Journal of Assisted Reproduction and Genetics, Vol. 13, No. 9, 1996

NEWS AND VIEWS PRODUCTIVE HEALTH CARE POLICIES AROUND THE WORLD The Duties of Ethical Committees Applied to Human Reproduction

on adherence to professional rules of conduct by practising physicians, tn the last half of the twentieth century ethics has transformed into a field of its own. Medical ethics, also known as bioethics, is now dominated by moral philosophers, theologians, lawyers, and sociologists who advise physicians on what they should do and how they should act. A rapidly expanding body of literature on bioethical topics has developed, and the subject has been introduced into the curriculum of most medical schools (1). The medical profession has a history of ethical codes which dates back to at least 2000 B.C. In the Codex Laws by Hammurabi, various legal systems have incorporated, to some extent, regulation of physicians. In the ancient Hebrew writing, the Talmud, there are passages about the high moral standards and responsibilities expected of physicians and instructions about the relations between the physician and the patient, as well as specific ethical dilemmas. The Hippocratic Oath indicates the early concern of the medical profession for regulating itself by laying down basic standards of conduct between the physician and the patient (2). Aristotle's two books, the Nichomachaen and the Eudaemian Ethics, are central texts for what is generally referred to as moral philosophy.

INTRODUCTION There is a duty on the moral profession to endeavor continually to improve the health of patients. Part of adequate health giving is maintaining medical ethics in patient care. Modern society is pluralistic, influenced by religion, culture, and historical events. Medical ethics is necessarily affected by these factors. Many believe that nowadays the physician should not be left to make decisions of an ethical nature by himself. This has prompted the development of ethics committees in institutions and by governments and international bodies. This article discusses medical ethics, and ethics committees of different kinds, and gives as an example committees in the field of human reproduction.

MEDICAL ETHICS Ethics has become an important part of all medical research and treatment. In the past it was based

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The foundations of modern medical ethics reside less in arcane philosphic and bioethic texts and more in recent social history. Modern society is pluralistic in character and influenced by religion, culture, and different social trends. The philosophic theories and principles of bioethics are derivative of human experience by patients, research volunteers, doctors, and an informed and engaged public. Much depends on reactionary tendencies to certain occurrences in history. The lessons of history have helped to change traditional medical practices. Ethics is an enterprise of disciplined reflection on the moral intuitions and the moral choices that people make. Medical ethics is the obligation of a moral nature which governs the practice of medicine. There are several main historical trends and events which have influenced the formation and evolution of bioethics. Previous Unethical Practices. Early this century regulations were issued in Germany regarding such issues as informed consent and excluding minors and the mentally incompetent from study. Despite this, the greatest atrocities performed in research occurred during the Nazi regime in Germany. The physicians in Nazi Germany performed all sorts of cruel, often fatal research on victims of the Holocaust confined to concentration camps. Most of these experiments ended in disfigurement or death, and greatly shocked the medical world. It showed that doctors could be put under extreme pressure by the governing body, such that they could be involved in practices that were essentially harmful to humans. The justifications expressed by these physicians during the Nuremberg medical war crimes trials were, that they believed that this research would lead to knowledge that could help combat disease and disability in the future and that the experiments were needed to further the war effort. They further argued that the fate of the victims was simply an unfortunate part of the process. This tragic era in medical history brought about guidelines expressed by the Nuremberg Declaration, which restated medical ethics. The issues included in the code were of voluntary consent of the human subject, absence of coercion, use of prior animal studies, avoidance of injury or suffering, competence of the investigator, freedom of the subject to withdraw at any time, and willingness of the investigator to refrain from further research should any harm become apparent. The Helsinki declaration of 1964 drafted standards for ethical biomedical research on human subjects. Some

