pp. 370-374 in Bioethics in Asia

Editors: Norio Fujiki and Darryl R. J. Macer, Ph.D.
Eubios Ethics Institute

Copyright 2000, Eubios Ethics Institute All commercial rights reserved. This publication may be reproduced for limited educational or academic use, however please enquire with the author.

F7. Proposed World Health Organization Guidelines on Ethical Issues in Medical Genetics

Dorothy C. Wertz.

The Shriver Center, Waltham, MA, USA

In July, 1995, the Hereditary Diseases Programme of the World Health Organization published a 91-page document entitled "Guidelines on Ethical Issues in Medical Genetics and the Provision of Genetics Services." This draft document, available free of charge from Dr. Victor Boulyjenkov of W.H.O., CH-1211 Geneva, 27, Switzerland, was the result of a February, 1995 consultation among Dorothy C. Wertz (Social Science, Ethics, and Law, The Shriver Center Waltham, MA USA), John C. Fletcher (Center for Biomedical Ethics, University of Virginia, Charlottesville, VA, USA), K_re Berg (Institute of Medical Genetics, University of Oslo, Norway), in cooperation with Victor Boulyjenkov (Human Genetics Programme, World Health Organization, CH-1211 Geneva 27-Switzerland). Wertz has a background in social science and social ethics, and has been doing surveys on ethics and genetics since 1984. Fletcher's background is in bioethics. Berg is a practicing medical geneticist with a special research interest in heart disease, for which he counsels individuals and families at risk.

W.H.O. undertook the writing of the draft document because genetics poses some unique ethical problems not found in other areas of medicine. These appear in Table 1.

Table 1: How Genetics Differs from Other Areas of Medicine

Genetics...

1. Provides information about other blood relatives.

2. Provides information predicting the future of persons who are now healthy, including children

3. Provides unexpected nonmedical information, such as nonpaternity.

4. Has a history of "nondirectiveness" in counseling.

Most genetics professionals work in developed nations. Table 2 shows the approximate members of genetics professionals in developed and developing nations, according to a survey by Wertz and Fletcher in 1993-96, that included all nations with ten or more practicing geneticists. Numbers of genetics professionals in the United States (including masters-level genetic counselors) have grown substantially since the survey.

Table 2: Worldwide Distribution of Geneticists

Geneticists Population (approx.)

Developed nations 3291 733,928,000

Developing nations 989 3,574,133,000

Eastern European nations 590 409,042,000

The eight basic ethical problems in medical genetics appear in Table 3. The draft proposed guidelines address all of these issues, especially the voluntary nature of genetics services, the need for nondirectiveness in genetic counseling, full disclosure to persons counseled, freedom of choice about reproductive options, and privacy from institutional third parties. The Guidelines developed in part as a foundation for a future international code of ethics in medical genetics.

Major arguments in favor of a code of ethics appear in Table 4. At this time in history, when public education about genetics and its uses in medicine and society is so woefully inadequate, even in developed nations, it is important that genetics services be provided in the most ethical climate possible, in order to protect people and to reduce public fears about genetics. In the absence of a professional code, there will be a tendency of governments to ban particular services or areas of research that could be useful in alleviating suffering or developing future treatments. Once passed, laws are often difficult to overturn. An ethical code would help to prevent passage of restrictive laws. It could also help to prevent lawsuits, by preventing professionals from the kinds of practices that could give rise to lawsuits, such as withholding information from patients or breaching confidentiality.

A code of ethics is one of the hallmarks of a profession, which designates a new specialty as a unique profession rather than a branch of some already existing profession. A code of ethics transmits the moral experience of one generation of professionals to the next generation of professionals. This is particularly important in genetics, where half of today's professionals have entered the field within the last 12 years.

Genetics professionals would be in a better position to influence public policy if they had a code of ethics. A code could also promote international cooperation, by assuring professionals that their colleagues in other countries adhered to similar standards, for example, informed consent.

A code could make genetics more accountable to society and improve the moral climate for research, testing, and treatment. Although a code would improve the moral image of the profession, this should not be its major purpose.

