Creating common ground : women's perspectives on the selection and introduction of fertility regulation technologies, report of a meeting between women's health advocates and scientists

Publication date: 1991

I CREATING COrtlrtlON GROllND WHOIHRPIITT191 W omen's Perspectives on the Selection and Introduction of Fertility Regulation Technologies Report of a meeting between women's health advocates and scientists Geneva, 20-22 February, 1991. organized by ~ Special Programme of Research, Development and Research Training in Human Reproduction and The International Women's Health Coalition World Health Organization Geneva 1991 I © World Health Organization 1991. All rights are reserved by the World Health Organization (WHO). The document may not be reviewed, abstracted, quoted, reproduced or translated, in part or in whole, without the prior written permission of WHO. No part of this document may be stored in a retrieval system or transmitted in any form or by any means - electronic, mechanical or other without the prior written permission of WHO. The views expressed in this document are either those of individual participants or represent a consensus view of the whole group. They do not necessarily represent the views and policies of the World Health Organization or the Interna- tional Women's Health Coalition. The mention of specific companies or of certain manufaclUrers' 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 proprie- tary products are distinguished by initial capital letters. I TABLE OF CONTENTS Foreword 5 Research needs 34 - Clients' needs and preferences 35 Introduction 6 Health and family planning delivery systems 35 Summary of suggested actions 8 - Fertility regulation methods 36 Who should do the research Setting the stage for dialogue 10 and how 36 - Different perspectives, different language 10 Collaboration between scientists and - Who speaks for women? women's health advocates 38 For whom do scientists speak? 13 - Enablement 39 - Moral dilemmas 14 - Information exchange 39 - Funding and staffing 40 Selecting fertility regulation methods for introduction 16 Recommendations 41 - Safety, efficacy, acceptability and availability 17 List of participants 43 - Other critical factors in selection of methods 21 Unwanted pregnancy and abortion 23 Considerations for introductory trials 27 - Ethical issues 27 The process of introduction 29 - Evaluation of introductory trials 31 - Cost of method introduction 33 I I FOREWORD Since 1960 we have both watched and participated in the evolution of values, ideas and strategies to address the twin problems of population pressures and the health and welfare of women. We have observed this evolution from different perspectives, from differ- ent vantage points and from different hemispheres. As we jointly planned the meeting described in this volume, it seemed to us that the last thirty years produced several generations of ideas. In the late 1950s, policy-makers and those concerned with social and eco- nomic development asked themselves the question: "Is population growth a problem?" When the answer to that question appeared to be in the affirmative, the question for the 1960s was: "How can technologies be developed and distributed to solve this problem ?" A partial answer was found in the invention of modern birth control technologies. In the 1970s, the international commu- nity focused on the production and distribution of these technologies and on persuading governments to recognize the urgency of controlling population growth. In the 1980s, and into the next century, this generation is asking: "How can the technologies be adapted and adopted to best serve both the individual women - the consumer - as well as the community? How can we balance the scales of public policy?" We are also asking: "How can we en- courage and engage a broad and deep political will to improve the quality of the technologies, to enhance their use and to ensure free and fully informed choices for the consumer?" The Special Programme of Research, Development and Research Training in Human Reproduction of the World Health Organization and the Inter- national Women's Health Coalition have come together with a shared commit- ment to build on the values and ideas that have evolved over the past thirty years. We want to create understanding and strategies that will enhance scientific exploration, improve the quality of technology and encourage advocacy on behalf of women's health and well-being. The meeting described here represents the beginning of a process. We are oT). the threshold of collaboration between the users of technology and the creators of it. This requires development of trust through honest and straightforward dialogue between groups which conven- tional wisdom said could not talk to one another. The meeting described here defied that conventional wisdom, proving that scientists and women's health advocates can hear each other and respect each others' views even when they differ. This is the first in a series of discussions which we plan with our colleagues and friends from all walks of life. Joan Dunlop President, International Mahmoud Fathalla Director, Special Programme of Research, Development and ResearchTraining in Human Reproduction Women's Health Coalition INTRODUCTION O ver the past three decades, women around the world have increasingly sought to space and limit their childbearing, and millions are now using modern methods of fertility regulation. Although women pioneered the family planning movement and make up the majority of contraceptive users, they have had little or no hand in the de- sign and introduction of modern fertility regulation methods. Nor have they been Significantly involved in establishing poli- cies relating to fertility regulation meth- ods. Many women have encountered problems with these methods and the systems used to provide them. Lack of ac- cessible information about how methods work, experience with and fears about method safety and side effects, along with documented cases of coercion, have led some women to question the appropriate- ness of particular fertility regulation tech- nologies and to distrust family planning programmes. As a result, over the past 15-20 years, women in different parts of the wDrld have taken up issues Df reproductive health. Their CDncern has been to em- power WDmen to cDntrDI their own fertil- ity and sexuality with maximum choice and minimum health prDblems by provid- ing infDrmation and alternative services, and by campaigning fDr wDmen's right to make infDrmed chDices abDut their fertil- ity, fDr improved services and fDr mDre ap- propriate technDIDgies. Such activities, among others, have become knDwn as "women's health advDcacy". Recognizing the impDrtance Df these CDn- cerns and Df cDnsumers' views, research- ers, pDlicy-makers and service providers have recently begun to seek dialogue and collaboration with women's health advo- cates. In 1990, an external evaluation of the Special Programme of Research, De- velopment and Research Training in Hu- man Reproduction of the World Health Organization (WHO) recommended that the Special Programme consult with women's groups about its work. As a first step, the Special Programme and the International Women's Health Coalition (IWHC) jOintly organized a meeting between scientists and women's health advocates to define how women's needs and perspectives can be brought to bear on the work of the Special Programme and of other organizations concerned with fertility regulation. The Internation- al Women's Health Coalition, committed to engaging women's health advocates in the design and development of public policy on reproductive health, saw the meeting as an opportunity to narrow the distance between institutions that formu- late policy and the consumers affected by policy. It was agreed that the meeting sho.uld fo- cus on only one aspect of fertility regula- tion the selection and intrDduction Df fertility regulatiDn technDIDgies because the field is vast and cDmplex and because it was thDUght that the selectiDn and in- troductiDn process offers Significant op- pDrtunities for CDllaboratiDn between sci- entists and WDmen's health advDcates. The specific Dbjectives Df the meeting were to.: • Establish a dialDgue between the sci- entists and scientific cDllabDrators Df the Special Programme, and those in- vDlved in women's health advocacy;" I • Identify means by which women can influence and be involved in both the choice and introduction of methods of fertility regulation, and find ways in which the Special Programme and other research programmes can work with women's health advocates on a continuing basis; • Recommend specific actions to in- volve women's groups in the selection and introduction of fertility regula- tion technologies at national, region- al, and international levels. To ensure a balance of perspectives, simi- lar numbers of scientists and women's health advocates were invited to partici- pate. Eight international scientists (one from Africa, three from Latin America, two from Asia, and two from Western countries) who collaborate with the Spe- cial Programme, and eight staff of the Special Programme attended. Most of the scientists are physicians, working in a range of disciplines including epidemiol- ogy, reproductive biology, obstetrics and gynaecology, biochemistry, and social sci- ence. The six women and ten men were selected for their expertise on contracep- tive safety and efficacy, sexually trans- mitted diseases, provider-dependent methods such as implants and intraute- rine devices OUDs), and the introduc- tion of new methods. The fourteen women's health advocates included three women from Africa, four from Latin America, three from Asia, and four from international women's health advocacy organizations. They were cho- sen on the basis of their long experience in working with women and their ability to represent a broad range of women's views. Some are physicians who work in clinic or other service settings; others are involved in counselling and referral, in- formation exchange and networking. Most work closely with low income women in both urban and rural settings. (Page 43 gives the list of participants.) The overall theme was addressed in four parts - selection of fertility regulation methods, method introduction, the re- search process, and women's participation - on which both womens health advocates and scientists were invited to prepare for- mal comments. Following plenary discus- sion of these issues, the participants worked in groups to develop recommen- dations, which were then discussed and agreed upon in a final plenary session. De- bate was spirited and rich as participants candidly related their experiences and views, which were often quite divergent. Many questions which participants brought to Geneva were answered, but some remained unresolved and important new questions emerged. This report is a synthesis of the presenta- tions and discussion at the meeting. It aims to clarify key issues and encourage continued discussion and action at local, national and international levels. It is ad- dressed to all those involved in fertility regulation who wish to make their policies and programmes more responsive to women's needs. I SUMMARY OF SUGGESTED ACTIONS • Deepen and extend dialogue between women's health advocates and scien- tists on both the ethical and practical dimensions of fertility regulation technologies, programmes and poli- cies. • Bring women and women's perspec- tives into the work of the Special Pro- gramme and of other organizations and institutions that develop fertility regulation technologies and services. • Re-examine the basic concepts of safety, efficacy, acceptability and avail- ability to incorporate women's per- ceptions and experiences in the defi- nition of each and to define an appro- priate balance among them as criteria for method selection and introduc- tion. • Review and modify criteria used by national governments and donors in the selection of fertility regulation methods. • Promote health and family planning systems that emphasize high quality care. • Undertake further research on wom- en's and men's attitudes, beliefs and practices about sexuality and fertility regulation in particular settings. • Increase investment in male contra- ceptive methods and involve men in taking personal responsibility for re- productive health and fertility regula- tion. • Support collaboration between scien- tists and women's health advocates on initiatives to eliminate unsafe abor- tion. • Develop guidelines collaboratively to specify under what circumstances particular methods should be intro- duced and to clarify the criteria by which introductory trials determine whether a method is appropriate for widespread introduction. • Include