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main points of the declaration are the use of a research protocol approved by a special committee, assessment of possible risks, obtaining informed consent, and conforming to accepted scientific principles. The doctor must always protect the well-being and interests of the patient (3). In 1966 a paper was published in The New England Journal of Medicine outlining evidence for a wide array of clinical research performed in the United States that was suspect or clearly unethical in terms of procedure and risk to subjects (4). A broad public awareness followed prompting governments to formulate regulations. The result was that other international codes followed, and together with the Helsinki declaration, they form the basis of modern medical bioethics. Government Commissions. In response to public revelations about troubling biomedical and behavioral research projects, government commissions were set up to answer ethical principles. The main issues emanating from these commissions were of the proper conduct of research. These included respect for an autonomous person's wishes and interests and protection for those with diminished autonomy; beneficience to do good and avoid harm; and justice--to treat people fairly in selection for research and in making the benefits of research available. Legal IntervenUons. Patients are increasingly more prone to turn to legal solutions if they think their doctors have made bad decisions. Doctors need to be protected by codes of practice and guidelines to be followed, in order to escape accusations of malpractice in the courts of law. Several well-publicized cases about moral dilemmas in medical decision-making have been resolved in the judicial system. Cases reach courts when there is a dispute between or among patients and their affiliates and the physicians and the health care institution. In 1975 the parents of Karen Ann Quinlan, an irreversibly comatose young woman, sought to withdraw the respirator which was believed to sustain her life. The doctors refused and eventually the New Jersey court allowed the removal of the respirator. Ironically she lived on for many more years. It was out of this case that the impetus for the creation of hospital ethics committees was first generated. Advances of Medical Science and Technology. The advent of new medical technologies cre-

ated the dilemma of withholding or withdrawing them from patients when the use of them became Journal of Assisted Reproduction and Genetics, Vol. 13, No. 9, 1996

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inappropriate or unwanted. These have brought about issues concerning right and wrong in dealing with life and death issues, as welt as the issue of equality, justice, and personal preferences. The advent of organ transplantation brought about further debate, related mainly to supply and demand. Advances in reproductive technologies created yet another series of ethical questions, such as, what is important in parenting: the genes, the procreative effort, or the rearing environment? Gamete and embryo donation and in vitro fertilization enable pregnancies outside of conventional social arrangements, such as surrogacy or single parents. Modern genetics created yet a new set of ethical questions, such as privacy, insurance risks, denied employment opportunities, and possible stigmatization if a person's genetic makeup becomes known. There are the fears of a resurgence of the eugenics movements or of germline genetic engineering and biologic genetic enhancement. The availability of early diagnostic methods such as ultrasound, chorion villous sampling, and amniocentesis to diagnose abnormal fetuses brings forth the question of whether to terminate the pregnancy. This has again and again reheated the argument surrounding abortion. Change in Social Values. The social unrest of the 1960s and 1970s brought about the strength of the Civil Rights movement, and the counterculture of the time changed education and social attention. The practice of medicine was also changed as a result of this, such as the ending of racial segregation in hospitals and clinics. The period also generated greater attention toward malpractice. Patient bills of rights were generated and proclaimed the new ethics, which relied on full disclosure, telling the truth, and the patient's right to self-determination in medical matters. Patient-Physician Relationship. Medical ethics is concerned with the proper behavior, duties, and obligations a person assumes by virtue of being a physician. The physician must be objective in obtaining and using the scientific knowledge that should underlie medical practice. The physicians must stay current with the standards of care of their discipline. Medical ethics require scientific objectivity and competence in a medical discipline, while recognizing that medicine is an inexact science and that outcomes cannot be accurately predicted or guaranteed. The previous patient-physician relationship assumed that the physician would keep the Journal of Assisted Reproduction and Genetics, VoL 13, No. 9, 1996

