INFORMED CONSENT

Informed consent is an individual's voluntary agreement, based on adequate understanding of relevant facts, to permit some type of intervention by a second party. This term is most commonly used in medical contexts to refer to individuals' agreements to undergo medical treatment or to participate in research. In most cases, informed consent is required both ethically and legally prior to the commencement of treatment or enrollment in research.

Recent History

The ethical and legal mandate for informed consent as understood in the early twenty-first century was not established until the latter half of the twentieth century. Before that time, a paternalistic paradigm governed the relationship between patient and health care provider. However, driven by landmark cases, revelations of abuse, and a changing professional ethic, there has been a shift toward patient autonomy and away from physician paternalism. The establishment of a requirement for informed consent occurred independently but concurrently in the two contexts of medical treatment and research with human subjects.

MEDICAL TREATMENT. U.S. courts first recognized the need for patients to give consent for medical treatment in Schloendorff v. Society of New York Hospital in 1914. It was not until Salgo v. Leland Stanford, Jr. University Board of Trustees in 1957, however, that the additional provision requiring physicians to give patients information relevant to their treatment decisions was established. This requirement for physician disclosure was expanded, developed, and solidified by Natanson v. Kline (1960), Mitchell v. Robinson (1960) and Canterbury v. Spence (1972). These precedents were then incorporated into statements by the Judicial Council of the American Medical Association (AMA) in 1981 and the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research in 1982. The need to obtain patients' informed consent has since been incorporated into the medical practice guidelines of numerous national and international organizations of medical professionals.

RESEARCH SUBJECTS. The evolution of informed consent in research with human subjects was spurred not by legal decisions but by public and professional reaction to several cases in which people were used as research subjects without their knowledge or permission. The Nuremberg Code of 1947 established general guidelines for human subjects research in response to the revelation of the Nazi medical experiments, stating that the informed and voluntary consent of subjects was "absolutely essential." In an effort to create more specific ethical guidelines for research, the World Medical Association (WMA) adopted the first version of the Declaration of Helsinki in 1964, which also held the subjects' informed consent to be a necessary element of ethical research.

In 1966, Henry K. Beecher published an article in the New England Journal of Medicine identifying twenty-two ethically problematic studies involving human subjects, including studies at the Jewish Chronic Disease Hospital and Willowbrook State Hospital. Beecher concluded that patients must give informed and voluntary consent before participating in research. The uncovering of the Tuskegee syphilis study that took place between 1932 and 1972 brought widespread attention to violations of the rights of human subjects. In the Tuskegee case, poor and uneducated African American men were enrolled in a study of the progression of untreated syphilis without their knowledge or consent. At least partially in response to these abuses, The Belmont Report, published in 1978, and finally the federal Common Rule (45 CFR 46) in 1991 incorporated the requirement for informed consent into United States regulation.

PHILOSOPHICAL FOUNDATIONS. The moral requirement for informed consent can be grounded in both deontological and consequentialist ethical theory. Immanuel Kant (1724–1804) held that moral worth is based upon the ability to reason and that the ability to reason must be respected by others. Rational choices are expressions of the ability to reason and so have intrinsic value. As a result, people have obligations to make rational choices and others are obligated to respect those choices. Giving (or refusing to give) informed consent is a form of rational choice and so therefore has intrinsic value within a Kantian deontological framework.

The value of informed consent can also be derived from consequentialist ethical theory. Consequentialists hold that something is good if it produces good outcomes. In most cases, people know their own goals and values better than anyone else, and therefore are in the best position to decide how to promote their own good. Even though people may, on occasion, be mistaken about what is good for them, they benefit overall from exercising self-determination. As a result, the best outcomes are brought about when people make decisions for themselves. The requirement for informed consent is one way to protect and encourage self-determination and therefore to bring about good consequences.

Five Elements of Informed Consent

There are at least five necessary elements of informed consent: disclosure, understanding, capacity or competency, voluntariness, and assent. These elements can take different forms in research and treatment contexts and can entail various ethical and legal standards.

DISCLOSURE. Informed consent can only be given if the person consenting is adequately informed. The first part of this process involves the disclosure of information. The physician, researcher, or in some cases another individual, must make available to the patient or potential subject sufficient information to make a decision about treatment or participation in research.

What constitutes sufficient disclosure is ambiguous, but there are three plausible ways this can be interpreted. The professional practice standard of disclosure requires physicians to give patients as much information as is generally disclosed by other medical professionals about a particular procedure or research protocol. The reasonable person standard sets the disclosure requirement at whatever a reasonable person would want to know in a given situation. A final disclosure standard is the subjective standard, which states that a physician should tell a patient whatever that subject would want to know. Each of these views on disclosure has advantages and disadvantages.