women's groups and women's health advocates in all parts of the in- troductory trial process, including ethical and scientific committees that deSign, monitor and evaluate intro- ductory trials. • Broaden the evaluation team to in- clude service proViders, social scien- tists, and representatives of women's groups, women's health advocacy groups and community groups. • Disseminate the results of evaluation widely. • Provide for long-term follow-up stud- ies. • Before selecting and introducing fer- tility regulation methods, undertake studies on: clients' needs and per- spectives; knowledge, attitudes and practices of scientists, managers and prOViders; and the health and family planning infrastructure in each coun- try. I I • Foster research on the effectiveness and acceptability of barrier methods and withdrawal. • Involve women and women's health advocates in all stages of research, in- cluding elaboration of ethical guide- lines and standards for research, defi- nition of priorities, research design and implementation, and analysis of findings. • Develop and include innovative re- search techniques that are participa- tory, multidisciplinary and sensitive to the clients' situation. • Train women in both biomedical and social sciences, and train scientists and policy-makers in women's per- spectives on reproductive health. • Disseminate scientific information in a more accessible form and language to women's and other non govern- mental groups, and provide the re- sults of women's research and experi- ence to scientists. • Generate financial resources to sup- port collaboration between women's health advocates and scientists. SETTING THE STAGE FOR DIALOGUE Different perspectives, different language B oth scientists and women's health advocates emphasized that there is neither one mono- lithic "scientists' perspective" nor one "women's perspective", but rather a broad spectrum of opinions within each community. They recognized as well that both groups are sometimes constrained from acting fully and conSistently ac- cording to their perspectives. Women's health advocates often face lack of infor- mation, poor funding and various kinds of opposition or exclusion, while scien- tists face pressure from colleagues, do- nors or other agencies that have their own views on what research should be funded and carried out. For instance, scientists working in the field of family planning have different approaches. Some might be termed "hardware enthusiasts" who believe that fertility regulation can be achieved through development of a wider range of effective, safe and acceptable contracep- tive technologies. Some are "software ad- vocates" who stress the importance of social and cultural variables and service delivery systems as factors determining fertility regulation. However, there are many who recognize that both hardware and software are needed. While some re- search agencies, like the Special Pro- gramme, have adopted the combined ap- proach, many scientists have concentra- ted on the hardware, pursuing techno- logical innovations. From a biomedical scientist's point of view, the process of developing a fertility regulation method from toxicological testing to final clinical assessment is the accumulation of information on safety and efficacy. This process is in part dic- tated by drug regulatory agencies that re- quire specific tests to establish the safety and efficacy of new products. Once through these stages, biomedical and so- cial scientists, along with family plan- ning programme managers continue to test safety and efficacy, as well as accept- ability, through introductory trials. These trials can also help assess the appropri- ateness of the service delivery system, and develop an understanding of the concerns of users and the needs of the service providers. One of the problems some scientists encounter in this process is with communication and understand- ing among themselves. For example, so- cial scientists are an essential interface between the community and biomedical scientists, because they study the qual- itative aspects of users' and providers' needs. However, most biomedical scien- tists work with quantitative data and find it difficult to make use of qualitative data generated by social scientists. Women's health advocates often concep- tualize the issues in l completely differ- ent way. They see their bodies and their autonomy as the central concern. Wom- en's health advocates thus start with women, not technology, and act accord- ing to at least three fundamental as- sumptions. First, they assume that wom- en have the right to control not only their fertility but also their sexuality. Sec- ond, they believe that the exercise of this right requires not only improved meth- ods of fertility regulation and health de- livery systems, but also broader improve- ments in women's circumstances. Third, they know that women can and will make their own rational decisions about I I their fertility and sexuality if they have access to appropriate information and appropriate services. The basic objective for women's health advocates is thus to maximize women's choices and control over their fertility, their sexuality, their health and their lives as citizens. Some scientists sympathize with this view, but women's health advocates feel that many scientists, along with policy- makers, see fertility regulation primarily as a means to limit population growth and speed development, not to empower women. The relative weight assigned to population control compared to women's empowerment has profound effects on the criteria each group uses to set re- search and policy priorities. Scientists at the meeting agreed that modem methods of contraception have often been asso- ciated with the political dimensions of population control. They felt, however, that many scientists involved in this field have undertaken development of fertility regulation methods with the intention of broadening choices for users and pro- tecting their health. Scientists' concern is to establish safety of methods according to specific, mea- surable parameters. They assess toxicity, first in animals and then in carefully controlled studies in human volunteers. Subsequent studies address efficacy and short- to medium-term safety. Scientists are able to assess the long-term safety of a drug or device by epidemiological studies only after a product has been in use for many years. Women's health ad- vocates tend to define safety in different terms. They give more priority to meth- ods that have fewer side effects and that protect against sexually transmitted dis- eases and their consequences such as in- fertility. While scientists have tended to give priority to methods which minimize users' control, women's health advocates prefer methods controlled by the user. "On the question of side effects, there is always a tendency to over-emphasize the benefits and underplay the risks.Most of the lime it is we women who undergo the risks and the benefits are taken by the pharmaceutical companies or by popula- tion control experts or governments of Thinl World countries". Rani Bang Women's health advocates and scientists may often use different language or as- sign different meanings to some words. For instance, scientific language is noto- riously incomprehensible to laypersons, and feminist terminology can be off- putting to those who hold different views. Participants gave several examples of the ways in which language can inhib- it communication and understanding. Scientists pointed out that women have used the term "high tech" to refer to cer- tain fertility regulation methods because they are prOvider-dependent (such as im- plants, injectable contraceptives or lUD's), while for scientists, these meth- ods are technologically Simple. In an- other example, women's health advocates explained that the scientific community's use of the word "couples" is inappropri- ately restrictive. While fertility regulation should concern two people, the word "couple" implies established or married people, which excludes adolescents, the unmarried, and commercial sex workers. [I] Further, scientists and programme plan- ners conventionally define the "unmet need for family planning" in terms of "non-users at risk of unwanted or un- timely pregnancy". A women's health ad- vocates' definition would add to non- users, unsatisfied users, incorrect users, users of inappropriate methods, users and non-users with special needs (such as adolescents and sex workers), and most men. Other fundamental differenc- es in the use of terms, such as "safety," "acceptability" and "efficacy" are ex- plored in depth in later sections of this report. Both scientists and women's health advo- cates at the meeting recognized that dif- ferences in perspectives and language have led to polarization between the two groups, which in turn has fostered dis- trust and criticism rather than creative collaboration and a search for shared val- ues. Excluded from decision-making and the research process, many women have reacted negatively to decisions by re- searchers and policy-makers. This nega- tive reaction has often resulted from anecdotal evidence of misuse of contra- ceptive methods in family planning pro- grammes that do not offer women free and informed choice of fertility regula- tion methods, and that do not adequately protect women's health. Scientists, if they have heard women's perspectives at all, have often heard only the extreme views, and many have con- cluded that it is best to ignore women's groups and the questions they raise. Sci- entists in general have not attempted to communicate with such groups. They have considered their primary concern to be to generate and publish objective information in the scientific literature. Very few scientists have considered how to convey their findings to women in a form that might allay their fears. It is thus not surprising that women's health advocates currently find that the realities of women's sexual and reproductive lives have had relatively little impact on the setting of research priorities in fertility regulation, or on population pro- grammes and policies. "It is our task as women's health advo- cates to assist scientists in the tremendous challenge of creating fertility regulation methods that take into account the wel- fare, sexuality, mental and physical health of women . Male researchers can themselves become more receptive, empa- thizing with women's biological experi- ence, and open to qualities which have been socially attributed to women such as receptivity, sensitivity, intuition . n. Amparo Claro Now however, scientists are realizing that involving women and women's health advocacy groups in their work may enhance the appropriateness and ac- ceptability of the technologies they de- velop. They are seeking dialogue both in order to broaden the scope of their own work and to enable women's groups to better understand the process, the limita- tions and the results of scientific re- search. Women's health advocates, simi- larly; are seeking opportunities to under- stand scientists and programme manag- ers, and to lend their experience and knowledge to the scientific process. I I Who speaks for women? For whom do scientists speak? W hile there was consensus about the need to bring women's perspectives and experiences to bear on the development, selection, and introduction of fertility regulation technologies, the participants debated the question of who can legiti- mately and effectively articulate those perspectives. A number of scientists questioned whether, for instance, wom- en's health advocates, such as those at the meeting, represent the views of poor and rural women. Some participants pointed out that, although women's health advocates may be relatively well educated, most work directly with rural as well as urban women, including low income women. They are thus a legiti- mate source of information about both the content and the value of the variety of women's perspectives that exist. Each brings a point of view based on her own experiences, having listened to and worked with a wide range of women in her own country and internationally. "[ think a central charaueristic [of wom- ens health advocates} is that we are able not to speak for ourselves a.s an indi- vidual woman, but we are able to say, "1 might think this but 1 know other wom- en think diJTerently." - Judy Norsigian Although some scientists remained skepti- cal that women's health advocates can rep- resent the views of the majority of women, others recognized that they themselves have had little personal contact with the women who should benefit from the tech- nologies they help develop. Ultimately, most participants agreed that women's health advocates and other women's groups can act