patient's best interest in mind in a paternalistic fashion. Modern ethics has shifted the emphasis of the interaction toward empowering the patient. In the balance between paternalism and respect for the patient's autonomy, the role of compassion is sometimes neglected. But being compassionate does not require lying to the patient or withholding information. Another important element of this relationship is the obligation of confidentiality. There is a general opinion that confidentiality can be breached only to avoid a serious, specific harm to others. Ironically, the major threat to a patient's privacy comes from the unsecured nature of medical charts and computer information in hospitals and clinics, not from the physician. Patients also sign away privacy rights when they apply to health insurers for reimbursement purposes. The essential moral elements of the physician's duty to a patient include competence, compassion, honesty, confidentiality, and adequate informed consent. Informed consent has several components: information, comprehension, and voluntariness. The information provided must include all possible risks and benefits of therapy and its alternatives. The patient must comprehend in order for the consent to be valid, and the competence and language skills of the patient must be considered. The patient must be free of any pressure or coercion. The public is extremely interested in how and to whom health care is provided. This public awareness has lead to a growing need for the medical profession to be fully aware of the public view on issues of human rights, social structure, and health care policies and how these affect our daily practice. Ethics committees have developed widely in the last 25 years, whether institutional, national, or international.

HOSPITAL ETHICS COMMITTEES

Changes in medical technology, social structure, and the practice of medicine in an increasingly complicated institutional setting make it difficult for the individual physician to cope correctly with the complex ethical dilemmas arising in medical practice. This situation prompted the establishment of hospital ethical committees in leading institutions, mainly in the Western world. The committee is answerable to the hospital management or to a local health authority. Hospital ethics committees

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are concerned primarily with clinical practice, but also with clinical research. The main functions of these hospital ethics committees are the following. 1. Consultation: To offer counsel on ethical issues arising in individual cases. 2. Education: To develop educational programs on bioethical issues. Educating hospital staff about issues in ethical decision making and about how to use the hospital ethics committee. 3. Multidisciplinary discussion: To provide an interdisciplinary forum for discussion of bioethical issues, leading to conflict resolution. 4. Institutional commitments: To express the spirit of the hospital with regard to its mission, philosophy, image, and identity. 5. Policy formulation: To assist and advise in formulating institutional policies by addressing ethical concepts. 6. Resource allocation: Recommending allocation policies to maintain quality of care in the face of cost-cointainment measures. Some hospitals have a different committee for this purpose. By raising and maintaining the level of ethical awareness in the hospital setting, institutional ethical committees can play a significant role in preserving the quality of patient care. The rights and the interests of the patient must be protected from the possibility of exploitation during treatment or during research. The hospital committee has an advisory function rather than a decision-making function. It is generally not involved in specific patient care decisions and does not enter into individual doctor-patient relationships. Ethics committees may be an attractive alternative to the courts. The judicial system is often too slow for clinical decisions. Furthermore, the ethics committee has the advantage of reconciliatory divergent views. The committee may have to decide in cases of new and untried treatments. One example is the use of patients as controls in an experimental treatment procedure, when they do not know whether they are receiving the treatment or placebo. The question of adequate informed consent arises here. The Nuremberg code and the declaration of Helsinki required that all "experimental protocols should be transmitted to a specially appointed independent committee for consideration, comment and guidance." Therefore, the committee must be concerned pri-

