I ETHICAL ISSUES ^10 ^96 ^179 ^352

Medical knowledge and technology offer an increasing array of options for managing reproductive processes. Assisted reproductive technologies, maternal-fetal surgery, and interventions at the end of life raise questions that cannot be addressed by physicians or by the field of medicine alone.

• Clinicians should explicitly understand their own value system and the ways in which personal judgments influence clinical decision­making and the care of patients.

• Clinicians should have general knowledge of the discipline of ethics.

• The process by which clinicians make and implement ethical deci­sions should be systematic, logically consistent, and consistent with accepted frameworks of ethics.

Ethics is the formal study of behavior in which moral obligations are analyzed in terms of recognized methods. After critical reflection, an attempt is made to determine which of a number of commonly held assumptions are justifiable. In applying ethical frameworks to the analysis of human action, the discipline of ethics does not identify any particular moral view as the correct one. It serves instead as a framework for system­atically analyzing different points of view and rationally justifying one course of action over another, based on consideration of recognized prin­ciples and accepted values.

Ethical principles and practices are important in a broad variety of areas in obstetrics and gynecology. They are the foundation of professional behavior (see also the “Human Resources” section earlier in Part 1) and underpin actions taken to protect the interests and autonomy of patients.

A basic understanding of ethical principles and practices will aid in deci­sion making.

Ethical Foundations

Several methods exist for ethical decision making in medicine. In recent decades, medical decision making has been dominated by principle-based ethics; several alternative approaches have been promoted, including virtue-based ethics, the ethic of care, feminist ethics, communitarian ethics, and case-based approaches. Each of these methods has merits and limita­tions. These methods, when put into practice, can promote understanding of common ethical practices regarding informed consent, honesty, and confidentiality.

Principle-Based Ethics

In principle-based ethics, four principles are used to identify, analyze, and address ethical dilemmas. They are 1) respect for autonomy, 2) benefi­cence, 3) nonmaleficence, and 4) justice.

Autonomy (literally, “self-rule”) refers to a person’s freedom to establish personal norms of conduct and to choose a course of action voluntarily based on personal beliefs and values. Respect for a patient’s autonomy acknowledges an individual’s right to hold views, make choices, and take actions based on these beliefs and values. Respect for autonomy is impor­tant, but it cannot be regarded as absolute. At times it may conflict with other principles or values and sometimes must yield to them. A clinician may consider a particular course of treatment to be best for a patient, and respect for autonomy provides a strong moral foundation for informed consent; once a patient has been adequately informed about her medical condition and the available therapies, she freely chooses, based on her values and beliefs, specific treatments or nontreatment.

Beneficence is the obligation to promote the well-being of others. The related principle of nonmaleficence obliges an individual to avoid doing harm. With roots in the Hippocratic tradition, beneficence and nonmalefi­cence also are fundamental to the ethical practice of medicine.

Justice is the principle of rendering what is due to others. Justice has been defined as a complex and important concept that requires medical professionals and policymakers to treat individuals fairly and requires the provision of medical services to individuals to be nondiscriminatory. Some theories of justice determine distribution of benefits and burdens based on criteria such as need, effort, contribution, or merit. Other theories specify that all benefits and burdens be distributed equally (distributive justice). It is important that criteria to be used are determined in advance and selected in a manner consistent with accepted moral rules and principles; criteria also should be relevant to the benefits and burdens being assigned.

Although competing claims for care or services may have appeared equal when resources were ample, scarcity of resources may require clini­cians and policymakers to reevaluate the criteria used for distribution of benefits and burdens. Different criteria must then be chosen as a result of this scarcity, and selection of these criteria is in itself a moral decision.

Virtue-Based Ethics

Virtue-based medical ethics relies on health care providers possessing qualities in character that dispose them to make choices and decisions that achieve the well-being of others. These qualities of character include hon­esty, trustworthiness, prudence, fairness, fortitude, temperance, integrity, self-effacement, empathy, and compassion. Virtues complement rather than replace principles because they are necessary to interpret and apply methods in medical ethics with moral sensitivity and judgment.

