Contraception and Public Health Ethics
Abstract and Keywords
This chapter discusses how potential conflicts between individual rights and public health goals can be managed in the context of contraceptive service delivery and research. It applies three ethical principles—respect for persons, beneficence, and justice—to illustrate how those tensions play out in a variety of challenging situations prevalent in the fields of family planning and reproductive health. That analysis is followed by a discussion of the consequences of those conflicts for health systems, family planning providers, and users of health systems. The chapter focuses on developing countries and makes relevant parallels for global policymaking and service delivery.
(p. 391) Introduction
Contraception is a core public health issue. It has the potential to reduce family size and improve birth spacing, which in turn lead to better health outcomes for infants, children, and women. In addition, contraception provides women with choices to pursue their education, participate in the labor force, and contribute in economic and other ways to the lives of their families and communities. Furthermore, some contraceptives, such as male and female condoms, provide protection not only against unintended pregnancy, but also against sexually transmitted infections (STIs), including human immunodeficiency virus (HIV) (WHO, 2018). For all these reasons, ensuring access to contraception and family planning services is recognized as a policy decision that will facilitate economic development.
The decision to use contraception, however, is one that women and men make in private as they decide if and when they want to have children. Many factors affect that decision—the nature of the relationship between the sexual partners, including power dynamics; availability of and access to contraceptive services; the broader family context; and wider socioeconomic and cultural factors. Family planning programs have sought to increase access to contraceptives, based on the 1968 International Conference on Human Rights in Tehran, which affirmed the basic human right of men and women to decide freely and responsibly the number and spacing of their children (UN, 1968). Since the Tehran conference, three decennial World Population Conferences (Bucharest, 1974; Mexico City, 1984; and Cairo, 1994) have reaffirmed the central role that individual rights and family planning programs have in advancing individual and national development interests (UNFPA, 1974, 1984, 1994).
In response, government-sponsored family planning programs in many developing countries began to actively promote and provide contraceptive services to their citizens. (p. 392) By the time of the 1984 Mexico City conference, many governments of developing countries expressed firm support for family planning and population programs, as did some donor countries, although their implementation strategies varied. In contrast to programs that promoted helping individuals plan their families, some countries promoted population policies that emphasized the demographic imperative of reducing national birth rates (e.g., China, India), prompting unease about potential state regulation of individual reproductive decisions and behaviors (Jain, 1998). However, the 1994 Cairo conference reaffirmed the importance of respecting and protecting individual reproductive health and rights over the achievement of demographic targets. Other global policy frameworks—originating from the 1995 Fourth World Conference on Women in Beijing, the Sustainable Development Goals (SDGs), and Family Planning 2020 (often referenced as FP2020)—have continued the trend of framing reproductive health and family planning within the context of human rights, including the right to health. Despite that acknowledgment, there continues to be a tension in balancing individual rights and well-being with demographic and public health goals.
This chapter discusses how the potential conflict between individual rights and public health goals can be managed in the delivery of routine contraceptive services and in the conduct of research on contraceptive product development and innovative service models. The following discussion illustrates how the tension plays out in the application of three ethical principles—respect for persons, beneficence, and justice—and highlights the consequences of those tensions for health systems, family planning providers, and users of health systems.
The Three Ethical Principles
Numerous ethical guidelines, including the Nuremberg Code, the Declaration of Helsinki, the Belmont Report, relevant US federal regulations, and the International Conference on Harmonisation’s Guideline for Good Clinical Practice (GCP), emphasize three guiding ethical principles: respect for persons; beneficence; and justice. Each of these principles plays out in different ways in service delivery and research as illustrated in the following discussion (Fischer, 2006; RamaRao, Friedland, and Townsend, 2007).
Respect for Persons
Most ethical guidelines highlight that respect for persons, sometimes referred to as autonomy, is critical to the ethical conduct of health care delivery and clinical research (Fischer, 2006). For example, the 1979 Belmont Report, issued by the US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission, 1979), explains that the principle of respect for persons means (p. 393) that individuals with decision-making capacity should be treated as autonomous agents, and that those with diminished capacity should be entitled to protections.
Respect for persons embodies the notion that individuals are given the opportunity to decide for themselves if, and to what extent, they wish to participate in therapy or research. The operationalization of that principle occurs through the informed consent process, which involves providing relevant information to patients, clients, or research subjects in a format they can understand, and ensuring that decisions about therapy or research participation are made voluntarily (i.e., without undue influence or coercion).
