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Review of Ethical Issues in Medical Genetics

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Hereditary conditions affect millions of families throughout the world. About 5% of all pregnancies result in the birth of a child with a significant genetic disorder, congenital malformation or disability. An estimated 43% of cases of severe mental retardation (IQ
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Part I
General considerations Introduction : Importance of Genetics
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WHO/HGN/ETH/00.4





Review of Ethical Issues
in Medical Genetics

Report of Consultants to WHO
Professors D.C. Wertz, J.C. Fletcher, K. Berg










World Health Organization
Human Genetics Programme



Human Genetics Programme
WHO/HGN/ETH/00.4
Management of Noncommunicable Diseases
World Health Organization





Review of Ethical Issues
in Medical Genetics

Report of Consultants to WHO
Professors D.C. Wertz, J.C. Fletcher, K. Berg




Copyright © WORLD HEALTH ORGANIZATION, 2003
All rights reserved. Publications of the World Health Organization can be obtained from Marketing and Dissemination, World
Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel: +41 22 791 2476; fax: +41 22 791 4857; email:
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noncommercial distribution – should be addressed to Publications, at the above address (fax: +41 22 791 4806; email:
permissions@who.int).
The designations employed and the presentation of the material in this publication do not imply the expression of any opinion
whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its
authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines
for which there may not yet be full agreement.
The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended
by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions
excepted, the names of proprietary products are distinguished by initial capital letters.
The World Health Organization does not warrant that the information contained in this publication is complete and correct and
shall not be liable for any damages incurred as a result of its use.


Table of contents
PREFACE............................................................................................................................................................... I
PART I GENERAL CONSIDERATIONS ......................................................................................................... 1
INTRODUCTION : IMPORTANCE OF GENETICS ...................................................................................................... 1
1. RESOURCES FOR ADDRESSING ETHICAL ISSUES IN MEDICAL GENETICS ........................................................ 1
1.1 Major Ethical Issues in Medical Genetics .............................................................................................. 1
1.2 Needs of Medical Geneticists in the Study of Ethics............................................................................... 2
1.3 Resources for Ethical Guidance ............................................................................................................. 2
1.4 The Special Position of Women and Children ........................................................................................ 6
1.5 Respecting those whose Views are in the Minority................................................................................. 6

2. GENETIC SERVICES IN ETHICAL AND SOCIAL CONTEXT ................................................................................. 7
2.1 Goals and Practices of Medical Genetics............................................................................................... 7
2.2 Application of Ethical Principles to Genetic Services ............................................................................ 7
2.3 Facilitating Individual/Couple Choices Regarding Parenthood ............................................................ 7
2.4 “Is Medical Genetics Eugenics?” ........................................................................................................ 10
2.5 Voluntary Approach Necessary ............................................................................................................ 16
2.6 Need to Avoid Discrimination .............................................................................................................. 16

3. EDUCATION AS THE KEY TO ETHICAL GENETICS SERVICES.......................................................................... 16
3.1 Public Education .................................................................................................................................. 16
3.2 Professional Education: A Team Approach ......................................................................................... 17
3.3 Others Associated with Service Provision ............................................................................................ 19
3.4 Clergy ................................................................................................................................................... 19
3.5 Organizations for Affected Families..................................................................................................... 19
3.6 Preventing Stigmatization..................................................................................................................... 20

4. THE CONTEXTS OF GENETICS SERVICES IN HEALTH CARE SYSTEMS ........................................................... 20
4.1 Premarital Genetic Counselling ........................................................................................................... 20
4.2 Family Planning ................................................................................................................................... 21
4.3 Preconception Counselling................................................................................................................... 21
4.4 Preconception Care .............................................................................................................................. 22
4.5 Prenatal Care ....................................................................................................................................... 24
4.6 Childhood Care .................................................................................................................................... 24
4.7 Adult Care ............................................................................................................................................ 25

5. PRIORITY OF GENETICS SERVICES IN HEALTH CARE SYSTEMS..................................................................... 25
5.1 Distributive Justice ............................................................................................................................... 25
5.2 Cost-Benefit Considerations................................................................................................................. 26
5.3 The Role of Users of Genetics Services in Establishing Policy: Need for Grievance Procedures ....... 28