Table 3: Eight Ethical Problems in Medical Genetics

1. Access to/demand for services

2. Abortion choices

3. Confidentiality problems

4. Protection of privacy from 3rd parties (insurers, employers, government agencies)

5. Disclosure dilemmas

6. Indications for prenatal diagnosis

*information to benefit others (e.g., prenatal paternity testing; tissue-typing a fetus as a

potential organ donor)

*sex selection

7. Voluntary or mandatory screening

8. Non-directive counseling

Table 4: Arguments for a Code of Ethics

• Protect present and future patients

• Reduce the public's fear of genetics

• Prevent restrictive laws

• Prevent lawsuits

_ Transmit moral experience to next generation

• Influence public policy

• Promote international cooperation

• Make genetics accountable to society

• Improve image of the profession

Improve moral climate for research
Table 5: Arguments Against a Code of Ethics

Ethics is too subjective

• Reproductive decisions are too personal

• Technology changes too fast

_ Increase in laws and lawsuits

• Exclusion of minority ethical views

_ Code might not be used

Restriction of beneficial research
The arguments against a code of ethics appear in Table 5. The first two arguments are that ethics is too subjective and is a matter of case-by-case decisions by individual professionals and persons; therefore no code is possible. The authors of the draft proposed guidelines agree that in medicine many decisions are made partly on the basis of individual circumstances and personal beliefs, but these decisions are made within a larger framework of principles and relationships such as would be embodied in a code.

The argument that "technology changes too fast" for a code of ethics to keep pace with it is false. New technologies arise, but the basic ethical problems listed in Table 3 remain the same. Basic underlying principles include social justice (access to genetic services), personal autonomy (rights to know, rights to decide, rights to confidentiality), avoidance of harm, protecting the integrity of the family, and increasing the Common Good (beneficence). New techniques such as multiplex tests, cloning, and germline therapy will not change the basics of the code, though international bodies such as W.H.O. may wish to add to it from time to time.

For reasons described above, a code will not increase the number of laws and lawsuits. Exclusion of those whose views are in the minority is a more complex problem. Ideally, a code would be agreed upon only after hearing as many views as possible, including those of patients and parents, and would be broad enough to not to oppress anyone.

Probably the best argument against a code is that it will not be used. This is a real possibility in nations with a strong belief in the autonomy of medical practitioners and a tradition of economic free enterprise in medicine, such as the United States. In many nations, however, especially in developing nations, discussion of ethical issues in genetics services is just beginning, and public health officials are seeking the guidance that a code would provide.

A code could restrict potentially beneficial research if it tried to ban some avenues of research outright. The authors of the draft proposed guidelines have tried to leave the door open to future research, while arguing that all research with humans must be preceded by adequate animal studies proving safety and efficacy, and must be approved by the appropriate ethical boards within a country.

A list of existing international codes of ethics appears in Table 6. None of these deals with genetics. The July, 1997 UNESCO "Declaration on The Human Genome" speaks of "the dignity of the human genome" but provides no guidelines whatsoever for the practice of medical genetics. Therefore it cannot really be considered a code of ethics.

The contents of the draft proposed guidelines appear in Table 8. The guidelines stress the importance of individual decision-making after receiving full and unbiased information, the importance of receiving full information before all genetic tests, the absence of coercion by professionals or the state, the importance of preventing stigmatization and discrimination, and equal access to all legal genetics services, regardless of ability to pay. The Guidelines also state that use of prenatal diagnosis for sex selection is unacceptable. A summary appears in Table 9.

Appendices are listed in Table 10. The International Bibliography was limited to 5 or 6 publications per country. The authors hope that the International Bibliography will be expanded in a future revision, and invite interested parties from all countries to send publications to Dr. Boulyjenkov at W.H.O. The W.H.O. Judicial Affairs Committee asked for the changes listed in Table 11.

