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Guidance on ethical considerations in planning and reviewing research studies on sexual and reproductive health in adolescents.
Geneva, Switzerland, World Health Organization, 2018. 52 p.This document is intended to address commonly occurring situations and challenges that one faces in carrying out research with adolescents (people aged 10–19 years), the majority of whom are deemed not to have reached the recognized age of majority in their respective settings. To this end, adolescents aged 18 and 19 years are classified as adults in many settings and have the legal capacity to make autonomous decisions regarding their participation in research. In this document, the term “children” refers to people below the age of 18 years, and the term “minor adolescents” refers specifically to people aged 10-18 years.
Geneva, Switzerland, World Health Organization [WHO], 2018. 458 p.Girls and women who have been subjected to female genital mutilation (FGM) need high quality, empathetic and appropriate health care to meet their specific needs. This handbook is for health care providers involved in the care of girls and women who have been subjected to any form of FGM. This includes obstetricians and gynaecologists, surgeons, general medical practitioners, midwives, nurses and other country-specific health professionals. Health-care professionals providing mental health care, and educational and psychosocial support – such as psychiatrists, psychologists, social workers and health educators – will also find this handbook helpful. It includes advice on how to: 1) communicate effectively and sensitively with girls and women who have developed health complications due to FGM; 2) communicate effectively and sensitively with the husbands or partners and family members of those affected; 3) provide quality health care to girls and women who have health problems due to FGM, including immediate and short-term urogynaecological or obstetric complications; 4) provide support to women who have mental health and sexual health complications caused by FGM; 5) make informed decisions on how and when to perform deinfibulation; 6) identify when and where to refer patients who need additional support and care; and 7) work with patients and families to prevent the practice of FGM.
Ethical and safety recommendations for intervention research on violence against women. Building on lessons from the WHO publication, "Putting women first: ethical and safety recommendations for research on domestic violence against women".
Geneva, Switzerland, WHO, 2016. 43 p.As the evidence base on the magnitude, context and consequences of violence against women (VAW) has grown, research efforts and attention have begun to focus on decreasing the knowledge gap on effective responses through intervention research. Demonstrating this focus, in November 2012 the WHO Department of Reproductive Health and Research convened a group of experts to discuss health sector-based research to respond to violence against women. This global network of researchers, scientists and practitioners was brought together to enhance existing research efforts and to advocate for greater funding for research on interventions to address VAW and policies and programmes related to it. With the increased interest in and attention of the global community of researchers, practitioners and policy-makers regarding rigorous intervention research for preventing and responding to VAW, a discussion of the ethical considerations specific to this type of research is warranted. These recommendations have been developed to help answer questions specific to conducting research on health-based interventions to prevent and respond to VAW. Research on strategies that use health or health care as an entry point (regardless of the implementation setting, such as a clinic or community) is the focus. However, the discussion may be relevant to research on other kinds of VAW interventions.
Global standards for quality health care services for adolescents. A guide to implement a standards-driven approach to improve the quality of health-care services for adolescents. Volume 4: Scoring sheets for data analysis.
Geneva, Switzerland, World Health Organization, 2015. 132 p.Global initiatives are urging countries to prioritize quality as a way of reinforcing human rights-based approaches to health. Yet evidence from both high- and low-income countries shows that services for adolescents are highly fragmented, poorly coordinated and uneven in quality. Pockets of excellent practice exist, but, overall, services need significant improvement and should be brought into conformity with existing guidelines. The aim of Global standards for quality health-care services for adolescents is to assist policy-makers and health service planners in improving the quality of health-care services so that adolescents find it easier to obtain the health services that they need to promote, protect and improve their health and well-being. This volume is to be used in conjunction with the monitoring tools in Volume 3. Using this data analysis method, countries can determine compliance with quality standards. How to use this volume: The scoring sheets in this volume are organized by criterion. There is a separate scoring sheet for each criterion. The total scores for all the criteria that apply to a standard are averaged to yield an overall score for that standard.
Global standards for quality health care services for adolescents. A guide to implement a standards-driven approach to improve the quality of health-care services for adolescents. Volume 3: Tools to conduct quality and coverage measurement surveys to collect data about compliance with the global standards.