There is no consensus on which standard best describes the ethical obligation of disclosure. Generally, however, disclosure must include at least a description of the treatment or procedure, the material risks and benefits, and the available alternatives. In research contexts, additional information must be provided to the individual considering participation. Examples of such additional information include: a statement about the experimental nature of the procedures, information about confidentiality of the subject's records, information about what to do in case of injury from the study, and a statement that participation in the research is voluntary.

Legally, state jurisdictions are approximately evenly split between using the professional practice standard and the reasonable person standard in treatment contexts. Only a few jurisdictions hold physicians to the subjective disclosure standard. The U.S. Common Rule provides an itemized list of the information that must be conveyed to potential subjects within research contexts.

UNDERSTANDING. In order for an individual to be informed in the ethically relevant sense, that individual must respond to the disclosure in an appropriate way. That is, the individual must internalize the information that has been made available though the disclosure process. If a patient or potential subject is unable to understand the provided information, informed consent is not possible. It is the responsibility of a physician or researcher to make an effort to maximize the understanding of the patient or potential subject. For example, a researcher should convey the relevant information in language that the potential subject can comprehend and should answer clearly any questions that the subject asks about the protocol. In practice, formal assessment of an individual's level of understanding is rare. Instead, patients or potential subjects may simply be asked if they understand the information they have been given or if they have any questions.

CAPACITY AND COMPETENCY. Capacity refers to an individual's ability to appropriately manipulate the information that has been understood. There are a number of different ways that decision-making capacity could be defined and by which the presence or absence of capacity could be assessed. The ability to appreciate the consequences of one's life options, to weigh the various considerations and come to a decision, to reason logically about one's situation, and to evaluate the situation in light of one's own values could all be used as indicators of capacity. There is no ethical or legal consensus on which of these definitions should be used.

Capacity is a task-specific concept, meaning that the level of decision-making capacity needed to make a given decision varies depending on the nature of the decision itself. As a result, at any given time one may have the capacity to make some decisions but not others. Generally, the higher the risk posed by a procedure, the more capacity one must have to make a decision to undergo that procedure. For example, a patient may have capacity to consent to having an IV inserted but not to having invasive surgery.

Individuals without the capacity to make a given decision about treatment or research cannot give informed consent to undergo that treatment or research. When a person lacks decision-making capacity, informed consent is solicited from a surrogate decision maker, that is, a family member or other individual appointed to made decisions on behalf of that person.

Competency is the legal analogue to capacity. Adults are presumed to have competency unless it has been demonstrated to a court that they are unable to make autonomous decisions, in which case the court declares the adult to be incompetent. At that time, a legally authorized representative is appointed for that individual. In contrast, children and adolescents under the age of eighteen do not have competency to make their own decisions unless a court decides otherwise.

VOLUNTARINESS. An individual's decision to undergo treatment or to participate in research must be voluntary. That is, the individual must not be coerced or unduly influenced by either external or internal factors. Threats of unwanted consequences such as physical harm or withdrawal of medical care are obvious examples of coercion. More subtle challenges to voluntariness include the provision of substantial incentives and the manipulation of an individual's decision-making process through the biased presentation of information. Because of the importance of voluntariness, informed consent is often denominated "free and informed consent" or just "free informed consent."

A physician or researcher may not coerce or unduly influence a patient or potential subject to make a desired decision. The conditions under which and the manner in which the physician or researcher solicits consent should be designed to minimize the possibility that voluntariness will be compromised.

ASSENT. The final element of informed consent is the decision made about undergoing treatment or participating in research. Inherent in the idea of informed consent is a positive decision—one gives informed consent to undergo a particular treatment or procedure. A negative decision—that is, a decision not to undergo the treatment or procedure—constitutes an informed refusal.

Generally, verbal agreement is sufficient for low-risk treatment decisions. When treatment methods involve higher levels of risk, however, the patient may be required to sign a consent form. The form summarizes the relevant information and states that the individual is voluntarily agreeing to the treatment or procedure. In research contexts, an individual's consent to participate in the research protocol must almost always be documented by the individual's signature on a consent form.

Exceptions to Informed Consent

There are a few exceptions to the requirement for informed consent for medical treatment. In emergency situations, treatment can be administered without the patient's consent because it is presumed the patient would consent if given the opportunity. Other exceptions include cases in which an individual poses a threat to public health. In such cases, treatment may be forced on that individual without consent. For example, a person with tuberculosis may be compelled to undergo treatment. Individuals may also waive their right to informed consent, stating that they do not wish to be informed of a diagnosis or to make decisions about their own treatment. Finally, children and incompetent adults do not give informed consent for treatment, although consent must be obtained from parents or guardians.