as a bridge between women and scientists, helping to interpret scien- tists' findings to other women, and bring- ing women's concerns to the attention of the scientific community. "On the [assertion} that urban women activists cannot really represent the views of rural women, 1 think that, while this can be true in some cases . you have a big gap between so-called "experts" and very poor women, rural and urban. Sometimes it i.s necessary to have a buffer zone which is what women's activists cunsti- tute. [Ideally,] you should have sensitive experts both male and female, then the question of who is representing [women} bewmes irrelevant". - Adetoun Ilumoka Moral dilemmas T he participants recognized that dialogue is urgently needed to re-solve, or at least clarify, a funda- mental dilemma in the population field that is present in other fields as well. 50- cietal goals and strategies, as defined by policy-makers, do not necessarily coin- cide with the goals and needs of individ- uals. Those who focus on the societal level, emphasize providing services to the largest number of people and have often sacrificed both service quality and choices among technologies. Those who focus on individual health and rights make service quality and choices among technologies paramount. Women's health advocates raised a num- ber of ethical questions during the course of the meeting that stem from this tension. Is it ethical, for example, to in- troduce fertility regulation methods without at the same time addressing oth- er equally critical aspects of women's re- productive health, such as pregnancy care, sexuality or reproductive tract in- fection? Another question raised was whether it is morally acceptable to re- strict access to safe abortion services and simply promote contraception, when contraceptive technologies are imperfect, failure rates and abortion rates are high, and the consequences of unsafe abortion are catastrophic for women. Is it ethical and responsible to introduce contraceptive methods that are heavily dependent on skilled health personnel in countries where health services are gen- erally poor? Is it ethical that developing and developed countries use different cri- teria and standards for the regulation and monitoring of technologies and services? Do precarious health conditions in resource-poor settings place women at higher risk of side effects from certain contraceptives and, if so, is it ethical to introduce those methods where general health is poor? Do the developers of fer- tility regulation technologies have an ob- ligation to consider these contextual fac- tors when first initiating work on a new method and throughout the process? Are they or should they be concerned about the ways in which their technologies are likely to be used or abused by the state, service providers or women themselves? Many of these questions pose profound dilemmas not easily resolved, and some of them may not be resolvable at all. But discussing them openly helped identify some areas (described below) where res- olutions might be sought through collab- oration between scientists and women's health advocates. In general, the partici- pants recognized that, in any setting, fac- tors such as the particular experiences of a people, their culture, and their behavi- our, the quality of the existing health care system, social norms and values about sexuality, fertility and gender roles, and the political and economic climate will all play critical roles in how a meth- od is perceived and used and with what consequences for women. Participants agreed that every effort should be made to consider these factors when a decision is being made about the appropriateness of a particular method of fertility regula- tion. I I Suggested actions • Deepen and extend dialogue between women's health advocates and scien- tists on both the ethical and practical dimensions of fertility regulation technologies, programmes and poli- cies. • Bring women and women's perspec- tives into the work of the Special Pro- gramme and of other organizations and institutions that develop fertility regulation technologies and services. SELECTING FERTILITY REGULATION METHODS FOR INTRODUCTION E xisting contraceptive methods are of five types - hormonal, intrauterine devices, sterilization, barrier, and natural or traditional meth- ods. Both surgical and medical tech- niques exist for inducing abortion. Each method has intrinsic characteristics which must be considered when govern- ments or agencies choose a method for particular countries or programmes. Wo- men's health advocates emphasized, how- ever, that the selection process must also take into account the sexual, reproductive, social and economic realities of women's lives; their health; and the quality of family planning and health services in particular settings. That is, the technologies should not be selected in isolation from the condi- tions in which they are to be used. Women are concerned that, in many in- stances, this principle has not been fol- lowed. As a result, methods that should, in women's view, be provided only by well-trained personnel in settings with strong health infrastructure that can en- sure informed choice have been misused or abused. Scientists usually consider that they are contributing to knowledge about a particular technology and that they rarely have the possibility of influ- encing how and where a method is used. Participants discussed at length the stan- dards that should be set for selection and use of contraceptives, and the efforts needed to encourage adoption of these standards. It was agreed that women's health advocates and scientists, working together, might design more appropriate standards and also monitor selection and use, at least in some settings. The participants agreed that a woman's selection of a method of fertility regula- tion is affected by many considerations. These include such personal circum- stances as her health, sexual relation- ship(s) and point in her reproductive life cycle; the societal conditions that affect her sexuality such as her status in soci- ety, risk of violence, and possible expo- sure to infected partners; her prior expe- rience with fertility regulation methods; and her access to information. Her choice will also be affected by the avail- ability of health and family planning ser- vices, their quality and accessibility, the mix of methods offered as well as the availability of safe abortion. "Access is not only a question of how dis- tant her home is, or how much the trans- portation costs, or who will take care of the baby if she goes to the clinic. Wt have to ask what is the attitude of the husband, what is the altitude of the mother-in-law, what is the attitude of the neighbourhood, of the family, of the city, of the society at large with respect to that woman using that method? What are the source.~ of in- formalion? . Much more emphasis should be pui on this field". - Anibal Faundes It was also agreed that no one method can work for all women at all times in their lives, and that therefore, the broad- est possible number of fertility regulation methods should be offered. Some scien- tists see greater hope for improving choice through development of highly effective, reversible, long-acting meth- ods. Many women's health advocates see a greater need for .the promotion of al- ready existing methods that have mini- I I mal side effects, are user-controlled, and are protective against infection, such as barrier methods. Behind these preferenc- es lie differences in the definitions and relative weight assigned to four funda- mental characteristics of fertility regula- tion technologies: safety, efficacy, accept- ability and availability. Safety, efficacy, acceptability and availability Safety Scientists want to ensure that a meth-od they develop causes no danger-ous or permanent side effects. Through toxicological and clinical studies they assess whether a method might be carcinogenic, or might have severe effects on physiological functions such as those of the heart, the kidneys or the reproduc- tive organs, or might have other potential- ly severe outcomes. The women who use methods that have passed these tests are also concerned about how these methods might affect their overall health, including their sexual interest, physical stamina, or emotional well-being - aspects of health that generally have been given lower pri- ority by researchers and service providers. Side effects such as menstrual bleeding disturbances, which scientists consider unimportant medically, can be of extreme concern to women, and may affect how they perceive the safety of any method. For a woman, safety of use of a method during lactation, and the long-term effects of method use, are of particular concern, and her concept of safety may also require that the method is immediately reversible. Because safety is impossible to measure in absolute terms, and accurate technical in- formation is still insufficient, a broad spec- trum of society, certainly women, should participate in the process of weighing risks and benefits of technologies to be intro- duced. Some women feel that certain natural substances, such as herbs and plants used as contraceptives may be safer than modern methods and some women's health advocates felt that more emphaSiS should be put on researching traditional herbs and plants. Scientists pointed out that the Special Programme had funded a major international research programme in this area, albeit restricted to plants alleged to have properties preventing implantation of a fertilized egg in the uterus or to inhibit male fertility. No new chemical entities suitable for method development were identified. However, this area of research has by no means been exhausted. * "Natural" is not always simple and safe. all the other hand, there are many tradi- tional methods which I'm sure haven't been adequately explored and could very well tum out to have the advantage of simplicity alld safety". - Henry Gabelnick Women's health advocates felt that atten- tion needs to be given to the safety of particular methods in settings where dis- ease and malnutrition are very substan- tial. They emphasized the need to exam- ine interactions between fertility regula- tion methods and sexually transmitted diseases, especially AIDS. They suggest- ed, for example, that a community with endemic reproductive tract infections, especially where they are undiagnosed and untreated, is an inappropriate envi- ronment in which to introduce IUDs. Scientists pointed out that some agencies do carry out studies on the wider health implications of method use. The Spe- cialProgramme, for example, is conduct- ing cross-cultural research in more than 20 countries to examine the effect of vari- * A two-volume monograph on the WHO multi- centre study on plants, the research operation and findings, is in preparation for publication in 1993. A brief off-print summarizing the findings is available from the SpeCial Programme. ous contraceptives on a range of problems including HIV transmission, neoplasia, infant development, anaemia, hepatitis B and cardiovascular diseases. It was recog- nized, however, that more needs to be done, and that the results of such studies need to be made available much more widely than is presently the case. Scientists indicated that they need to know more about how clients perceive and define safety. However, they also urged that what is known medically about safety should be more adequately conveyed to women. For instance, a once-a-month injectable contraceptive sold over the counter in Latin American countries has been very popular among women because bleeding remains regu- lar. However, the drug contains a high dose of estrogen which increases the risk of metabolic and cardiovascular diseases - a long-term problem which is not no- ticed on a daily basis by the user. This example underlines the essential need for communication between scientists and users. As a result of this situation the Special Programme has supported the development of an alternative, once- a-month injectable with a lower dose of estrogen, which is currently being intro- duced into six countries. Both scientists and women's health advo- cates agreed that cultural and service de- livery factors influence the actual safety of any method. The safety of sterilization or IUDs, for instance, depends largely on the care with which they are delivered. Fur- thermore, for certain methods, the service provider determines a dimension of safety critical to most women: immediate and effective reverSibility on demand. I I A fundamental difference in perspectives on the relative safety of methods re- mains. Scientists tend to argue that the health risks of any method should be measured against the risks of a clandes- tine