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."

Informed Consent

Sections within this essay:

Background

The doctrine of "informed consent" within the context of physician-patient relationships goes far back into English common law. As early as 1767, doctors were charged with the tort of "battery" (i.e., an unauthorized physical contact with a patient) if they had not gained the consent of their patients prior to performing a surgery or procedure (e.g., Slater v. Baker and Stapleton).

Within the United States, the seminal case is generally accepted to be that of Schloendorff v. Society of New York Hospital, 211 NY 125 (1914). In that case, involving allegations of unauthorized surgery during an exploratory examination, Justice Cardozo's oft-quoted opinion was that "Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent commits an assault, for which he is liable in damages." The court further described the offense as a "trespass" (upon the patient's body and self).

However, requiring that the patient first consented was only half the task. The other half involved the patient's receipt of sufficient information upon which to make a sound decision. Thus, the concept of "informed consent" was developed on the premise of two distinct components: a person's inherent right to determine what happens to his or her body and a doctor's inherent duty to provide a person with enough information so as to ensure that the patient's ultimate decision is based on an appreciable knowledge of his/her condition, the available options for treatment, known risks, prognoses, etc. Importantly, this means that the patient does not have a duty to inquire about risks or options; the duty rests with the treating doctor.

From Common Law to Statute

Virtually all states recognize, either by express statute or common law, the right to receive information about one's medical condition, the treatment choices, risks associated with the treatments, possible outcomes, and prognoses. Generally, the law requires that medical information be in plain language terms that can readily be understood and in sufficient amounts such that a patient is able to make an "informed" decision about his or her health care. If the patient has received this information (and is otherwise competent to receive the information), any consent to treatment that is given will be presumed to be an "informed consent." A doctor who fails to obtain informed consent for non-emergency treatment may be charged with a civil and/or criminal offense. In 1972, the American Medical Association (AMA) incorporated the concept of informed consent in its Patient's Bill of Rights movement, and almost all state versions of patient rights include provisions related to informed consent.

Application of the Doctrine

Typically, an "informed consent" issue arises when a patient suffers an injurious or harmful outcome from a treatment, surgery, or procedure. The harmful or injurious outcome does not appear to be the result of any negligence. The patient alleges that he or she was never informed of the possibility of occurrence of the resulting injury or harm.

From that point, the causative factor of the harm or injury must be analyzed. If the negative result (injury or harm) was a foreseeable complication or foreseeable risk, but the possibility of its occurrence had not been communicated to the patient in advance, there may be an actionable case of "lack of informed consent."

In order to prevail on a charge that a doctor performed a treatment or procedure without "informed consent," the patient must usually show that, had the patient known of the particular risk, outcome, or alternative treatment allegedly not disclosed, the patient would not have opted for the chosen treatment or procedure and thus, would have avoided the risk. In other words, the patient must show a harmful consequence to the alleged failure to disclose.

There are unique applications of the doctrine of informed consent, such as in cases involving medical subjects for research, patients of minority age, mentally incompetent patients, etc. The basic premises still apply, however, either directly or indirectly through a surrogate decision maker.

Defenses

Certain injuries or harms may occur inevitably, and even be foreseeable, despite the best of care and the presentation of comprehensive information to the patient regarding options, risks, foreseeable outcomes, and prognoses. In fact, one of the most viable defense to a charge of "lack of informed consent" is that the resulting harm or injury was a "known risk" and that the patient assumed the risk of its occurrence when the patient consented to the surgery, treatment, or procedure. (This would be true if the patient had been warned of the potential occurrence of the specific harm or injury and chose the surgery, treatment, or procedure anyway.)

Other viable defenses include the unforeseeability of the harm or injury or that its occurrence was so remote that the doctor had no duty to otherwise advise the patient of the possibility of that particular harm or injury. There is no duty to obtain consent in an emergency where attempts to obtain consent would delay vital emergency treatment. Additionally, doctors may withhold information from a patient if, in the doctor's professional judgment, disclosure would be upsetting to the patient or would substantially interfere with effective treatment. This is referred to as "therapeutic privilege."

Finally, a physician may defend that the patient chose not to hear all the information. Some patients do not wish to participate in medical decision-making and simply defer to the physician's best judgment. Under such circumstances, doctors generally have patients sign waivers giving up their rights to full disclosures. If the patient had prior knowledge of the risks (having undergone the surgery or procedure previously), or if the risks are common knowledge (such as pain following suturing a wound), there is generally no duty to repeat or expressly inform of these risks.

Measuring the Duty to Inform

States are divided in their approach as to how much information a doctor must disclose to a patient in order to facilitate an "informed consent" to the proposed surgery, treatment, or procedure.

Professional Standard

The professional standard (for judging the scope of a doctor's duty to disclose) is alternately referred to as the "community standard," the "professional community standard," or the "reasonable physician standard." It generally asks: what would a reasonably prudent physician with the same background, training, experience, and practicing in the same community, have disclosed to a patient in the same or similar situation? This standard is the same as that applied to other forms of alleged medical malpractice.