Application in Service Delivery
In contraceptive service delivery, public health systems and family planning providers bear primary responsibility for ensuring respect for persons. Health advocates can facilitate respectful care through third-party monitoring and accountability of services, and by educating service users about their rights and what to expect from services in a range of settings. The intended outcome is a satisfied service user who has made an informed decision about his or her contraceptive use and provider after receiving relevant, accurate, comprehensive, and comprehensible information.
Informed choice is an essential component of contraceptive decision-making. Users and potential users need to be informed about how available contraceptive methods work, their potential side effects, the location and skills of providers, and the time frames required for health checkups and ongoing contraceptive supply. With that information, individuals can determine which method best meets their needs, preferences, stage of reproductive life cycle, and life circumstances. From both ethical and programmatic points of view, there is clear evidence suggesting that users who receive the contraceptive of their choice and are well-informed tend to be satisfied users who adhere to the requirements of their chosen contraceptive method (Jain et al., 2012; Pariani, Heer, and Van Arsdol, 1991; RamaRao and Mohanam, 2003). Satisfied contraceptive users contribute to the success of public health programming and health impact while meeting their own personal needs.
Informed consent, however, is only one aspect of respect for persons. In many developing countries, for example, sexually active adolescents face barriers to the sexual and reproductive health care that are critical to their well-being (Bankole and Malarcher, 2010). Family planning providers may refuse to provide information or care to adolescents for a variety of reasons. The cultural milieu may stigmatize sexual activity among unmarried adolescents, promote pro-natalist attitudes among married adolescents, or offer contraceptives and service outlets that do not match adolescent preferences or lifestyles. Furthermore, existing laws and policies may restrict the provision of contraception to unmarried adolescents or those below a certain age (Chandra-Mouli et al., 2014). The failure to respect adolescents as persons too often leaves them with unmet contraceptive needs that place them at substantially greater risk of unintended pregnancy and unwanted infection (WHO, 2018).
Even in family planning programs that intend to improve access to good quality contraceptives and services, tensions can arise between individual decision-making, provider (p. 394) preferences, and public health. For example, long-acting reversible contraceptives (LARCs) are increasingly seen as a panacea by family planning program managers and other decision-makers for addressing plateauing unintended pregnancy rates and for providing long-term contraceptive protection for women who may not be able to access services easily (Gomez, Fuentes, and Allina, 2014; Jacobstein, 2018). While LARCs certainly add to women’s contraceptive options, how women receive information about LARCs can shape their decisions, and even nudge them to make choices that may not be in line with their preferences or needs (Gomez, Fuentes, and Allina, 2014). In a highly influential project that demonstrated the feasibility of promoting LARC uptake, providers presented women with information from the most to least effective contraceptive. As Gomez, Fuentes, and Allina, (2014, 173) argue, the counseling model adopted by the project prioritized the effectiveness of the method over the “range of concerns, preferences and priorities that individual women bring to their contraceptive decision making.” Such a counseling model has the potential to override the preferences of individual women, thereby reducing their autonomy, but it can be successful in achieving the public health goal of more effective contraceptive protection.
Application in Research
In research, informed consent is a critical first step in respecting persons. The onus of ensuring informed consent lies with researchers, their institutions, and the sponsors supporting the scientific inquiry. In the research context, the intended outcome should be a fully informed individual who understands the nature of the research as well as its potential risks and benefits, and who has voluntarily agreed to participate in the research and comply with its requirements. Examples of clinical research include safety and efficacy trials of a new contraceptive, feasibility studies to determine the costs and benefits of deploying new cadres of providers to deliver family planning services, and studies examining new ways of counseling family planning clients. In all research studies, investigators should use accessible language to inform participants about the nature and scope of the research.
Issues and Consequences
Ensuring informed consent and respect for individual choice is a resource-consuming process, but the effort is necessary. Supportive policies and programmatic frameworks, such as performance incentives, can help facilitate these goals if they are in harmony with the principle of respect for persons. Individual contraceptive choice and public health goals need not be in tension, as treating contraceptive users and research participants with respect and providing them with information and choice will result in win-win situations for all stakeholders. The public health program will achieve impacts in terms of improved health and well-being of women, men, and their offspring. High contraceptive uptake and continuation will avert unintended pregnancy, birth, and unsafe abortion while promoting better planned and spaced pregnancies. Health system users will be satisfied with services and empowered to use contraception in ways that help them achieve (p. 395) their reproductive intentions. Providers, too, will be gratified that they contributed to their clients’ health and well-being by addressing their needs.