abortion or of a full-term pregnancy (wanted or unwanted). Their priority is to develop the most effective contracep- tive methods to reduce the likelihood that women will resort to dangerous abortions or go through a high-risk preg- nancy. Women's health advocates, on the other hand, often see the risks of some methods, whether inherent or caused by poor services, to be too high. Many argue for the provision of methods that have minimal side effects, along with safe abortion as a back-up. They also point out that emphasis on family planning services should not detract from efforts to improve pregnancy and delivery care. Efficacy Scientists measure the efficacy of a con- traceptive method by quantifying how of- ten it fails to prevent pregnancy. The measures applied are rates of "method failure" and of "user failure". Women, however, may define efficacy by how well a method "works for them in their lives". Their measures include not only pregnan- cy prevention but also "satisfaction". The latter may encompass the effects the method has on the woman's sexual rela- tionship, her sense of control over the method, the freedom to use it when she pleases, and its efficacy in preventing in- fection. For many women, these aspects of effectiveness, along with safety as de- fined above, may be as or more important than contraceptive efficacy. Women's health advocates felt that the scientific community tends to give too much weight to contraceptive efficacy. Scientists stressed that safety is their first concern and indicated that women's perception of their priorities in this regard is incorrect. Scientists and women's health advocates agreed that this is evidence of a serious communication gap that should be closed through continuing dialogue. Women's health advocates questioned scientists' bias toward systemic or provider-dependent methods that have less likelihood of user failure. They sug- gested that this emphaSiS has led re- searchers to overlook low user accepta- bility or significant dissatisfaction with the method which may be masked by high continuation rates when assessing the efficacy of methods such as the IUD or subdermal implants. At the same time, what appears to be the lower ef- fectiveness of barrier methods may be due not so much to the methods them- selves as to failure to prOVide adequate information and support to women who use them. Furthermore, service provid- ers have often simply asserted that the diaphragm is inappropriate for low- income women who do not have priva- cy, water, education or other resources. It has been assumed, rightly or wrongly, that instruction in the proper use of barrier methods places undue demands on understaffed, overworked clinics. The meeting participants agreed that such assumptions need to be tested and the use-effectiveness of barrier methods further studied. They also agreed that clinical studies of effectiveness are not sufficient, since efficacy also depends on the social and health environment, on service providers, and on users, not just on the method itself. Women's health advocates also suggested that the safety-efficacy balance of barrier meth- ods, backed up by safe abortion facil- ities, should be compared to the safety- efficacy balance of systemic, provider- dependent methods. Acceptability This concept permeated discussions throughout the meeting. The measures commonly used by scientists and policy- makers are rates of acceptance (agreeing to start using a contraceptive method) and rates of continuing a method. Wom- en's health advocates argued for indica- tors of acceptability that also measure in- formed choice and user satisfaction. Re- search on the reasons not only foraccep- tance, but also for satisfaction and dissat- isfaction, could help to increase under- standing of what acceptability really means to women. Scientists pointed out that the Special Programme carries out research on these and other aspects of acceptability, particularly on reasons for discontinuation. It was agreed that acceptance and accept- ability are influenced by many factors. For example, if health service providers judge one method better than another, then the counselling and information they provide is likely to reflect that bias and affect acceptance and use of that method. Similarly, policy-makers and providers may make incorrect assump- tions about what is acceptable to women and men. A common assumption is that women will not touch their genitals. In Thailand, a clinical trial of a vaginal ring run by clinicians was unsuccessful be- cause of this assumption on the part of the male clinicians, whereas a trial of a similar ring run by midwives met with considerable success, because they spent time demonstrating how the method works. A similar experience occurred in the Dominican Republic. In Brazil, do- nors, health authorities and gynaecolo- gists have regarded the diaphragm as in- effective and unusable, particularly for low-income women. Yet, a feminist health centre in Sao Paulo has shown that, if women are given information and counselling about a range of methods in- cluding the diaphragm, many of them, regardless of income level, choose the di- aphragm and find it easy to use. In an- other instance, in Turkey, family plan- ning officials assumed that women were their primary clients, even though the main method used up to that time was withdrawal. Early family planning efforts failed because men, who control contra- ceptive practice in Turkey, were not fully involved. Women's health advocates indicated that women's definitions of acceptability change over time with changes in their circumstances. As women become more concerned with their rights and have more knowledge of their bodies, for ex- ample, they may be less willing to accept methods that can adversely affect their health. Many of the participants felt strongly that not only risks but also more responsibility for fertility regula- tion should be shared by men and that resources for the development of male methods should be increased. Some par- ticipants nonetheless expressed concern I I that even women in stable relationships may not trust their partners to use con- traceptives effectively and, therefore, fe- male methods should continue to have priority. Finally, acceptability is also conditioned by the availability of methods. The par- ticipants agreed that if only one or two methods are available, it is not meaning- ful to speak of acceptability because there is no choice. Availability For a method to be truly "available", a number of conditions must be met, in- cluding easily accessible distribution points (clinics, commercial outlets, etc.), where the supplies are consistent, staff are properly trained, and opening hours are convenient for clients. A key aspect of availability discussed at length is af- fordability, both for the service provider (e.g., a national government programme) and for the consumer. Participants ex- pressed considerable concern that some recently developed methods, such as im- plants, are costly. This also raised the question of manufacture. Participants from Africa and Asia in particular, stressed that many countries in their re- gions have no control over manufacture and supply of fertility regulation prod- ucts, and that this affects availability. Other critical factors in selection of methods Health and family planning infrastructure W omen's health advocates and scientists agreed that, in an ideal world, women and men should have the freedom to choose any method, the right to change meth- ods, and the ability to afford any meth- od. This requires properly staffed and maintained health and family planning services and the provision of safe abor- tion services. In reality, health and fami- ly planning services tend to be over- worked, understaffed and under- financed. Adding fertility regulation methods, especially those that require sophisticated delivery and follow-up, may simply compound existing service weaknesses. "We get the feeling now and then that the method gets the blame whilst it is the ser- vices that should be the target of com- plaints". - Olav Meirik There was general agreement that the health and family planning infrastruc- ture has a very significant impact on the safety and efficacy of fertility regu- lation methods. Those responsible for selecting methods therefore must deter- mine whether the infrastructure is well enough staffed and equipped to ensure safety and efficacy. Are necessary sup- plies available consistently, along with trained staff who have both the skills and the time required to deliver the various methods safely? Can the staff ensure informed choice, provide coun- selling and follow up clients? Are ser- vices readily available to deal adequate- ly with method complications, method removal, side effects or unwanted preg- nancy? There were different views on the criteria that might be used in answering these questions. ~ome participants argued that certain methods should simply not be se- lected by countries with very weak infra- structure. Others suggested that methods dependent on sophisticated facilities should perhaps be provided first (or only) at higher levels of the health system or in urban areas. Clearly, this is an area of on- going debate which may be best resolved in particular countries through dialogue among policy makers, service providers and women's health advocates. Quality of services Women's health advocates suggested that qualitative aspects of existing health and family planning programmes should be taken into account in selecting fertility regulation methods to introduce into those systems. A service that emphasizes quantitative targets is unlikely to provide or reward counselling, may have coercive elements (e.g., denies women abortions unless they agree to accept a particular method of contraception or steriliza- tion), and may not maintain privacy or treat clients with respect. "Any type oJ new technology that we in- troduce in any country oJ the world will Jail iJ you don't have good service deliv- ery and good counselling". Kerstin Hagenfeld Such systems will not provide any method appropriately, but especially those that are not reversible (steriliza- tion), are reversible only with the coop- eration of the service provider (IUDs, implants) or are not immediately rever- sible (e.g. long-acting injectables). Many of these aspects of quality of care could be improved at little or no cost by adjusting objectives to emphasize choice among methods and respect for the client. Others, like counselling, demand time from already over-worked staff- a demand that will increase with the intro- duction of each additional method. One way to address this problem is to broad- en personnel to include non-physicians in the delivery of services - an approach that has proved to be very successful in a number of countries. Participants gener- ally agreed that, regardless of the method to be selected or introduced, family plan- ning services must do more to ensure respect for the user and for her or his cultural, sexual and religious values. Government and donor criteria for method selection Women's health advocates expressed a need for more information on the defini- tion and application of criteria for meth- od selection at national levels. Since many countries are dependent upon sup- plies from donors, the criteria used by the donors are especially important. For example, a recent attempt to manufac- ture diaphragms in Brazil has been thwarted by lack of donor support, while in Bangladesh, until very recently, only high-dose contraceptive pills have been available. Government policies can also be very re- strictive. Natural methods of fertility regu- lation are often not included in the offiCial I list of contraceptive methods and thus ser- vices are not provided. Health ministries sometimes set supply quotas for certain methods such as condoms, and this can result in serious shortages. Although some public sector agencies are beginning to ac- cept the need for barrier methods, a gener- al prejudice still exists among donors and government programmes against provid- ing methods that require spermicides be- cause of the difficulty of maintaining sup- plies of spermicides in developing coun- tries. Unwanted pregnancy and abortion T he primary purpose of very large investments in contraceptive technologies and services to date has been to prevent unwanted, ill-timed or otherwise inappropriate pregnancies. In some countries, nonetheless, induced abortions equal or surpass the number of live births. Worldwide, it is estimated that between 36 and S3 million induced abortions occur every year, and as many as 200,000 women may die each year due to unsafe abortion. Clearly, as yet contraceptive technologies and services neither meet the needs of, nor