. Marketing of growth hormone and CF screening
IV. Genetics in an Interdependent World

A. Increasing interdependence of nations and potential impact of HGP on the entire species have led to calls for international policy on ELSI

B. Cultural and economic differences among nations will greatly complicate any effort to achieve uniform policy for all
C. Experience of U.S., a culturally and economically diverse nation, may provide a general model for international approaches

1. Identify basic principles and broad boundaries of acceptable activity to which all nations can agree
2. "Laboratory of nations" will implement the basic principles in different ways, some appropriate for other nations, some not
a. Nations will decide, within the boundaries of common notions of acceptability
3. Policy process must be dynamic
a. Even broad principles may require change to accommodate new circumstances
b. "Laboratory" results may identify approaches suitable for other nations
4. Chief difference from U.S. model: international accords generally voluntary v. domestic legislation and judicial actions generally mandatory

D. Conclusion: need for continuing international discourse on ELSI
The support of the United States Department of Energy in preparation of this manuscript is acknowledged.
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