![PARAMOUNT Eli Lilly Informed Consent Document](https://upload.wikimedia.org/wikipedia/commons/7/7f/PARAMOUNT_Eli_Lilly_Informed_Consent_Document.djvu)
Informed consent is a principle in
medical ethics
Medical ethics is an applied branch of ethics which analyzes the practice of clinical medicine and related scientific research. Medical ethics is based on a set of values that professionals can refer to in the case of any confusion or conflict. T ...
and
medical law
Medical law is the branch of law which concerns the prerogatives and responsibilities of medical professionals and the rights of the patient. It should not be confused with medical jurisprudence, which is a branch of medicine, rather than a br ...
, that a patient must have sufficient information and understanding before making decisions about their medical care. Pertinent information may include risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their
right to refuse treatment. In most systems, healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed. This principle applies more broadly than healthcare intervention, for example to conduct research and to disclosing a person's medical information.
Definitions of informed consent vary, and the standard required is generally determined by the state. Informed consent requires a clear appreciation and understanding of the facts, implications, and consequences of an action. To give informed consent, the individual concerned must have adequate reasoning faculties and possess all relevant facts. Impairments to reasoning and judgment that may preclude informed consent include intellectual or emotional immaturity, high levels of stress such as
post-traumatic stress disorder
Post-traumatic stress disorder (PTSD) is a mental and behavioral disorder that can develop because of exposure to a traumatic event, such as sexual assault, warfare, traffic collisions, child abuse, domestic violence, or other threats on ...
or a severe
intellectual disability
Intellectual disability (ID), also known as general learning disability in the United Kingdom and formerly mental retardation,Rosa's Law, Pub. L. 111-256124 Stat. 2643(2010). is a generalized neurodevelopmental disorder characterized by signifi ...
, severe
mental disorder
A mental disorder, also referred to as a mental illness or psychiatric disorder, is a behavioral or mental pattern that causes significant distress or impairment of personal functioning. Such features may be persistent, relapsing and remitti ...
,
intoxication
Intoxication — or poisoning, especially by an alcoholic or narcotic substance — may refer to:
* Substance intoxication:
** Alcohol intoxication
** LSD intoxication
** Toxidrome
** Tobacco intoxication
** Cannabis intoxication
** Cocaine i ...
, severe
sleep deprivation,
dementia
Dementia is a disorder which manifests as a set of related symptoms, which usually surfaces when the brain is damaged by injury or disease. The symptoms involve progressive impairments in memory, thinking, and behavior, which negatively affe ...
, or
coma
A coma is a deep state of prolonged unconsciousness in which a person cannot be awakened, fails to respond normally to painful stimuli, light, or sound, lacks a normal wake-sleep cycle and does not initiate voluntary actions. Coma patients exhi ...
.
Obtaining informed consent is
not always required. If an individual is considered unable to give informed consent, another person is generally authorized to give consent on their behalf—for example, the parents or
legal guardians of a child (though in this circumstance the child may be required to provide
informed assent
The term informed assent describes the process whereby Minor (law), minors may agree to participate in clinical trials. It is similar to the process of informed consent in adults, however there remains some overlap between the terms.
Background
...
) and conservators for the
mentally disordered. Alternatively, the doctrine of
implied consent
Implied consent is consent which is not expressly granted by a person, but rather implicitly granted by a person's actions and the facts and circumstances of a particular situation (or in some cases, by a person's silence or inaction). For examp ...
permits treatment in limited cases, for example when an unconscious person will die without immediate intervention. Cases in which an individual is provided insufficient information to form a reasoned decision raise serious ethical issues. When these issues occur, or are anticipated to occur, in a
clinical trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...
, they are subject to review by an
ethics committee
An ethics committee is a body responsible for ensuring that medical experimentation and human subject research are carried out in an ethical manner in accordance with national and international law.
Specific regions
An ethics committee in the E ...
or
institutional review board
An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee that applies research ethics by reviewing the methods proposed for research to ens ...
.
Informed consent is codified in both national and international law. 'Free consent' is a cognate term in the
International Covenant on Civil and Political Rights
The International Covenant on Civil and Political Rights (ICCPR) is a multilateral treaty that commits nations to respect the civil and political rights of individuals, including the right to life, freedom of religion, freedom of speech, freedo ...