Geneva, Switzerland, World Health Organization, 2015. 100 p.Global initiatives are urging countries to prioritize quality as a way of reinforcing human rights-based approaches to health. Yet evidence from both high- and low-income countries shows that services for adolescents are highly fragmented, poorly coordinated and uneven in quality. Pockets of excellent practice exist, but, overall, services need significant improvement and should be brought into conformity with existing guidelines. The aim of Global standards for quality health-care services for adolescents is to assist policy-makers and health service planners in improving the quality of health-care services so that adolescents find it easier to obtain the health services that they need to promote, protect and improve their health and well-being. This volume includes tools to determine whether the implementation of the standards has been achieved. These tools can be adapted for use in different contexts -be it self-assessments on a limited number of criteria, or external assessments (monitoring visits) by district managers, on a wider, or full range, of standards and criteria. The tools can be equally adapted to develop checklists for supportive supervision. The toolkit included in this volume contains seven tools to collect data about quality of care (as measured by the criteria of the standards) and two tools to gather information about coverage.
Global standards for quality health care services for adolescents. A guide to implement a standards-driven approach to improve the quality of health-care services for adolescents. Volume 2: Implementation guide.
Geneva, Switzerland, World Health Organization, 2015. 28 p.Global initiatives are urging countries to prioritize quality as a way of reinforcing human rights-based approaches to health. Yet evidence from both high- and low-income countries shows that services for adolescents are highly fragmented, poorly coordinated and uneven in quality. Pockets of excellent practice exist, but, overall, services need significant improvement and should be brought into conformity with existing guidelines. The aim of Global standards for quality health-care services for adolescents is to assist policy-makers and health service planners in improving the quality of health-care services so that adolescents find it easier to obtain the health services that they need to promote, protect and improve their health and well-being. This volume, the Implementation guide, provides detailed guidance on identifying what actions need to be taken to implement the standards at the national, district and facility levels. It can be used to develop checklists to assess the status of implementation.
Global standards for quality health care services for adolescents. A guide to implement a standards-driven approach to improve the quality of health-care services for adolescents. Volume 1: Standards and criteria.
Geneva, Switzerland, World Health Organization, 2015 40 p.Global initiatives are urging countries to prioritize quality as a way of reinforcing human rights-based approaches to health. Yet evidence from both high- and low-income countries shows that services for adolescents are highly fragmented, poorly coordinated and uneven in quality. Pockets of excellent practice exist, but, overall, services need significant improvement and should be brought into conformity with existing guidelines. The aim of Global standards for quality health-care services for adolescents is to assist policy-makers and health service planners in improving the quality of health-care services so that adolescents find it easier to obtain the health services that they need to promote, protect and improve their health and well-being. The implementation plan and the monitoring tools that accompany the standards in this document provide guidance on identifying what actions need to be taken to implement the standards and to assess whether the standards have been achieved. The primary intention of the standards is to improve the quality of care for adolescents in government healthcare services; however, they are equally applicable to facilities run by NGOs and those in the private sector. The ultimate purpose of implementing the standards is to increase adolescents’ use of services and, thus, to contribute to better health outcomes.
London, United Kingdom, IPPF, 2012 May.  p.Obtaining the consent of your client before treating them is a cornerstone of good medical practice and in most countries, a legal requirement, and the process of obtaining it is a specific example of when health professionals must apply the concept of evolving capacity. To be fully included in the decision-making process and to give informed consent, young people need accurate and comprehensive information presented in an accessible manner.
Guidance on couples HIV testing and counselling including antiretroviral therapy for treatment and prevention in serodiscordant couples: Recommendations for a public health approach.
Geneva, Switzerland, WHO, Department of HIV / AIDS, 2012 Apr.  p.These guidelines recommend increasing the offering of HIV testing and counselling (HTC) to couples and partners, with support for mutual disclosure. They also recommend offering antiretroviral therapy (ART) for HIV prevention in serodiscordant couples. Recommendations include: 1.Couples and partners should be offered voluntary HIV testing and counselling with support for mutual disclosure (Strong recommendation, low-quality evidence). 2. Couples and partners in antenatal care settings should be offered voluntary HIV testing and counselling with support for mutual disclosure (Strong recommendation, low-quality evidence). 3. Couples and partner voluntary HIV testing and counselling with support for mutual disclosure should be offered to individuals with known HIV status and their partners (Strong recommendation, low-quality evidence for all people with HIV in all epidemic settings / Conditional recommendation, low-quality evidence for HIV-negative people depending on country-specific HIV prevalence). 4. People with HIV in serodiscordant couples and who are started on antiretroviral therapy (ART) for their own health should be advised that ART is also recommended to reduce HIV transmission to the uninfected partner (Strong recommendation, high-quality evidence). 5. HIV-positive partners with >350 CD4 cel ls/µL in serodiscordant couples should be offered ART to reduce HIV transmission to uninfected partners (Strong recommendation, high-quality evidence. (Excerpts)
Policy requirements for HIV testing and counselling of infants and young children in health facilities.
