Committee Opinion Header
Number 466, September 2010
(Reaffirmed 2013)


Committee on Ethics and Committee on Global Women's Health
This Committee Opinion was developed by the Committee on Ethics of the American College of Obstetricians and Gynecologists as a service to its members and other practicing clinicians. While this document reflects the current viewpoint of the College, it is not intended to dictate an exclusive course of action in all cases. This Committee Opinion was approved by the Committee on Ethics and the Executive Board of the American College of Obstetricians and Gynecologists.
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Ethical Considerations for Performing Gynecologic Surgery in Low-Resource Settings Abroad

ABSTRACT: International humanitarian medical efforts provide essential services to patients who would not otherwise have access to specific health care services. The Committees on Ethics and Global Women's Health of the American College of Obstetricians and Gynecologists encourage College Fellows and other health care professionals to participate in international humanitarian medical efforts for this reason. However, such programs present Fellows with a unique set of practical and ethical challenges. It is important for health care providers to consider these challenges before participating in international surgical efforts in these settings. Health care professionals should ensure that they have the necessary surgical competence and training, including sufficient mentorship, prior to functioning as the primary surgeon abroad. Before they perform surgery, health care professionals should ensure that patients have access to adequate medical resources and preoperative and postoperative care. They should be willing and prepared to postpone or cancel surgery when the standards of ethical medical care cannot be met and the members of the surgical team believe that the best interest of the patient cannot be achieved with the current available resources. Health care professionals' efforts should contribute to the long-term well-being of the patients and the communities being served through the ethical practice of medicine, responsible conduct of research, and investment in the sustainability of services. The care of the patient should be the highest priority for those participating in these medical programs.


International humanitarian medical efforts provide essential services to patients who would not otherwise have access to specific health care services. The Committees on Ethics and Global Women's Health of the American College of Obstetricians and Gynecologists encourage College Fellows and other health care professionals to participate in international humanitarian medical efforts for this reason. International medical programs may be affiliated with a variety of academic, private, and religious institutions and organizations. Regardless of the origin of the program, these efforts present health care professionals with a very different clinical environment than what they may be accustomed to in the United States. Unique ethical challenges arise in conjunction with the provision of medical and surgical services for patients in low-resource communities abroad. It is important for health care providers to consider these challenges before participating in international surgical efforts in these settings.

International medical efforts present the opportunity to benefit patients through the provision of medical and surgical services that are not adequately available. At the same time, some of these activities have the potential to inadvertently exacerbate the situation of patients, despite the best intentions to facilitate access to quality health care. Patients in these situations are exceptionally vulnerable because of limited resources in their communities. Many clinicians in the United States are unfamiliar with the type and degree of vulnerability found in these areas of the world. Thus, when performing gynecologic surgery internationally in such settings, it is important for health care providers to be aware of the important ethical considerations that arise as a result of this vulnerability.

Health care professionals should take the necessary steps to ensure that patients receiving services benefit from and are not harmed by medical humanitarian efforts. In the discussion that follows, the Committees on Ethics and Global Women's Health present commonly encountered ethical issues that arise in resource-limited regions of the world with the intention of helping health care professionals provide the best care possible to patients within these uniquely challenging clinical settings. The Committees make the following recommendations:

  • Health care professionals are encouraged to participate in international humanitarian efforts to provide essential services to patients who would not otherwise have access to specific health care services.
  • The care of the patient should be the highest priority for those participating in these medical programs. When caring for patients in low-resource settings in other countries, health care professionals should strive to uphold fundamental standards of ethical practice afforded to patients in industrialized nations. As a guideline, health care professionals should keep the best interests of the patient as a central tenet to determine what services should and should not be provided in the local context.
  • Before traveling abroad to provide care, health care professionals should become familiar with the challenges that arise when caring for patients in the community and country they will visit and make every effort to ensure that these challenges will not interfere with the responsible and ethical care of patients.
  • Health care professionals should ensure that they have the necessary surgical competence and training, including sufficient mentorship, prior to functioning as the primary surgeon abroad. In-country health care professionals and leaders within the local community may be an excellent resource for this type of mentorship and training.
  • Before they perform surgery, health care professionals should ensure that patients have access to adequate medical resources and preoperative and postoperative care.
  • Health care professionals should be willing and prepared to postpone or cancel surgery when the standards of ethical medical care cannot be met and the members of the surgical team believe that the best interest of the patient cannot be achieved with the current available resources.
  • Health care professionals' efforts should contribute to the long-term well-being of the patients and the communities being served through the ethical practice of medicine, responsible conduct of research, and investment in the sustainability of services.