Informed consent is almost always required prior to enrollment in research. However, federal regulation allows individuals to be enrolled without their consent in research protocols in some emergency situations if obtaining consent would be impossible. It further allows emergent use of an investigational drug or procedure on a case-by-case basis if it is believed that doing so will have therapeutic value for the patient. A second exception to the requirement for informed consent in research contexts enables parents or guardians to give consent for the participation of children and incompetent adults. It has, however, been recommended that physicians and researchers seek the assent of these individuals when possible.

Informed Consent and Science and Technology

Although the concept of informed consent is most thoroughly developed within the contexts of medical treatment and biomedical research, it has ethical implications for the development and use of the products of science and technology more broadly defined. Research into and implementation of innovations in fields such as civil engineering, nuclear energy, genetic engineering, and nanotechnology have inherent risks. In many cases, the members of the community in which these innovations are being developed and put into use are exposed to these risks. The ethical requirement for informed consent, however, suggests that these individuals should not have to bear this burden without their knowledge and voluntary consent.

In most cases, the process of obtaining consent for medical treatment or for enrollment in biomedical research is dyadic, consisting of a dialogue between a physician or investigator and a subject. In non-medical contexts, however, this model of obtaining consent is often not feasible. Practically, it would be impossible to obtain individual consent from each member of the community that could be exposed to risk. Further, many of those who may be affected by these innovations could not even theoretically be asked for consent, such as members of future generations.

Despite these difficulties, the requirement for informed consent generates ethical obligations for those who develop and implement the products of science and technology. These obligations may be discharged through various community consent mechanisms, such as allowing public participation in the creation of policies that govern innovations, consultation with community leaders, and assessment of public opinion. The use of these and other community consent methods may help to ensure that science and technology move forward in an ethically appropriate way, and therefore that the goods that they produce are not achieved at too great a cost.

JANET MALEK

SEE ALSO Bioethics;Human Subjects Research;Medical Ethics;Sociological Ethics.

BIBLIOGRAPHY

Beauchamp, Tom L., and Ruth R. Faden. (2004). "Informed Consent: Meaning and Elements." In Encyclopedia of Bioethics, 3rd edition, ed. Stephen G. Post. New York: Macmillan. A concise and updated review of the elements of informed consent.

Beecher, Henry K. (1966). "Ethics and Clinical Research." The New England Journal of Medicine 274(24): 1354–1360. A landmark article identifying numerous ethically problematic research protocols.

Berg, Jessica W., et al. (2001). Informed Consent: Legal Theory and Clinical Practice, 2nd edition. Oxford, UK: Oxford University Press. Comprehensive review of the legal history and current practical applications of informed consent.

Committee on Bioethics, American Academy of Pediatrics. (1995). "Informed Consent, Parental Permission, and Assent in Pediatric Practice." Pediatrics 95(2): 314–317. Statement establishing the ethical requirement for children's assent for participation in research.

Faden, Ruth R.; Tom L. Beauchamp; and Nancy P. King. (1986). A History and Theory of Informed Consent. New York: Oxford University Press. Reviews the development of informed consent and provides a detailed analysis of its elements.

Grisso, Thomas, and Paul S. Appelbaum. (1995). "Comparison of Standards for Assessing Patients' Capacities to Make Treatment Decisions." American Journal of Psychiatry 152(7): 1033–1037. Discusses the possible standards and their implications for evaluating capacity.

Jones, James H. (1981). Bad Blood: The Tuskegee Syphilis Experiment. New York: Free Press. A historical report and analysis of the Tuskegee syphilis experiment.

Levine, Robert J. (1986). Ethics and Regulation of Clinical Research, 2nd edition. Baltimore, MD: Urban and Schwartenberg. Detailed review of the ethical requirements for clinical research.

Levine, Robert J. (2004). "Informed Consent: Consent Issues in Human Research." In Encyclopedia of Bioethics, 3rd edition, ed. Stephen G. Post. New York: Macmillan. Concise review of the concept of informed consent as it applies to research with human subjects.

Shrader-Frechette, Kristin. (1991). Risk and Rationality. Berkeley: University of California Press. Exploration of the conditions under which risks may be imposed on societies.

Shrader-Frechette, Kristin. (1994). Ethics of Scientific Research. Lanham, MD: Rowman & Littlefield. Discussion of scientific research emphasizing the importance of public welfare and public decision making.

United States Department of Health and Human Services. (1991). "Protection of Human Subjects." Code of Federal Regulations, Title 45, Part 46. United States federal regulation governing research involving human subjects; also known as the "common rule."