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Informed Consent—What Is It?

By February 27, 2024No Comments

In any code of medical ethics, informed consent is a bedrock principle—the solid foundation upon which all other principles of the medical profession should rest.

Informed consent, in the context of medical treatment or medical research, transcends the unspoken ethical responsibilities of the patient-physician relationship. It is, in fact, a legal obligation. 

Seen from the legal perspective, informed consent in a medical setting entails the bodily integrity of the individual patient or research subject. It is grounded in the idea of an individual’s personal autonomy—that is, their capacity for self‐determination and self‐governance. 

What this means in practice is that a patient or research subject must be given sufficient information about any and all pending treatments, including the risks and benefits of those treatments, the existence and availability of any alternative treatments, the patient’s role in treatment, and the patient’s right to refuse treatment.

The concept of informed consent extends beyond healthcare intervention into medical research as well as into the protection of private medical information.

While the parameters of informed consent vary from country to country and, in the US, from state to state, the conceptual framework of informed consent is universal. 

A patient’s consent to all treatments must be voluntary, with “no coercion or unfair persuasion and inducements.”

The patient must have a clear understanding of all the facts and consequences of treatments.

The patient must be in full possession of their reasoning faculties and be free from any impairments that may preclude them from making sound judgments. Examples of such impairments include, but are not limited to, intellectual or emotional immaturity, severe intellectual disabilities, severe mental disorders, post-traumatic stress disorder, and dementia.

If an individual is unable to give or withhold informed consent, someone else may be authorized to do so on the individual’s behalf. Parents or legal guardians give or withhold informed consent for a child, and conservators commonly do the same for individuals who are unable to handle their personal affairs due to their mental capacity, age, or physical disability.

The doctrine of implied consent permits treatment in limited cases, such as when an unconscious person would die without immediate intervention. 

Informed consent is codified in international treaties as well as in both national and international law and is widely considered to be a key element for the protection and welfare of patients and research participants. 

Before receiving informed consent to proceed with treatment, a medical professional must meet certain criteria by engaging in educational interactions with the patient or patient’s advocate.

These criteria include an explanation of clinical conditions, a clear and detailed description of proposed treatments, an assessment of potential benefits and risks of that treatment and follow-up care, alternative treatment options, and a discussion about the risks or benefits of having no treatment.

History of Informed Consent

The concept of informed consent is relatively recent. It began with a series of four judicial decisions in the early 20th century that laid the groundwork for physician and institutional responsibility, for individual rights, and for a patient or research subject’s bodily autonomy. 

The first two of these cases, Mohr v. Williams and Pratt v. Davis, were decided in 1905.

In the Mohr v. Williams case, the Supreme Court of Minnesota agreed with the plaintiff that the surgeon should have obtained consent before changing a surgical procedure while in the middle of the operation.

In the Pratt v. Davis case, the surgeon acknowledged intentionally misleading the patient and then performing an unauthorized hysterectomy on her. His admission led to an appellate court ruling that stated, in part:

[U]nder a free government at least, the citizen’s first and greatest right, which underlies all others, [is . . .] to the inviolability of his person, in other words, his right to himself is the subject of universal acquiescence, and this right necessarily forbids a physician or surgeon, however skillful or eminent, who has been asked to examine, diagnose, advise and prescribe [. . .] to violate without permission the bodily integrity of his patient.

Two subsequent cases, Rolater v. Strain (1913) and Schloendorff v. Society of New York Hospital (1914), established and solidified principles of patient autonomy—principles that advanced the practice of informed consent as a requirement in medicine and research.

The case of Schloendorff v. Society of New York Hospital was especially important in that it legally established the principle of patient autonomy. In that ruling, Judge Benjamin Cardozo wrote:

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.

As ideas surrounding informed consent were gradually being established, the term itself was incorporated into a legally binding principle in the 1957 case of Salgo v. Leland Stanford Jr. University Board of Trustees, which officially effectuated the phrase “informed consent” and established what that principle should look like in medical practice.

This ruling set up the scaffolding for the legal framework of informed consent in medical practice and therapeutic medical procedures and launched more detailed discussions of the meaning and ethics of informed consent in medicine, research, law, and philosophy.