Beneficence requires that service providers and researchers maximize possible benefits and minimize possible harms to users and research participants. Beneficence is assessed by comparing the potential risks and benefits that a service user or research participant may experience as a result of the contraceptive service/method or proposed research. The ethical rationale for conducting the activity is met if the potential benefits outweigh the potential risks. Such an assessment is complex, because contraceptives offer benefits, such as avoiding unintended pregnancy, along with risks, such as side effects and potential contraceptive failure, even when used correctly.
Furthermore, while risks are borne solely by the service user or research participant, the benefits might accrue both to them and to the broader society. For example, contraceptive research can generate knowledge useful to all in society, and the benefits of individuals using contraception can result in better public health outcomes due to reductions in rates of unintended pregnancy, unsafe abortion, and maternal mortality. The risk need not be confined to health risks but may include risks to clients’ interests (e.g., how they would like to deal with associated bleeding or amenorrhea, which add a more nuanced social dimension to the assessment).
Application in Service Delivery
The ethical conundrum that arises when individual risk is balanced against societal benefit is well illustrated by the use of Depo-Provera (DMPA) in countries with high HIV prevalence. DMPA is a progestin-only injectable contraceptive that has received significant attention since 2010 (Polis et al., 2014) because observational studies indicate that women using DMPA might be at higher risk of acquiring HIV (Heffron et al., 2012; Polis et al., 2016). A risk-benefit assessment of DMPA involves weighing its benefits to women (e.g., avoiding unintended pregnancy) and society (e.g., improved maternal health outcomes) against its potential risks to women (e.g., heightened susceptibility to HIV). In settings where HIV infection rates are high and contraceptive use is low, risk-benefit assessments are especially challenging (Covshoff, Sauer, and Pittrof, 2015; Haddad, Philpott-Jones, and Schonfield, 2015a, 2015b; Han et al., 2017).
In many sub-Saharan African countries, where DMPA is the most commonly used contraceptive, the challenge is providing appropriate guidance to women and family planning providers about a popular method that may also increase the risk of HIV acquisition for some women. For example, what type of counseling on HIV-risk reduction, or restrictions on DMPA use, should be put in place?
One view is that restrictions on the use of DMPA, while intended to protect women from a heightened risk of HIV acquisition, would limit access to an effective contraceptive (p. 396) for many women, thereby exposing them to unwanted harm (Haddad, Philpott-Jones, and Schonfield, 2015a, 2015b) and increasing maternal mortality (Rodriguez, Reeves, and Caughey, 2012). Others have argued that such restrictions limit women’s opportunity to make informed decisions about whether they wish to use DMPA (Covshoff, Sauer, and Pittrof, 2015).
Recognizing the alternate viewpoints on public health benefits versus individual risks, the state of existing scientific evidence, and the need for clear policy guidance, the World Health Organization (WHO) issued an update to the Medical Eligibility Criteria for progestin-only injectables in women at high individual risk of HIV (WHO, 2017). The updated guidance changes the provision of those contraceptives from Category 1 (no restriction) to Category 2 (benefits outweigh risks), and reflects the WHO’s attempt to balance public health concerns with individual rights.
Application in Research
Many countries of sub-Saharan Africa and Asia are challenged by health worker shortage and retention, which limit access to and availability of essential family planning services. Task shifting and task sharing have been proposed as mechanisms for improving access and cost-effectiveness within health systems in these regions (WHO, 2012). Under these strategies, lower cadres (occupational groups) of health staff, including “lay health workers,” would be trained and enabled to deliver the same family planning services currently offered by higher-level or specialized staff. From an ethical perspective, task shifting and sharing may improve equity of access to family planning services, especially for remote and underserved communities, without compromising quality of care, providing the associated training is appropriate.
Since the early years of the twenty-first century, research evidence has been slowly accumulating on the types of health workers and the types of contraceptives they can safely deliver. For example, studies from Kenya, Madagascar, Nigeria, and Uganda have documented the feasibility, effectiveness, and acceptability of community-based distribution of injectable contraceptives through non-medically trained workers (Hoke, Brunie, et al., 2012; Hoke, Wheeler, et al., 2012).