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marily with the protection of the patients, their rights and interests. Another problem that these committees deal with is requests of patients to withdraw treatment from the terminally ill, and with problems of obtaining consent in such matters. In specific moral questions it is best if the committee develops certain guidelines, which hopefully would be practiced consistently. The policies may be revised from time to time as necessary. In order for such guidelines to be followed, the committee must have a respectable membership so as to carry its own authority. The members must, also, be able to apply some sort of sanction should the guidelines be disregarded. The tradition of following guidelines should exist within the hospital, and there will be an element of peer pressure involved in their maintenance. The committee will constantly aspire to achieve a consensus on important issues. The committee must not seek to intervene at every stage of clinical practice or research. Hospital policies are available for ethics advisory groups, which can be formed ad hoc in specific cases. Such a group should include the attending physician, the patient or a family member, a significant nurse in the case, a member of the clergy or a bioethicist, and a physician or other member of the ethical policy subcommittee of the subject area. An attorney may be included in cases where civil or criminal liabilities appear to be unresolved. The ethics advisory group may serve the purpose of ethics consultation in specific cases. However, the final treatment decisions remain with the physician and the patient or family. It is generally accepted that a hospital ethics committee should be divided as evenly as possible among physicians, nurses, and others. Others would include an administrator, a social worker, a member of the hospital board, and an ethics specialist or clergyman. Its size varies and is dependent on the size of the hospital. The medical staff members should represent various departments and divisions within the hospital, some with actual clinical experience and others with administrative capacities. It is preferable if the committee includes an ethicist with some theoretic background about the state of art of ethics (5). It is preferable if the chairman of the committee is a reputed hospital physician in order for the committee to be better accepted among the medical staff. Muttidisciplinary discussion serves to alleviate emotional responses regarding specific decisions by physicians which may meet with disagreement Journal of Assisted Reproduction and Genetics, VoL 13, No. 9, 1996

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by other members of the medical staff. Such discussion is required by the inherently multidisciplinary nature of the ethical dilemmas that occur presently. Physicians and consultants are involved in daily decisions which are affected by legal, moral, and professional standards. Some clinical ethical problems need to be resolved with the involvement of all these participants. Siegler, an opponent of hospital ethics committees, cites several disadvantages. The committee may include an unmanageable collection of noninvolved professionals and so called moral experts. The committee may have serious conflicts of interest between their responsibility to the patient and their efforts to minimize hospital risk, to develop sound hospital policies, and to allocate resources efficiently (6). The committee may attenuate the decision-making authority of the physician, who is the one who is responsible, medically, morally, and legally, for the patient's care. If most persons on the committee are removed from the clinical setting and lack the desired sensitivity, immoral decisions may be made which will harm, rather than benefit, the patient. In order to prevent any injustice, ethics committees should not involve themselves in patient decision making and should not review and criticize decisions that have been made previously. Other specialized committees, such as a quality assurance committee, a morbidity and mortality committee, and a medicolegal committee, are those that should monitor and correct deficiencies in patient care. One of the most important roles of ethics committees is that of education. The committee should develop and coordinate institutional resources in clinical ethics and should develop formal training programs for physicians, nurses, and other carerelated staff. The goal should be to educate clinicians from each clinical discipline who have a knowledge in ethics and law and the clinical experience to assist their colleagues in reaching sound clinical-ethical decisions. Siegler believes that once this role is achieved, the committee should be disbanded (6). He prefers the formation of many small advisory groups possessing great clinical expertise in their particular field composed primarily of involved clinicians. The advisory groups would be located in "high-risk ethical areas," such as the intensive care unit and burn unit. Pressures on ethics committees to reach agreement may lead to recommendations that are ethically questionable (7). Agreement or even Journal of Assisted Reproduction and Genetics, Vol. 13, No. 9, 1996

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consensus does not confer infallibility. An example of this is the method by which hospital committees in the 1960s selected patients with chronic renal failure for dialysis treatment, based on their social worth. In some circumstances committees may inadvertently pressure members to reach consensus, avoid controversial issues, underestimate risks and objections, and fail to consider alternative treatments or search for additional information. This collective "group thinking" may lead to grave errors in judgment. There arises the issue of whether patients and their family members should have access to the deliberations of ethics consultation meetings. The patients and their families should be informed of the existence of such a committee. But should they be informed of each meeting? Must the committee obtain informed consent from the patients and their families before a case review can be undertaken? Should patients be allowed to initiate meetings? Should they be allowed to attend meetings? Should they be informed of the outcome of the committee's deliberations? There is a wide range of access to ethics committees. Each committee must set its own preferences. A 1992 survey by the American Hospital Association found that 51% of responding hospitals had an ethics committee (8). The beginnings of these committees was in the area of research. In the area of patient care, ethics committees were established in some institutions in response to the Quinlan case recommendations of the New Jersey Supreme Court. Later instigations were in response to recommendations of a president's commission and the "Baby Doe" guidelines. Some states have passed legislative mandates, such as Maryland, New Jersey, and New York. Ethics committees need to undergo some degree of evaluation before they become standard practice. It may be prudent in some cases to allow access to the committee by patients and their surrogates. The recommendations of the committee should be made available to the parties involved. A note in the medical record might be a requirement. The recommendations of the committee should be consistent with ethical and legal guidelines. The parties in disagreement should be satisfied with the process of review and with the recommendations of the committee. The committee should have its own internal system of review to ensure that goals are met (7).