, adopted in 1966 by the
United Nations
The United Nations (UN) is an intergovernmental organization whose stated purposes are to maintain international peace and international security, security, develop friendly relations among nations, achieve international cooperation, and be ...
, and intended to be in force by 23 March 1976. Article 7 of the covenant prohibits experiments conducted without the "free consent to medical or scientific experimentation" of the subject.
, the covenant has 173 parties and six more signatories without ratification.
Assessment
Informed consent can be complex to evaluate, because neither expressions of consent, nor expressions of understanding of implications, necessarily mean that full adult consent was in fact given, nor that full comprehension of relevant issues is internally digested. Consent may be implied within the usual subtleties of human communication, rather than explicitly negotiated verbally or in writing. In some cases consent cannot legally be possible, even if the person protests he does indeed understand and wish. There are also structured instruments for evaluating capacity to give informed consent, although no ideal instrument presently exists.
Thus, there is always a degree to which informed consent must be assumed or inferred based upon observation, or knowledge, or legal reliance. This especially is the case in sexual or relational issues. In medical or formal circumstances, explicit agreement by means of signature—normally relied on legally—regardless of actual consent, is the norm. This is the case with certain procedures, such as a "
do not resuscitate
A do-not-resuscitate order (DNR), also known as Do Not Attempt Resuscitation (DNAR), Do Not Attempt Cardiopulmonary Resuscitation (DNACPR), no code or allow natural death, is a medical order, written or oral depending on country, indicating tha ...
" directive that a patient signed before onset of their illness.
Brief examples of each of the above:
# A person may verbally agree to something from fear, perceived social pressure, or psychological difficulty in asserting true feelings. The person requesting the action may honestly be unaware of this and believe the consent is genuine, and rely on it. ''Consent is expressed, but not internally given.''
# A person may claim to understand the implications of some action, as part of consent, but in fact has failed to appreciate the possible consequences fully and may later deny the validity of the consent for this reason. ''Understanding needed for informed consent is present but is, in fact (through ignorance), not present.''
# A person signs a
legal release
A legal release is a legal instrument that acts to terminate any legal liability between the releasor and the releasee(s), signed by the releasor. A release may also be made orally in some circumstances. Releases are routinely used by photographer ...
form for a
medical procedure
A medical procedure is a course of action intended to achieve a result in the delivery of healthcare.
A medical procedure with the intention of determining, measuring, or diagnosing a patient condition or parameter is also called a medical test. ...
, and later feels he did not really consent. Unless he can show actual misinformation, the release is usually persuasive or conclusive in law, in that the clinician may rely legally upon it for consent. ''In formal circumstances, a written consent usually legally overrides later denial of informed consent (unless obtained by misrepresentation)''.
# Informed consent in the U.S. can be overridden in emergency medical situations pursuant to
21CFR50.24, which was first brought to the general public's attention via the controversy surrounding the study of
Polyheme
A blood substitute (also called artificial blood or blood surrogate) is a substance used to mimic and fulfill some functions of biological blood. It aims to provide an alternative to blood transfusion, which is transferring blood or blood-based ...
.
Valid elements
For an individual to give valid informed consent, three components must be present: disclosure, capacity and voluntariness.
* ''Disclosure'' requires the researcher to supply each prospective subject with the information necessary to make an autonomous decision and also to ensure that the subject adequately understands the information provided. This latter requirement implies that a written consent form be written in lay language suited for the comprehension skills of subject population, as well as assessing the level of understanding through conversation (to be informed).
* ''Capacity'' pertains to the ability of the subject to both understand the information provided and form a reasonable judgment based on the potential consequences of his/her decision.
* ''Voluntariness'' refers to the subject's right to freely exercise his/her decision making without being subjected to external pressure such as coercion, manipulation, or undue influence.
Waiver of requirement
Waiver of the consent requirement may be applied in certain circumstances where no foreseeable harm is expected to result from the study or when permitted by law, federal regulations, or if an ethical review committee has approved the non-disclosure of certain information.
Besides studies with minimal risk, waivers of consent may be obtained in a military setting. According to 10 USC 980, the United States Code for the Armed Forces, Limitations on the Use of Humans as Experimental Subjects, a waiver of advanced informed consent may be granted by the Secretary of Defense if a research project would:
# Directly benefit subjects.
# Advance the development of a medical product necessary to the military.
# Be carried out under all laws and regulations (i.e., Emergency Research Consent Waiver) including those pertinent to the FDA.