Geneva, Switzerland, WHO, 2010.  p.Currently, many opportunities to diagnose HIV infection in infants and children are missed within the health system. These opportunities for diagnosis of HIV arise at facilities providing services for antenatal care, prevention of mother-to-child transmission (PMTCT) of HIV, immunization, nutrition, inpatient admissions and within programmes for other vulnerable children. It is estimated that only 8% of HIV-exposed infants received early virological testing in 2008. Analysis of international cohort data confirms that very few HIV-infected infants are started on antiretroviral therapy, and those who do receive it, are started when they are already very sick, largely due to a delay in HIV testing. The benefits of expanded access to HIV testing and counselling for infants and children are numerous and include the following: early identification of HIV-infected infants and children as a first step to treatment and care; identification of HIV-exposed but uninfected infants, which facilitates follow-up care and prevention measures that will help to ensure that they remain uninfected and healthy; life-planning for parents and/or children who are HIV infected; and increased access to care and antiretroviral therapy for parents. Providing HIV testing for infants and children, however, presents unique challenges for policy-makers, programme managers and health-care providers. To address these challenges, WHO and the United Nations Children’s Fund (UNICEF), in consultation with the Interagency Task Team on Prevention of HIV Infection in Pregnant Women, Mothers and their Children, have prepared this policy brief, which is in line with existing WHO technical recommendations, including guidance on provider-initiated HIV testing and counselling issued by WHO in 2007. The brief aims to outline key issues that should be addressed within national policy guidance to support country programming. It is designed to be used by country programmes and technical working groups as they review and develop policy and practice guidelines relevant to HIV testing for children. For the purposes of this brief, infants and children should be considered to include all children who are 14 years of age or younger. Specific attention should be given to those issues related to children below the age of 10 years. (Excerpt)
Lancet Infectious Diseases. 2007 Jul; 7(7):446.WHO and UNAIDS have issued new guidance on scaling up informed voluntary HIV testing and counselling in health facilities globally. The guidance promotes provider-initiated HIV testing, alongside existing patient-initiated HIV testing, with a view to ensuring earlier diagnosis, reducing transmission, and maximising the benefits of treatment. At a press conference in London, UK, Kevin De Cock (WHO, Geneva, Switzerland) told journalists: "WHO now recommends that in countries with generalised epidemics, all patients - with or without symptoms -who present to health services for whatever reason, should be offered testing". In countries with low-level HIV epidemics, the testing of all patients is now recommended at specific health services catering for at-risk groups. Additionally, all patients presenting to a health service with symptoms suggestive of HIV infection should be encouraged by health professionals to undergo testing. According to WHO, too many opportunities to diagnose HIV infection are being missed. (excerpt)
Geneva, Switzerland, UNAIDS, 2000 May. 48 p. (UNAIDS/04.07E)In the present document, UNAIDS seeks to offer guidance emanating from this process. This document does not purport to capture the extensive discussion, debate, consensus, and disagreement which occurred at these meetings. Rather it highlights, from UNAIDS' perspective, some of the critical elements that must be considered in HIV vaccine development activities. Where these are adequately addressed, in UNAIDS' view, by other existing texts, there is no attempt to duplicate or replace these texts, which should be consulted extensively throughout HIV vaccine development activities. Such texts include : the Nuremberg Code (1947); the Declaration of Helsinki, first adopted by the World Medical Association in 1964 and subsequently amended in 1975, 1983, 1989 and 1996; the Belmont Report - Ethical Principles and Guidelines for the Protection of Human Subjects of Research, issued in 1979 by the US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; the International Ethical Guidelines for Biomedical Research Involving Human Subjects, issued by the Council for International Organizations of Medical Sciences (CIOMS) in 1993 (and developed in close cooperation with WHO); the World Health Organization's Good Clinical Practice (WHO GCP) Guideline (1995); and the International Conference on Harmonisation's Good Clinical Practice (ICH GCP) Guideline (1996). It is hoped that this document will be of use to potential research participants, investigators, community members, government representatives, pharmaceutical companies, and ethical and scientific review committees involved in HIV preventive vaccine development. It suggests standards, as well as processes for arriving at standards, and can be used as a frame of reference from which to conduct further discussion at the international, national, and local levels. (excerpt)
Increasing access to HIV testing and counselling. Report of a WHO Consultation, 19–21 November 2002, Geneva, Switzerland.