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NATIONAL ETHICS COMMITTEES National ethics committees are set up by governments in order to advise on regulations or legislation attempts concerning moral bioethical programs that raise controversy among professionals and the public. The government brings in outside advise and expertise from leading professionals in each field. Warnock (9) further divides these into two types of committees. One is a national committee designed to monitor the operation of existing law and it is answerable to the Ministry of Health. This committee may issue licenses for research or practice that is within the law, as well as publish yearly statistics. The other committee is one set up by the government in order to examine specific ethical issues which have arisen through the operation of other committees or because of new biological or medical advances. For example, more than 100 reports on ethical and legal aspects of assisted reproduction were issued by governmental or nongovernmental bodies over the years. Scientific progress is still much ahead of what society is willing to accept. The reports of the bioethical committees protect the public by monitoring and, when necessary, regulating scientific practice. National committees were originally created due to an increasing demand among doctors and researchers for some authoritative guidance as to what was permissible in issues where no law exists. The membership of this committee is of even greater importance than that of hospital committees. The chairman must be unrelated to the medical or research profession. The members of national ethical committees must represent a broad range of values and professional expertise in the fields of medicine, law, administration, media, economics, and public policy, as well as moral philosophy. Within committees dealing with reproductive health, for example, at least 50% of the members must be female. It is important to recognize that there is no one single solution to a moral problem. A committee must incorporate a number of different moral ideals and reach a workable compromise (9). The law which these committees create must be in step with moral beliefs, or it will not be implemented. There must be a societal consensus in the committee's operation. It is the task of the ethics committee to try to produce some consensus, based on all considerations, and to recommend it for practice.

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Several problems arise in the setup of the committees. Who should make moral decisions in public controversial issues? How is the committee's membership to be determined? The work of a committee is, in a way, subject to a democratic process, since representations can be made in the course of its deliberations. In a pluralistic, mainly secular society there are no moral experts per se. Committees who serve public morality must conform to certain specifications of expertise (9). The committee members must be capable of understanding the scientific background of the subject matter of the issue. They must be acquainted with moral philosophy and understand the nature of ethics. The members must be intelligent and imaginative and not incurably dogmatic. The members must also be available timewise to perform this extremely timeconsuming task. It is, on the other hand, imperative that people who represent a particular moral or religious view in such a way that makes them impervious to the language of consensus will not be included in the committee's team. They will not be of use since they may be incapable of sympathy and flexibility. One major disadvantage of these committees is that sometimes the advent of new technologies is ahead of committee deliberations. If there exists a previous opposing committee decision, the use of specific new advances may be delayed until the committee changes its original deliberation. It is imperative that the committees should be able to convene to deal with controversial issues as they arise. In several countries committees are set up ad hoc to address specific subjects of public bioethical concern. The Warnock Committee on Human Fertilization and Embryology, for example, which reported in 1984, had a great influence on subsequent legislation. Other countries have established national committees concerned with bioethics. The French government established a national ethics committee in 1983, which also influenced legislation. Most countries have a form of national ethics committee, sometimes several, to deal with specific issues. Ethical committees in the field of human reproduction have to deal with new reproductive technologies, which raise many diverse ethical issues, some of which have not been dealt with before. Conventional notions of family and conception are questioned due to the availability of assisted reproduction techniques, gamete and embryo donation, Journal of Assisted Reproduction and Genetics, Vol. 13, No. 9, 1996