While informed consent is a basic right and should be carried out effectively, if a patient is incapacitated due to injury or illness, it is still important that patients benefit from emergency experimentation.
The Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS) joined to create federal guidelines to permit emergency research, without informed consent.
However, they can only proceed with the research if they obtain a waiver of informed consent (WIC) or an emergency exception from informed consent (EFIC).
21st Century Cures Act
The
21st Century Cures Act enacted by the 114th United States Congress in December 2016 allows researchers to waive the requirement for informed consent when clinical testing "poses no more than minimal risk" and "includes appropriate safeguards to protect the rights, safety, and welfare of the human subject."
Medical sociology
Medical sociologists
Medicine is the science and practice of caring for a patient, managing the diagnosis, prognosis, prevention, treatment, palliation of their injury or disease, and promoting their health. Medicine encompasses a variety of health care pract ...
have studied informed consent as well
bioethics
Bioethics is both a field of study and professional practice, interested in ethical issues related to health (primarily focused on the human, but also increasingly includes animal ethics), including those emerging from advances in biology, m ...
more generally. Oonagh Corrigan, looking at informed consent for research in patients, argues that much of the conceptualization of informed consent comes from research ethics and bioethics with a focus on patient autonomy, and notes that this aligns with a neoliberal worldview.
Corrigan argues that a model based solely around individual decision making does not accurately describe the reality of consent because of social processes: a view that has started to be acknowledged in bioethics.
She feels that the liberal principles of informed consent are often in opposition with autocratic medical practices such that norms values and systems of expertise often shape and individuals ability to apply choice.
Patients who agree to participate in trials often do so because they feel that the trial was suggested by a doctor as the best intervention.
Patients may find being asked to consent within a limited time frame a burdensome intrusion on their care when it arises because a patient has to deal with a new condition.
Patients involved in trials may not be fully aware of the alternative treatments, and an awareness that there is uncertainty in the best treatment can help make patients more aware of this.
Corrigan notes that patients generally expect that doctors are acting exclusively in their interest in interactions and that this combined with "clinical equipose" where a healthcare practictioner does not know which treatment is better in a randomized control trial can be harmful to the doctor-patient relationship.
History
''Informed consent'' is a technical term first used by attorney, Paul G. Gebhard, in a medical malpractice United States court case in 1957. In tracing its history, some scholars have suggested tracing the history of checking for any of these practices:
# A patient agrees to a health intervention based on an understanding of it.
# The patient has multiple choices and is not compelled to choose a particular one.
# The consent includes giving permission.
These practices are part of what constitutes informed consent, and their history is the history of informed consent.
They combine to form the modern concept of informed consent—which rose in response to particular incidents in modern research.
Whereas various cultures in various places practiced informed consent, the modern concept of informed consent was developed by people who drew influence from
Western tradition.
Medical history
![First informed consent document Turkey 1539](https://upload.wikimedia.org/wikipedia/commons/4/4b/First_informed_consent_document_Turkey_1539.png)
Historians cite a series of medical guidelines to trace the history of informed consent in medical practice.
The
Hippocratic Oath, a Greek text dating to 500 B.C.E., was the first set of Western writings giving guidelines for the conduct of medical professionals. Consent by patients as well as several other, now considered fundamental issues, is not mentioned. The
Hippocratic Corpus
The Hippocratic Corpus (Latin: ''Corpus Hippocraticum''), or Hippocratic Collection, is a collection of around 60 early Ancient Greek medical works strongly associated with the physician Hippocrates and his teachings. The Hippocratic Corpus cove ...
advises that physicians conceal most information from patients to give the patients the best care.
The rationale is a
beneficence model for care—the doctor knows better than the patient, and therefore should direct the patient's care, because the patient is not likely to have better ideas than the doctor.
Henri de Mondeville
Henri de Mondeville (1320) was a medieval French surgeon who made a significant number of contributions to anatomy and surgery, and was the first Frenchman to author a surgical treatise, ''La Chirurgie'' (1306-1320). Very little is known about th ...
