Informed Consent

September 14, 2011

Informed consent is the central ethical and legal practice standard in clinical care and human research. Informed consent, in its ideal form, should be viewed by clinicians, researchers, patients and their families as an opportunity to engage in a substantive, sustained dialogue that not only provides information but also helps all involved to clarify questions, preferences, and values, and gives rise to authentic decision-making. This process is an expression of the ethical principles of respect for persons, autonomy, justice, and truth-telling. Informed consent is sometimes signified in formal documents (e.g., “consent forms” for vaccinations, diagnostic tests, voluntary participation in research projects, or the release of health information), but is much more important and is not reducible to this bare exchange of paper and ink. It is for these reasons that informed consent serves as the practice that embodies the ideals of the profession of medicine and as a formal safeguard for individual rights in both clinical and research contexts.

Informed consent takes place in numerous contexts—professional relationships and personal situations with certain goals. For example, in preventive health contexts, an informed patient is most able to make the important choices that will optimize her wellbeing. This could mean choosing whether to have screening tests or making certain lifestyle decisions. In persons who become ill, the process of informed consent serves beneficent aims, with the goal of helping patients address their illness, obtain a diagnosis, and make informed and reasoned choices about treatment. For individuals who are considering participating in research studies, informed consent is at the heart of the relationship between the investigator and prospective volunteer; informed consent is vital not because it protects the investigator or institution in case something goes wrong (a popular misconception), but rather because it helps to clarify the balance between the scientific goals of the study (e.g., randomization and double-blind procedures) with respectful, beneficent, and just regard for the individual. In all of these contexts, as screening techniques, diagnostic tests and procedures, and treatment options become more varied—and often, highly technical and sophisticated— informed consent can be an intensely interactive, most human of enterprises. This view is becoming more widespread as empirical studies of informed consent highlight its importance and potential.

Informed consent is composed of three key components. The first, information sharing, requires that the patient or prospective volunteer be fully informed about the proposed test, treatment, procedure, or protocol. Full information includes the purpose of the treatment or study, the procedures involved, and the foreseeable risks and potential benefits. Careful exploration of information regarding all standard alternatives is essential in this process. For example, when considering whether to enter into a randomized clinical trial for cancer treatment, it is important to know what the usual standard of care consists of, how the patient can obtain access to standard treatment, and whether every arm of the trial is generally comparable to the usual standard of care. These specific pieces of information almost always involve probabilities and inherent uncertainty. Thus, patients and families must be encouraged to ask questions, and the process should be viewed as an iterative interchange, rather than a didactic session. In this regard, methods of sharing information are evolving, from the traditional paper-based consent form to interactive question-and-answer sessions, to augmentation with videotapes, multimedia, or web-based decision aids. At this time, research into the most productive methods for information sharing is progressing in treatment and research-related contexts, promising novel strategies and a bright future for this fundamental aspect of the informed consent process.

Decisional capacity, the second key element of informed consent, implies that the person making the decision possesses adequate decision-making capacity (the clinical term encompassing the legal concept of “competency”). Decision-making capacity itself, as defined by experts and legal authorities, consists of four related abilities: (a) communicating a stable preference regarding the decision; (b) understanding the information relevant to the decision; (c) reasoning rationally with the shared information; and (d) appreciating the significance of the choice and its consequences for one’s own situation.

The third component of informed consent is the capacity for voluntarism. Decisions about clinical care or research participation must be free from coercion, and authentic, representing the wishes of the individual. One conceptual model of voluntarism proposes four domains of possible influence on an individual’s ability to give consent voluntarily to treatment or research. First, developmental factors may make certain groups and individuals more or less vulnerable to coercion or to more subtle influences that decrease voluntarism. For example, some adolescents may be swayed by peer pressure while still forming their own set of values and preferences. A second domain of influence on voluntarism concerns illness-related factors. A person with a brain tumor, metabolic disturbances, or adverse reactions to medications (e.g., steroids) may experience distortions in their thinking, for instance, that cause them to feel hopeless and powerless. Yet another area of influence on the capacity for voluntarism is the broad category of psychological, cultural, and religious factors. For example, individuals who are not of the dominant culture may perceive causes of symptoms quite differently from more “mainstream” physicians. This disparity may affect the informed consent process and voluntarism in ways that we have yet to understand. Similarly, receiving a diagnosis of breast cancer may be such a traumatic event, for instance, that an individual may, even temporarily, be less able to assert herself in asking questions, gathering information, and considering all of her treatment options. Finally, external features and pressures (e.g., very rushed consent processes in an emergency situation or being institutionalized or physically or emotionally dependent) may result in subtle, or not-so-subtle, influences on voluntarism.