Geneva, Switzerland, WHO, 2003. 30 p.In November 2002, WHO convened a larger consultation to consider strategies to increase access to HIV testing and counselling. Those at the Consultation reconfirmed the commitment to voluntary HIV testing and counselling and explored new modalities by which to ensure informed consent as access to HIV testing and counselling expands in a variety of settings. In this context, the participants urged that HIV testing and counselling be offered as standard best practice in the provision of prevention, care and treatment services whenever testing and counselling can benefit the health and well-being of those affected by HIV/AIDS. This report summarizes the main conclusions reached at this Consultation. (excerpt)
Putting women first: ethical and safety recommendations for research on domestic violence against women.
Geneva, Switzerland, WHO, Department of Gender and Women's Health, 2001. 31 p. (WHO/FCH/GWH/01.1)In order to guide future research in this area, the World Health Organization has developed the following recommendations regarding the ethical conduct of domestic violence research. These build on the collective experience of the International Research Network on Violence Against Women (IRNVAW). They have been reviewed and approved by the WHO Steering Committee for the Multi-Country Study on Women’s Health and Domestic Violence Against Women, and also reviewed by key members of the Scientific and Ethical Review Group (SERG) of the Special Programme on Research and Research Training on Human Reproduction (HRP). The recommendations are in addition to those outlined in the CIOMS International Guidelines for Ethical Review of Epidemiological Studies (1991). These recommendations are designed for use both by anyone intending to do research on domestic violence against women (such as investigators, project co-ordinators and others implementing such research), and also by those initiating or reviewing such research (such as donors, research ethical committees etc.). The guidelines focus on the specific ethical and safety issues associated with planning and conducting research on this topic. They do not intend to give general guidance or recommendations on the planning, methodology, and logistics of research on domestic violence against women, or issues associated with the ethical conduct of research in general. (The latter is addressed by the CIOMS Guidelines referred to above). These recommendations emerged from discussion of those prepared for the WHO Multi-country Study on Women’s Health and Domestic Violence Against Women. They focus in particular on the ethical and safety considerations associated with conducting population-based surveys on domestic violence against women. However, many of the principles identified are also applicable to other forms of quantitative and qualitative research on this issue. The recommendations were not written for research on other forms of violence against women, such as violence in conflict situations, or trafficking of women. Whilst it is likely that some aspects of the guidelines will be applicable in those situations, there may also be some important differences. (excerpt)
BMJ. British Medical Journal. 2004; 328: p..A Roma woman who alleges she was sterilised without her consent during an emergency procedure at a Hungarian hospital is taking her case to the United Nations. Records show that the woman, then aged 28, who was undergoing labour pains and bleeding heavily, was taken by an emergency vehicle to Szatmár-Beregi Hospital in Fehérgyarmat in northeastern Hungary on 2 January 2001. Examinations determined that the placenta had ruptured and that her unborn infant had died, said Dr András Kanyó, who, with other members of the hospital's emergency team, had been alerted by emergency medical personnel to the woman's imminent arrival. "Following the ultrasound and a physical examination, I asked her about her family, and she said she had three children. I asked if she planned to have any more, and she said no," said Dr Kanyó, a gynaecologist, anaethesiologist, and intensive care specialist. (excerpt)
Geneva, Switzerland, [WHO], Division of Family Health / Unit of Family Planning and Population, 1994. , 35 p. (WHO/FHE/FPP/94.2 Rev.1)Female sterilization represents a viable option for women who are certain they want no more children. It is critical, however, that family planning programs offering female sterilization provide careful counseling that highlights the permanence of the procedure and the availability of safe, effective alternatives for couples who desire long-term reversible protection from pregnancy. This booklet provides health workers with basic information on how female sterilization works, its advantages and disadvantages, its risks and benefits, and how to help women make informed choices. It also provides answers to the most commonly asked questions about the procedure. Ample illustrations and charts are included. Appendices present a sample informed consent form and suggested pre- and postoperative instructions for sterilization acceptors.