Materiality and Subjective Patient Standards

A significant number of states have employed the use of a standard commonly referred to as the materiality standard. It is alternately referred to as the "reasonable patient standard," or the "prudent patient standard." It purports to ask: what would a reasonable patient in the same or similar situation need to know in order to make an appropriate decision regarding a proposed surgery, treatment, or procedure? In other words, what information would be "material" to the patient's decision?

Still other jurisdictions have developed a "subjective patient" standard which asks what that particular patient, in his or her own unique set of circumstances and conditions, would need to know, but this has proven to be a hard standard to establish.

Select State Law Provisions Regarding Disclosure Requirements

ALASKA: Alaska has adopted a reasonable patient (materiality) standard (Alaska Stat. Ann. 09.55.556(a) but articulates four specific defenses that may be raised on the part of the physician.

ARKANSAS: Arkansas Stat. Ann. 16-114-206(b) provides that "the plaintiff shall have the burden of proving … that the medical care provider did not supply that type of information regarding the treatment, procedure, or surgery as would customarily have been given to a patient … by other medical care providers with similar training and experience."

CALIFORNIA: California generally applies the professional community standard, as developed by case law. Cobbs v. Grant, 8 Cal 3d 229 (1972).

DELAWARE: Delaware applies the professional community standard. Del. Code Ann. Title 18-6852.

FLORIDA: Florida Statute Section 766.103 expressly adopts the professional community standard, providing that actions are barred if "the action of the [physician] in obtaining the consent of the patient … was in accordance with an accepted standard of medical practice among members of the medical profession with similar training and experience in the same or similar medical community."

GEORGIA: Georgia Code Ann. 31-9-6.1 follows a professional community standard but requires that the harm caused from the alleged failures to disclose be associated with "the material risks generally recognized and accepted by the reasonably prudent physician."

HAWAII: Hawaii Rev. Stat. 671-3(a) establishes a board of medical examiners to develop standards ensuring that a "patient's consent to treatment is an informed consent." It further provides that the standards may be admissible in court as evidence of the standard of care required of health care providers.

IDAHO: Idaho Code Section 39-4301 et seq., specifically 39-4304, expressly adopts the objective professional community standard.

ILLINOIS: The state of Illinois has adopted the objective professional community standard (Ill. Ann. Stat. Ch. 110, 2-622) and requires that the alleged breach of duty be reviewed and substantiated by a physician reviewing the case (medical expert) prior to filing a complaint.

INDIANA: Indiana Code Ann. 16-9.5.1 adopts a reasonably prudent patient or "materiality" standard, requiring a disclosure of "material risks."

IOWA: Iowa Code Ann. 147.137 follows an objective professional community standard and further requires that the information disclosed include a detailed list of potential outcomes.

KENTUCKY: Kentucky Revised Statutes (KRS) 304.40-320 adopts the objective professional community standard.

LOUISIANA: Louisiana Rev. Stat. Title 40, Section 1299.40, and 1299.50 (Louisiana Medical Consent Law) raise a presumption of informed consent if information is provided in writing and sets forth certain factors (consistent with general requirements of informed consent).

MAINE: Maine Rev. Stats. Ann., Title 24-2905 adopts the professional community standard.

MASSACHUSETTS: Massachusetts recognizes implied consent as developed by case law. It generally follows the "materiality" standard, i.e., a doctor must disclose that information which the doctor should reasonably recognize as material to the patient's decision. Halley v. Birbiglia, 458 N.E.2d 710 (1983).

MICHIGAN: Michigan recognizes implied consent as developed by case law. It generally applies the professional standard. Michigan also treats, as an assault and battery, any physical contact with a patient that exceeds the scope of the granted consent. Patient consent may be expressed or implied. Werth v. Taylor, 190 Mich App 141 (1991).

MISSOURI: Missouri recognizes implied consent as developed by case law. It generally follows the professional standard, i.e., that of a reasonably prudent provider (of medical care or treatment) in the medical community.Baltzell v. VanBuskirk, 752 S.W.2d 902 (Mo. App. 1988).

NEBRASKA: Nebraska Revised Statutes, Section 44-2816 adopts the objective professional community standard.

NEW HAMPSHIRE: N.H. Rev. Stat. Ann. 507-C:2 adopts the objective professional community standard.

NEW YORK: NY Public Health Laws, Section 2805-d, applies the professional community standard and specifically provides that "[l]ack of informed consent means the failure … to disclose to the patient such alternatives … and the reasonably foreseeable risks and benefits involved as a reasonable medical … practitioner under similar circumstances."

NORTH CAROLINA: North Carolina General Statute 90-21.13(a)(3) applies an objective professional community standard to a physician's duty to inform.

OHIO: The Ohio Revised Code, Section 2317.54 adopts a reasonably prudent patient or materiality standard, expressly requiring the disclosure of "reasonably known risks."

OREGON: Oregon Rev. Stat. 677.097 adopts the reasonably prudent patient or materiality standard and requires a disclosure "in substantial detail."