Ethic of Care

The ethic of care raises the importance of dimensions of moral experi­ence generally excluded from traditional moral theories and is concerned primarily with obligations that arise from relationships with others rather than the impartiality that traditional ethics demands. The moral founda­tions underlying the ethic of care are not rights and duties, but commit­ment, empathy, compassion, caring, and love. The application of the ethic of care requires attention to context and particularity rather than abstrac­tion. An ethic of care overlaps with a virtue ethic in emphasizing the care­giver’s orientation and qualities.

Feminist Ethics

Feminist ethics compels us to recognize that gender roles and power dif­ferentials between the genders in our culture may distort traditional ethical analyses. Ethical decisions about women’s health care may be biased by attitudes and traditions about gender that are embedded in our culture. Historically, gender-entrenched associations regarding men and women contribute to the tendency in traditional moral theory to view “feminine” perspectives or emotions as irrelevant or distorting. Appropriate emotion and empathy are indispensable to moral reasoning in the ethical conduct of medical care. Feminist ethics challenges gender-based and sex-based pre­suppositions and their consequences, including the relative societal value of men and women.

Communitarian Ethics

Communitarian ethics challenges the primacy often attributed to respect for autonomy in principle-based ethics. It emphasizes shared values, ideals, and goals and suggests that the needs of the larger community may take precedence, in some cases, over the rights and desires of individuals, as in the case of vaccination.

Case-Based Reasoning

Case-based reasoning is ethical decision making based on precedents set in specific cases, analogous to the role of case law in jurisprudence. An accumulated body of influential cases and their interpretation provide moral guidance. Case-based reasoning asserts the priority of practice over theory, rejects the primacy of principles, and recognizes the emergence of principles from a process of generalization from the analysis of cases.

Ethics in Practice

Several ethical norms can be derived from the application of theory to practice. These norms or concepts are important because they influence many of the decisions made in obstetrics and gynecology.

Informed Consent

Informed consent is the process during which a patient makes a voluntary choice regarding a medical intervention after appropriate explanation and disclosure by the clinician of the nature of the intervention and its risks and benefits as well as the risks and benefits of alternatives. The primary purpose of the consent process is the exercise of patient autonomy. Informed consent also has been associated with health care quality and safety. A patient’s right to make her own decisions about medical issues extends to the right of informed refusal—the right to refuse recommended medical treatment. By encouraging ongoing and open communication about relevant information, the health care provider enables the patient to exercise personal choice. This sort of communication is central to the patient-clinician relationship. Specific requirements for informed consent of U.S. research participants have been codified in the Code of Federal Regulations. They are addressed in the “Governance” section earlier in Part 1.

Ethically and legally, adult patients are presumed to be capable of mak­ing health care choices. At times, however, a patient’s capacity to com­prehend and process the medical information presented to her may be in doubt. In such cases, the health care provider, through consultation and further discussion with the patient, should attempt to clarify and improve the patient’s ability to provide consent. The attempt to clarify is based on disclosure of information and the interpretation of its meaning. The adequacy of the information disclosed has been judged by various criteria, which may include the following:

• The common practice of the profession

• The reasonable needs and expectations of the ordinary individual who might be making a particular decision

• The unique needs of the individual patient faced with a given choice

If a patient is unable to provide consent, a substitute decision maker should be sought. A surrogate decision maker should be identified to pro­vide a “substituted judgment” (a decision based on what the patient would want, assuming some knowledge of what the patient’s wishes and values would be). If the patient has previously executed an advance directive, that document should guide the selection of a surrogate decision maker, the specific decisions made by the surrogate, or both depending on the nature of the advance directive. If a patient who lacks decision-making capacity has not designated a surrogate, state law may dictate the order in which relatives should be asked to serve in this role. In rare occasions, a court will determine the decision maker.

If a patient does not have decision-making capacity, the appropriate decision-maker to provide authorization for health care should be deter­mined before the initiation of an examination or procedure. In doing so, it is important to ascertain whether the patient is capable of understanding findings and recommendations or whether this information needs to be transmitted to an identified guardian or caregiver. This process should not preclude including the patient in counseling and determining the degree to which she may participate in decisions.

It is important to emphasize that informed consent is a process. In some minds, it has become synonymous with the informed consent forms used to document that the informed consent process has taken place. Documenting the informed consent process, of course, is important from a medical-legal perspective, but completion of a written document is never a substitute for the communication needed to have an informed and vol­untary consent.

