International Medical Ethics: The FIGO Committee for the Ethical Aspects of Human Reproduction and Women's Health

In the last two decades, ethical issues in medicine have come to the forefront of public consciousness, with concern focusing on several important areas. Advances in scientific and technological knowledge have created ethical dilemmas about what is right and wrong, about life and death issues, as well as issues of equality, justice and personal preferences. Biomedical ethics also raised issues on patients’ rights, which required steps to be taken to protect patient's welfare and to promote patients’ autonomy. Society's concern for ethical issues in medical practice has led to a growing need for the medical profession to become fully aware of the public view not only on individual patient–physician relationships, but also on how medical developments affect social structure and health policies. Health policy makers as well must examine the ethical basis of decision-making, prioritization, and conflicts of interest as they influence health care locally, nationally and internationally. The FIGO Committee for the Ethical Aspects of Human Reproduction and Women's Health (Ethics Committee) states, in its November 2003 edition of the collected recommendations, that its main objectives are ‘recording and studying the general ethical problems, that emanate from research and practice in women's health as well as bringing these issues to the attention of physicians and the public in developed and developing countries’ [1]. From its inception this committee was not intended to solve these ethical dilemmas, but rather to raise discussion by suggesting perspectives that this group of health professionals, lawyers, and ethicists came to in carefully crafted analysis and debate over these issues. Given the rich field of ethical issues in women's health that derive from not only the reproductive life cycle, but the economic and political status of women internationally—this committee will always confront new issues and even new aspects of old issues that challenge ethical perspectives and practice. There are continual variations on themes the committee has raised in the past through new medical developments. The social status of women, the constraints on health care dollars, and the health status of women have also increased the need for the committee to address the broader set of rights and economic issues that directly influence the health of women and the ethical setting of their care. The committee was established in 1985, at the time of the rise of bioethics as a special focus internationally, and met regularly often at the FIGO Secretariat (Figs. 1 and 2). As technology expanded, the issues of access and proper use as well as the basic tenets of patient consent began to change, and the need for a place to set these emerging ethical perspectives in the framework of the care of women, particularly the obstetrical and gynecologic care of women, became critical. (Top) Ethics Committee meeting at the FIGO Office in London, 4–5 September 1998. From left: J. Milliez, G. Serour, S. Arulkumaran, J. Schenker, M. Plata, M. Liljestrom, C. Pradier, J. Cain, J. Barzelatto, P. Baird, H. Ludwig, P. Dunn. (Bottom) Ethics Committee meeting at the FIGO Office in London, 14 and 15 June 2001. (a). Ethics Committee meeting, Jerusalem, 3–5 November 1996. Mishkenot Sha'ananim, Left. Patricia Baird, Chantal Pradier; Center, Isabel Plata, Hans Ludwig, Joseph Schenker, Rama Samil, Joanna Cain; Right, Jose Barzelatto, Marita Liljestrom, Lidja Andolsek, Callum Macnaughton, Florence Manguyu; (b). King David Hotel, Jerusalem, Mrs. Ludwig, Miss. Larsen, Mrs. Schenker, Miss. Mizmor, Mrs. Macnaughton. The Ethics Committee was officially called into existence by the General Assembly of FIGO held in Berlin on 17 September 1985, which created a standing committee for the study of ethical aspects of human reproduction. A nucleus of the members of the Committee for the Study of Ethical Aspects of Human Reproduction was elected by the executive board. Claude Sureau, Past President of FIGO, was elected to chair the Committee (Fig. 3). Prof. Claude Sureau, Chairman of the Committee (1985–1994). The first meeting occurred in Paris, 28–30 July 1986, on the final day of Tour de France. Chairman: Prof. C. Sureau (France) Members: Prof. F. Beller (FRG) Dr. J. Dionsi (Argentina) Prof. P. Correa (Senegal) Prof. P. Dunn (UK) Prof. H. Hathout (Kuwait) Prof. L. Lampe (Hungary) Dr. G. Lauritsen (WHO-Copenhagen) Prof. Sir Malcolm Macnaughton (UK) Prof. S. Michalas (Greece) Prof. S. Sakamoto (Japan) Dr. B. Saxena (India) Prof. J. Schenker (Israel) Prof. J. Sciarra (USA) In attendance: Ms. Chantal Pradier, FIGO Secretariat. Composition of the Committee The goals of the Committee Methods of work Preparation of official resolutions of FIGO Financial support of the activities The committee was composed of a range of international members who represented developing and developed countries and had a significant interest and/or expertise in medical ethics. Among