PENNSYLVANIA: Pa. Stat. Ann. Title 40-1301.103 adopts the "materiality" standard.

TENNESSEE: Tennessee has adopted an objective professional community standard. Tenn. Code. Ann. 29-26-118.

TEXAS: Texas Code Ann. Article 4590i-6.02 adopts the "materiality" standard. Texas law has created the Texas Medical Disclosure Panel, comprised of three attorneys and six physicians, to establish "the degree of disclosure required and the form in which the disclosure will be made."

UTAH: Utah Code Ann. 78-14-5(f) follows an objective reasonably prudent patient standard, i.e., "reasonably prudent person in the patient's position."

VERMONT: Vermont Stat. Ann. Title 12-1909 adopts the objective professional community standard, requiring that the information disclosed be provided in a manner that allows a reasonably prudent patient to "make a knowledgeable evaluation."

WASHINGTON: Washington has adopted the reasonably prudent patient or "materiality" standard under Wash Rev. Code Ann. 7.70.050.

WEST VIRGINIA: West Virginia has abrogated the professional community standard and adopted a materiality standard. W. Va. Stat 55-7B-3

Additional Resources

"Exploring the Gray Areas of Informed Consent" Dunn, Debra, 1999. Available at http://www.findarticles.com.

"Informed Consent" Cutter, Mary Ann G. University of Colorado Dept. of Philosophy. Available at http://www.du.edu/-craschke/consent.html.

"Informed Consent." Ethics in Medicine. University of Washington School of Medicine. Available at http://eduserv.hscer.washington.edu/bioethics/topics/consent.html.

"Informed Consent." Available at http://www.channel1.com/users/medlaw/prm/informed.html.

"Informed Consent Does Not Mean Rational Consent." Journal of Legal Medicine. Jon F. Merz and Baruch Fischoff. Hemisphere Publishing Corporation: 1990.

Informed Consent

Twenty-five hundred years of Western medicine, starting with Hippocrates, have been built on the preferred conception that physicians should protect their patients from information about their diseases or treatment options. The oath that has been repeated by physicians for thousands of years articulates clearly that the physician knows what is best for his or her patients. For over two millennia, the culture has put the physician in an almost Godlike position in terms of his or her wisdom to practice in the patient's best interest. However, since the mid-twentieth century there has been a trend toward patients rights, that has included the right to know what the physician intends to do and why. This is the essence of informed consent.

The Emergence of Informed Consent

In one form or another, the question of who gets to decide beats at the heart of the most difficult medical situations. Will it be the physician, the patient, or the family members? Whose values will ultimately be respected? What should a patient be told regarding the range of complicated life and death decisions commonplace in today's medical arena?

The definition of informed consent is equally complicated. An informed consent is an autonomous authorization by an individual regarding a medical intervention or involvement in biomedical research. An individual must do more than express agreement or comply with a proposal for this to be considered informed consent. Informed consent is a process between physician and patient that must contain an information component and a consent component. The information component refers to the disclosure of information and comprehension of what is disclosed. The consent component refers to a voluntary decision and agreement to undergo a recommended procedure. Legal, regulatory, philosophical, medical, and psychological literature tend to favor the following elements as the necessary components of informed consent: (1) competence; (2) disclosure; (3) understanding; (4) voluntariness; and (5) consent.

If one is competent to act, receives thorough disclosure, has an understanding, and is voluntary in his or her consent, then informed consent is viable. For informed consent to be legally recognized in medical practice, the following steps need to be clearly articulated:

1. Preconditions: Includes competence (to understand and decide) and voluntariness (in deciding).
2. Information elements: Includes disclosure (of risks/benefits); recommendation (plan); and understanding (of information and plan).
3. Consent elements: Includes authorization (based on patient autonomy).

Physicians are obligated to disclose a core set of information including: (1) those facts or descriptions that patients usually consider material in deciding whether to refuse or consent to the proposed intervention; (2) information that the physician thinks is critical; (3) the professionals' recommendation; (4) the purpose of seeking consent; and (5) the nature and limits of consent as an act of authorization.

History of Informed Consent within Medical Practice

Civil litigation emerged over informed consent to include injury to one's person or property that is intentionally or negligently inflicted by a physician's failure to disclose the injury, measured in terms of monetary damages. With the medical advances that emerged in the beginning of the twentieth century, such as improved anesthesia and surgical interventions, physicians began to disclose basic information without necessarily outlining all potential risks.

The first important introduction of the notion of informed consent is in the classic case of Mohr v. Williams (1905). In this case, a physician obtained Anna Mohr's consent to an operation on her right ear. While operating, the surgeon determined that the left ear needed surgery instead, and proceeded to operate on it. A court found that the physician should have obtained the patient's consent to the surgery on the left ear. The judge decided that a physician needs to advise a patient of all the information related to a particular procedure and must review all the risks and benefits. Only after this exchange does the patient enter into a contract, a contract that authorizes the physician to operate only to the extent of the consent given.