Background

There is growing recognition of global disparities in the health of women. These disparities increasingly attract the attention of gynecologists who are motivated to use their skills to address deficiencies in international women's health care, often in socioeconomically disadvantaged areas outside of the United States. These humanitarian efforts have the capacity to provide specific surgical expertise to women who could not receive care otherwise. The experiences of clinicians who embark on these efforts have brought to light some of the ethical challenges arising from the provision of health care in low-resource settings and to the patients who live under conditions that make them exceptionally vulnerable. It is important for gynecologists considering participating in international medical programs to be aware of the unique vulnerability of these patients and how these conditions generate ethical questions and challenges. With the growth of international medical programs, it has become evident that, even with the best intentions and humanitarian goals, some efforts can create ethical challenges for patients and health care providers of a kind that are not encountered in industrialized nations (1). It is important for Fellows to consider these challenges prior to engaging in medical care in low-resource settings to ensure that patients are not inadvertently harmed while receiving much-needed services.

In this document, the Committees on Ethics and Global Women's Health highlight some of the particular ethical issues College Fellows and other health care professionals should consider when providing medical and surgical care in low-resource settings. Women in these countries deserve high-quality medical care that can prevent illness and restore health, but the constraints of low-resource settings and the extreme vulnerability of patients that often exist in such settings can make this goal difficult to obtain. The case of obstetric fistula that follows serves as a model condition, exemplifying the central challenges to providing care in low-resource settings, regardless of the actual condition that is being prevented or treated.

Health care providers must give careful consideration to the goal of maintaining the highest standards of care possible within the limitations of the environment and the context of the local culture. Strategies to accomplish this goal may be organized differently and may involve the use of technologies other than those Fellows use in their day-to-day practices. The effort to reduce the global burden of cervical cancer stands out as an example of how the provision of health care in international settings can take place in a way that is consistent with this goal (2).

Although this document focuses on obstetric fistulas, the issues raised have implications for other women's health issues, such as those related to maternity care, family planning, and human immunodeficiency virus (HIV) and other sexually transmitted infections. For this reason, there is broad relevance in addressing the issues health care professionals should consider before embarking on international health care projects, particularly those in low-resource settings.

Case Study: Addressing Obstetric Fistula

Worldwide, there are an estimated 130,000 new cases of fistulas identified each year and approximately 3.5 million women have fistulas. These numbers may be an underestimate of the global impact of this condition because existing data are inadequate. Many cases occur in women in Sub-Saharan Africa, where a constellation of issues contribute to fistula formation. Obstetric fistula results from a complex social and cultural dynamic that is intertwined with local cultural beliefs, poverty, lack of education, malnutrition, and limited access to antepartum and postpartum care (3). Specific factors also include the tradition of childhood marriage, which leads to childbearing at an age before maturation of the female pelvis; inadequate nutrition; and lack of access to adequate and timely health care (4–6).

Most obstetric fistulas are preventable with attention to the progress of labor and the provision of emergency obstetric care. However, many women in resource-poor settings do not have access to such services for a variety of reasons, including lack of trained medical personnel, insufficient financial resources, absence of transportation to medical facilities, or lack of recognition of the need for skilled care during labor. Often, women will labor for many days without delivery. Prolonged pressure from an obstructed fetal head causes tissue necrosis that can lead to extensive vesicovaginal and rectovaginal fistulas and fetal death (4). Large fistulas also may occur as a result of sexual trauma such as rape, an injury known as traumatic gynecologic fistula (7). Gynecologic fistulas present similar technical issues as obstetric fistulas. But as survivors of violent sexual assault, women with traumatic gynecologic fistulas may have sustained additional physical and psychologic injuries that need to be addressed. They are also at risk for unwanted pregnancy and sexually transmitted infections, including HIV.

Once a fistula is formed, women lose control of bladder or bowel function or both and constantly leak urine and feces. The presence of the fistula leads to a series of health problems, involving the skin, urologic tract, gastrointestinal tract, and the joints (eg, contractures) (8). Because of the lack of local resources to repair fistulas, a woman's subsequent medical condition worsens over time. In addition, women affected with fistulas are often isolated from their community. The isolation may be volitional because of embarrassment from associated odor and secretions. Social ostracism also may occur from families and communities (9). Without community and family support systems, women with fistulas suffer from worsening poverty, health, and social isolation (3, 10).