, a French surgeon who in the 14th century, wrote about medical practice. He traced his ideas to the Hippocratic Oath.
Among his recommendations were that doctors "promise a cure to every patient" in hopes that the good prognosis would inspire a good outcome to treatment.
Mondeville never mentioned getting consent, but did emphasize the need for the patient to have confidence in the doctor.
He also advised that when deciding therapeutically unimportant details the doctor should meet the patients' requests "so far as they do not interfere with treatment".
In Ottoman Empire records there exists an agreement from 1539 in which negotiates details of a surgery, including fee and a commitment not to sue in case of death.
This is the oldest identified written document in which a patient acknowledges risk of medical treatment and writes to express their willingness to proceed.
Benjamin Rush
Benjamin Rush (April 19, 1813) was a Founding Fathers of the United States, Founding Father of the United States who signed the United States Declaration of Independence, and a civic leader in Philadelphia, where he was a physician, politician, ...
was an 18th-century United States physician who was influenced by the
Age of Enlightenment
The Age of Enlightenment or the Enlightenment; german: Aufklärung, "Enlightenment"; it, L'Illuminismo, "Enlightenment"; pl, Oświecenie, "Enlightenment"; pt, Iluminismo, "Enlightenment"; es, La Ilustración, "Enlightenment" was an intel ...
cultural movement.
Because of this, he advised that doctors ought to share as much information as possible with patients. He recommended that doctors educate the public and respect a patient's informed decision to accept therapy.
There is no evidence that he supported seeking a consent from patients.
In a lecture titled "On the duties of patients to their physicians", he stated that patients should be strictly obedient to the physician's orders; this was representative of much of his writings.
John Gregory, Rush's teacher, wrote similar views that a doctor could best practice beneficence by making decisions for the patients without their consent.
Thomas Percival
Thomas Percival (29 September 1740 – 30 August 1804) was an English physician, health reformer, ethicist and author who wrote an early code of medical ethics. He drew up a pamphlet with the code in 1794 and wrote an expanded version in 18 ...
was a British physician who published a book called ''Medical Ethics'' in 1803.
Percival was a student of the works of Gregory and various earlier Hippocratic physicians.
Like all previous works, Percival's ''Medical Ethics'' makes no mention of soliciting for the consent of patients or respecting their decisions.
Percival said that patients have a right to truth, but when the physician could provide better treatment by lying or withholding information, he advised that the physician do as he thought best.
When the
American Medical Association
The American Medical Association (AMA) is a professional association and lobbying group of physicians and medical students. Founded in 1847, it is headquartered in Chicago, Illinois. Membership was approximately 240,000 in 2016.
The AMA's sta ...
was founded they in 1847 produced a work called the first edition of the ''American Medical Association Code of Medical Ethics''.
Many sections of this book are verbatim copies of passages from Percival's ''Medical Ethics''.
A new concept in this book was the idea that physicians should fully disclose all patient details truthfully when talking to other physicians, but the text does not also apply this idea to disclosing information to patients.
Through this text, Percival's ideas became pervasive guidelines throughout the United States as other texts were derived from them.
Worthington Hooker was an American physician who in 1849 published ''Physician and Patient''.
This medical ethics book was radical demonstrating understanding of the AMA's guidelines and Percival's philosophy and soundly rejecting all directives that a doctor should lie to patients.
In Hooker's view, benevolent deception is not fair to the patient, and he lectured widely on this topic.
Hooker's ideas were not broadly influential.
The US
Canterbury v. Spence case established the principle of informed consent in US law. Earlier legal cases had created the underpinnings for informed consent, but his judgment gave a detailed and thought through discourse on the matter. The judgment cites cases going back to 1914 as precedent for informed consent.
Research history
Historians cite a series of
human subject research experiments to trace the history of informed consent in research.