In the late 1950s a series of legal cases in California and the District of Columbia forever changed society's vision of the doctor-patient relationship. In California, radiation therapy went awry for a young woman, leaving her in much worse condition than prior to the treatment. After the therapy she was acutely fatigued and suffering from radiation burns. These side effects far exceeded the side effects described by the physician. She sued the physician, saying he never adequately explained the risks of her radiation procedure. The court found that unless such consent was based on full information, and that the patient fully understood all of the risks of the procedure, the doctor was not protected for liability. In several jurisdictions, beginning in 1972 in the District of Columbia, Canterbury v. Spence, informed consent emerged as a legal right with full legal redress equivalent to battery if informed consent was not provided.

With the mid-1970s came the introduction and growing utilization of extraordinary life-sustaining treatments such as dialysis, respirators, cardiac resuscitation, and a wide array of organ transplantation. To protect oneself from the automatic use of such heroic measures, patients and their family members experienced an urgent need to be fully informed of risks and benefits and to have the authority to protect their wishes. Legal methods, including advance directives, living wills, and health care proxies, came to the fore of patient's rights as mechanisms to articulate and protect the patient's wishes over the imperative central tenet to medicine: If it can be done, it should be done.

Advance directives. The Patient Self-Determination Act (PSDA) was passed in 1990 and went into effect in December 1991. The essence of this legislation is to empower the public with the right to be fully informed and fully self-determining regarding end-of-life decisions. However, since its implementation there is little evidence of national acceptance by the health care industry. The law applies to all health care facilities that receive any federal reimbursement for services, and includes hospitals, nursing homes, home health agencies, and clinics. The PSDA requires a health care mechanism for disseminating information about advance directives with patients.

Advance directives have been available in parts of the United States since the late 1980s, but research shows that only a small percentage (5% to 25%) have some form of written advance directive. Advance directives allow a competent person to express who should be a decision maker and what preferences the patient may have.

Psychiatric advance directives are a legal means by which a person with mental illness, while competent to make health care decisions, may specify his or her preferences for treatment and may designate a surrogate decision maker to act on his or her behalf in the event of an incapacitating mental health crisis.

When informed consent is not viable for the patient, and he or she does not have advance directives, the process of surrogate decision making is initiated. Surrogate decision making refers to the process in which a loved one has to make a medical decision because the patient's judgment is incapacitated. Surrogate decision makers reach decisions for those with fluctuating decisionmaking capacity that is doubtful and thus need to be aware of all the side effects in order to make decisions on behalf of someone else.

Courts and legislatures have been actively involved in the right of surrogate decision makers and the various related ethical dilemmas. Within the context of advanced life-sustaining treatments, patients and their family members have been confronted with life and death choices. The questions regarding who is competent to make which decisions is still a much-litigated scenario. Many judgments about terminating or continuing treatment are made daily for patients who are no longer able to choose for themselves—patients with HIV (human immunodeficiency virus), Alzheimer's disease, and Parkinson's disease, and those suffering from stroke effects, heart and kidney failure, dementia, and psychosis.

History of Informed Consent within Biomedical Research

A comprehensive movement toward informed consent began after World War II with the 1947 Nuremberg trials. In these war trials, it was revealed that physicians conducted abhorrent medical research experiments on concentration camp prisoners. The research included human experimentation with germ warfare, freezing individuals to learn what temperature kills individuals most effectively, and many more horrifying research trials. Between 1930 and 1945 Japan conducted human experimentation in biological warfare, including physical responses to infection and trauma, and thousands were killed. The Nuremberg Code, which emerged from the trials, abandons the earlier paternalistic perspective of medicine and research and replaces it with the centrality of patient self-determination by asserting that the voluntary consent of the human subject is necessary under all circumstances of medical research. With this, the modern era of ethics within biomedical research emerged with a particular emphasis on the patient's rights expressed by the practice of informed consent.

The term informed consent first received wide awareness and prominence in public health research, as well as in the practice of medicine, in 1972, in response to the public outcry regarding unethical practices in the Tuskegee research. In 1932 the U.S. Public Health Service initiated a study that examined the effects of untreated syphilis among rural black men in Tuskegee, Alabama. Thousands of men were kept in total ignorance of the experiment, their infection, and the seriousness of syphilis. They were consistently steered away from receiving effective treatment so the United States government could monitor how the disease progressed, its many serious side effects, and its rate of fatality.

Immediately following this disclosure, the first national government commission, the National Commission for the Protection of Human Subjects of Biomedical Research and Behavioral Research was established. One of its primary goals was to initiate a variety of legislation to further ensure a patient's right to be fully informed regarding any medical research. A decade later, the President's Commission on the Study of Ethical Problems in Medicine and Biomedical Research and Behavioral Research was formed in 1983 to replace the first commission. Its mandate was to deal with the full range of medical and ethical issues, including the care of the dying, genetics, and issues of health care decisions such as informed consent and allocation of resources.