Informed consent for human subjects in research emerged as a result of Nazi war crime investigations post-World War II. The Nuremberg Code, which delineated ten basic rules for conducting human experiments, represented the first explicit attempt to regulate the ethical conduct of research experiments with human subjects. It is notable for the emphasis it placed on voluntary consent—meaning that a consenting individual “must have sufficient knowledge and comprehension” to understand what he or she is agreeing to as part of the research.

The first sentence and paragraph of the Nuremberg Code remind us: 

The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.

In 1964, the World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects was adopted at the 18th WMA General Assembly in Helsinki, Finland.

The Declaration of Helsinki was developed as “a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data [and is] intended to be read as a whole and each of its constituent paragraphs should not be applied without consideration of all other relevant paragraphs.”

It is widely regarded as the cornerstone document on human research ethics.

The fundamental principle in the Declaration is the “rights and interests of individual research subjects” (Article 8) and the individual’s right to self-determination and to make informed decisions (Articles 20, 21 and 22). The investigator’s duty is “solely to the patient” (Articles 2, 3 and 10) or to the volunteer research subject (Articles 16, 18). The participant’s welfare “must always take precedence over the interests of science and society” (Article 5), and “ethical considerations must always take precedence over laws and regulations” (Article 9).

In addition to the clear delineation on individual rights, the Declaration notes that informed consent in medical research involving human subjects must include informing each potential subject “of the aims, methods, sources of funding, any possible conflicts of interest, [and] institutional affiliations of the researcher.”[Emphasis added.]

Article 7 of the International Covenant on Civil and Political Rights, adopted in 1966 by the United Nations, continued in that vein, affirming that “no one shall be subjected without his free consent to medical or scientific experimentation.

In the United States, concepts of informed consent were further catalyzed by the 1972 revelations and ensuing outrage over the infamous Tuskegee Experiments, which led to the establishment of the National Research Service Award Act on July 12, 1974

A fundamental provision of this Act was the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This was the first public national body to shape bioethics policy in the United States. The Commission’s publication of the Belmont Report in 1979 further concretized three basic ethical principles critical to the process of informed consent in research: information, comprehension, and voluntariness. 

INFORMATION. The Belmont Report characterizes an autonomous agent as “an individual capable of deliberation about personal goals and of acting under the direction of such deliberation” and says that such individuals must “be given the opportunity to choose what shall or shall not happen to them.”

COMPREHENSION. Echoing the Nuremberg Code, the second principle articulated in the Belmont Report is the indispensable idea of comprehension. 

In the opening paragraphs of the Belmont Report section on comprehension, it is affirmed that: 

The manner and context in which information is conveyed is as important as the information itself. For example, presenting information in a disorganized and rapid fashion, allowing too little time for consideration or curtailing opportunities for questioning, all may adversely affect a subject’s ability to make an informed choice. 

Because the subject’s ability to understand is a function of intelligence, rationality, maturity and language, it is necessary to adapt the presentation of the information to the subject’s capacities. Investigators are responsible for ascertaining that the subject has comprehended the information.

VOLUNTARINESS. The Belmont Report also highlights that the concept of voluntary participation is of paramount importance. Integral to this element of informed consent are that the conditions must be “free of coercion and undue influence” and that the participant must be informed of two points: (1) he or she is free to discontinue participation at any time, and (2) a decision to withdraw from participation will not result in any punitive actions.

As the Belmont Report puts it:

Unjustifiable pressures usually occur when persons in positions of authority or commanding influence—especially where possible sanctions are involved—urge a course of action for a subject. [Emphasis added.]

In 1981, the US Department of Health and Human Services and the US Food and Drug Administration (FDA) established regulatory definitions and policies for the protection of human research subjects through the Code of Federal Regulations (CFR) 45 CFR 46

In 1991, adoption of Title 45, Public Welfare, Part 46, Protection of Human Subjects included “The Protection of Human Subjects,” which codified, in regulations affecting fifteen different US federal departments and agencies, what would become known as the “The Common Rule.”   

In 2017, revisions to the Common Rule clarified that: 

Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. [Emphasis added.]

Recognizing that “ethical issues raised by the rapid advances in science and their technological applications should be examined with due respect to the dignity of the human person and universal respect for, and observance of, human rights and fundamental freedoms,” UNESCO adopted the Universal Declaration on Bioethics and Human Rights in 2005.