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and surrogate motherhood. The public is concerned about future directions in biomedical research. Since 1979 at least t 00 committee statements on the new reproductive technologies have been issued. Some statements were issued by large and influential committees. Most of these committees were officially appointed by governments to help resolve controversial or technically complex issues in an academic mode (10). Most of these deliberations were in the 1980s and some committees issued revisions or additions later on. Some main committees are presented below. 1. U.S. Department of Health, Education and Welfare (HEW), Ethics Advisory Board, HEW Support of Research Involving Human In Vitro Fertilization and Embryo Transfer, May 4, 1979 (11). 2. Victoria, Australia, Committee to Consider the Social, Ethical and Legal Issues Arising from In Vitro Fertilization. Four reports, issued in September 1982, April 1983, and April 1984 (12-15). 3. South Australia, Report of the Working Party on In Vitro Fertilization and Artificial Insemination by Donor, January 1984 (16). 4. Queensland, Australia, report of the special committee appointed by the Queensland government to Enquire into the Laws Relating to Artificial Insemination, In Vitro Fertilization and Other Related Matters, March 1, 1984 (17). 5. Council for Science and Society, United Kingdom, Working Party, Human Procreation: Ethical Aspects of the New Techniques, May 1984 (18). 6. United Kingdom, Department of Health and Social Security, Report of the Committee of Inquiry into Human Fertilization and Embryology, Warnock, July 1984 (19). 7. Tasmania, Australia, Committee to Investigate Artificial Conception and Related Matters, June 1985 (20). 8. Ontario, Law Reform Commission, Report on Human Artificial Reproduction and Related Matters, June 13, 1985 (21). 9. Australia, Family Law Council. A Uniform Approach to the Law and Practice of Reproductive Technology in Australia. Family Law Council, July 1985 (22). 10. Federal Republic of Germany, Minister for Research and Technology and Justice MinisJournal of Assisted Reproduction and Genetics, Vol. 13, No. 9, 1996

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12. 13.

14.

15.

ter, Working Group, In Vitro Fertilization, Genome Analysis, and Gene Therapy, Bend& November 1985 (23). Spain, Congress of Deputies, General Secretariat, Special Commission for the Study of Human In Vitro Fertilization and Artificial Insemination, report, April 10, 1986 (24). American Fertility Society, Ethics Committee, Ethical Considerations of the New Reproductive Technologies, September 1986 (25). Western Australia, Committee to Enquire into the Social, Legal and Ethical Issues Relating to In Vitro Fertilization and Its Supervision, October 1986 (26). The Netherlands, Health Council, Committee on In Vitro Fertilization and Artificial Insemination by Donor (and Surrogate Motherhood), Dutch Health Council, October 16, 1986 (27). France, National Consultative Committee on Ethics (two reports: Artificial Reproduction, Research Involving Human Embryos), October 1984 and December 1986 (28,29).

In Israel a committee set up by the Ministry of Health deliberated in the mid 1980s. Its recommendations were specifically used in legislation. Generally new committees are formed in order to deal with specific issues as they arise (30). Common to all these committees is the general acceptance of IVF practice. When dealing with specific issues, for example, surrogate motherhood, only the Ontario Law Reform Commission statement, the report of the American Fertility Society Ethics Committee, and the Dutch Health Council Committee found fee-based surrogacy to be ethically acceptable. Each committee cited suggested oversight measures. INTERNATIONAL COMMITTEES

Within international committees are represented diverse geographic, ethnic, cultural, linguistic, and religious backgrounds. The only bioethical problems that have been considered for international harmonization are those related to scientific research and the application of medical technologies. The principles described above pertain to the formation of these committees. Some diplomacy may also be required, as the members of these committees represent diverse nations, cultures, religions, and social structures.