For certain types of medical procedures, such as hysterectomy and steril­ization, additional elements that affect informed consent bear mentioning. The clinician should be familiar with any federal and state laws and regu­lations that may constrain sterilization (even as a result of hysterectomy), such as limitations on the patient’s age and requirements for the consent process. For example, when a sterilization procedure will be covered under Medicare, Medicaid, or other U.S. Public Health Service programs, 30 days must elapse after the consent form has been signed before the procedure can be performed (except in emergencies). Additionally, the patient must be 21 years of age or older and mentally competent, and she may not be institutionalized.

Women may be vulnerable to various forms of coercion in their medical decision making. Laws, regulations, and reimbursement restrictions con­cerning sterilization have been created to protect vulnerable individuals, including those with mental disabilities and other specific populations, from abuse. However, regulations intended to protect vulnerable indi­viduals may in some cases serve as barriers to care. Women should not be denied access to care they choose to have (eg, a sterilization procedure) simply because they also may be members of vulnerable populations or have common characteristics with such populations. Clinicians caring for patients who request or require procedures that result in sterilization may find themselves in a dilemma when legal and reimbursement restrictions interfere with a patient’s choice of treatment. Rigid timing and age require­ments can restrict access to good health care and result in unnecessary risk. Clinicians are encouraged to seek legal or ethical consultation whenever necessary in their efforts to provide care that is most appropriate to indi­vidual situations.

Acknowledgment of the importance of respect for patient autonomy and increased patient access to information has prompted some patients to request surgery or other interventions that their physicians may view as not in the patients’ best interests. An example may be requests for prophylactic oophorectomy by women at low risk to reduce their risk of ovarian can­cer. When patients request surgical interventions that are not traditionally recommended, physicians should make sure that their counseling about specific risks and benefits is based on current evidence. Determining an appropriate course of treatment for individual patients who request such a surgical intervention requires particularly careful communication. The goal should be to reach a decision in partnership between the patient and physician. Depending on the context, agreeing to a request for a surgical option that is not traditionally recommended can be ethical. Decisions should be based on strong support for patients’ informed preferences and values; be understood in the context of an interpretive conversation; and be consistent with considerations of safety, cost-effectiveness, and attention to effects on the health care system of expanded choice. After the physician has provided information and careful counseling, the patient and physi­cian often will reach a mutually acceptable decision. If the patient and physician cannot reach an agreement, then referral or second opinion may be appropriate.

Conscientious Objection

There are limits to which appeals to conscience may justifiably guide deci­sion making. Professional ethics requires that health care be delivered in a way that is respectful of patient autonomy, timely and effective, evidence based, and nondiscriminatory. When, as a matter of conscience, physicians plan to deviate from standard practices, including abortion, sterilization, and provision of contraceptives, they must provide potential patients with accurate and prior notice of their personal moral commitments and should not use this opportunity to argue or advocate their positions. When con­scientious refusals conflict with moral obligations that are central to the ethical practice of medicine, ethical care requires either that the physician provide care despite reservations or that there be resources or a referral system in place to allow the patient to gain access to care in the presence of conscientious refusal.

Providing complete and scientifically accurate information about options for reproductive health is fundamental to respect for patient autonomy. Those who choose the profession of medicine are obligated to act in good faith to protect patients’ health, particularly to the extent that a patient’s health interests may conflict with a physician’s personal beliefs or self-interests. In the case of interventions performed during pregnancy, the physician should respect the woman’s autonomous decisions on the very rare occasions when the interest of the fetus and woman diverge. Pregnancy does not obviate or limit the requirement to obtain informed consent.

In resource-poor areas, access to safe and legal reproductive services should be maintained. A health care provider with moral or religious objections should either practice in proximity to individuals who do not share his or her views or ensure that referral processes are in place so that patients have access to the service that the physician does not wish to provide. Rights to withdraw from caring for an individual should not be a pretext for interfering with patients’ rights to health care services.

Honesty

The principle of respect for autonomy requires that a patient be given complete and truthful information about her medical condition and about any proposed treatment. Only with such information is she able to exercise her right to make choices about health care. If complete infor­mation is not available, existing uncertainty should be shared with the patient. The perception that a health care provider has concealed the truth or has engaged in deception will weaken patient trust and undermine the patient-clinician relationship. This statement is true regardless of the intent of the clinician; for example, improper diagnostic coding to allow insurance coverage of a service the clinician judges to be medically indi­cated is nonetheless deceptive and fraudulent.