Informed Consent in the Managed Care Climate

With the era of cost-containment in the 1980s and managed care in the 1990s, informed consent became even more critical. Informed decision counseling (IDC) has been used to promote cost-effective care and provide over-the-phone medical information from twenty-four-hour-a-day clinicians. Designed to promote appropriate utilization and effective patient-provider communication, IDC is based on the premise that health care consumers make appropriate utilization decisions if adequately informed.

Informed consent will continue to evolve in response to continued advances in medical treatment, the shift toward partnership in patient-physician relationships, and new avenues of biomedical research. At the center of informed consent remains the critical primacy of the right for a patient to understand any medical treatment, medical procedure, or participation in medical research.

See also: Advance Directives; Cruzan, Nancy; Hippocratic Oath; Natural Death Acts; Quinlan, Karen Ann; Suicide Types: Physician-Assisted Suicide

Bibliography

Annas, George J., and Michael Grodin. The Nazi Doctors and the Nuremberg Code. New York: Oxford University Press, 1992.

Applebaum, Paul S., Charles Lidz, and Alan Meisel. Informed Consent: Legal Theory and Clinical Practice. New York: Oxford University Press, 1989.

Basile, C. M. "Advance Directives and Advocacy in End of Life Decisions." Nurse Practitioner 23, no. 5 (1998):44–54.

Beauchamp, Tom L., and James F. Childress. Principles of Biomedical Ethics. Oxford: Oxford University Press, 1994.

Buchanan, Allen, and Dan W. Brock. Deciding for Others: The Ethics of Surrogate Decision-Making. Cambridge: Cambridge University Press, 1989.

Fairman, Kevin, and C. Murphy. "Drug Benefit Trends: Using Informed Decision Counseling to Promote Cost-Effective Care." Drug Benefit Trends 12, no. 4 (2000):44–48.

Gostin, Lawrence. "Deciding Life and Death in the Courtroom: From Quinlan to Cruzan, Glucksberg and Vacco—A Brief History and Analysis of Constitutional Protection of the 'Right to Die.'" Journal of the American Medical Association 278, no. 18 (1997):1523–1528.

Hanssen, Michael. "Balancing the Quality of Consent." Journal of Medical Ethics 24, no. 3 (1998):182–187.

Veatch, Robert M. Medical Ethics. Boston: Jones and Bartlett, 1989.

NANCY L. BECKERMAN

Informed Consent

Definition
Description
Results

Definition

Informed consent is a legal document in all 50 states. It is an agreement for a proposed medical treatment or non-treatment, or for a proposed invasive procedure. It requires physicians to disclose the benefits, risks, and alternatives to the proposed treatment, non-treatment, or procedure. It is the method by which fully informed, rational persons may be involved in choices about their health care.

Description

Informed consent stems from the legal and ethical right an individual has to decide what is done to his or her body, and from the physician’s ethical duty to make sure that individuals are involved in decisions about their own health care. The process of securing informed consent has three phases, all of which involve information exchange between doctor and patient and are part of patient education. First, in words an individual can understand, the physician must convey the details of a planned procedure or treatment, its potential benefits and serious risks, and any feasible alternatives. The patient should be presented with information on the most likely outcomes of the treatment. Second, the physician must evaluate whether or not the person has understood what has been said, must ascertain that the risks have been accepted, and that the patient is giving consent to proceed with the procedure or treatment with full knowledge and forethought. Finally, the individual must sign the consent form, which documents in generic format the major points of consideration. The

KEY TERMS

Consent— Permission or agreement.

Informed— From full knowledge; not coerced.

only exception to this is securing informed consent during extreme emergencies.

It is critical that a patient receive enough information on which to base informed consent, and that the consent is wholly voluntary and has not been forced in any way. It is the responsibility of the physician who discusses the particulars with the patient to detail the conversation in the medical record. A physician may, at his or her discretion, appoint another member of the health care team to obtain the patient’s signature on the consent form, with the assurance that the physician has satisfied the requirements of informed consent.

The law requires that a reasonable physician/patient standard be applied when determining how much information is considered adequate when discussing a procedure or treatment with the patient. There are three approaches to making this discussion: what the typical physician would say about the intervention (the reasonable physician standard); what an average patient would need to know to be an informed participant in the decision (the reasonable patient standard); and what a patient would need to know and understand to make a decision that is informed (the subjective standard).

There is a theory that the practice of acquiring informed consent is rooted in the post–World War II Nuremberg Trials. At the war crimes tribunal in 1949, 10 standards were put forth regarding physicians’ requirements for experimentation on human subjects. This established a new standard of ethical medical behavior for the post–WW II human rights age, and the concept of voluntary informed consent was established. A number of rules accompanied voluntary informed consent. It could only be requested for experimentation for the gain of society, for the potential acquisition of knowledge of the pathology of disease, and for studies performed that avoided physical and mental suffering to the fullest extent possible.