PART II SPECIFIC SERVICES ....................................................................................................................... 29
1. BASIC PRINCIPLES IN INTERACTIONS BETWEEN PROFESSIONALS AND LAYPERSONS .................................... 29
1.1 Respect for Persons .............................................................................................................................. 29
1.2 Preserving Family Integrity.................................................................................................................. 29

2. GENETIC COUNSELLING ............................................................................................................................... 30
2.1 Counselling Competent Adults ............................................................................................................. 30
2.2 Counselling Children and Adolescents................................................................................................. 36
2.3 Counselling Persons with Diminished Mental Capacity ...................................................................... 36
2.4 Competent Adults who Abdicate Moral Autonomy ............................................................................... 37
2.5 Effects of Professionals' Gender........................................................................................................... 37

3. RIGHTS TO REFERRAL .................................................................................................................................. 37
4. DUTY TO RECONTACT .................................................................................................................................. 38
5. SCREENING AND TESTING............................................................................................................................. 38
5.1 Definitions and Requirements for Programmes ................................................................................... 38
5.2 Voluntary
versus Mandatory Screening ............................................................................................... 39
5.3 Newborn Screening............................................................................................................................... 39
5.4 Screening in the Workplace .................................................................................................................. 41



5.5 Jobs Involving Public Safety................................................................................................................. 41
5.6 Premarital Screening for Carrier Status .............................................................................................. 42
5.7 Summary: Ethical Aspects of Genetic Screening and Testing .............................................................. 42

6. INFORMED CONSENT .................................................................................................................................... 43
7. PRESYMPTOMATIC AND SUSCEPTIBILITY TESTING ....................................................................................... 45
7.1 Definitions ............................................................................................................................................ 45
7.2 Benefits and Risks................................................................................................................................. 45
7.3 Recommendations for Offering Tests for Susceptibility to Common Diseases ..................................... 45
7.4 Recommendations for Offering Presymptomatic Tests......................................................................... 46
7.5 Summary of Presymptomatic and Susceptibility Testing ...................................................................... 46

8. DISCLOSURE AND CONFIDENTIALITY OF TEST RESULTS............................................................................... 47
8.1 Preparing People before Testing.......................................................................................................... 48
8.2 Situations Involving Disclosure and Confidentiality ............................................................................ 48
8.3 Methods for Protecting Privacy............................................................................................................ 56
8.4 Summary on disclosure and confidentiality.......................................................................................... 57

9. TESTING CHILDREN AND ADOLESCENTS ...................................................................................................... 58
9.1 Guidelines for Testing .......................................................................................................................... 58
9.2 Children Awaiting Adoption ................................................................................................................. 60
9.3 Conflicts between Parents .................................................................................................................... 60
9.4 Disclosure of Test Results to Children ................................................................................................. 60

10. BEHAVIOURAL GENETICS AND MENTAL ILLNESSES: DANGERS OF STIGMATIZATION................................ 60
11. ADOPTION .................................................................................................................................................. 61
12. PRENATAL DIAGNOSIS: INDICATIONS AND SOCIETAL EFFECTS ................................................................. 62
12.1 Prenatal Diagnosis without Abortion ................................................................................................. 62
12.2 Equal and Affordable Access.............................................................................................................. 64
12.3 Effects of Differential Use by Different Social Groups....................................................................... 64
12.4 Indications for Prenatal Diagnosis .................................................................................................... 65
12.5 Effects of Prenatal Diagnosis on Societal Attitudes Toward People with Disabilities....................... 70

13. PRENATAL DIAGNOSIS: OPTIMAL PROVISION OF SERVICES........................................................................ 71
13.1 Pre-Test Counselling .......................................................................................................................... 72
13.2 Full Disclosure of Test Results ........................................................................................................... 73
13.3 Post-Test Counselling after Findings of a Genetic Condition ............................................................ 74

14. TERMINATION OF PREGNANCY FOLLOWING PRENATAL DIAGNOSIS........................................................... 76
14.1 Respecting Different Cultural Perspectives........................................................................................ 76
14.2 Difficulties of Abortion Choices ......................................................................................................... 77
14.3 Twin and Other Multifetal Pregnancies ............................................................................................. 78
14.4 Third-Trimester Abortions.................................................................................................................. 79