Confidentiality

A patient’s right to make decisions about health care includes a right to decide how and to whom personal medical information will be commu­nicated. The principle of respect for autonomy underlies a health care pro­vider’s duty to respect patient confidentiality. As is the case with dishonesty, breaches of confidentiality threaten the patient’s trust and may destroy the patient-clinician relationship. Ethically, breaches of confidentiality may be justified in rare cases to protect others from serious harm. Physicians must weigh a patient’s claims of confidentiality against risks to others. How the health care provider’s responsibility to respect confidentiality plays out in daily practice, including in the care of minors, is addressed in the “Human Resources” section earlier in Part 1 and the “Adolescents” section in Part 3. Guidance on setting up systems to maintain confidentiality is detailed in the “Information Management” section in Part 2.

Patient Protection

A variety of mechanisms have been put in place to help ensure that patients’ rights are respected and that patients are protected from harm. A patient’s bill of rights outlines the rights and, sometimes, responsibilities of a patient who receives care at a health care facility. All patients who receive care, including those who participate in research studies and receive experi­mental interventions, should receive the same protection. In fact, there are usually special policies that provide protection for research participants, which are overseen by the institutional review board.

Patients can exercise their autonomy by making an advance directive. This may be an instructional directive (“living will”) or the identification of a surrogate with power of attorney. Physician orders for life-sustaining treatment (POLST; also known as medical orders for life-sustaining treat­ment) are available once a patient develops serious, progressive, chronic illnesses that may require standing medical orders. (For more information on advance directives and end-of-life decision making, see the “End-of-Life Considerations” section in Part 3.)

The intent of a patient’s bill of rights is to outline the rights and respon­sibilities of a patient within the health care system. Several organizations (the American Hospital Association, the American Medical Association, and The Joint Commission) have developed various versions. The contents usually include the following rights for patients:

• The right to adequate health care

• The right to considerate and respectful care

• The right to relevant, current, and understandable information con­cerning their condition

• The right to be involved in all aspects of their care

• The right to provide informed consent

• The right to refuse care

• The right to know the identity of their caregivers

• The right to be informed of institutional policies, including those that could affect patient choice

• The right to all appropriate treatments or procedures

• The right to make an advance directive and have it respected (see also the “End-of-Life Considerations” section in Part 3)

• The right to privacy and confidentiality except when otherwise man­dated by law

• The right to review their own medical records

• The right to know about the institution’s charges and payment methods

• The right to know about potential conflicts of interest, including business relationships among institutions and health care providers that may affect patient care

• The right to consent to or decline participation in research studies

• The right to a full explanation of potential risks and benefits of research studies, procedures to be followed, and alternative services available

• The right to the most effective care the institution can provide if par­ticipation in a research protocol is refused

• The right to reasonable continuity of care, when appropriate

• The right to know about resources available for resolving conflicts and grievances

• The right to quality and safe care in a health care system designed to minimize medical errors

The idea that all people have a right to some level of health care has developed since the end of World War II. The United Nations and the World Health Organization support this right. The issue of access to care has engendered much discussion in recent years. The President’s Advisory Commission on Consumer Protection and Quality in the Health Care Industry echoed this call in its patients’ bill of rights (see Resources). The 2010 Patient Protection and Affordable Care Act provides a number of health care benefits, including providing many preventive services with no co-payments or cost-sharing, allowing parents to cover on their health plans their children who are younger than 26 years, providing new cover­age options for those with preexisting conditions, and increasing funding for community health centers. As of 2014, most individuals who can afford it will be required to obtain basic health insurance coverage or pay a fee to help offset the costs of caring for uninsured Americans. If affordable coverage is not available to an individual, he or she will be eligible for an exemption.

A just health care system provides universal coverage in the form of affordable and effective health care for all residents of the United States regardless of citizenship or employment status. The American College of Obstetricians and Gynecologists (the College) calls for quality health care appropriate to every woman’s needs throughout her life and for ensuring that a full array of clinical services are available to women without costly delays or the imposition of geographic, financial, attitudinal, or legal barriers. When health care institutions have policies that limit patients’ reproductive options, including contraception, sterilization, or infertility services, patients should be advised of those policies openly and as early as possible.