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In 1985 the Council of Europe created a multidisciplinary body with experts appointed by each member country. This committee has already produced documents on reproduction, research on human subjects, prenatal diagnosis and screening, and genetic testing, among other subjects. Once these documents are approved by the Committee of Ministers, they become recommendations for the national parliaments, which may or may not decide to follow them. The European assembly and other committees have also issued reports related to bioethical problems. The Council of Europe, which represents all the democratic countries of Europe, has organized a European Convention on Bioethics. The first two protocols, which the committee reported in 1994, regarded human experiments and organ transplantations (31). In 1985 the FIGO Committee for the Study of Ethical Aspects of Human Reproduction was established. Its main objectives were the recording and studying of general ethical problems emanating from the research and practice of human reproductive medicine and to provide guidelines for practice. The members of the Committee are obstetricians and gynecologists, neonatologists, lawyers, and public health workers, all of which represent diverse geographic, ethnic, cultural, linguistic, and religious backgrounds. The Committee issues guidelines only after a consensus is met. The Committee has dealt with many issues, such as surrogate motherhood, preembryo research, and prenatal diagnosis, as well as general ethical principles, such as informed consent (2). These international committees convene only a few times a year due to the necessity to gather members from different countries. The deliberations are made public through committee statements published in scientific journals and in specific reports. CONCLUSIONS Modern ethics in today's pluralistic society has changed the face of medical practice. Commissions appointed by institutions, governments, and international bodies serve to alleviate the medical profession from making ethical decisions and to protect human subjects from any harm. The deliberations of these committees are usually followed by guidelines of operation, which in many cases have become abiding law. In order for committees

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to be of full advantage, they must convene promptly as issues arise, so as not to delay medical advances from being implemented. REFERENCES 1. Ryan KJ: Medical ethics. In Danforth's Obstetrics and Gynecology, 7th ed. JR Scott, PJ Oisaia, CB Hammond, WN Spellacy (eds). Philadelphia, J. B. Lippincott 1994, pp 1063-1071 2. FtGO News: FIGO Committee Guidelines. Report of the FIGO Committee for the Study of Ethical Aspects of Human Reproduction. JG Schenker, Chairman Int J Gynecol Obstet 1996;53 3. World MedicalAssociation: Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects, 18th World Medical Assembly, Helsinki, Finland, 1964. Revised by the 29th World Medical Assembly, Tokyo, Japan, 1975 4. Beecher HK: Ethics and clinical research. N Engl J Med 1966;274:1354 5. Kelly DF, Hoyt JW: Ethics consultation. Crit Care Clin 1996;12:49-70 6. Siegler M: Ethics committees: Decisions by bureaucracy. Hastings Center Rep 1986;16:22-24 7. Lo B: Behind closed doors: Promises and pitfalls of ethics committees. N Engl J Med 1987;317:46-50 8. Fletcher JC, Hoffmann DE: Ethics committees: Time to experiment with standards. Ann Intern Med 1994; t 20:335-338 9. Warnock M: Ethics Committees. Bailliere's Clin Obstet Gynaecol 1991 ;5:761-777 10. Waiters L: Ethics and new reproductive technologies: An international review of committee statements. Hastings Center Rep 1987;June:3-9 11. U.S, Department of Health, Education and Welfare (HEW), Ethics Advisory Board: HEW Support of Research Involving Human In Vitro Fertilization and Embryo Transfer. Washington, DC, Chairman: James C. Gaither, May 4, 1979 12. Victoria, Australia, Committee to Consider the Social, Ethical and Legal Issues Arising from In Vitro Fertilization: Chairman: Louis Waller. Unpublished document, Sept 1982 13. Victoria, Australia, Committee to Consider the Social, Ethical and Legal Issues Arising from In Vitro Fertilization: Chairman: Louis Waller. Issues paper on donor gametes in IVE Unpublished document, Apr 1983 14. Victoria, Australia, Committee to Consider the Social, Ethical and Legal Issues Arising from In Vitro Fertilization: Chairman: Louis Waller. Unpublished document, Aug 1983 15. Committee to Consider the Social, Ethical and Legal Issues Arising from In Vitro Fertilization: Chairman: Louis Waller. Melbourne, Atkinson Government Printer, Aug 1984 16. South Australian Health Commission: Report of the Working Party on In Vitro Fertilization and Artificial Insemination by Donor. Chairpersons: Aileen F Connon and Phillipa Kelly. Adelaide, Jan 1984 17. Queensland, Australia: Report of the special committee appointed by the Queensland government to Enquire into the Laws Relating to Artificial Insemination, In Vitro FertilizaJournal of Assisted Reproduction and Genetics, Vot. 13, No. 9, 1996

