A unique area for consideration of informed consent is providing care or conducting clinical research in foreign settings or caring for individuals from other countries who have differing viewpoints regarding individual autonomy. For example, if the prevailing standard for decision making by a woman is that her closest male relative makes it for her, how is that standard accommodated within our present autonomy-based system? In international research, these issues presented major concerns when women were assigned to placebo or treatment groups and consent was accepted from male relatives (26). The potential of coercion when no other access to health care is available creates real questions about the validity and freedom of choice for participants in entering clinical research studies in order to access health care in under-resourced areas (27). When caring for patients from certain cultures and foreign countries in daily practice, it is important to recognize that these issues exist in a microcosm. Ensuring that the patient can make the choice herself or freely chooses to have a relative make it for her remains an important element of informed consent.
The principles of beneficence and nonmaleficence are the basis of medical care—the “to do good and no harm” of Hippocrates. These issues can be clouded by other decision makers, consultants, family members, and sometimes financial constraints or conﬂicts of interest. Of all the principles of good medical care, benefit is the one that continually must be reassessed. Simple questions can help clarify choices. What is the medical indication? How does the proposed therapy address this issue? How much will this treatment benefit the patient? How much will it extend the patient’s life? When confronted with multiple medical problems and consultants, physicians should ask how much treatment will be of benefit given all the patient’s problems (e.g., failing kidneys, progressive cardiomyopathy, HIV-positive status, and respiratory failure) rather than considering treatment of one problem without acknowledging that the overall benefit is limited by the presence of all the other problems.
An additional area of balancing beneficence and nonmaleficence is ensuring that the medicine we practice is the safest and highest quality relative to medical evidence. The safety and quality agenda in medicine is growing and necessitates consideration of the role of experience (number of procedures, simulation for ongoing maintenance of skills and development of skills, team training) in ensuring that our patients have access to the highest quality of care. When evidence shows improved outcomes for specific interventions—for example, with timing difference in preoperative antibiotics—health care professionals must participate in and embrace efforts to achieve those metrics on behalf of their patients as part of their fiduciary duty and their obligation to seek the benefit of their patients. Steps specific to this in obstetrics and gynecology are listed by the American College of Obstetricians and Gynecologists as developing the commitment to encourage a culture of patient safety, implementing safe medication practices, reducing the likelihood of surgical errors, improving communication with health care providers and patients, and working with patients to improve safety (28).
The benefit or futility of the treatment, along with quality-of-life considerations, should be evaluated for all aspects of patient care. It is best to weigh all of the relevant issues in a systematic fashion. Some systematic approaches depend on a sequential gathering of all the pertinent information in four domains: medical indications (benefit and harm), patient preferences (autonomy), quality of life, and contextual issues (justice) (19). Other approaches identify decision makers, followed by facts, and then ethical principles. It is important for physicians to select an ethical model of analysis under which to practice so that, when faced with troubling and complex decisions, they have sufficient experience with an ethics-based analytic system to help clarify the issues.