Table 6: International Codes

1. World Medical Association,

Declaration of Geneva 1948

Amended in Sydney 1968

2. Nuremberg Code 1949

3. World Medical Association,

Declaration of Helsinki 1964

Revised in Tokyo 1975

4. International Council of Nurses,

Code for Nurses 1973

Table 7: North American Organizations with Codes of Ethics

• American Medical Association

• Canadian College of Medical Geneticists

• National Society of Genetic Counselors

Specialties with Guidelines on Specific Problems

American Academy of Pediatrics

• American College of Obstetricians and Gynecologists

_ American College of Physicians


Table 8: Contents of 1995 Guidelines

Goals of genetics

Priorities in health care systems

Basic principles

Respect for persons

Preserving family integrity

Genetic counseling

Informed consent

Rights to referral

Duty to recontact

Screening and testing

Disclosure and confidentiality of test results

Presymptomatic and susceptibility testing

Testing children and adolescents

Behavioral genetics and stigmatization

Adoption

Prenatal diagnosis: societal effects

Prenatal diagnosis: optimal services

Abortion after prenatal diagnosis

Preimplantation diagnosis

Keeping genetically impaired newborns alive

Protection of embryos from environmental harm

Research issues

DNA banking and privacy

Gene therapy

Table 9: Summary of Guidelines

1. Equal access to available services

2. Nondirective counseling.

3. Voluntary rather than mandatory services (except for newborn screening that benefits newborn).

4. Full disclosure of clinically relevant information.

5. Confidentiality, except when information could avert serious genetic harm to family.

6. Privacy from employers, insurers, etc.

7. Prenatal diagnosis only for health of fetus.

8. Availability of and respect for choices, including abortion choices.

9. Guidelines apply equally to adopted children.

10. Research follows protocols and informed consent. Includes preimplantation diagnosis.

11. National review for gene therapy protocols.

Table 10: Appendices

International Bibliography on Ethics and Genetics, represents 21 countries

Informed Listing of Laws, Regulations, and Guidelines on Genetic Screening/Testing and Other Aspects of Genetics

Table 11: Changes Required by WHO

WHO Judicial Affairs Committee Asked for:

l. Congruence with Cairo Conference statement that "abortion should not be promoted as a means of birth control".

2. Change "abortion" to "genetic abortion" so that WHO does not appear to support social abortions.

Suggested Changes Rejected by the Authors

1. Omit "The woman should have the final power of decision".

2. Omit embryo research

The process by which the document was developed appears in Table 12. CORN stands for "Council of Regional Networks of Genetics Services" (USA), and CCMG stands for "Canadian College of Medical Geneticists", the major Canadian professional body. In both cases, the organization's Ethics Committee reviewed the document. It was also reviewed in 1994 by representatives of CIOMS (Council for International Organizations of Medical Sciences) and of the Association of Clinical Cytogeneticists of the United Kingdom.

Table 12 also presents the course of events after the November, 1997 Fukui meeting. The December 15-16 meeting in Geneva developed a 16-page document representing consensus of all those present. Its basic recommendations are similar to those in the previous document, but with more nuanced wording and greater attention to points of view not present in the earlier document, especially Muslim, Asian, and African views. The 16-page document will be preceded by a 3-page executive summary and submitted to the W.H.O. Board of Directors in May for potential approval as an official W.H.O. document. In order to differentiate it from the 1995 document, it will be entitled "Proposed Ethical Guidelines in Medical Genetics....."

The 91-page 1995 document will be revised for use as a "Background Document" for the Proposed Guidelines. The Background Document will present various points of view on the issues and the rationale for courses of action, but will not necessarily represent consensus.

The W.H.O. expert advisors hope that the proposed guidelines will become the nucleus of an international code, similar to the Helsinki Declaration. They also expect future meetings with ongoing dialogue.

Table 12: Process

Summer 1993 Victor Boulyjenkov (WHO) asks Fletcher and Wertz for guidelines useful

in developing nations.

January-March 1994 First draft

July-December 1994 Review by experts from 12 countries; WHO Expert Advisory Panel on Human Genetics (9 persons); 7 Additional reviewers; CORN Ethics Committee; CCMG Ethics and Public Policy Committee

January 1995 Second draft

February 1995 3-day meeting in Geneva (Wertz, Fletcher, Berg, Boulyjenkov,

WHO Secretariat)

March-June 1995 Review by WHO Secretariat (7 persons)

August 1996 Discussion at Permanent Committee of International Congress of Human

Genetics in Rio de Janerio.

March 1996 Discussed by panel at American College of Medical Genetics meetings San Antonio, Texas. Reviewed at this meeting by Dr. Maimon Cohen, past President of American Society of Human Genetics.

Sept 1996 -Nov 1997 Reviews requested from additional experts. 31 replies from 24 countries,

including Japan Society of Human Genetics.

October 1997 Representatives of International Federation of Human Genetics Societies (European Society of Human Genetics, American Society of Human Genetics, Australasian Society of Human Genetics) meet in Baltimore, MD, USA. As a result of reviewing the draft proposed W.H.O. Guidelines, they decide to write their own guidelines in a shorter version.

November 1997 Draft proposed W.H.O. Guidelines discussed in Fukui, Japan at W.H.O. Assisted Satellite Symposium on Medical Genetic Services and Bioethics, following UNESCO Asian Bioethics Conference. A Japanese journalist expressed belief that the Japanese public is not ready for the draft guidelines because of inadequate education about genetics and its ethical problems.

December 14-15, 1997 15 W.H.O. expert advisors, from all W.H.O. regions, including developed and developing nations, meet in Geneva to revise guidelines. A 16-page document, representing a 100% consensus (not a majority vote) among all those present is developed and will be released after final revisions.


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