Numerous special considerations related to informed consent pertain to women’s roles as patients or research participants. In this vein, it is important to note the history of exploitative practices involving women as patients and research subjects; these instances frequently involved, at least in part, the lack of informed consent. Enslaved African American women in our country were experimented on by surgeons during the 1800s; more recently, however, a research project in which Hispanic women seeking birth control medications were, without their knowledge, randomized into a trial where some women received placebo and pregnancy rates were tracked. With heightened attention to these cases, new restrictions on study enrollment, ostensibly designed to protect women, excluded categories of women (e.g., pregnant women and women of childbearing potential) from important clinical research. This in turn impeded the acquisition of new knowledge on which clinicians and patients could base their decisionmaking. On a positive note, this situation has been recognized and is being rectified; crucial work is now proceeding in many areas of women’s health.

At present, women are participating in unprecedented numbers in clinical research and are increasingly proactive as patients and health care consumers, accessing as never before the wealth of information and opinions available online, in the media, and from family, friends, and health care professionals. With the innovations in experimental treatments for HIV, cancer, and mental illness, there is a growing sense of research participation as an opportunity and access to research as a societal right. As women gain stronger voices in clinical and research settings, it is important to keep in mind the role of psychological and cultural factors, as well as societal attitudes toward women. For many women, there exist potential barriers to informed consent, including socioeconomic or ethnic minority status, illiteracy, trauma, and illness itself. Many women face combinations of these factors.

Additionally, women generally speaking tend to emphasize relationship-related factors in their decisionmaking; this most likely applies as well to decisions about their own health care or research participation. Cultural factors can amplify this tendency, as interrelatedness and interdependence of one’s family and cultural group are more highly valued in many ethnic groups. Another consideration is the possibility that some women may be more likely to view the physician or researcher as an authority figure—and therefore hesitate to ask questions or otherwise “question authority.” An awareness of these subtle influences on the informed consent process can go a long way in making the process one that is meaningful and consonant with the individual’s authentic wishes.

In clinical care and research settings, informed consent should be viewed as an essential part of any treatment or research-related decision, rather than merely as a legal requirement. Informed consent serves as a tool to maximize autonomous decision-making of every woman contemplating her own care or participation in a study. To this end, a number of positive and proactive approaches to the informed consent process are available. Physicians, investigators, and patients alike need more information about why informed consent is important (a number of tutorials regarding informed consent are available online and on videotape). In addition, informed consent needs to be conceptualized as an ongoing, iterative process, rather than a discrete occurrence. Several sessions can be scheduled to discuss a decision; this also serves to decrease any perceived pressure on the individual to reach a decision (in nonurgent situations) prematurely. Finally, informed consent is a process that is best conceptualized as a conversation, discussion, or exchange.

Enhanced consent procedures (including multimedia presentation tools and computer-based decision aids) are available as well as in development. A key point, however, is that these kinds of tools are meant to augment rather than replace the fundamentally human interaction that informed consent embodies. Even writing a simplified or more structured consent form can benefit patients. Overviews of studies and take-home information sheets are very useful, and some groups provide videotapes summarizing important aspects. Patients and research participants should be encouraged to ask questions during the informed consent process, be made aware of resources for learning more about informed consent or the particular treatment or protocol, and be supported and respected in their decision-making. Thus, some women may require more time, information, or explanation than others; these needs should be met nonjudgmentally. Sensitivity to the cultural needs, as well as educational or linguistic challenges, facing many women is also vital.

In summary, this brief overview points out the progress that medical ethics has made in recognizing the importance of informed consent. Thus, the emergence of informed consent as a cornerstone of medical ethics has been a major advance for women’s rights and human rights in general. As medicine and biomedical research advance rapidly, the future is bright for women’s participation in this progress; informed consent remains the fundamental scaffolding for their crucial participation.

SEE ALSO: Capacity, Clinical trials, Conservatorship, Discrimination, Durable power of attorney for health care, Patients’ rights

Suggested Reading

  • Faden, R. R., Beauchamp, T. L., & King, N. M. P. (1986). A history and theory of informed consent. New York: Oxford University Press.
  • Gilligan, C. (1993). Concepts of self and morality: In a different voice. Cambridge, MA: Harvard University Press.
  • Grisso, T., & Appelbaum, P. S. (1998). Assessing competence to consent to treatment: A guide for physicians and other health professionals. New York: Oxford University Press.
  • Roberts, L. W. (2002). Informed consent and the capacity for voluntarism. American Journal of Psychiatry, 159, 705—712.
  • Stevens, P. E., & Pletsch, P. K. (2002). Informed consent and the history of inclusion of women in clinical research. Health Care for Women International, 23, 809—819.

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