SAFE MOTHERHOOD. 1996; (20):10.During a 1994 workshop sponsored by the World Health Organization and the International Federation of Gynaecology and Obstetrics (FIGO), participants discussed 1) women's right to family planning information, education, and services; 2) women's right to a choice of options and to voluntary decisions concerning their health; and 3) the link between women's rights and women's health. Participants noted that obstetricians and gynecologists must expand their role to become women's advocates and must insure that women's rights to informed choice and informed consent are protected. Women should participate as equals in the planning, implementation, and evaluation of policies which affect them so that they can make fully informed decisions. The workshop produced the following recommendations: 1) FIGO should discourage practices that abuse women's rights to information and education on the procedures and treatments they face; 2) adolescents should receive reproductive health information, counseling, and services; 3) obstetricians and gynecologists should be trained in communication and counseling skills; and 4) national societies of obstetricians and gynecologists should encourage the provision of comprehensive reproductive health services, discourage female genital mutilation, and encourage provision of counseling for female victims of violence.
Ann Arbor, Michigan, UMI Dissertation Services, 1996. , viii, 336 p. (UMI No. 9631613)This dissertation presents a social history of oral contraceptives (OCs) in the US during the period 1950-70. Chapter 1 examines the factors which combined to give birth to the OC. These include the state of scientific knowledge, sexual mores, women's role and status, interest in population control, and the influence of Margaret Sanger and Katherine McCormick, the role of the pharmaceutical industry, clinical trials, and US Food and Drug Administration (FDA) approval. Chapter 2 covers the introduction of the OC and its reception by physicians, Planned Parenthood, patients, and the media (by examining coverage on health effects, moral effects, the Roman Catholic debate, and population control). The third chapter relates ways the popular press cloaked the OC in social and moral terms during the mid-1960s by reviewing sociological research on premarital sex, demographic research on contraceptive unsafe, the role of the media, and the effect of the OC on population control efforts. Chapter 4 discusses medical controversy and public concern surrounding side effects and complications associated with OC use. Specific topics include early reports on blood clotting and on cancer, reports of the World Health Organization, FDA, and American Medical Association, and responses of physicians and patients to these reports. The final chapter follows the OC into the political arena by reporting on hearings held on "competitive problems in the drug industry" and on the OC. The response of the media, Planned Parenthood, patients, physicians, and feminists is presented, and debates over informed consent and the package insert are noted. The dissertation concludes that the unresolved medical controversies did not compel women to abandon the OC but caused women to worry about their health while taking it. Thus, informed consent procedures were given serious consideration, and the percentage of married women taking the OC dropped from 36 in 1973 to 20 in 1982. The OC's legacy to women is the belief in their right to simple, safe, and reliable contraception.
New York, New York, AVSC, 1993 Sep. 8 p.Neither the US Food and Drug Administration nor WHO have yet endorsed intrauterine insertion of quinacrine for tubal occlusion in women. Quinacrine is very inexpensive and easy to produce and insert, which make it open to abuse. Free and informed choice and safety must be upheld as well as quality of care in family planning services. The few studies of quinacrine use for nonsurgical sterilization have small sample sizes and very short-term follow-up. They have largely occurred in Chile, Egypt, and Indonesia. One study suggests that quinacrine increases the risk of cancer. Recently a field trial of 31,781 women undergoing nonsurgical sterilization with quinacrine pellets was conducted in Viet Nam. The pregnancy rate at 1 year was 2.63. At 2 years it was 4.31 for cases with 2 insertions. At 5 years, for women with just 1 insertion, it was 5.15. There were 19 ectopic pregnancies. Major complications included 2 cases of severe bleeding, 2 hysterectomies (severe pain and amenorrhea, adhesions in the cervical canal), 1 case of premenstrual pain and dysmenorrhea, 1 case of pelvic inflammatory disease, and 1 allergic reaction. Only minor side effects occurred. The study methodology was flawed, however. For example, the researchers did not bide by the inclusion criteria they claim to have used. They also extrapolated failure rates and side effects based on subsets to the whole group. Thus, this study cannot be used to conclude that quinacrine pellets are safe and effective. Further, well-designed studies addressing short and long-term safety are warranted. If studies find quinacrine pellets to be safe and effective, their low cost and ease of insertion make it a promising method in areas of high maternal mortality, with low access and availability of family planning services, and great unmet need for permanent methods.