are accessible to, millions of women who want to control their fertility. "Abortion has to be seen as an important integral aspect of reproductive rights which cannot be neglected. In my two years as coordinator of the women's health programme in Sao Paulo, I have been involved in research in 25 municipal hospitals in poor areas and have seen the increase in abortion and abortion compli- cations as a great issue. The total number of complicated abortions presented at the hospital in 1989 exceeded the number of births. It is therefore impossible for re- searchers not to involve themselves pub- licly in the abortion issue in their coun- tries". MariaJose Araujo Recognizing that it will be some time be- fore all women's contraceptive needs can be met, and that some women will al- ways need safe abortion services, most participants felt strongly that women's groups and scientists should actively col- laborate to encourage understanding of unwanted pregnancy and to prevent and eliminate unsafe abortion. A limited number of institutions and or- ganizations (such as the Special Pro- gramme) currently support research ac- tivities on particular aspects of abor- tion, including the very serious health effects of unsafe abortion, the factors that lead to unwanted pregnancy and unsafe abortion, and assessment of new technologies for safe induced abortion. These and other aspects of abortion ur- gently need more research, on which scientists and women's health advocates should collaborate. Women's health advocates also empha- sized that public education and advoca- cy are needed to decriminalize abortion. Women's health advocacy groups usual- ly work for safe and accessible abortion services, but initiatives are needed from others as well. In a number of coun- tries, physicians and other health pro- fessionals have taken the lead, some- times in alliance with women's organ- izations. It was suggested that research- ers could provide an additional strong and effective voice in national and international efforts to ensure women's access to safe services in all countries. It was pointed out that the World Health Organization, as an inter-governmental organization, serves the needs of its Member States, who have divergent poli- cies on the issue of abortion. In accor- dance with the recommendation of the 1984 International Conference on Popu- lation, WHO does not promote abortion as a method of family planning, but is concerned with the health aspects, parti- cularly of unsafe abortion. Suggested actions • Re-examine the basic concepts of safety, efficacy, acceptability and avail- ability to incorporate women's per- ceptions and experiences in the defi- nition of each and to define an appro- priate balance among them as criteria for method selection and introduc- tion • Review criteria used by national governments and donors in the selec- tion of fertility regulation methods and, where appropriate, recommend modifications. • Promote health and family planning systems that emphasize high quality care. • Undertake further research on wom- en's and men's attitudes, beliefs and practices about sexuality and fertility regulation in particular settings. • Increase investment in male contra- ceptive methods and involve men in taking personal responsibility for re- productive health and fertility regula- tion. • Support collaboration between scien- tists and women's health advocates on initiatives to eliminate unsafe abor- tion. I I The availability of methods and the reality of choice: Bangladesh and Brazil I n theory, a wide range of fertility regulation methods is available in Bangladesh but, at most, one third of reproductive age couples use a con- traceptive method, and many women resort to abortion. The methods avail" able through governmental and non- governmental channels include high- dose oral contraceptives, condoms, vag- inal foam tablets, IUDs (copper T380A), two- and three-month inject- abIes, Norplant subdermal implants, tu- bal ligation and vasectomy, and men- strual regulation. Other methods used include natural family planning, breast- feeding, withdrawal, ayurvedic and ho- meopathic methods. Most women in· Bangladesh do not have the wide choices that this list implies. The majority have no access to infor- mation about methods and only limited access to services, which are of poor quality. Many women are compelled to obey their husbands and in-laws, and, as a result, practice fertility regulation in secret, if at all. Consequently, meth- ods requiring male cooperation are dif- ficult or impossible for many women to adopt. Injectable contraceptives have become increasingly popular,in part because women can obtain them· under the guise of taking their children to a clinic for immunization. Methods which cause menstrual disruption are problematic, however, because bleeding interferes with praying, fasting; sexual intercourse, and a woman's feeling of health and well-being. Women also want to avoid methods believed to cause cancer and methods which might cause infections such as an IUD insen- ed under unsterile conditions. Given all these limitations, along with problems of service delivery, it is estimat- ed that every year 750,000 women in Bangladesh have an abortion. Perhaps one-fifth of these have access to safe menstrual regulation through Govern- ment clinics; the rest risk their lives in clandestine procedures. For many wom- en, a vasectomy for their partner is the ideal choice, but most men reject it. Most sterilization in Bangladesh is there- fore undertaken by women, even though vasectomy is easier, safer and lessexpen- sive than tuballigation. In Brazil, though the range of legal fertil- ity regulation methods is extremely nar- row, about two-thirds of women in mari- tal or consensual unions use some meth.:. od of contraception or are sterilized. AI" though the. government has adopted an integrated women's health programme which mandates the provision of· range of contraceptive methods, in fact, the only fertility regulation methodsac- cessible to most women are oral contra:.- ceptives provided through the private sector, clandestine abortion (legalabor- tion is severely restricted) ,and tuballi- gation. The lack of choiceofc(jiltr~cep~ tivemethods and the legaL restrictions on abortion mean that women pay.a very highpriceJor fertility regulation. For low-income wmnen, the recurring cost or pills, along Wi.thcostsofobtain . ing them, such as . transportation, 1055 of earnings, and. dlildcareare de,teqentstp oral qontraceptive use.Sid~ effeettiof oralcQntrac.eplives, such as IIlenstru~r disturbartces, . weight· gain, . heada~hes>of loss of libidQ are reported oftel1:,a~d. these kinds of effects ··frequently resuhin incorrect use, discontinuation of the method and, ultimately, unwanted preg- nancy. It is estimated that three million abor- tions occur each year in the country, compared to four million births. In a sur- vey of low-income women in the state of Santa Catarina, 18 methods to induce abortion were reported, including cathe- ters and knitting needles. In 1989, the number of cases with complications from induced abortion in the municipal hospital of Sao Paulo exceeded the num- ber of deliveries. With no temporary means of contracep- tion available to them, many women undergo tubal ligation. Not surprisingly, studies show that up to 50 percent of Brazilian women sterilized before 25 years of age regret it. Tuballigation is not officially provided in the public sector, but it is frequently done clandestinely at the time of Caesarean section. This helps explain the extremely high rate of "un- necessary" Caesarean sections and asso- ciated complications in Brazil. Given the negative experience many Bra- zilian women have had with hormonal methods and with the service system, the greatest weight should perhaps now be given to methods that have minimal health risks or side effects, are reversible, inexpensive and easy to use. Careful in- troduction of barrier methods and the IUD may be more appropriate than the introduction of new methods which have systemic effects, require a physician's in- volvement, and therefore are not under the user's control. By comparison, an ideal contraceptive in Bangladesh would be one that is easy to use with privacy, is inexpensive, and is not connected with sexual intercourse. It would not require leaving the home, would have minimal side effects and would be socially and culturally accept- able. But the issue in Bangladesh may be less selection of additional methods than improvement in service quality and availability along with broader changes in women's lives that would enable them to make choices for themselves. This text is based on presentations by Sandra Kabir and Maria Jose Araujo. I I CONSIDERATIONS FOR INTRODUCTORY TRIALS The first, systematic approach to public sector introduction of a contraceptive method was under- taken by the Population Council with the introduction of Norplant subdermal im- plants. No contraceptive method until that time had undergone so many years of safe- ty and efficacy research prior to introduc- tion. Introductory trials of Norplant began in 1983 follOwing 15 years of clinical re- search on safety and efficacy. Norplant has been approved in 18 countries. More than 55,000 women have used it in 46 devel- oped and developing countries. The objec- tive of the introductory trials has been to establish adequate clinical conditions, in- cluding training in insertion and removal, counselling, and clinical follow-up, in ad- dition to post-introductory surveillance. The Council made this substantial invest- ment for several reasons. Previous experi- ence with IUDs had often been very nega- tive, partly because neither providers nor users were adequately informed and trained. Norplant requires minor surgery for insertion and removal and has side ef- fects for which women and provid~rs need to be prepared. As a high-technology, provider-dependent method, Norplant can potentially be abused and a careful intro- duction process is one way to reduce that risk. l Drawing on the experience wit, Nor- plant, the presentations and disc~ssions on introductory trials considered i ethical issues, the process of introduction evalu- ation of such trials, and cost. Ethical issues I t was agreed that there have been and can be a number of ethical problems with the introduction of fertility regu- lation methods. It is therefore essential to formulate and follow clear ethical princi- ples at each stage of the process. Informed consent Although guidelines exist for research on human subjects (the Special Programme uses them in all of its clinical research), these gUidelines are often not followed completely or meaningfully at either na- tional or clinic levels. For example, partic- ipants in the trial may sign informed con- sent forms without fully understanding that the fertility regulation method is under development, or that the method may have as yet undetermined risks or side effects. Scientists, at both national and international levels, in collaboration with women's health advocates, could, it was agreed, undertake to improve ap- proaches to and standards for informed consent as well as to ensure consistent and effective use of the procedure. Freedom of choice Freedom to participate or not in a trial de- pends on the client's access to alternative methods. For instance, if the clinic has only the trial method, an oral contracep- tive and surgical sterilization, many cli- ents who are tired of the piU and do not want to be surgically sterilized may accept the trial method. This acceptance would not, however, reflect freedom of choice. Poor, illiterate women especially may of- ten have little or no choice among clinics or methods and therefore no real freedom to decide whether to participate in a trial. While participants in the meeting agreed in principle that availability of alterna- tive methods and services is important and that trials should not be conducted only with poor women, they did not dis- cuss how to achieve these standards. Quality of care Participants generally agreed that meth- ods should not be selected for introduc- tion unless minimum standards of qual- ity of care can be assured, but those minimum standards remain to be de- fined. "Method introduction requires that as much attention be paid to the service de- livery requirements oJ the method as to the characteristics and properties oJ the method itself. Methods are not intro- duced in isolation oJ existing service con· ditions; if conditions are not appropriate, it must be determined whether they can be strengthened, or whether it would be better not to oJJer the method in that lo- cale but instead use reJerral mechanisms to another centre", - Joanne Spicehandler Full and accurate information, sympa- thetic and