15. PREIMPLANTATION DIAGNOSIS .................................................................................................................. 79
16. KEEPING GENETICALLY IMPAIRED NEWBORNS ALIVE ............................................................................... 79
17. PROTECTION OF PRE-EMBRYOS, EMBRYOS AND FETUSES FROM ENVIRONMENTAL AND SOCIAL HARM .... 80
17.1 Prenatal Care ..................................................................................................................................... 80
17.2 Maternal-Fetal Conflicts .................................................................................................................... 81
17.3 Maternal Employment ........................................................................................................................ 81

18. RESEARCH ISSUES ...................................................................................................................................... 81
18.1 Informed Consent ............................................................................................................................... 81
18.2 Commercial Involvement and Conflicts of Interest ............................................................................ 82
18.3 New and Controversial Research ....................................................................................................... 82
18.4 Research Involving the Human Embryo ............................................................................................. 82
18.5 Fetal Tissue Transplant Research ...................................................................................................... 84
18.6 Researchers' Relations with the Media............................................................................................... 84

19. USES OF BANKED DNA .............................................................................................................................. 85
19.1 Access to Banked DNA ....................................................................................................................... 85
19.2 Use of Stored DNA Samples in Research ........................................................................................... 86

20. PATENTING................................................................................................................................................. 87
21. GENE THERAPY .......................................................................................................................................... 87
21.1 Somatic Cell Therapy ......................................................................................................................... 87
21.2 Germ-Line Gene Therapy ................................................................................................................... 88
21.3 Therapies Involving Expression of Genes .......................................................................................... 88
21.4 Cloning ............................................................................................................................................... 88



22. SUMMARY .................................................................................................................................................. 88
ACKNOWLEDGEMENTS................................................................................................................................ 90
REFERENCES.................................................................................................................................................... 91
LIST OF TABLES ............................................................................................................................................ 103
TABLE 1. RELEVANT ETHICAL PRINCIPLES IN MEDICINE ................................................................................... 2
TABLE 2. ETHICAL PRINCIPLES APPLIED TO GENETICS SERVICES ...................................................................... 9
TABLE 3. ETHICAL PRINCIPLES APPLIED TO GENETIC COUNSELLING .............................................................. 30
TABLE 4. PROPOSED ETHICAL GUIDELINES FOR GENETIC SCREENING AND TESTING....................................... 42
TABLE 5. AUTONOMY AND INFORMED CONSENT ............................................................................................. 44
TABLE 6. PROPOSED GUIDELINES FOR PRESYMPTOMATIC AND SUSCEPTIBILITY TESTING ............................... 47
TABLE 7. DISCLOSURE AND CONFIDENTIALITY................................................................................................ 58
TABLE 8. PROPOSED ETHICAL GUIDELINES FOR PRENATAL DIAGNOSIS........................................................... 63
TABLE 9. PROPOSED GUIDELINES FOR COUNSELLING PRIOR TO PRENATAL DIAGNOSIS................................... 73
TABLE 10. WHY TERMINATION OF A PREGNANCY WITH AN AFFECTED FETUS IS DIFFICULT.............................. 77
TABLE 11. PROPOSED ETHICAL GUIDELINES FOR ACCESS TO BANKED DNA................................................... 86
TABLE 12. REVIEW OF ETHICAL ISSUES........................................................................................................... 89



Preface

The international Human Genome Project (HGP) will rapidly make genetic information available
on a worldwide scale previously impossible to imagine. All adults have a right, if they so choose,
to know their genetic makeup and implications for the health of their potential offspring, to be
educated about their own genetics, and to have the services available to act upon their knowledge.
The HGP, while not raising generically new ethical issues in medicine, exacerbates old ones,
especially in regard to equitable access to genetic services, privacy, disclosure of genetic
information, and freedom of reproductive choices. The HGP holds great promise for advances in
human health but has also increased the public's concerns about genetics. To allay these concerns,
to protect people and families with genetic disabilities, and to promote international cooperation,
it is timely to discuss ethical issues in medical genetics and to propose guidelines on complex
ethical issues for the providers of genetic services.
Within the next decade, newborn and carrier screening, and screening for common disorders such
as heart disease, cancer, and neurodegenerative diseases, may greatly increase the role of genetics
within primary health care. The inclusion of clinical genetics services as an integral part of basic
health care should, therefore, be supported. All governments and their agencies related to delivery
of health care need to examine the adequacy of current genetics services and how these can be
improved in ethically acceptable ways.
This draft document reviewing ethical issues in medical genetics and genetic services in an
international perspective and serving as background information relating to a shorter consensus
statement "Proposed International Guidelines on Ethical Issues in Medical Genetics and Genetic
Services" (WHO, 1998) was further revised by the original Consultants and prepared for
publication. The entire content of the present version does not have the level of consensus among
professionals that was reached in the Proposed International Guidelines on Ethical Issues in
Medical Genetics and Genetic Services
(WHO, 1998). Some ethical problems of medical
genetics, e.g., abortion after prenatal diagnosis, choices about alternatives in assisted
reproduction, and the status of the human embryo in genetic research, are highly debatable and, at
this time in history, are issues beyond the reach of moral consensus among nations. It is also
recognizable that the laws of nations differ with respect to these particular issues and that law is
subject to debate and evaluation.
The recommendations in this document and in the Proposed International Guidelines on Ethical
Issues in Medical Genetics and Genetic Services
(WHO, 1998) are intended as points of
departure for genetics professionals and public health officials to develop policies and practices in
their own nations.