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t9.

20. 21.

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tion and Other Related Matters. Chairman: Mr. Justice Demack. Unpublished document presented to the Minister for Justice and Attorney-General, Mar 1, 1984 Council for Science and Society, United Kingdom: Working Party, Human Procreation: Ethical Aspects of the New Techniques. Chairman: GR Dunstan. New York, Oxford University Press, May 1984 United Kingdom, Department of Health and Social Security: Report of the Committee of Inquiry into Human Fertilization and Embryology. Chairman: Dame Mary Warnock, London, Her Majesty's Stationary Office, July 1984 Hobart, Tasmania, Australia, Director-General of Health Services. Committee to Investigate Artificial Conception and Related Matters: Chairman: Don Chalmers. June 1985 Ontario, Law Reform Commission, Ministry of the AttorneyGeneral: Report on Human Artificial Reproduction and Related Matters. Chairman: James R. Breithaupt. June 13, 1985 Canberra, Australia, Family Law Council. Attorney-General's Department: A uniform approach to the law and practice of reproductive technologies in Australia. Chairman: Mr. Justice Asche. Australian Government Publishing Service, July 1985 Federal Republic of Germany, Minister for Research and Technology and Justice Minister: Working Group, In Vitro Fertilization, Genome Analysis, and Gene Therapy. Chairman: Mr. Justice Ernst Benda. Bonn, Nov 1985 Spain, Congress of Deputies, General Secretariat, Special Commission for the Study of Human In Vitro Fertilization and Artificial Insemination: Report, Chairman: Marcelo Palacios. Madrid, Congress of Deputies, General Secretariat, Apr 10, 1986

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25. American Fertility Society, Ethics Committee: Ethical considerations of the new reproductive technologies. Fertil Steril 1986;46(3;Suppl 1):i-94S 26. Perth, Western Australia, Minister for Health, Committee to Enquire into the Social, Legal and Ethical Issues Relating to In Vitro Fertilization and Its Supervision: Chairman: C. A. Michael. Oct 1986 27. The Netherlands, Health Council, Committee on In Vitro Fertilization and Artificial Insemination by Donor (and Surrogate Motherhood), Dutch Health Council: Chairman: S. A. de Lange. Oct 16, 1986 28. Paris, France: National Consultative Committee on Ethics. Report on Ethical Problems Related to Techniques of Artificial Reproduction. National Ethics Committee I. Chairman: Jean Bernard. Oct 23, 1984 29. Paris, France, National Consultative Committee on Ethics: Report on Research Involving Human Embryos In Vitro and Their Use for Medical and Scientific Purposes. National Ethics Committee II. Chairman: Jean Bernard Dec 15, 1986 30. Schenker JG: In vitro fertilization (IVF), embryo transfer (ET) and assisted reproduction in the State of Israel. Hum Reprod 1987;2:755-760 31. Byk C: The European Convention on Bioethics. J Med Ethics 1993;19:13-16

Vered H. Eisenberg Joseph G. Schenker Department of Obstetrics and Gynecology Hadassah University Medical Center Ein Kerem P.O. Box 12000 91120 Jerusalem, Israel