Lancet. 1994 Jun 4; 343(8910):1425-6.Many Vietnamese women do not accept IUDs. Program planners, providers, and officials in Vietnam are therefore challenged with providing alternative methods of fertility control which are acceptable to the population. Nongovernmental organizations for women in Asia and the Pacific are concerned about Potts' assertion that the intrauterine insertion of quinacrine pellets is a safe and effective method of sterilization for Vietnamese women. Women's health advocates are most worried about safety, especially the long-term physiological effects and the risk of abuse or coercion. On the basis of a 1991 review, the World Health Organization Toxicology Panel recommended further study of the safety of quinacrine in sterilization, while Hieu et al from their report of a large field trial of Vietnamese women admitted their inability to study the risk of cancer of the uterus as a result of exposure with quinacrine. Work needs to be done before the use of quinacrine as a form of contraception may be declared safe and effective. Future field trials in Vietnam should interview users on their views and preferences. Moreover, since the administration of quinacrine involves no surgical procedure and the insertion procedure is identical for both IUD and quinacrine, some women may not fully understand that one method is permanent and the other is not. The right of women to make informed and individual choices about their fertility can easily be abused when countries try to achieve population growth and size targets. Efforts should be made to ensure that such abuses do not occur in Vietnam.
In: Reproductive Health and Justice. International Women's Health Conference for Cairo '94, January 24-28, 1994, Rio de Janeiro. New York, New York, International Women's Health Coalition, 1994. 34-5.At the January 28-29, 1994, meeting of the Working Group on Accountability Mechanisms and Human Rights, attended by 33 women from 15 countries who were participants in the International Women's Health Conference for Cairo 1994, a draft statement of principle was adopted. The statement asserts, "Issues related to bodily integrity women's health are fundamental human rights questions, and therefore all policies affecting these areas, particularly around reproduction and population, should be held accountable to economic, social, cultural, and political human rights standards." Of concern to participants was the lack of a woman-controlled accountability mechanism to prevent unethical clinical and experimental practices in contraception development. It was agreed that such a monitoring mechanism should be independent of governments and international organizations, receive sufficient funding, and insist on true informed choice regarding participation in clinical trials. Suggestions toward this end included circulation of a petition proposing such a mechanism among women's groups in attendance at the Cairo population conference, formation of a coalition of women's health networks as the basis for an accountability commission, development of minimum standards for consent, training workshops for providers and scientists to demonstrate ethical practices, and exploration of the possibility of an independent ombudsman for the World Bank.