Review of Ethical Issues in Medical Genetics
Part I
General considerations
Introduction : Importance of Genetics
Hereditary conditions affect millions of families throughout the world. About 5% of all
pregnancies result in the birth of a child with a significant genetic disorder, congenital
malformation or disability. An estimated 43% of cases of severe mental retardation (IQ <50) are
caused by single genes or chromosomal abnormalities (Institute of Medicine, 1994). In
developed nations, totally or partially hereditary conditions account for about 36% to 53% of
paediatric hospital admissions (Institute of Medicine, 1994). In developing nations hereditary
conditions account for about 15% to 25% of perinatal and infant mortality (Verma and Singh,
1989; Penchaszadeh, 1993 a,b). Most non-infectious diseases, which are the major causes of
death in developed nations, may have a genetic component (Holtzman, 1989).
Even though many affected individuals live full and happy lives and may not experience pain or
suffering, many families remain profoundly affected by genetic conditions, in spite of improved
treatment, education, and support services. In many developed nations, people with severe
mental retardation and developmental disabilities now live a nearly normal lifespan.
Responsibility for most of their care falls on their families. For example, in the USA, of an
estimated 1 to 2 million persons with mental retardation, only about 82,000 live in institutional
settings. Most of the rest live at home.
There is also a substantial cost to society for non-institutional, outpatient, educational, medical
and social services, as well as lost economic output from family members who care for persons
with genetic disorders. Therefore, continued efforts to develop effective treatments and make
them available worldwide are important to the health of communities as well as individuals and
families.
1. Resources for Addressing Ethical Issues in Medical Genetics
Ethics, as a field in philosophy or religion, is concerned with systematic reflection on the moral
life and its conflicts. "Ethics" is a generic term for various ways of understanding and examining
the moral life and for resolving ethical problems (Beauchamp and Childress, 1994). Biomedical
ethics (or bioethics) is an interdisciplinary field for the systematic study of ethical issues that arise
in research, medicine and society (WHO 1992a; UNESCO, 1993). These issues can be identified
within four large arenas: (1) research and its application to all forms of life, from bacteria and
viruses to plants, animals, and humans; (2) allocation and delivery of health care resources; (3)
ethical problems that arise in clinical encounters between health care professionals and patients,
and; (4) ethical problems in preventive medicine and public health.
1.1 Major Ethical Issues in Medical Genetics
This document discusses ethical problems in medical genetics today in developed and developing
nations. These problems include equitable access to services, voluntary versus mandatory
counselling, testing and screening, safeguarding of individual and parental choices, full disclosure
of information, confidentiality versus duties to relatives at genetic risk, privacy of genetic
information from institutional third parties, directive versus non-directive counselling, non-