The College and its membership represent expert voices in the social process of health care reform and creating and sustaining a just health care system, and they have a wide range of opportunities to advocate for and advance the goal of just health care. Fellows of the College should exercise their responsibility to improve the health status of women. They can do so in traditional patient-physician relationships and by working within their community and at the state and national levels to ensure access to high- quality programs that meet the health needs of all women. Involvement in the community may extend to nonmedical areas, such as building safe housing or donating food or clothing, that directly or indirectly improve women’s health.

Patients rightfully share responsibility for their care. Thus, patients should be encouraged to do the following:

• Ask questions about medical treatments they do not understand in order to make informed choices about their care.

• Follow through with collaboratively developed care decisions.

• Keep scheduled physician’s appointments, including follow-up appointments, and notify the office in a timely manner if they need to reschedule.

• Provide insurance information for reimbursement, and pay for ser­vices themselves if not covered by insurance.

• Provide accurate information necessary for appropriate diagnosis and treatment planning (including lifestyle factors, sexual practices, and religious or cultural beliefs).

• Maintain a complete list of medications, including herbal supple­ments and nonprescription medications, and provide this informa­tion to health care personnel.

Ethical Decision Making and Institutional Ethics Committees

In most cases, there is minimal conflict among the patient, family, health care provider, and health care facility in selecting the most appropriate health care option even though more than one course of action may be morally and ethically justifiable. Sometimes parties may disagree about the most appropriate choice. If the risk-benefit relationship is not optimal, no course of action will seem acceptable.

Although the key to ethical decision making is the patient-clinician relationship, the involvement of individuals with a variety of backgrounds and perspectives can be useful, especially if an impasse has been reached. Through establishment of institutional review boards and use of institu­tional ethics committees, ethics consultants, or ethics consultation services, health care facilities can support the protection of patient rights and assist in ethical decision making in difficult situations (see also the “Governance” section earlier in Part 1).

Changes in medical technology and social structure have moved the site of much medical decision making from the home to health care facilities. Decisions once made privately and confidentially now are more openly discussed, with wide social, economic, and ethical consequences. Moreover, nonmedical decision making (eg, third-party payer contracts, institutional purchasing, and cancellation of services that were not fiscally sound) is having a greater influence on patient care. Accordingly, patients, practitioners, and health care administrative personnel need a forum for discussion and education. The Joint Commission requires all U.S. hospitals to have a process that allows staff, patients, and families to address ethical issues or issues prone to conflict. An institutional ethics committee can provide such a forum, or hospitals may seek support in addressing ethical issues from an ethics consultant or an ethics consultation service. Whatever the process, it needs to be readily accessible to patients and their surrogate decision makers as well as staff, physicians and other licensed independent practitioners, and managers.

Ethics committees typically have the following functions:

• To foster awareness of ethical issues and create an environment of sensitivity

• To establish educational programs regarding ethical principles, bio­medical ethics literature, and relevant legal decisions

• To act as an expert informational resource concerning clinical ethics in the institutional setting

• To offer counsel on ethics for individual cases and organizational issues

• To help create, promote, and audit a code of ethical behavior for the entire institution

• To develop organizational policies that support ethical principles

Most committees serve in advisory, rather than decision-making, capaci­ties. In general, the committee may aid the patient, health care provider, and institution by serving as a resource for education, conflict resolution, support, and institutional quality improvement. The committee also can serve as a forum for the discussion of unresolved biomedical issues, such as the application of new reproductive technologies. Mechanisms other than institutional ethics committees exist within health care institutions to enforce institution policies and standards and to assume appropriate legal responsibility for practices within the institution (see also the “Human Resources” section earlier in Part 1).

Institutional ethics committees and bioethics consultants also can assist in ensuring that the processes of informed consent and decision making are followed with patients or their proxies. Consent for acceptance or refusal of treatment should be based on accurate and current medical information that presents all reasonable options. The committee should establish pro­grams to promote this goal. The committee also should determine that the institution has systems to ensure that the patient has the capacity to choose and that appropriate decision makers are identified when the patient does not have this capacity.

The use of institutional ethics committees is an evolving technique for helping with difficult decisions. Continuing appraisal of the form and function of these committees is important. They are not meant to supplant other good techniques that have been found effective in the institution.

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