The problem of obstetric fistula recently has received considerable attention from the media and health organizations. International efforts have continued to increase the organization and mobilization of medical equipment and personnel to low-resource regions of the world where fistula is prevalent. Gynecologic surgeons and other health care professionals staff these international medical programs by traveling abroad for a limited time (ranging from weeks to months) to perform fistula repair.

Caring for Vulnerable Women in International Settings

Health care professionals who participate in international medical programs likely will encounter patients living with a degree of vulnerability beyond that seen in highly industrialized settings. This exceptional vulnerability is due to factors such as malnutrition, poor health, poverty, and social injustice, which may occur alone or in combination. The lack of local medical resources compounds the effect of these inequities on the health and well-being of the local community. Disparities of this sort are not unique to international settings and are present even here in the United States. However, the extreme conditions found in low-resource regions of the world amplify the effects of chronic illness and injury to an extent to which most health care professionals are unaccustomed.

Women with obstetric fistulas represent such a vulnerable population. Many women who develop fistulas have been unable to exercise basic human and reproductive rights (3). Within societies in which fistula is endemic, personal decisions about sexuality and childbearing are customarily made for women by their families and communities through the practice of childhood marriage (11). Girls and women who develop fistulas become marginalized from their families and communities, resulting in additional discrimination, poverty, illness, and isolation. The unparalleled medical and social needs of women with fistulas require a unique type of health care.

In the provision of ethically appropriate care in resource-poor settings, professionals will encounter a breadth of unique and challenging ethical considerations. Some of the most commonly encountered issues pertain to informed consent in the international context, quantity and quality of medical resources, level of surgical competence and training required for these efforts, assurance of adequate preoperative and postoperative care, protection of human participants in clinical and social research, and sustainability. Health care providers in the international arena should strive to adhere to the highest standards of clinical practice possible while recognizing, in light of the local resources, this may not be feasible in all cases.

Informed Consent

Just as in the United States, informed consent should precede any medical and surgical interventions. The ethical principles of autonomy and respect for persons govern this practice (12). Informed consent is achieved through a discussion between a health care professional and patient in which relevant information about the indication, risks, benefits, and alternatives of proposed therapy is presented and discussed. This conversation will help a patient to make an informed and voluntary decision about accepting or declining therapy in a manner that reflects her values.

There has been some debate about the merits of informed consent when medicine is practiced in international contexts: ethical principles valued in one society may be understood very differently in another (13–15). Some cultures place a higher value on the role of the family or community in medical decision making than on individual autonomy. Despite such cultural differences in the weight accorded ethical principles, international health organizations agree that respect for persons is a universal principle applicable to the global population (16–18). Thus, despite its challenges, the process of informed consent is a vital component of the practice of ethical health care across countries and cultures.

Practitioners should be prepared for challenges that may arise in seeking consent in low-resource areas, including limited literacy and language differences. The informed consent conversation should take place in the native language of the patient. Ideally, this conversation would involve a consent process with a medical professional fluent in the language of the local community, but quality consent also can be obtained with a qualified on-site medical interpreter. The interpreter should be sufficiently skilled to provide an accurate and culturally sensitive translation of medical information. The content of information must be tailored to the education of the patient. Ineffective communication can have a negative impact on the quality of health care provided to the patient (19–21). Leaders of international health teams should work with local community members to establish a decision-making process that promotes informed and voluntary choice.

Medical Resources

Health care professionals should be aware of the potential limits of the local medical resources before traveling abroad to perform surgery. Well in advance of embarking, leadership of the health care team should make provisions to bring supplemental equipment or supplies to perform the planned surgery and necessary postoperative care as follows:

  • Surgical equipment: Surgeons should have access to necessary equipment in good working condition. Although the use of the most up-to-date technology might be ideal, surgeons should be prepared to use older but adequate models. Surgeons should anticipate a lack of imaging and automated instruments that may be readily available at their home institutions. Additionally, surgeons should prepare themselves to use instruments with a different design and nomenclature from those to which they are accustomed. Flexibility and the ability to adapt to foreign instrument sets or techniques are extremely important. It is also necessary to have an effective method of cleaning and sterile processing. Health care professionals' choices about if or how to use these local medical and surgical resources should always be guided by their obligation to patient safety and outcomes.
  • Pharmaceutical agents: Surgical management of patients will require adequate medications. At minimum, appropriate anesthetics, antibiotics, and pain medications should be available.
  • Basic supplies: Patients should have access to clean, potable water; food to provide adequate nutritional support for wound healing; and medical supplies necessary for wound care.
  • Personnel: Sufficient trained personnel should staff surgical centers to care for patients at all stages of treatment. This includes individuals trained to provide nursing care and adequate translation of medical information. If trained surgical assistants are unavailable in the local community, the surgeon should ensure that they are part of the traveling team.