The U.S. Army Yellow Fever Commission "is considered the first research group in history to use consent forms." In 1900, Major
Walter Reed
Walter Reed (September 13, 1851 – November 22, 1902) was a U.S. Army physician who in 1901 led the team that confirmed the theory of Cuban doctor Carlos Finlay that yellow fever is transmitted by a particular mosquito species rather than ...
was appointed head of the four man U.S. Army Yellow Fever Commission in
Cuba
Cuba ( , ), officially the Republic of Cuba ( es, República de Cuba, links=no ), is an island country comprising the island of Cuba, as well as Isla de la Juventud and several minor archipelagos. Cuba is located where the northern Caribbea ...
that determined
mosquito
Mosquitoes (or mosquitos) are members of a group of almost 3,600 species of small flies within the family Culicidae (from the Latin ''culex'' meaning " gnat"). The word "mosquito" (formed by ''mosca'' and diminutive ''-ito'') is Spanish for "li ...
es were the vector for
yellow fever
Yellow fever is a viral disease of typically short duration. In most cases, symptoms include fever, chills, loss of appetite, nausea, muscle pains – particularly in the back – and headaches. Symptoms typically improve within five days. In ...
transmission. His earliest experiments were probably done without formal documentation of informed consent. In later experiments he obtained support from appropriate military and administrative authorities. He then drafted what is now "one of the oldest series of extant informed consent documents."
The three surviving examples are in Spanish with English translations; two have an individual's signature and one is marked with an X.
''
Tearoom Trade
''Tearoom Trade: Impersonal Sex in Public Places'' is a 1970 non-fiction book by American sociologist Laud Humphreys, based on his 1968 Ph.D. dissertation "Tearoom Trade: A Study of Homosexual Encounters in Public Places." The study is an ana ...
'' is the name of a book by American psychologist
Laud Humphreys
Robert Allan Humphreys (1930–1988), known as Laud Humphreys, was an American sociology, sociologist and Episcopalianism, Episcopal priest. He is noted for his research into cottaging, sexual encounters between men in public bathrooms, published a ...
. In it he describes his research into male
homosexual
Homosexuality is romantic attraction, sexual attraction, or sexual behavior between members of the same sex or gender. As a sexual orientation, homosexuality is "an enduring pattern of emotional, romantic, and/or sexual attractions" to peop ...
acts.
In conducting this research he never sought consent from his research subjects and other researchers raised concerns that he violated the right to
privacy for research participants Privacy for research participants is a concept in research ethics which states that a person in human subject research has a right to privacy when participating in research. Some typical scenarios this would apply to include, or example, a surveyo ...
.
Henrietta Lacks On Jan. 29, 1951, shortly after the birth of her son Joseph, Lacks entered Johns Hopkins Hospital in Baltimore with profuse bleeding. She was diagnosed with cervical cancer and was treated with inserts of radium tubes. During her radiation treatments for the tumor, two samples—one of healthy cells, the other of malignant cells—were removed from her cervix without her permission. Later that year, 31-year-old Henrietta Lacks died from the cancer. Her cells were cultured creating Hela cells, but the family was not informed until 1973, the family learned the truth when scientists asked for DNA samples after finding that HeLa had contaminated other samples. In 2013 researchers published the genome without the Lacks family consent.
The
Milgram experiment
The Milgram experiment(s) on obedience to authority figures were a series of social psychology experiments conducted by Yale University psychologist Stanley Milgram. They measured the willingness of study participants, 40 men in the age range ...
is the name of a 1961 experiment conducted by American psychologist
Stanley Milgram. In the experiment Milgram had an authority figure order research participants to commit a disturbing act of harming another person.
After the experiment he would reveal that he had deceived the participants and that they had not hurt anyone, but the research participants were upset at the experience of having participated in the research.
The experiment raised broad discussion on the ethics of recruiting participants for research without giving them full information about the nature of the research.
Chester M. Southam
Chester Milton Southam (October 4, 1919 – April 15, 2002) was an immunologist and oncologist at Memorial Sloan Kettering Cancer Center and Cornell University Medical College; he went to Thomas Jefferson University in 1971 and worked there unti ...
used HeLa cells to inject into cancer patients and
Ohio State Penitentiary
The Ohio State Penitentiary (OSP) is a 502-inmate capacity supermax Ohio Department of Rehabilitation and Correction prison in Youngstown, Ohio.
Throughout the last two centuries, there have been two institutions with the name Ohio Penitent ...
inmates without informed consent to determine if people could become immune to cancer and if cancer could be transmitted.
Medical procedures
The doctrine of informed consent relates to
professional negligence and establishes a breach of the duty of care owed to the patient (see
duty of care
In tort law, a duty of care is a legal obligation that is imposed on an individual, requiring adherence to a standard of reasonable care while performing any acts that could foreseeably harm others. It is the first element that must be establi ...