Conducting a risk-benefit assessment of research on task shifting and task sharing involves balancing potential risks to research participants against potential benefits that they or society may gain, including knowledge emanating from the research. Early participants, for example, may bear harms, such as those arising from poor contraceptive services, stemming from the limited training of lower cadres of health workers and community-based health workers. Research participants who wish to keep their contraceptive use secret also face risks related to their privacy and confidentiality, particularly in small communities. Research participants should be provided information on the various types of risks during the informed consent process to enable their decision-making about participation. If those risks are outweighed, however, by benefits that will accrue to individuals and underserved communities, such as increased or early access to novel contraceptives, then the proposed research may satisfy the principle of beneficence.
(p. 397) Issues and Consequences
The two examples discussed above—of restrictions on injectable use and task shifting and task sharing—highlight the weighing of risks and benefits and the balancing of public health goals and individual benefits. In both cases, the consequences are borne by health systems (including providers), contraceptive users, and society at large. In the case of DMPA, the extent to which all three stakeholders may bear the impact of reduced access will depend on the extent to which contraceptive users are provided with a choice of alternate methods and are able to make an educated and informed decision that enhances their reproductive health.
Research on task sharing and shifting benefits health systems in two ways—first, through the identification of cost-efficiencies associated with the decreased cost of deploying lower cadres of health workers, and second, by increasing family planning coverage. Higher cadres of family planning providers benefit by reduced pressure to serve large volumes of clients, and lower cadres of workers gain opportunities for training, employment, and social prestige. Overall, contraceptive users benefit from easier and more convenient access to family planning services.
Distributive justice refers to the equitable distribution of benefits and burdens across members of society. There are numerous theories of distributive justice, each of which offers a moral principle to guide decisions about how society ought to distribute goods fairly. One frequently invoked principle requires that societies distribute benefits and burdens in a manner that provides the greatest benefit to the least advantaged groups (Rawls, 1971). In the context of family planning, political and institutional decision-makers who adhere to that principle might conclude, for example, that they have an obligation to ensure that vulnerable groups—as defined by factors such as age, gender, poverty level, and ethnicity—not only benefit from the full range of contraceptive delivery services, but also are protected from burdens associated with overrepresentation in research.
Application in Service Delivery
Historically, contraceptive services targeted women of reproductive age because doing so was viewed as a cost-effective way to achieve a substantial public health impact. That approach, however, led to a dearth of services for significant subpopulations, including men and young people (both girls and boys). Other factors, most notably medical and social norms, have further exacerbated the lack of services for those subpopulations. Once contraceptive services were medicalized for women (e.g., oral contraceptives, IUDs, implants, injectables, and female sterilization), they were provided in settings largely devoted to women’s health. As a consequence, products and services for men—beyond condoms—were largely ignored, even for contraceptive methods that require (p. 398) men’s cooperation in the timing of intercourse and nature of sexual activity. Local norms that suggest unmarried people should not be sexually active, and therefore should not have access to information and services for “family planning,” have similarly led to the exclusion from family planning services of young unmarried people below the age of eighteen. As a matter of social justice, however, men and sexually active youth need contraception and protection from sexually transmitted infection as much as any other sexually active group.
Increasing access to vasectomy and investments in emerging male technologies would allow men to share the responsibility and risks of contraception (health, social, and financial) fairly and in a just manner. This may be easier to achieve before a range of safe and effective male contraceptive products become available with the backup of safe abortion services. Nevertheless, distributive justice requires that underserved groups receive additional protections, particularly when the burden of side effects, costs, and complications currently fall on women. In the current context of private-sector services and a reliance on short-term methods, a case may be made that older women seeking to terminate childbearing are also underserved by the current constellation of services, particularly in resource-poor countries.
Universal health coverage (UHC), policy initiatives such as conditional cash transfers, and provider incentives for performance aim to increase access to underserved groups and bypass barriers such as geography and gender. However, such policies often do not include explicit investments in contraceptive supplies, information, and services that are consistent with the long-term policy goals of helping families at the community level have the children they want, and of slowing unwanted population growth at the country level. The emphasis is on achieving a public health impact by increasing the coverage and quality of basic health care, but individuals or vulnerable groups may still not benefit from contraceptive or other maternal health services as intended if these services are ignored or inadequately covered in the policy’s essential care packages.