1

Review of Ethical Issues in Medical Genetics
medical uses of prenatal diagnosis (including sex selection), and issues in research and gene
therapy.
1.2 Needs of Medical Geneticists in the Study of Ethics
Belonging to a health care profession involves understanding the ethical problems that most
frequently face its members in their care of patients and in their responsibilities to society and to
one another. Medical geneticists have several needs in their study of ethics:
• To know the major ethical obligations of medical geneticists in the context of the most
frequent ethical problems arising in their practice today.
• To learn to lead, or to participate in, a process of practical moral deliberation to consider
obligations and problems (the process must be grounded in careful examination of the
circumstances of each case and respect for all persons with moral standing in the case).
• To learn to bring resources in concepts, moral experience, and professional role to bear upon
such obligations and problems: e.g., (a) major ethical principles, (b) experience in prior cases
and in the available literature, and (c) professional values of clinicians, including caring for
patients and their relationships.
• To know how to shape policies and practices to address ethical problems and to prevent them,
where possible.
1.3 Resources for Ethical Guidance
Approaches to medical ethics are varied. In describing the various approaches, we begin with
principles-based ethics.
1.3.1 Ethical Principles in Medicine
The traditional sources of ethical guidelines in medicine apply also to medical genetics, which is
a field of medicine (Table 1). Medical genetics' main concerns, however, extend beyond those of
the traditional structure of medicine and the physician-patient relationship. For example: a)
genetic information may affect an entire family, rather than only the individual; b) genetic
discoveries may be predictive of future adverse events in an individual's or family member’s
health; c) genetic information and the choices of the present may affect future generations; and d)
medical genetics has a tradition of non-directiveness in counselling.
Table 1. Relevant Ethical Principles in Medicine
Respect for the autonomy of persons: respecting self-determination of individuals and
protecting those persons with diminished autonomy.
Beneficence: giving highest priority to the welfare of persons and maximizing benefits to their
health.
Non-maleficence: avoiding and preventing harm to persons or, at least, minimizing harm.
Justice: treating persons with fairness and equity and distributing benefits and burdens of health
care as fairly as possible in society.

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Review of Ethical Issues in Medical Genetics
The principle of respect for autonomy includes: a) respecting the self-determination and choices
of autonomous persons, and b) protecting persons with diminished autonomy, e.g., young
children and persons with mental impairments.
The principle of beneficence (L. "bene" = good) is the source of physicians' obligation to give
highest loyalty to the welfare of individuals and families. Beneficence also bears upon a goal of
medicine to improve the health of populations with the voluntary cooperation of the populations
involved.
Non-maleficence (L. "male" = evil, harm) is the source of the traditional medical norm of "do no
harm", meaning a duty to prevent harm altogether, or, if harm cannot be avoided, to minimize
harm to individuals and families.
The goals of justice can be described somewhat differently: treating persons fairly, giving persons
what they deserve, or giving persons that to which they are entitled. The term “distributive” (or
social) justice means to allocate benefits (e.g., property) and burdens (e.g., taxation) fairly and
with equity, in order to enhance social harmony and cooperation.
Distributing the benefits (e.g., of diagnosis and treatment) and the burdens (e.g., rationing of
expensive care or of research) of health care ought to be governed by ethically justified rules such
as: to each according to need, to each according to an equal share or opportunity, etc.
At present, the principles in Table 1 are not applied with equal force around the world, especially
respect for the autonomy of "persons". Health professionals need to pay special attention to these
principles in areas of the world where they are unfamiliar or infrequently used.
It is a misconception that prevention and care of genetic diseases and birth defects concerns only
people living in industrialized nations. Genetic conditions occur with similar frequencies in
different nations and irrespective of the socio-economic status of individuals. In fact, at all levels
of society, children born with genetic disadvantages have higher risks of getting sick and dying of
environmental causes such as infections and malnutrition. A meaningful right to health care must
include access to services for the diagnosis, treatment, and prevention of genetic disorders. The
priority assigned to genetic services with respect to other health services is a matter of public
health policy in each country.
WHO Member States should be encouraged to draw up public health policies that include
standards for genetic services along the lines recommended in the Report of a WHO Scientific
Group on Control of Hereditary Diseases (1996). People have the right to equitable access to
genetic services according to the standard of care that exists in each country, according to need
and, irrespective of the ability to pay. Some parties, such as women, children and people with
disabilities, are especially disadvantaged and vulnerable in some societies and deserve special
consideration. Professionals should help protect such persons wherever they are at risk of harm.
Within genetic services, priority should be given to programmes that address the heaviest burdens
and needs of the majority of the population. In particular, efforts should be directed towards
extending the reach of genetic services at the primary care level, with the utilization of
technologies and personnel that are appropriate to the needs, expectations, and beliefs of the
community. On the other hand, it is an inequitable use of scarce resources to develop expensive
high technology services that cater only to the wealthier sectors of society while being largely
inaccessible to the majority.

3

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