respectful provider-client interaction, continuity of care, and avail- ability of other basic reproductive health services, are essential for informed con- sent and freedom of choice. These qualities are not very often present, and it was suggested that the introduction process can be used to stimulate improve- ments in quality of care, at least in clinics or programmes where the trials are under- taken. Women's health advocates were skeptical, however, and pointed out that improve- ments in the few sites used for introducto- ry trials could not ensure improvements throughout a national programme. They questioned whether the experience with an introductory trial would be generaliz- able to a national programme. There was some discussion on how to achieve a rea- sonable balance between optimal and re- alistic conditions for introductory trials, and it was agreed that progress could best be made through collaboration and dia- logue between scientists, women's health advocates and programme managers at na- tional and local levels, I I The process of introduction T he basic purpose of an introducto-ry trial, whether of a new fertility regulation method or of an exist- ing one not used previously in the partic- ular place, is to evaluate the method in an actual service delivery setting. In the past, the focus has been on how best to deliver the method. How should staff be trained? What are the logistical challenges? What changes need to be made in the delivery system? More recently, partly as a result of concerns raised by women's health groups, it has been recognized that intro- ductory trials should be used to deter- mine whether a method should be intro- duced. Women's health advocates, there- fore, made a number of suggestions about the design of introductory trials. It was agreed that the design of a trial should al- low for the possibility of deciding not to proceed with full scale introduction if the method seems unacceptable or inappro- priate to many women. Preparation for the trial Women's health advocates suggested that ethnographic studies should be done to help ensure that method selection and trial design are appropriate to local pat- terns of sexuality, reproductive health, and other considerations. Ethnoanatomy (how people view their own bodies) and ethnoterminology (the language people use to describe various organs, functions and symptoms) are important tools which can be used to design trials and to educate providers and users. Scientists agreed that such studies could be very useful not only for the design of intro- ductory trials but also for their basic work on method development. Some participants also pointed out that community participation and sensitivity to community needs will be key factors in the success of an introductory trial. In- forming and involving various segments of the community, including the media, should help create a positive environ- ment for a trial and for later expansion. Size of the trial and relationship to the health care system Women's health advocates from India and Indonesia who have had direct experience with contraceptive introduction urged that introductory trials be done on a small scale and be carried ou t only in areas where there are adequate health person- nel, training, and equipment. Most parti- cipants agreed that introductory trials should begin on a small scale and should test whether facilities and personnel are adequate, after which they could be ex- panded to get a broader base of informa- tion to understand the needs of both ur- ban and rural populations. However, women's health advocates felt that such phaSing has not usually been done and that, while it should be possible to design trials for rural areas, this may be appropri- ate for some methods and not others. All agreed that the weaknesses of an ex- isting health or family planning system can be magnified by introductory trials. Scientists and women's health activists with experience of introductory trials stressed that a trial must therefore in- clude assessment of the limitations of the health service, and identification of means to improve the system and the quality of care offered. "Even introduction (~f one item like Nor- plant means that a clinic which previously did not need to use local anaesthesia has to find local anaesthet.ics. 50 you are dealing with introduction of consequences to the health care system and there should always be provision for this in in- troduction". - Joseph Kasonde In particular, women's health advocates suggested that providers taking part in a trial should receive training in counsel- ling, be taught how to discuss sexuality and gender issues, and be trained in the diagnosis and treatment of gynaecologi- cal diseases such as reproductive tract in- fections. The risk of pregnancy should be explained clearly to the women taking part in the trial, and where allowed, pro- viders should be prepared to provide safe abortion services as a back-up. Monitoring Women's health advocates suggested that monitoring be concerned not only with the number of women who accept and continue the method but also with the recruitment process itself - how women are recruited, whether they are aware that they are taking part in a trial, whe- ther their partners know about it, in what language information is provided, whether they understand it, who signs the consent form (woman or partner), whether she or he understands what she or he is signing, and what other choices of contraception women are given. Provider-client interaction should be documented to determine whether risks, side effects and benefits were properly explained, whether an examination was performed, whether follow-up instruc- tions were given, whether gUidelines for use were followed and whether women were aware of their right to stop partici- pating in the trial if they so wished. It was suggested that women's groups can play a major role in collecting data on all of these, through direct and indirect ob- servation, and through interviewing us- ers on their experiences, including those who discontinue. An example of such collaboration has oc- curred in Peru. The Peruvian Ministry of Health consulted with women's groups and scientists on whether to begin an in- troductory trial of Norplant. Women's groups were then invited to participate in an adviSOry role for the duration of the study. One example of their contribution in this role is that they advised that illit- erate women should be excluded from the study since the educational materials had been prepared for a literate popula- tion. The main constraint for the wom- en's groups was a lack of funds for broad- er participation in the triaL It was agreed that women's groups should be encour- aged to develop and submit research pro- jects for funding on issues related to in- troduction that could be coordinated with the introductory triaL Follow-up Participants agreed that follow-up is a complex issue which requires much more attention and investment, particu- larly with provider-dependent methods such as IUDs and implants, both of which should be removed after a recom- I mended period. Many women may not return for routine follow-up visits and special outreach efforts will be needed. But, very often, clients do not have ad- dresses, or they may move frequently. Can women be found five years later for removal of the implants? Will those who remember that removal is necessary be able to find a properly trained and expe- rienced provider to remove it? What constitutes an acceptable percentage of loss-to-follow-up in such a case? Evaluation of introductory trials The discussion focused on the di-vergence of views regarding the overall goals of trials. If the goal is to find out how best to make a method widely available, on the assumption that the method should be made available, then evaluators will be primarily con- cerned with operational issues. If the goal is to determine whether a method should be more widely distributed in a country, then the evaluation must assess the acceptability and appropriateness of the method for that country. "Introductory trials have provided us with the opportunity to establish dialogue between health providers, scientists and user\ groups and women's health acti- vists. However, it seems lo me for the fu- ture it will be extremely important to es- tahUsh this dialogue at an earlier point.". Gregorio Perez-Palacios Concern was expressed that introducto- ry trials to date have focused on how a method can be introduced and have had a built-in momentum that made nation- wide introduction inevitable. Women's health advocates argued strongly for a "pause" in the introduction process to allow for analysis of data and lessons learned from the introductory trials. For example, it was argued that the trial period for a long-acting method like Norplant, which requires removal at the end of five years, should be the full du- ration of efficacy of the method, so that all stages of use of the method can be assessed before a decision is taken to expand provision. Otherwise, large numbers of new users may begin the method, generally under less controlled conditions, before major lessons can be learned from the introductory trial. A number of scientists responded that the appropriate time for a pause is not after introductory trials but rather after toxicology testing and clinical trials. Dialogue and collaboration with wom- en's health advocates and other con- cerned groups at these earlier stages would prevent costly mistakes in later selection of methods for introduction. They were concerned that a "pause" following the introductory trial would be extremely expensive and would cause the service providers and the women taking part in the trial to undu- ly conclude that the trial had produced negative findings. It was agreed, that, if women are fully informed about the na- ture of the research at the outset and are kept informed as the trial proceeds, their fears of being used as guinea-pigs will be reduced. "There was a political pause in the case of Notplant in Brazil. As uncomfortable, bad-mannered, and controversial as this episode has been, I think . that, in the historical process of contraceptive re- search, it might have been a landmm'k that makes us now think about pausing in the process of intl·oduction". - Sonia Correa It was suggested that the need for a pause could be satisfied if introductory trials were started on a small scale and expand- ed very gradually. Some methods, such as surgical sterilization, implants and IUDs for instance, might be prOvided at levels of a health care system where more so- phisticated facilities exist, while dia- phragms, pills and condoms might be in- troduced at the community level. While the meeting came to no clear posi- tion on the need for a "pause" at the con- clusion of an introductory trial prior to wide-scale expansion, there emerged from the discussion an understanding that an introductory trial is a trial as well as an in- troduction process. Its results must there- fore be carefully evaluated. The trial should include time for reflection and consultation at every stage of the process and should allow for decisions that might curtail country-wide introduction of a fer- tility regulation method. Whatever the results of a trial might be, it was suggested that full, impartial infor- mation on benefits and side effects, ob- tained from clients (both users and dis- continuers) as well as from medical records, should be made rapidly and widely available. This information should be published in national and international journals and presented in such a way that it is accessible to the general public as well as to the scientific community. I I Cost of method introduction T he cost of some modern methods may be prohibitive for countries burdened by international debt and multiple demands on their meagre foreign exchange earnings. In these same countries, the costs of service delivery by highly skilled personnel may also be pro- hibitive. Scientists and women's health advocates urged that every effort be made to estimate the likely costs of in- troducing a method before a trial starts. Estimates should include not only the costs of services and supplies, but also the costs of changes needed in existing health infrastructure and of technology transfer for local production. One participant noted that, even at a late stage in the method development pro- cess, it is not always possible to estimate with any accuracy the cost of introduc- ing some methods, particularly those which depend on drug delivery systems. However, methods such as pills, injec- tions, condoms and other lower- technology methods can be adequately costed. Continuing efforts are being made by the Special Programme and oth- ers to negotiate lower public sector pric- es