New contraceptives are often introduced in urban markets aimed at paying consumers. This is a strategy for ensuring quick and easy returns on investments made by market players. Consequently, less privileged or less wealthy consumers may not have the opportunity to benefit from the new product, even though they may potentially benefit more from it, and may indeed have participated in greater numbers in the clinical trials, thus shouldering many of the early risks. With decreasing engagement of the public sector in family planning service delivery, contraception is viewed as more of a routine commodity in the family budget. At the same time, the extent to which the private sector serves poor and underserved populations is evolving and highly variable by context. Given the flow of benefits both to users and health systems in terms of unwanted pregnancies and births avoided, the state has an obligation to serve those populations with unmet need, so as to facilitate their access to beneficial services and products.
Application in Research
Justice demands that all subpopulations relevant to a research inquiry be represented in the study population. For example, product development and implementation research should ensure that adequate samples of young people are represented in early-phase (p. 399) clinical studies, as well as in planning and piloting interventions designed for testing strategies to scale up services. At the end of the study, justice demands that the public, including the segment represented by research participants, and policymakers have access to the results of the research in a way that might address their interests and facilitate their use of the data. If the results of the research are positive for segments of the participant pool, efforts must be made by duty bearers—that is, public-sector decision-makers in health and finance leadership roles—to utilize the results, as appropriate, in the development and implementation of policies, guidelines, and services. For early research on product development, this may mean making reasonable efforts to support translational research to facilitate the movement of the product along the development pipeline from small phase I proof-of-concept studies to large phase III studies on efficacy, safety, and acceptability.
Issues and Consequences
Paying attention to distributive justice in contraceptive services will lead to greater coverage and cost efficiencies. Individuals will benefit from contraceptive protection when they need it, and states and health systems will benefit by reducing the costs associated with unintended pregnancies and, in turn, poor maternal and child health outcomes. When the local standard of care differs from international research standards on implementation, international consensus suggests that care is ethical if it is based on a valid scientific purpose for using a lesser standard, provides social benefits for the local host community, and shows a favorable risk-benefit ratio for the individual research participants (Wendler, Emmanuel, and Lie, 2004).
Ethical analysis of family planning services and research remains as critical now as it was a half-century ago, when human rights were first recognized by world governments. In part, this is due to the unique role contraception plays in the context of health systems. It is a service for healthy individuals, and, at the same time, it is one of the most cost-effective, “smart investments” for international development (Copenhagen Consensus, 2015). As a result, issues of population growth—and more often, issues of contraceptive access and use—become a locus of conflict between individual decisions on reproduction, the preferences and biases of researchers and health providers, and the objectives of the state to preserve health and simultaneously influence overall population size and social welfare.
Can these apparent tensions be managed in such a way that governments, health systems, societies, and individuals all benefit from investments in family planning services and research? We believe that renewed commitment to the rights of individuals, coupled with efforts to develop approaches to the application and oversight of these principles, hold promise for duty bearers (i.e., policymakers and health providers) and potential beneficiaries alike. While the principles have remained the same (i.e., respect for (p. 400) persons, beneficence, and justice), their applications have become much more diversified, including, for example, the use of social media to recruit research participants and the delivery of contraceptive services in a wide variety of settings (e.g., community health workers, pharmacies, health centers, and even Internet-based distribution of information and supplies). Moreover, new mechanisms are being employed to oversee the provision of consent, the analysis of risks and benefits, and, above all, the accountability of health systems in the distribution of the benefits of contraceptive services and research. Contraception for men, outside of condom use, remains one of the few areas where both research on methods for men and services for men remain marginal to most health system investments.
Persistent issues remain that require continuous reflection on our assumptions and ethical standards. We must be cognizant of the evolving context in which contraceptive services and research take place, as well as the regulatory environments that govern them. Development programs now have a more diverse range of stakeholders beyond government, including the community, private-sector entities, and religious groups. When implementing protections in challenging environments, we must seek the right balance between compliance with prevailing policy practice and adherence to sound ethical principles.
The authors would like to acknowledge the generous support of USAID, NICHD, the Packard Foundation, and the Hewlett Foundation in the development of the ideas and organization of the paper. The opinions expressed in this paper are solely those of the authors and do not necessarily reflect the views of the funding agencies.
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