the 14 members, 13 were chairs of leading obstetric and gynecologic departments; one observer was a neonatologist (P. Dunn). All the members were of male gender. It was agreed that the Committee should not be limited to obstetricians and gynecologists. Dr. Dunn was therefore invited to join the Committee as a full member. It was also agreed to invite as external advisers a representative of WHO (Dr. José Barzelatto), and Dr. Rebecca Cook, a lawyer and an assistant clinical professor at Columbia University. The initial task of the FIGO Committee for the Study of Ethical Aspects of Human Reproduction was to identify and study the important ethical problems confronting health care practitioners in human reproduction. The identified ethical problems were to be brought to the attention of physicians and the public in the developed and developing countries to provide ethical guidelines where appropriate. This task has assumed greater importance with the continuing challenge of ensuring that women are granted human and reproductive rights worldwide. Furthermore, the complexity of incorporating the many ethical aspects of reproductive issues in differing societies for issues such as cloning, or patenting of the human genome, argue for the need for such a consensus body. There is no other body internationally that confronts these issues with a view towards the impact on the health care of women. Because of this, the opinions of the committee are used by womens’ health practitioners internationally to assist them in setting national or local standards, to expand the depth of discussion of these issues locally, and to support their advocacy for improvements in the health and status of women internationally. In the face of rapid cultural and scientific change, this is a critical role of ever-greater need. Women are clearly vulnerable in countries where their health care rights are either non-existent or threatened, and, thus, these guidelines can be a powerful force to support the rights of women. This committee membership remained the same until the 1994 Congress, when the Chair passed to Dr. Joseph Schenker (Israel) (Fig. 4), and then to Dr. Joanna Cain (USA) at the 1998 Congress (Fig. 5), and in 2004 to Dr. Gamal Sereau (Egypt) with Dr. Jacques Milliez (France) as Co-Chair. Committee membership over these years is outlined in Table 1. Along with this international membership diverse in gender and disciplines, the committee attempted to move the meetings to different international settings to draw from local expertise and culture and share in an international exchange of ideas (Table 2). Prof. Joseph G. Schenker, Chairman of FIGO Committee for Ethical Aspects of Human Reproduction 1994–1998. Prof. Joanna M. Cain, Chairman, Committee for Aspects of on Human Reproduction (1998–2004). At the FIGO Congress in Rio de Janeiro, 25–26 October 1989, the Executive Board of FIGO appointed nine standing committees for the study of particular problems relating to research, education, and practice in the fields of gynecology, obstetrics, and human reproduction. The Committee for the Study of Ethical Aspects of Human Reproduction was re-appointed at this time. Committees had a general template of one chair and 8–12 members. This number was increased for the Ethics Committee 15–18 at the 1994 Congress, and then decreased to 8–10 in 2000. The chair, normally an obstetrician/gynecologist, nominated by the General Assembly on the proposal of the Executive Board, was to be appointed for a term of office of 3 years with the possibility of re-election. The chairman of each standing committee was to be invited to attend the meetings of the Executive Board. The membership of standing committees, of which the Ethics Committee was one, was to be discussed, modified, completed, and agreed to by the Executive Board at its annual meeting. The term of office of the members was also 3 years, with the possibility of re-election. The Chair could request a contribution from FIGO for secretarial work and other activities of the standing committee (a sum of US $2000 per year in 1989). In its first Congress as a standing committee, the Ethics Committee presented three seminars: medical ethics and medically assisted reproduction, AIDS with emphasis on ethical aspects, and refusal of obstetrical care (maternal health, fetal health, and neonatal health), which were published in the proceedings of the Rio Congress. How much are mothers worth? (M. Fathalla) Distribution of resources between primary and tertiary reproductive care (Ms. Inayatullah) Availability of resources for newborn care (M. Chiswick) Macroethical issues in obstetrics and gynecology (L. Lampé) This key seminar was chaired by Profs. Sureau and Schenker, and marked an important expansion of the thinking of the Committee beyond that of the common bioethical analysis of the time, which focused on principals such as benefit (beneficence), harm (maleficence), and patient autonomy in the area of human rights and justice. During this time, the Committee also began to align its meetings