The stated aim of UNESCO’s Declaration was “to provide a universal framework of principles and procedures to guide States in the formulation of their legislation, policies or other instruments in the field of bioethics [and to] promote respect for human dignity and protect human rights, by ensuring respect for the life of human beings, and fundamental freedoms, consistent with international human rights law.”

Article 5 of the Declaration articulates the importance of individual sovereignty:

The autonomy of persons to make decisions, while taking responsibility for those decisions and respecting the autonomy of others, is to be respected. For persons who are not capable of exercising autonomy, special measures are to be taken to protect their rights and interests. 

Article 6 emphasizes that genuinely established consent is contingent upon full and accurate information being presented to the subject and notes thatthat component of the agreement is immutable and solely the responsibility of those applying the medical intervention or conducting the research [emphasis added]:

Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. Scientific research should only be carried out with the prior, free, express and informed consent of the person concerned. 

How Informed is the Informed Consent?

As evidenced by numerous court rulings, national legislation, and international documents, it is indisputable that informed consent is a vital and non-negotiable aspect of all doctor-patient relationships and of all scientific or medical experiments involving human subjects.

Unfortunately, data show that participants often have a limited understanding of the information presented, even when they have signed a consent form. The informed consent process often fails to provide information in an understandable format.

A 1983 article in the Journal of the American Medical Association titled “Readability of informed consent forms for research in a Veterans Administration medical center” concluded that “little progress has been made in ensuring that the information is comprehensible, understood, and used.”

These criticisms have continued. Evidence demonstrates that consent forms have only increased in length and involve “complexity of wording that exceeds average reading levels” as well as “problems with the accuracy with which key studies are described.” [Emphasis added.]

Physicians themselves are largely ill-informed about—or choose to be remiss in—their duties towards informed consent. Yet they cannot provide informed consent if they don’t have full knowledge of the procedures involved or of the products they are prescribing. If physicians have little understanding of the full obligations and processes required of them, it is not possible for them to give full information to their patient—and, thus, for their patient’s consent to be truly informed.

Only a few studies have been done that examine how well physicians understand their obligations in the process of informed consent. The results of those studies are not encouraging.

For instance, a cross-sectional study in Romania assessed physicians’ legal knowledge of informed consent and found that 275 of the 305 respondents believed they never committed any legal violation. When presented with ten scenarios “that best reflected their practice,” the reality was that “their median correct answer score was 5.35 ± 1.66 out of 10,” indicating a clear deviation from what they believed to be their obligations towards informed consent.

When knowledge of informed consent legislation was tested among physicians in the same study, the results were even worse.

Only 55% of them knew they should “seek written permission from patients before collecting and examining biological samples.”

And, when confronted with an ethical dilemma, only 32% of them recognized that the law required them to accept the patient’s decision if a patient declines emergency assistance in a life-threatening situation.

The same study noted, “While most physicians correctly answered simple questions, only a tiny minority identified the correct solution when confronted with ethical dilemmas.” 

This Romanian physicians’ study has been corroborated by findings from studies done in other countries (here, here and here), leading their authors to suggest that there is a “fundamental incomprehension of the core idea of informed consent.” The authors suggest that one possible explanation for this is an “abiding absence of legal or ethical education from university curricula.”

What Can You Do?

The American Medical Association (AMA) Code of Medical Ethics section 2.1.1 on Informed Consent states unequivocally: 

Informed consent to medical treatment is fundamental in both ethics and law. Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care.

The problems lie not with this agreement in principle but with the real-time execution of patients’ basic right to informed consent.

In practice, most doctors spend little-to-no time explaining to their patients the finer details of a medication, treatment, or procedure. This lack of communication is worsened by the fact that consent forms are universally “long and complicated, obscure important details and are often designed to serve the interests of institutions and sponsors.” 

The trouble with informed consent is that patients and research participants are rarely, if ever, giving fully educated and legally observed consent. 

Even if the patient or experimental subject is exposed to some degree of information, is reassured that his or her rights will be honored, and is given a formal, quasi-legal statement to read and sign, still, that individual rarely comes away with full knowledge of what this statement encompasses. 

For patients to recognize and fully appreciate that informed consent is more than a casual routine or pro forma contractual arrangement would greatly improve the physician-patient association and would empower patients to take requisite control of that relationship.

Informed consent is more than an ethical duty of physicians. It is their legal obligation. And it is your inalienable right. Demand it.