with pharmaceutical companies. Given these issues, participants recom- mended that all parties involved, includ- ing policy-makers, industry and donors, should be better informed on women's and scientists' views, and should work towards an approach which would cover all the concerns expressed in this sec- tion. Suggested actions • Develop guidelines collaboratively to specify under what circumstances particular methods should be intro- duced and to clarify the criteria by which introductory trials determine whether a method is appropriate for widespread introduction. • Include women's groups and women's health advocates in all parts of the in- troductory trial process, including ethical and scientific committees that design, monitor and evaluate intro- ductory trials. • Broaden the evaluation team to in- clude service providers, social scien- tists, and representatives of women's groups, women's health advocacy groups and community groups. • Disseminate the results of evaluation widely. • Provide for long-term follow-up stud- ies. RESEARCH NEEDS W omen's health advocates were of the view that re-. search on fertility regulation is not neutral, but is influenced by politi- cal factors such as the policies of popula- tion funding agencies, the search for markets by pharmaceutical companies, and political restrictions on the develop- ment of safer abortifacients. Priority has been given to: laboratory and clinical re- search to generate information about pharmacology and to satisfy require- ments for registration of methods by drug regulation agencies; development of new fertility control methods (espe- cially provider-controlled methods); and demographic research (especially fertility trends, marriage patterns and contracep- tive prevalence). Only recently, has at- tention been paid to health service deliv- ery systems or to users' needs. "I don't know oJ a time that the develop- ment oJ a new contraceptive was started by saying, what women need is this, so lets try to study a method that responds to this need. What really happens is that there is an opportunity oJ developing a new contraceptive method because oJ a new discovery in the biological sciences. And it has been very difJicult to reconcile the women's needs or the clients' needs with the opportunities oJ developing a method. I think the only example that I have is the new studies directed to the needs oJ women who are breastJeeding, which is not led by demographic interests, but by women's interests". - Antbal Faundes It was agreed that new discoveries in the biological sciences, rather than women's needs, have most often stimulated the development of new contraceptive meth- ods. However, two recent examples were given of fertility regulation methods which have been developed to reduce side effects that the women are worried about: the low-dose once-a-month in- jectable which was developed because bleeding problems frequently occurred with two- or three-monthly injectables; and hormone-releasing IUDs developed with a view to reducing menstrual blood loss associated with ordinary IUDs. While acknowledging the importance of such efforts, women's health advocates pointed out that responding to women's criticisms of existing methods was not sufficient. They suggested that research should begin by studying the needs of a particular population and the existing delivery system, as the basis for selecting a mix of methods, both old and new, for introduction. I Clients' needs and preferences C urrently, research on sexual ac-tivity, reproductive health, and fertility desires is inadequate. Many more studies are needed to find out what women think about various methods, how they understand them to work, what are their fears, why they dis- continue methods, what they find ac- ceptable (both in terms of methods and services received), and what are their views on the financial and social costs of methods. Much more also needs to be learned about women's sexual experien- ces, their experiences with and attitudes towards reproductive morbidity such as reproductive tract infections, and indige- nous fertility control practices and pref- erences. The Special Programme supports re- search on the dynamics of contraceptive use which aims to determine what hap- pens to a woman once she starts practic- ing contraception, how she chooses among the options available, and how she manages the complexities of contra- ceptive use, pregnancy, delivery, and post-partum family planning. "When we talk about selection and intro- duction of methods, not only biomedical research . is important, but along with it . study of women's attitudes and rela- tionships, their way of life, their relig- ion . ". Ninuk Widyantoro Health and family planning delivery systems T he extent to which clients' needs can be met depends fundamental-lyon health and family planning infrastructure, including, among others, supply and logistics systems, service de- livery points, staff skills, regulations and management capacity. Participants gave particular emphasis to the need to assess the skills, knowledge, attitudes, and practices of providers, including not sim- ply medical skill and provision of tech- nologies to clients, but also their ability to provide information and counselling. Several participants pointed out that ser- vice providers often have very little in- formation about new methods and that provider bias can certainly affect method use. It was suggested that KAP (knowledge, attitudes and practice) surveys which are normally carried out on the general pub- lic, should also be carried out among sci- entists, programme managers and pro- viders in order to determine the extent to which they are likely to enable clients to make fully informed choices and provide technically competent services. The par- ticipants recognized that such research may be particularly challenging as health systems and personnel are medically- oriented and may find it difficult to think and work in terms of broader so- cial needs. In addition, most health and family planning systems give priority to services and will need to be persuaded of the importance of research and their par- ticipation in it. Fertility regulation methods The objective of methods research should be to develop a range of methods to suit a wide variety of clients. Women's health advocates point- ed out that very little research has been done on withdrawal as a method and that barrier methods are given far less priority than hormonal or provider- dependent methods. Scientists suggested that because of AIDS there is a renewed interest, including in the Special Pro- gramme, in barrier methods, especially condoms. Some interest also exists in traditional methods such as withdrawal, although this work focuses on why cou- ples choose these methods rather than on their use effectiveness. Participants urged that more emphasis be placed on research into male methods. Women's health advocates felt that re- search is needed on the interaction of fertility regulation methods with com- mon disease conditions such as recurrent diarrhoea, parasitic infestation, anaemia and recurrent reproductive tract infec- tions. Staff from the Special Programme reponed that considerable research on such issues is being supported by the Special Programme. Who should do the research and how M OSt researchers laboratory and clinical scientists, demog-raphers, and social scientists - tend to be men. Service managers and physicians who are or should be in- volved in introduction research also tend to be men, while non-physician provid- ers such as midwives and village health workers are generally women and are lower in the programme hierarchy. This results in a severe gender imbalance in research that influences both the ques- tions that are asked and the interpreta- tion of the findings. " . there can be different interpretations of the same results of scientific studies, and diJJerent condusions drawn from dir ferent interpretations. Finding ways of discussing those differences is really im- T)(Jrtant. ". - Anita Hardon Two ways were suggested to broaden and balance current research activities: first, to add women to the research team; and second, to draw on the expertise of groups who work closely with women and are likely to represent clients' and women's perspectives. It was agreed that it is vital to include women's perspec- tives at the very earliest stages of re- search and throughout the process in- cluding the final interpretation of results. The scientists in the meeting pointed out that laboratory and clinical research must be carried out according to certain scientific norms and standards and ex- pressed some doubt whether non- scientists could be fruitfully involved in these processes. In this regard, the wom- en's health advocates felt that scientific I I expertise needed to be broadened and in- formed by the skills and experience of other professionals who work closely with women. Participants agreed that many different approaches can be used in research on health systems and on clients. In recent years, for example, several techniques have been used - participatory research, focus groups, and "action-oriented" re- search - to learn about clients' perspec- tives while assessing delivery systems. A women's health advocacy group in Brazil, for instance, involved women from the barrios in designing and carrying out re- search on women's attitudes to steriliza- tion, contraception, and local health ser- vices. The women then used the results to educate other women and to take ac- tion where needed. Research of this kind can empower women as well as generate important and reliable information. Participants agreed that women and women's health advocates must be in- cluded on ethical committees and should participate in the elaboration and revi- sion of research gUidelines, both nation- ally and internationally. Research and trial protocols could include an instruc- tion to scientists to consult with wom- en's groups and guidelines for protocols could include information about how to encourage the participation of women, especially at local levels. Suggested actions • Before selecting and introdUcing fer- tility regulation methods, undertake studies on: clients' needs and per- spectives; knowledge, attitudes and practices of scientists, managers and providers; and the health and family planning infrastructure in each coun- try. • Foster research on the effectiveness and acceptability of barrier methods and withdrawal, and increase research on male methods. • Involve women and women's health advocates in all stages of research, in- cluding elaboration of ethical guide- lines and standards for research, defi- nition of priorities, research design and implementation, and analysis of findings. • Develop and include innovative re- search techniques that are participato- ry, multidisciplinary and sensitive to the clients' situation. COLLABORATION BETWEEN SCIENTISTS AND WOMEN'S HEALTH ADVOCATES P articipants acknowledged that di-alogue and collaboration between scientists and women's health ad- vocates, as well as other groups con- cerned about women's health, requires the development of trust, respect, and mutual confidence, as well as willingness to listen and learn. It was agreed that this meeting was an important first step in the process. Many collaborative activities have been suggested throughout this re- port that should take place at both inter- national and national levels. It was agreed that the international women's health movement now has sufficient ma- turity, organizational capacity, networks and direct experience to recommend qualified women to participate in the various activities and to join the staffs of key agencies and programmes. Such women, it was agreed, would have fluent communication skills, a commitment to building communication with scientists, and an ability to foster confidence and mutual respect in such a dialogue, along with required technical and professional qualifications. " . the important thing is we must enter into a dialogue. Women's health advo- cates groups should be utilized by policy planners and the activist groups should really force policy planners to bring more human aspects to the programme". - Badri Saxena Participants cautioned that it will not be sufficient simply to increase the numbers of women in decision making positions, on staff, in meetings or on committees. Women scientists mayor may not ap- proach their work from a woman's per- spective. The participation of women's health advocates (both men and women) is important to ensure that women's needs, based on broad exposure to wom- en's experiences, are effectively articulat- ed and pursued. Participants also agreed that, where appropriate, research should be carried out by multidisciplinary teams