Today, all of the 50 United States have legislation that delineates the required standards for informed consent. For example, the State of Washington employs the second approach outlined as the reasonable patient standard (what an average patient would need to know to be an informed participant in the decision). This approach ensures that a doctor fulfills all professional responsibilities and provides the best care possible and that patients have choices in decisions about their health care. However, the patient’s competence in making a decision is considered. This points to the issue of the patient’s mental capacity. Anyone suffering from an illness, anticipating surgery, or undergoing treatment for a disease is under a great deal of stress and anxiety. It may be natural for a patient to be confused or indecisive. When the attending physician has serious doubts about the patient’s understanding of the intervention and its risks, the patient may be referred for a psychiatric consultation. This is strictly a precaution to ensure that the patient understands what has been explained; declining to be treated or operated on does not necessarily mean the person is incompetent. It could mean that the person is exercising the right to make his or her own health care decisions.

Although the law requires a formal presentation of the procedure or treatment to the patient, physicians do express doubt as to the wisdom of this. Some believe that informing patients of the risks of treatment might scare them into refusing it, even when the risks of non-treatment are even greater. But patients might have a different view. Without the complete story, for example, a patient might consent to beginning a particular course of chemotherapy. Convinced by the pressures from a pharmaceutical company, it is conceivable that a doctor will use an agent less effective than a newer treatment. By withholding information about treatment alternatives, the physician may be denying the patient a choice and, worse, perhaps a chance of an extended life of greater quality.

Undeniably, physicians in surgery, anesthesia, oncology, infectious disease, and other specialties are faced with issues regarding informed consent. As the federal government takes a more active role in deciding the extent to which patients must be informed of treatments, procedures, and clinical trials in which they voluntarily become enrolled, more and more health care providers must become educated in what must be conveyed to patients. This is emphasized by the report of a case in which a federal court (Hutchinson v. United States [91 F2d 560 (9th Cir. 1990)]) ruled in favor of the physician, despite his failure to advise his asthmatic patient, forwhom he had prescribed the steroid, prednisone, of the drug’s known risk of developing aseptic necrosis(bone death ), which did occur. The practitioner neglected to inform the patient that there were other drugs available with much less serious side effects that could have treated the asthma. However, a higher appellate court reversed the ruling and found the physician guilty. Apparently, the patient had used more conservative drugs in the past with good results. The court believed that if the physician had merely advised the patient of the more serious side effects of prednisone and offered the patient more conservative treatment, the physician would have avoided liability.

Nursing professionals have a greater role than they might believe in evaluating whether or not consent is informed. When a nurse witnesses the signature of a patient for a procedure, or surgery, he or she is not responsible for providing the details. Rather, the role is to be the patient’s advocate, to protect the patient’s dignity, to identify any fears, and to determine the patient’s degree of comprehension and approval of care to be received. Each patient is an individual, and each one will have a different and unique response depending on his or her personality, level of education, emotions, and cognitive status. If a patient can restate the information that has been imparted, then that will help to confirm that he or she has received enough information and has understood it. The nurse is obligated to report any doubts about the patient’s understanding regarding what has been said or any concerns about his or her capacity to make decisions.

Results

The result of informed consent is greater safety and protection for patients, physicians, and society.

Resources

BOOKS

Clarke, S., and J. Oakley. Informed Consent and Clinician Accountability: The Ethics of Report Cards on Surgeon Performance. New York: Cambridge University Press, 2007.

Fix, R. M. Informed Consent. Florence, KY: Frontline Publishing, 2007.

Getz, K., and D. Boritz. Informed Consent: The Consumer’s Guide to the Risks and Benefits of Volunteering for Clinical Trials. Boston, MA: Center Watch, 1999.

Glenn, S. Informed Consent. Paris, Ontario, Canada: David C. Cook, 2007.

Manson, N, C., and O. O'Neill. Rethinking Informed Consent in Bioethics. New York: Cambridge University Press, 2007.

PERIODICALS

Helmreich, R., J., V. Hundley, A. Norman, J. Ighedosa, and E. Chow. “Research in pregnant women: the challenges of informed consent.” Nursing for Women’s Health 11, no. 6 (2007): 576–585.

Johnson, L. J. “Get informed consent for risky drugs.” Medical Economics 84, no. 21 (2007): 20–23.

Perez-Carceles, M. D., M. D. Lorenzo, A. Luna, and E. Osuna. “Elderly patients also have rights.” Journal of Medical Ethics 33, no. 12 (2007): 712–716.

Rossel, M., M. Burnier, and R. Stupp. “Informed consent: true information or institutional review board-a pproved disinformation?” Journal of Clinical Oncology 25, no. 36 (2007): 5835–5836.

Sheach-Leith, V. M. “Consent and nothing but consent? The organ retention scandal.” Sociology of Health and Illness 29, no. 7 (2007): 1023–1042.

ORGANIZATIONS

American Academy of Family Physicians. 11400 Tomahawk Creek Parkway, Leawood, KS 66211-2672. (913) 906-6000. E-mail: [email protected]. http://www.aafp.org.

American Bar Association. 321 N Clark St., Chicago, IL 60610. 800-285-2221. http://www.abanet.org/home.html.

American College of Physicians. 190 N Independence Mall West, Philadelphia, PA 19106-1572. (800) 523-1546, x2600, or (215) 351-2600. http://www.acponline.org.