Despite the best preparatory efforts, the circumstances of some health care settings abroad may not be evident until the international medical program is under way. When the standards of medical care cannot be met and the members of the surgical team believe that the best interest of the patient cannot be achieved with the current available resources, the health care professional should be prepared to postpone or cancel surgery.

Surgical Competence and Training

Most health care professionals practicing in the industrialized world do not have experience with the specific type or severity of medical or surgical conditions present in low-resource settings. For this reason, additional education and training is often needed for participants before engaging in international medical programs. Health care professionals must candidly and carefully consider their surgical competence and training for the specific gynecologic condition before traveling abroad. With this in mind, they must be prepared to provide care at a level at which they are qualified and opt out of procedures in which they do not have adequate experience. Just as with all procedures, practitioners should not undertake complex surgery without adequate mentorship, training, and experience. The risks of doing so include injury, worsened disability, or death to the patient and loss of trust of the health care system.

If surgeons do not have the adequate training and experience needed for the type of services that must be provided, then an experienced mentor should take on the role of primary surgeon. In-country expertise may exist and can provide an excellent resource for this kind of mentorship and training. In this situation, the traveling professional should undergo a period of on-site training as an assistant before taking on primary surgeon responsibilities. It is the ethical duty of the traveling physician to ensure that an experienced surgical practitioner will be available when needed.

Even in the context of adequate training and surgical skills, there may be some patients who would not benefit from surgery given the medical condition or local resources for postoperative care. Health care providers also must be prepared to recognize the situation in which a patient may have injuries that are too extensive to be corrected with the resources within the community and be ready and able to formulate alternative management approaches.

In preparation for medical programs focusing on women with fistulas, health care professionals should be prepared to meet the specific needs of these patients through the appropriate cultural, medical, and surgical training and experience. Obstetric fistulas are rare in industrialized nations because of the medical and surgical resources available to manage labor and delivery. When fistula is encountered in industrialized nations, it is often of a very different nature than that observed in low-resource settings and, thus, surgical experience for the correction of these types of defects does not necessarily provide sufficient skills for the management of more complicated obstetric fistulas. Compared with postsurgical fistulas, obstetric fistulas are commonly much larger and require more complex surgery to achieve continence of urine and feces. In some cases, surgical repair of the fistula entails sequential pelvic reconstruction, requiring more than one surgical procedure to restore anatomy and function. Furthermore, tissues surrounding the obstetric fistula are often compromised, resulting in additional challenges of tissue reapproximation and wound healing.

Preoperative and Postoperative Care

Preoperative and postoperative care are essential parts of responsible surgical management. Lack of adequate perioperative management places patients at increased risk for injury and complications such as wound dehiscence, infection, and death. The complexity of some surgical procedures, such as those for fistula repair, demands that patients receive postoperative care by trained caregivers to optimize the chances of restoration of bladder or bowel function.

Health care professionals most often participate in short-term international medical programs, because they can take only a limited number of weeks from their own practice to perform surgery abroad. However, they must ensure that their surgical patients will have continuity of care during the postoperative period. Just as they do when practicing in their home country, practitioners have an ethical obligation not to abandon their patients.

When a surgeon will no longer be able to provide care, he or she should facilitate the transfer of care to another qualified health care professional. This could require arranging for an equally proficient medical practitioner to arrive onsite and accept the transfer of care before the physician's departure. Another possibility is transferring care to a local health care professional who has been specifically trained to care for these postoperative patients.

Adequate postoperative care for patients also should incorporate health care issues not directly related to the surgical repair. Fistula illustrates both the complexity and the importance of adequate short- and long-term postoperative management. Family planning is especially important for those women who have experienced gynecologic morbidity secondary to pregnancy or lack of adequate antepartum and postpartum care. Furthermore, these patients also should have access to family planning, including contraceptive management, fertility preservation, and management of future pregnancies. Another important postoperative consideration is the reentry of patients with extensive gynecologic injury, such as fistula, back into the local community. For many women, this includes addressing the social marginalization experienced before undergoing surgical reconstruction that separates them from their families and networks within their communities. The care of patients with fistula illustrates how postoperative care extends beyond medical and surgical issues in the immediate postoperative period. As a result, health care professionals participating in international medical programs must be prepared to support such services.