that include women health professionals as well as women's health advocates. This will require establishing protocols that are understandable to women's groups and encouraging dialogue on such protocols. I I Enablement I n order for true collaboration to take place, a two-way communication between peers has to be fostered. It was suggested that most established sci- entific and policy committees, for in- stance, have a certain power structure which is not easy to penetrate or change, and that it will usually not be effective to add one or two token women to a partic- ular structure. Rather, a critical mass is needed, along with leadership and com- mitment from the top. It was suggested that collaboration will require, on the one hand, training "lay" women in both the biomedical and social sciences at na- tional as well as international levels, and on the other hand, promoting the train- ing of scientists and policy-makers in feminist health analysis. Both efforts will require substantial commitment and in- novative action from scientists and from women. It was suggested that, as a start, scientists and policy-makers could par- ticipate more in women's health meet- ings and visit women's health projects at local, national and regional levels, to be- come more familiar with women's repro- ductive health issues as women define them. Information exchange A necessary tool to create and sus-tain collaboration is exchange and dissemination of appropri- ate information. Many women's health groups already carry out their own re- search, but the results are often not avail- able to or promoted in the scientific community. Scientific research institu- tions could actively help to disseminate this kind of information. Similarly, infor- mation about research programmes and the results of scientific research, includ- ing that supported by the Special Pro- gramme, are usually published in spe- cialized journals. While efforts are being made to spread relevant information more widely, results of research still re- main largely inaccessible to non- technical audiences. Articles appropriate to lay audiences could be disseminated through the extensive national, regional and international communication net- works developed by the women's health movement over the past two decades. "1 believe strongly that women~ . groups can interact productively with scientists and physicians in [thc/ area lof incorpo- rating women's testimonies and experi- ences/. 1 also believe strongly that coop- eration would be enhanced if each party acknowledged the importance of the other while recognizing its own limitations". Adeyemi Adekunle Funding and staffing M ost of the hundreds of wom-en's health groups in Southern countries operate on shoe- string budgets. Their national and inter- national collaboration in the selection and introduction of fertility regulation methods will only be possible with spe- cial support. Even well established re- search institutes will probably find that they need earmarked staff time, or spe- cial staff, to ensure that communication and collaboration take place and to man- age specialized activities (such as consul- tative meetings). These institutions as well as donors will need to allocate funds for collaboration. It was suggested that, in some cases, budgets for research and introduction of fertility regulation methods could include specific alloca- tions for collaboration of women's health advocates and other women's groups. Suggested actions • Train women in both biomedical and social sciences, and train scientists and policy-makers in women's per- spectives on reproductive health. • Disseminate scientific information in a more accessible form and language to women's and other non-govern- mental groups, and provide the re- sults of women's research and experi- ence to scientists. • Generate financial resources to sup- port collaboration between women's health advocates and scientists. I I RECOMMENDATIONS FOR ACTION C onsensus was reached on the fol-lowing recommendations, many of which are addressed specifi- cally to the Special Programme. The es- sence of the recommendations has been preserved here, but they have been con- densed and expressed in a broadly appli- cable form. In this form they are ad- dressed to all agenCies that undertake and/or fund research on fertility regula- tion methods, method introduction, and service delivery. Participation by women • Ensure that women's health advocates are incorporated into policy and programmatic activities. • Promote national and regional ex- changes between scientists and wom- en's groups, in order to help the scien- tific community, international agencies and national governments to incorpo- rate women's perspectives into their health and family planning priorities. • Convene special meetings for scien- tists and women's health advocates, along the lines of this meeting, to dis- cuss key topics, including: - the development of new methods; - the development of contraceptive vaccines; the use and further development of barrier methods; - induced abortion. • Involve women, and include women's perspectives, in the identification of research needs and priorities and in the implementation of research on reproductive health at country and re- gionallevels. Research • Revise technical, methodological, and ethical gUidelines for research, in line with women's perspectives and experi- ences; promote widespread awareness of these gUidelines; and foster their implementation at the country level. • Promote the institutionalization of ethics committees at country level, with the participation of women's health advocates. • Establish minimum standards for the quality of care in clinical and introduc- tory trials, and mechanisms for pro- moting and monitoring quality of care. • Discuss and revise, incorporating women's perspectives, the definitions of and relative weight to be aSSigned to safety, efficacy, affordability and acceptability in selecting and intro- ducing fertility regulation methods. • Encourage the formation of multi- diSciplinary research teams which include women's health advocates, and the use of participatory research methods at national, regional, and international levels. Support research on: - women's and men's views on and expe- riences with existing methods, and the attributes they most like or dislike; - the comparative effects on women's health of fertility regulation methods, with attention to both pregnancy pre- vention and pregnancy termination; the use-effectiveness and acceptability of the withdrawal method; the safety and appropriateness of RU486 compared to surgical or vacu- um aspiration abortion; the balance among safety, efficacy, af- fordability and acceptability for par- ticular methods, in relation to other methods, in particular settings. Training • Promote training in reproductive health issues including family plan- ning, in medical, midwifery and nurs- ing schools and other key institu- tions. Such training should pay atten- tion to women's perspectives and to the "human" as well as technical di- mensions of fertility regulation and reproductive health. • Increase the number of women scien- tists; incorporate women's perspec- tives into scientific curricula and pro- grammes; and train women's health advocates to participate in research on fertility regulation. Introduction of fertility regulation methods • Encourage the introduction of safer, more user-controlled methods. • Involve women's health advocates in all phases of introductory trials in- cluding design, provider training, management, implementation, moni- tOring and evaluation. • Review approaches to method intro- duction to encourage use of integrat- ed health services, other aspects of quality of care, and more participato- ry approaches. • Develop criteria and methods to eval- uate the settings into which particular fertility regulation methods might be introduced, including the characteris- tics of health care infrastructure, the recurring costs of providing the meth- od on a national scale, the quality and quantity of existing family planning services, and the status and roles of women. • Encourage governments to do every- thing possible to prevent and elimi- nate unsafe abortion. Information dissemination • Disseminate results of research as widely as possible, in particular to women's health advocates and wom- en's groups worldwide, in appropriate languages. • Support existing women's health ad- vocacy networks and publications, and promote dissemination of their information widely among the scien- tific community. I I LIST OF PARTICIPANTS Dr. Adeyemi O. Adekunle Department of Obstetrics and Gynaecology College of Medicine University College Hospital Ibadan, Nigeria Dr. MariaJose Araujo Coletivo Feminista Sexualidade e Saude Bartolomeo Rua Zunega 49 CEP 05426 Sao Paolo, Brazil Dr. Catherine d'Arcangues Task Force on Long Acting Systemic Agents for Fertility Regulation Special Programme of Research, Devel- opment and Research Training in Human Reproduction World Health Organization Dr. Rani Bang SEARCH Gadchiroli (Maharashtra) PIN 442 605, India Dr. Heli Bathija Task Force on Safety and Efficacy of Fertility Regulating Methods Special Programme of Research, Devel- opment and Research Training in Human Reproduction World Health Organization Ms. Frescia Carrasco (Movimiento Manuela Ramos, Peru) SmalleJade, 36B 3TV 2000 Svereskberh Copenhagen, Denmark Ms. Amparo Claro Latin America and Caribbean Women's Health Network Isis International Casilla 2067, Correo Central Santiago, Chile Ms. Sonia Correa SOS Corpo Rua do Hospicio 859/40 andar Boa Vista, Recife PE, 50050 Brazil Ms. Jane Cottingham 6 Places des Charmettes 1227 CarougelGE, Switzerland Dr. Banoo J Coyaji Department of Obstetrics and Gynaecology KEM Hospital Research Centre Sardar Moodliar Road Rasta Peth Pune 411 0 11, India Dr. Mahmoud Fathalla Director Special Programme of Research, Devel- opment and Research Training in Human Reproduction World Health Organization Dr. Anibal Fatindes The Population Council and Universidade Estadual de Campinas Caixa Postal 6181 13081 Campinas SF, Brazil Dr. Henry Gabelnick Director CONRAD Suite 806 1611 North Kent Street Arlington, VA 22209, USA Ms. Adrienne Germain International Women's Health Coalition 24 East 21st Street, 5th Floor New York, NY 10010, USA Dr. Kerstin Hagenfelt Department of Obstetrics and Gynaecology Karolinska Hospital P.O. Box 60500 10401 Stockholm, Sweden Mr. Peter Hall Task Force on Introduction and Transfer of Technology Special Programme of Research, Devel- opment and Research Training in Human Reproduction World Health Organization Dr. Anita Hardon WEMOS Minahassastraat 1 P.O. Box 4263 1009 AG Amsterdam, Netherlands Ms. Adetoun llumoka 25 Reverend William Euba Street Oyadiran Estate Sabo, Yaba Lagos, Nigeria Ms. Sandra Kabir Bangladesh Women's Health Coalition House 46A, Road 6A Dhanmondi RA Dhaka 1209, Bangladesh Dr. Joseph Kasonde Resources for Research Special Programme of Research, Devel- opment and Research Training in Human Reproduction World Health Organization Dr. Olav Meirik Task Force on Safety and Efficacy of Fertility Regulating Methods Special Programme of Research, Devel- opment and Research Training in Human Reproduction World Health Organization Ms. Catherine Mulholland Office of the Director General World Health Organization Ms. Judy Norsigian The Boston Women's Health Book Collective 240A Elm Street Somerville MA 02144, USA Dr. Maria-Coletta de Oliveira Nucleo de Estudios de Populacao Universidade Estradual de Campinas Caixa Postal 1170 13100 Campinas Sp, Brazil Dr. Gregorio Perez-Palacios Department of Reproductive Biology Instituto Nacional de la Nutricion Salvador Zubiran Calle Vasco de Quiroga 15 14000 Mexico DF, Mexico Ms. Deborah Rogow International Women's Health Coalition 24 East 21st Street, 5th Floor New York, NY 10010, USA I I Dr. Patrick Rowe Task Force on Prevention and Management of Infertility Special Programme of Research, Development and Research Training in Human Reproduction World Health Organization Dr. Badri Saxena Indian Council of Medical Research Ansari Nagar New Delhi 110029, India Ms. Joanne Spicehandler Task Force on Introduction and Transfer of Technology Special Programme of Research, Devel- opment and Research Training in Human Reproduction World Health Organization Dr. Nahid Toubia The Population Council I Dag Hammarskjold Plaza New York, NY 10017, USA Dr. Eka Williams Department of Biological Sciences University of Calabar PMB 1115, Rm 223 Calabar, Nigeria Dr. Rita Thapa Women, Health and Development Division of Family Health World Health Organization Ms. Ninuk Widyantoro Indonesian Planned Parenthood Association Wisma Pancawarga Jalan Dr Kusuma Atmaja SH 85 Jakarta, Indonesia

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