,
breach of the duty, and
respect for persons
Respect for persons is the concept that all people deserve the right to fully exercise their autonomy. Showing respect for persons is a system for interaction in which one entity ensures that another has agency to be able to make a choice.
This ...
). The doctrine of informed consent also has significant implications for medical trials of medications, devices, or procedures.
Requirements of the professional
Until 2015 in the
United Kingdom
The United Kingdom of Great Britain and Northern Ireland, commonly known as the United Kingdom (UK) or Britain, is a country in Europe, off the north-western coast of the continental mainland. It comprises England, Scotland, Wales and North ...
and in countries such as
Malaysia
Malaysia ( ; ) is a country in Southeast Asia. The federation, federal constitutional monarchy consists of States and federal territories of Malaysia, thirteen states and three federal territories, separated by the South China Sea into two r ...
and
Singapore
Singapore (), officially the Republic of Singapore, is a sovereign island country and city-state in maritime Southeast Asia. It lies about one degree of latitude () north of the equator, off the southern tip of the Malay Peninsula, borde ...
, informed consent in medical procedures requires proof as to the standard of care to expect as a recognised standard of acceptable professional practice (the
Bolam Test
''Bolam v Friern Hospital Management Committee'' 9571 WLR 582 is an English tort law case that lays down the typical rule for assessing the appropriate standard of reasonable care in negligence cases involving skilled professionals such as doctor ...
), that is, what risks would a medical professional usually disclose in the circumstances (see
Loss of right in English law). Arguably, this is "sufficient consent" rather than "informed consent." The UK has since departed from the Bolam test for judging standards of informed consent, due to the landmark ruling in ''
Montgomery v Lanarkshire Health Board
''Montgomery v Lanarkshire Health Board'' 015UKSC 11is a Scottish delict, medical negligence and English tort law case on doctors and pharmacists that outlines the rule on the disclosure of risks to satisfy the criteria of an informed consent. T ...
''. This moves away from the concept of a reasonable physician and instead uses the standard of a
reasonable patient, and what risks an individual would attach significance to.
Medicine in the United States, Australia, and Canada also takes this patient-centric approach to "informed consent." Informed consent in these jurisdictions requires healthcare providers to disclose significant risks, as well as risks of particular importance to that patient. This approach combines an objective (a hypothetical reasonable patient) and subjective (this particular patient) approach.
The doctrine of informed consent should be contrasted with the general doctrine of medical consent, which applies to
assault or
battery
Battery most often refers to:
* Electric battery, a device that provides electrical power
* Battery (crime), a crime involving unlawful physical contact
Battery may also refer to:
Energy source
*Automotive battery, a device to provide power t ...
. The consent standard here is only that the person understands, in general terms, the nature of and purpose of the intended intervention. As the higher standard of informed consent applies to negligence, not battery, the other elements of negligence must be made out. Significantly, causation must be shown: That had the individual been made aware of the risk he would not have proceeded with the operation (or perhaps with that surgeon).
Optimal establishment of an informed consent requires adaptation to cultural or other individual factors of the patient. For example, people from Mediterranean and Arab appear to rely more on the context of the delivery of the information, with the information being carried more by who is saying it and where, when, and how it is being said, rather than ''what'' is said, which is of relatively more importance in typical "Western" countries.
The informed consent doctrine is generally implemented through good healthcare practice: pre-operation discussions with patients and the use of medical consent forms in hospitals. However, reliance on a signed form should not undermine the basis of the doctrine in giving the patient an opportunity to weigh and respond to the risk. In one British case, a doctor performing routine surgery on a woman noticed that she had cancerous tissue in her womb. He took the initiative to remove the woman's womb; however, as she had not given informed consent for this operation, the doctor was judged by the
General Medical Council to have acted negligently. The council stated that the woman should have been informed of her condition, and allowed to make her own decision.
Obtaining informed consents
To document that informed consent has been given for a procedure, healthcare organisations have traditionally used paper-based consent forms on which the procedure and its risks and benefits are noted, and is signed by both patient and clinician. In a number of healthcare organisations consent forms are scanned and maintained in an electronic document store. The paper consent process has been demonstrated to be associated with significant errors of omission, and therefore increasing numbers of organisations are using digital consent applications where the risk of errors can be minimised, a patient's decision making and comprehension can be supported by additional lay-friendly and accessible information, consent can be completed remotely, and the process can become paperless. One form of digital consent is
dynamic consent
Dynamic consent is an approach to informed consent that enables on-going engagement and communication between individuals and the users and custodians of their data. It is designed to address the many issues that are raised by the use of digital t ...