Clinical and Social Research

Clinical research has an important role in the care of patients in international settings. Research extrapolated from other populations provides imperfect guidance because the incidence and exacerbation of disease found in resource-limited areas are often a function of local culture, environment, and resources. Without population-specific data, patients will be subject to therapies or procedures that either are not evidence based or may not be relevant to their population. For example, there is a need for well-designed research to establish optimal treatment guidelines for complex obstetric fistula in international settings. Much of what is known about the care of obstetric fistula has been acquired from informal studies, case reports, and on-the-ground experience, rather than from well-designed clinical studies. Important clinical questions remain, such as the optimal timing of fistula repair, the best technique to correct large and complex defects, the usefulness of urinary diversion, and the duration of postoperative catheterization. Social research questions to be investigated include appropriate strategies to help patients reintegrate into their communities after an attempt at fistula repair. This information is necessary to provide continuous quality improvement with the goal of optimizing the care delivered to these patients (22, 23).

Health care professionals may not have the primary intention of performing research while participating in an international medical program. However, they may find that their sponsoring organization conducts clincal research in conjunction with clinical services. They should be aware that they may be directly or indirectly contributing to clinical research (eg, collecting data about new techniques, devices, or therapeutics) when providing health care abroad.

Research standards should not change from country to country, although the application of such standards generates controversy. Given the unique vulnerabilities of many populations, international standards for protection of human research participants should exist to prevent harm to research participants (24). Although a complete discussion of the conduct of ethical research in international settings is beyond the scope of this document, listed as follows are guidelines for ethical and responsible conduct of research:

  • All studies should be well designed and reflect research integrity. Informal trials and other investigations that do not meet the standards of scientific rigor should not be conducted.
  • The institutional review board at the researcher's home institution should approve a research protocol before it is conducted. In addition, mechanisms should exist for review and oversight by the local community or institution.
  • Informed consent for clinical research should be obtained in a separate manner from informed consent for clinical care. Researchers must inform patients that they are participating in research and explain the differences between clinical care and clinical research before their participation is secured.

Limitations presented by a perceived lack of resources among the local community do not preclude following these standards for the ethical conduct of research. Health care professionals who feel that the sponsoring organization is not meeting these standards of research should not participate in any research component while practicing abroad and are encouraged to discuss their concerns with the appropriate review board. Exclusion from research participation may not necessarily preclude health care providers from providing medical and surgical care apart from research efforts.

Sustainability

Sustainability is an essential component of all efforts to deliver medical care to individuals in resource-limited areas. This entails an investment of education, medical supplies, and personnel to the resource-limited country so that local community members can take an active role in maintaining and improving the health of the population and in preventing disease.

Practitioners who perform surgery abroad should contribute to the sustainability of their efforts. Although the temporary nature of overseas efforts means that many practitioners cannot personally participate in continued efforts to provide care, there are several opportunities to contribute to the goal of sustainability.

Health care professionals should collaborate with organizations demonstrating a long-term interest in the health of the local community, particularly when those organizations have a continuing community presence after the surgical teams leave. Education is one of the most effective opportunities to advance sustainability. Efforts to educate members of the community and health care professionals are a vital part of instituting enduring sustainability after the departure of the traveling health care team. Before departure, traveling health care professionals should assist the community in the identification and utilization of resources from within the local environment for the management of gynecologic patients. Community leaders serving as advocates for women's health and locally available medical and surgical equipment are examples of the resources available at a local level that can be mobilized for sustainability. Issues such as the primary prevention of fistula, management of fistula both before and after repair, and rehabilitation are the key components to combating the condition of fistula.

Conclusion

International surgical programs present Fellows with a unique set of practical and ethical challenges. This document has highlighted some of the leading issues that health care professionals should consider before participating in these endeavors. Because this document cannot address all issues that may arise, the surgeon should always keep the interests of the patient as a central tenet to guide adaptations of medical care to the local context.

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ISSN 1074-861X

Ethical considerations for performing gynecologic surgery in low-resource settings abroad. Committee Opinion No. 466. American College of Obstetricians and Gynecologists. Obstet Gynecol 2010;116:793–9.