American Medical Association. 515 N. State Street, Chicago, IL 60610. 312) 464-5000. http://www.ama-assn.org.

OTHER

American Academy of Pediatrics. Information about Informed Consent. 2007 [cited December 24, 2007]. http://www.aap.org/policy/00662.html.

American Medical Association. Information about Informed Consent. 2007 [cited December 24, 2007]. http://www.ama-assn.org/ama/pub/category/4608.html.

Food and Drug Administration. Information about Informed Consent. 2007 [cited December 24, 2007]. http://google2.fda.gov/search?output=xml_no_dtd&lr=&proxystylesheet=FDA&client=FDA&site=FDA&getfields=*&q=informed+consen

Office for Human Research Protections. Department of Health and Human Services. Information about Informed Consent. 2007 [cited December 24, 2007]. http://search.hhs.gov/search?q=informed+consent&entqr=0&ud=1&sort=date%3AD%3AL%3Ad1&output3xml_no_dtd&site=HHS&ie=UTF-8&oe=UTF-8&lr=lang_en&client=HHS&proxystylesheet=HHS.

L. Fleming Fallon, Jr, MD, DrPH

Informed consent

Definition

Informed consent is a legal document in all 50 states, prepared as an agreement for treatment, nontreatment, or for an invasive procedure that requires physicians to disclose the benefits, risks, and alternatives to said treatment, nontreatment, or procedure. It is the method by which a fully informed, rational patient may be involved in choices about his or her health care.

Description

Informed consent stems from the legal and ethical right the patient has to decide what is done to his or her body, and from the physician's ethical duty to make sure that the patient is involved in decisions about his or her own health care. The process of securing informed consent has three phases, all of which involve information exchange between doctor and patient and are part of patient education . First, in words the patient can understand, the physician must convey the details of a planned procedure or treatment, its potential benefits and serious risks, and any feasible alternatives. The patient should be presented with information on the most likely outcomes of the treatment. Second, the physician must evaluate whether or not the person has understood what has been said, must ascertain that the risks have been accepted, and that the patient is giving consent to proceed with the procedure or treatment with full knowledge and forethought. Finally, the patient must sign the consent form, which documents in generic format the major points of consideration. The only exception to this is securing informed consent during extreme emergencies.

It is critical that the patient receive enough information on which to base informed consent, and that the consent is wholly voluntary and has not been forced in any way. It is the responsibility of the physician who discusses the particulars with the patient to detail the conversation in the patient's record. A physician may, at his or her discretion, appoint another member of the health care team to obtain the patient's signature on the consent form, with the assurance that the physician has satisfied the requirements of informed consent.

Paul H. Ting, M.D., Assistant Professor of Anesthesiology at the University of Virginia and editor of the “About Anesthesiology” web site discusses why patients are apprehensive. “I think that people's greatest concerns are … whether they will live or die … whether they will feel any pain or be uncomfortable … whether they will be well taken care of (and I include in this whether their care will lead to a successful result and whether they will be treated with dignity)….

“The boilerplate consent form has good intentions; it is comprehensive and therefore should reflect that a comprehensive discussion was completed,” said Dr. Ting. “The actual form itself is in place to protect the hospital and the physician. Legally, it is proof that things have been covered and the patient agrees to the procedure, risks, benefits, options, etc. However, the informed consent process (which the form merely is supposed to document) is in place for the protection of the patient. The process is in place to make sure that everything is discussed with the patient—all of the options, all of the common risks, the worst thing that can happen, etc.”

The law requires that a reasonable physician standard be applied when determining how much information is considered adequate when discussing a procedure or treatment with the patient. There are three approaches to making this discussion: what the typical physician would say about the intervention (the reasonable physician standard); what the average patient would need to know to be an informed participant in the decision (the reasonable patient standard); and what the patient would need to know/understand to make a decision that is informed (subjective standard).

Viewpoints

There is a theory that the practice of acquiring informed consent is rooted in the post-World War II Nuremberg Trials. At the war crimes tribunal in 1949, 10 standards were put forth regarding physicians' requirements for experimentation on human subjects. This established a new standard of ethical medical behavior for the post-WWII human rights age, and the concept of voluntary informed consent was established. A number of rules accompanied voluntary informed consent. It could only be requested for experimentation for the gain of society, for the potential acquisition of knowledge of the pathology of disease, and for studies performed that avoided physical and mental suffering to the fullest extent possible.

As of 2001, most of the 50 United States had legislation that spells out the required standards for informed consent. For example, the State of Washington employs the second approach outlined as the reasonable patient standard. This ensures that the doctor fulfills all professional responsibilities and provides the best care possible and that the patient has a choice in decisions about his or her health care. However, the patient's competence in making a decision is considered. This points to the issue of the patient's “capacity.” Anyone suffering from an illness, anticipating surgery, or undergoing treatment for a disease is under a great deal of stress and anxiety . It may be natural for a patient to be confused or indecisive. When the attending physician has serious doubts about the patient's understanding of the intervention and its risks, the patient may be referred for a psychiatric consultation. This is strictly a precaution to ensure that the patient understands what has been explained; declining to be treated or operated on does not necessarily mean the person is incompetent. It could mean that the person is exercising the right to make his or her own health care decisions.