with regional meetings that paralleled the focus of the committee on ethical aspects of human reproduction. The first of these took place in Cairo at the invitation of Prof. Gamal Serour in 1991 and focused on Bioethics in human reproduction research in the Muslim World. The committee meeting foreshadowed an area of ongoing controversy in medicine—that of transplantation of fetal and embryonic tissue, with the initial paper presented by Prof. Schenker in Athens in 1989. First, research on pre-embryos was only ethically acceptable when its purpose is for the benefit of human health and only if animal models would not suffice. The Committee felt that no developing human pre-embryo might be kept alive beyond 14 days after fertilization (not including any time during which the embryo had been frozen). Research projects on pre-embryos should be authorized by ethical and/or other appropriate bodies in the country and, if allowed, appropriate informed consent must be obtained before undertaking research on pre-embryos, normally both gamete donors. Furthermore, provision of gametes and pre-embryos should not be subject of commercial profit. The Committee was unable to reach a consensus as to whether research should be limited to surplus pre-embryos or should also include pre- embryos specifically generated for research, a debate that continues worldwide. The discussion over this issue established the precedent that committee statements required consensus, and where that was not possible, debates were either not included or included with the caveat that there was no consensus. The first bound publication of the collated Issues and Guidelines appeared in 1994, and by 2000 had grown to a body of work that encompassed such a broad territory that the index divided the work into categories: general issues in women's health and advocacy, issues in genetics, pre-embryo research; issues in conception and reproductive endocrinology, issues regarding pregnancy and maternal fetal issues, issues regarding neonates; issues in contraception and abortion; and issues in advertising and marketing health services. With the translations into Spanish and French, the present volume (2003) covers 232 pages. The method of analysis adopted by the committee evolved early on and consisted of position papers on a topic identified by the committee that were circulated prior to committee meetings in the working language of the committee, English. These research papers explicated the problem, the present status of knowledge, and the various ethical stances or issues that were identified in the literature. At times, the committee invited outside experts in areas where there was not felt to be adequate depth of expertise or where there were other FIGO Committees working on the medical or rights aspects of the same issue. The papers were presented at the meeting and a consensus about the important background and ethical issues was identified. Depending on the issues, further work on synthesizing these into a set of reflections or guidelines might take place at the meeting or over several meetings, until every word of each document was reviewed, read, and revised by all the members of the committee. Proposed statements were read line by line and edited by the entire committee to assure that not only the content was acceptable to the committee, but that the translations to French and Spanish would not contain errors because of the likely translation from English. One of the key elements of the Committee's work was the ‘arm length’ distance required from the executive board and general assembly in order to fully consider, without conflicts of interest or coercion, the often highly charged issues discussed. To assure that this was adequately represented a rider for any publication of the recommendations of the committee was added in the 2000 edition (and all editions since) that stated: ‘The FIGO Committee for Ethical Aspects of human reproductions and women's health considers the ethical aspects of issues that impact the discipline of obstetrics, gynecology, and women's health. The following documents represent the result of that carefully researched and considered discussion. This material is not intended to reflect an official position of FIGO, but to provide material for consideration and debate about these ethical aspects of our discipline for member organizations and their constituent membership.’ This independence has been particularly helpful to FIGO in providing ethical guidance regarding relationship of the federation to industry, initially formulated as internal ‘Guidelines for Relations Between Industry and FIGO’ in 1991 [3]. These guidelines have been revised several times as new developments such as publications, web-based education and advertising, or new relationships of FIGO to industry raised previously unaddressed questions. The published materials have been used to do everything from developing curriculum for schools of medicine internationally to formatting laws in the area of reproductive health. In addition, the Committee members have participated in many international seminars representing the Committee in order to expand thinking in the area of ethics in women's health. Among these, a key event occurred in Paris, 6–8 July 1994. Cultural, ethical, and legal issues of fetal-parental conflict. Responsible procreation. Informed consent in contraception. Acquisition and use of fetal tissue for transplantation. Law, ethics and justice in the human reproduction. Gamete donation and surrogacy. Ethical aspects of substitutive hormone therapy at menopause. Female genital mutilation. Conflicts at the roots of bioethics and health care policy. Sex selection. Research on pre-embryos. With members of the committee and invited speakers in each session, which followed the committee pattern of presentation of the topic by a rapporteur, then discussion by selected discussants, and open discussion from the floor. This model led to broad input into committee thinking as well as spreading discourse on the ethical aspects of human reproductions and women's health, and has been used since for task force development and other symposia. An additional role of the Committee that has continued to develop from the late 1990s on has been that of collaborative work with other standing committees or task forces, notably the Perinatal Committee and the Task Force on Sexual and Reproductive Rights. With both committees, members of the committees crossed between the two groups to produce specific recommendations to underpin the joint discussions and areas of concern such as ‘Ethical Guidelines in the Prevention of Iatrogenic Multiple Pregnancy (2000)’ with the Perinatal Committee and ‘The Role of the Ob/Gyn as Advocates for Women's Health (1999) with the Task Force on Sexual and Reproductive Rights. In addition, committee members served on other publications and work of the Task Force. This role of ethical input into the deliberations of other committees offers FIGO a significant depth of consideration unique in any organization. The committee also organized a session at the ninth World Congress on Human Reproduction in Philadelphia in May 1996. The program included an introduction giving a brief history of the committee and its objectives (J. Schenker); and discussion papers on violence against women (J. Cain); ethical aspects of HIV in reproduction (M. Macnaughton); ethical aspects of the management of the severely malformed fetus (P. Dunn). This session was well attended and resulted in a lively interchange. Members of the Committee also presented papers at the International Congress on the Fetus as Patient in Rome, Italy (May 1997), at the National Philippines Obstetrics & Gynecology Society Congress (November 1996), the 10th World Congress of IVF and Assisted Reproduction in Vancouver, Canada (May 1996) and the National Congress of Brazilian Federation Gynecology and Obstetrics (November 1997). In 1997, members of the committee also organised a session at the XVth FIGO World Congress in Copenhagen, Denmark. The session was entitled ‘Ethical Dilemmas in Clinical Practice: HIV and Assisted Reproductive Technology’. The committee with international as the World Health various aspects of women's health to that the ethical aspects are fully The committee members represent a of and and members have with international committees to and of these ethical aspects in and One of the of the committee occurred during the meeting in Jerusalem, when committee members were to be to the of and Joseph Schenker for a with the of Jerusalem, of and on November It was by that the and the of had been by a who of to in the at a in a by the Committee the day The at the was followed by a when word came of The Committee members the day with the of the and of the and the in their The critical need for continued international and that to common and and is in the Committee was well by this The ethical issues that underpin practice and rights of women are critical of the work of FIGO and provide a set of documents for member health professionals, and to debate the issues As the Committee has remained a key of FIGO since its The of women's rights and the ethical that or should health care of women has become and has brought in the perspectives of the international rights and to the work of the committee. there are other international for women's rights and health from the World Health to specific groups focusing on rights, there no other international ethics committee working in the broad area of women's health and reproductive health. of the for for and on the (2003) are of the continued of technology and the of a on the practice of statements from the past need as the use and that they were on have over time, and the ongoing of these documents is of the work of the This Committee has been one of the of the basic tenets of to provide an international where issues and support could impact the care of women worldwide. It a role that FIGO to assure that ethical issues that influence women's they are raised by social or economic

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