CONSCIENCE. 1991 Sep-Oct; 12(5):6.When IPPF was formed in 1952, its driving force was concern for women, for women's health and women's reproductive rights. 40 years on, those same issues are still at the heart of IPPF's policies and programs. Marge Berer has made a plea for a feminist approach within international family planning, and IPPF is in complete agreement that women's needs and choices should be paramount. All individuals and couples must have the basic human right to decide freely and responsible the number and spacing of their children. Women must also have the right to receive full information and counselling to choose their contraceptive method. Our secretary general, Dr. Halfdan Mahler, stresses that if family planning is to be effective, it must always begin with the individual, taking the whole issue of reproductive health into consideration. Men must share the responsibility for sexual behavior and family planning, and real equality will only be attained when women are empowered to regulate their own fertility. As nongovernmental health care organizations, IPPF's member associations offering services in 133 countries are able to work towards the principles of informed choice and voluntary family planning--even where governments may not be giving women the choices they deserve. (full text)
MARHIA - MEDIUM FOR THE ADVANCEMENT AND ACHIEVEMENT OF REPRODUCTIVE RIGHTS, HEALTH INFORMATION AND ADVOCACY. 1989 Jul-Sep; 2(3):1, 3-9.4 major contraceptives are being examined by health care professionals throughout the world. They are: injectables, the IUD, condoms and the pill. This article discusses the advantages and disadvantages of all four. Injectable contraceptive are most commonly either Depo-provera or Noristerat. Depo-provera is approved for use as a contraceptive in 90 countries. Noristerat is approved for use in 40 countries. Detractors of Depo-provera say that is produces breast tumors in beagle dogs, possible tetratogenecity upon failure concern that abnormal bleeding might lead to additional estrogen therapy, and that the simple nature of this type of drug might lead to abuse of informed consent. However, World Health Organization studies have shown no cancerous effects of the drug and a failure rate of 1 in 100 women. When failure occurs, tetratogenecity is very low. It must be looked at in the context of risk assessment before judgement is passed on it. In countries where pregnancy can mean a decrease in the quality of life for the mother or the family, this is an easy method of birth control. The IUD has many questions surrounding its use: infection, expulsion, tubal infertility, ectopic pregnancy and uterine laceration. While it is an effective method of birth control, not an abortifacient, it does have certain disadvantages that must be considered. Condoms have the added benefit of preventing the spread of disease as well as preventing pregnancy. However, in many countries there is a cultural bias against using a condom. Men complain about reduced sensitivity. Also, they break with a certain frequency that is unavoidable in a mass produced product (about 1 in 10,000). Their biggest weakness is most users do not use them consistently. This is where injectables, the IUD and the pill have an advantage over the condom. Use patterns also increase their failure rate in terms of contraception. The pill is the most popular and widely used form of hormonal contraception. It has been proven safe at lower doses and is very effective. It is however, incapable of preventing the spread of disease. Also, women who smoke and use the pill run a higher risk of breast cancer.
ECONOMIC AND POLITICAL WEEKLY. 1989 Jun 17; 24(24):1308-9.The World Health Organization's (WHO's) research program in human reproduction has been criticized by health and women's organizations for its use of poor, illiterate women in developing countries as "guinea pigs." In response, an impact assessment team--currently in India--was established to seek ways of making the WHO research program more acceptable to women. A fundamental shortcoming of this assessment process, however, is the team's assumption that ethical guidelines regarding informed consent are being followed in WHO clinical trials. Women who participate in trials of new contraceptives such as injectables, implants,a nd pellets are not being given unbiased information about possible risks. Another concern is the recent effort to reduce the intensity of the animal studies that precede human testing. It has been argued that animal research, which has in many cases revealed serious drug side effects, is not applicable to humans. Finally, the surveillance of participants in contraceptive trials--a basic guideline for research activities--has proved infeasible. Both health and women's groups have documented violations of medical ethics that occurred in WHO-sponsored multicenter clincial trials of the injectable contraceptive, Net-En. Unfortunately, the assessment team has been less critical in its review of the program.
In: Population policy: contemporary issues, edited by Godfrey Roberts. New York, New York/London, England, Praeger, 1990. 21-37.On the basis of the orthodox assumption that population growth constitutes an obstacle to economic development, most countries have established programs aimed at reducing fertility through contraception. The methods used by family planning programs, ranging from voluntary acceptance through educational and informational campaigns to financial incentives or disincentives to outright forced sterilization, raise complex ethical issues. Specifically, there are 5 ethical principles--freedom, justice, welfare, truth-telling, and security/survival--that can be used to evaluate deliberate attempts to control human fertility. Such an approach suggests that forced abortion, compulsory sterilization, and all other forms of heavy pressure on clients to accept a given means of fertility control violate human freedom, justice, and welfare. The violations inherent in financial incentives are demonstrated by the fact that they are attractive only to the poor and disadvantaged sectors of the population. Family planning programs that offer incentives to field workers to meet acceptor quotas often lead to a disregard of client health and welfare by subtly encouraging workers to withhold information on medical side effects, outright deceive clients about methods that are not being promoted by the family planning program, and fail to take the time for adequate medical counseling and follow-up. Even programs that provide free choice to clients are illusory if the methods offered include controversial agents such as Depo-Provera and acceptors lack the capacity to make an informed choice about longterm effects. Recommended is the establishment of an international code of ethics for population programs drafted by a broad working group that does not have a vested interest in the code's terms.