Although it is the law to formally present the procedure or treatment to the patient, physicians do express doubt as to its wisdom. Some believe that informing patients of the risks of treatment might scare them into refusing it when the risks of non-treatment are even greater. But patients might have a different view. Without the complete story, for example, a patient might consent to beginning a particular course of chemotherapy . Convinced by the pressures from a pharmaceutical company, it is conceivable that a doctor will use an agent less effective than a newer treatment. By withholding information about treatment alternatives, the physician may be denying the patient a choice and a chance of an extended life of greater quality.

The international community has also had much to say in this regard. Martin Tattersall, professor at the Sydney University Cancer Medicine Department, and Alan Langslands, professor in Radiation Oncology at Westmead, said in the August 1995 issue of the Medical Journal of Australia, “Our findings indicate the extent of variation in the practice of providing information to cancer patients commencing treatment. … The current double standard between former clinical trials (where ethics committees require that patients be given a ‘plain language statement,’ as well as giving their signed consent) and the ‘usual’ practice outside such trials, is apparently narrowing. The reasons for this may relate to the fear of litigation, rather than recognition of the need to provide full information.” A litigious society such as the United States might be plagued by an even greater number of lawsuits than at present if informed consent were not legally mandated.

Professional implications

Undeniably, physicians in surgery, anesthesia, oncology, infectious disease—the list is endless—are faced with issues regarding Informed Consent. As the federal government takes a more active role in deciding the extent to which patients must be informed of treatments, procedures, and clinical trials in which they voluntarily become enrolled, more and more health care providers must become educated in what needs to be conveyed to patients. This is emphasized by the report of a case in which a federal court (Hutchinson vs. United States [91 F2d 560 (9th Cir. 1990)]) ruled in favor of the physician, despite his failure to advise his asthmatic patient (for whom he had prescribed the steroid, prednisone), of the well-known risk of developing aseptic necrosis (bone death ), which did occur. The practitioner neglected to inform the patient that there were other drugs available with a much less serious side effect profile that could have treated the asthma . However, and despite this “neglect,” a higher, appellate court reversed the ruling and found the physician guilty. Apparently the patient had used more conservative drugs in the past with good results. The court believed that if the physician had merely advised the patient of the more serious side effects of prednisone and offered the patient more conservative treatment, the physician would have avoided liability.

Nursing professionals have a greater role in evaluating whether the consent is informed or not than they might believe. When a nurse witnesses the signature of a patient for a procedure, or surgery, he or she is not responsible for providing its details. Rather, the role is to be the patient's advocate; to protect the patient's dignity; identify any fears; and determine his or her degree of comprehension and approval of care to be received. Each patient is an individual, and each one will have a different and unique response depending on his or her personality, level of education, emotions, and cognitive status. If the patient can restate the information that has been imparted to him or her, then that will help to confirm that he or she has received enough information and has understood it. The nurse is obligated to report any doubts about the patient's understanding regarding what has been said, or any concerns about his or her capacity to make decisions.

Resources

PERIODICALS

Dunn, Debra. “Exploring the Gray Areas of Informed Consent.” Nursing (1999). http://www.findarticle.com.

Lehman, C.M., Rodgers, G.M., “To IRB or Not to IRB?” American Journal of Clinical Pathology 115, no. 2 (2001):187–191.

Lutz, S., Henkind, S.J. “Recruiting for Clinical Trials on the Web.” Healthplan 41, no. 5(2000):36–43.

“Nuremberg Code (1947): standards for medical experimentation.” British Medical Journal 7070, no. 313 (1996). Circumcision Information and Responses Position? … http://www.cirp.org/library/ethics/nuremberg.

Wirshing, D.A., Wirshing W.C., Marder S.R., Liberman R. P., and Mintz, J. “Informed Consent: assessment of comprehension.” American Journal of Psychiatry 155, no. 11 (1998):1508-11.

OTHER

“Cancer treatment and informed consent.” Sydney University Cancer Medicine Department. http://jinx.sistm.unsw.edu/au/greenlft/1996/216/216p13.htm.

“Health Information for surgical procedures, family health, patient education ….” http://www.docs4patients.com/informed-consent.asp.

“Informed consent.” http://www.nocirc.org/consent.

“Informed Consent.” The University of Washington. http://eduserv.hscer.washington.edu/bioethics/topics/consntc1.html.

“Informed Consent.” Risk Management Handbook. Yale New Haven Hospital & Yale University School of Medicine. http://info.med.yale.edu/cim/risk/handbook/rmh_informed_consent.html.

“Medical-Legal Issues in HIV Treatment.” http://www.medscape/SCP/TAR4/2001.

“Risk Management Issues: Improved Informed Consent.” http://www.rmf.harvard.edu/rmLibrary/rmissues/infconsent/body.html.

Randi B. Jenkins