, which invites participants to provide consent in a granular way, and makes it easier for them to withdraw consent if they wish.
Electronic consent methods have been used to support indexing and retrieval of consent data, thus enhancing the ability to honor to patient intent and identify willing research participants.
More recently,
Health Sciences South Carolina, a statewide research collaborative focused on transforming healthcare quality, health information systems and patient outcomes, developed an open-source system called Research Permissions Management System (RPMS).
Competency of the patient
The ability to give informed consent is governed by a general requirement of competency. In common law jurisdictions, adults are presumed competent to consent. This presumption can be rebutted, for instance, in circumstances of mental illness or other incompetence. This may be prescribed in legislation or based on a common-law standard of inability to understand the nature of the procedure. In cases of incompetent adults, a
health care proxy
In the field of medicine, a healthcare proxy (commonly referred to as HCP) is a document (legal instrument) with which a patient (primary individual) appoints an agent to legally make healthcare decisions on behalf of the patient, when the patient ...
makes medical decisions. In the absence of a proxy, the medical practitioner is expected to act in the patient's best interests until a proxy can be found.
By contrast, '
minors' (which may be defined differently in different jurisdictions) are generally presumed incompetent to consent, but depending on their age and other factors may be required to provide
Informed assent
The term informed assent describes the process whereby Minor (law), minors may agree to participate in clinical trials. It is similar to the process of informed consent in adults, however there remains some overlap between the terms.
Background
...
. In some jurisdictions (e.g. much of the U.S.), this is a strict standard. In other jurisdictions (e.g. England, Australia, Canada), this presumption may be rebutted through proof that the minor is 'mature' (the '
Gillick standard'). In cases of incompetent minors, informed consent is usually required from the parent (rather than the 'best interests standard') although a
parens patriae
''Parens patriae'' is Latin for "parent of the nation" (lit., "parent of one's country"). In law, it refers to the public policy power of the state to intervene against an abusive or negligent parent, legal guardian, or informal caretaker, and to ...
order may apply, allowing the court to dispense with parental consent in cases of refusal.
Deception
Research involving deception is controversial given the requirement for informed consent. Deception typically arises in social psychology, when researching a particular psychological process requires that investigators deceive subjects. For example, in the
Milgram experiment
The Milgram experiment(s) on obedience to authority figures were a series of social psychology experiments conducted by Yale University psychologist Stanley Milgram. They measured the willingness of study participants, 40 men in the age range ...
, researchers wanted to determine the willingness of participants to obey authority figures despite their personal conscientious objections. They had authority figures demand that participants deliver what they thought was an electric shock to another research participant. For the study to succeed, it was necessary to deceive the participants so they believed that the subject was a peer and that their electric shocks caused the peer actual pain.
Nonetheless, research involving deception prevents subjects from exercising their basic right of autonomous informed decision-making and conflicts with the ethical principle of
respect for persons
Respect for persons is the concept that all people deserve the right to fully exercise their autonomy. Showing respect for persons is a system for interaction in which one entity ensures that another has agency to be able to make a choice.
This ...
.
The
Ethical Principles of Psychologists and Code of Conduct
The American Psychological Association (APA) Ethical Principles of Psychologists and Code of Conduct (for short, the Ethics Code, as referred to by the APA) includes an introduction, preamble, a list of five aspirational principles and a list of t ...
set by the
American Psychological Association
The American Psychological Association (APA) is the largest scientific and professional organization of psychologists in the United States, with over 133,000 members, including scientists, educators, clinicians, consultants, and students. It ha ...
says that psychologists may conduct research that includes a deceptive compartment only if they can both justify the act by the value and importance of the study's results and show they could not obtain the results by some other way. Moreover, the research should bear no potential harm to the subject as an outcome of deception, either physical pain or
emotional distress
In medicine, distress is an aversive state in which a person is unable to completely adapt to stressors and their resulting stress and shows maladaptive behaviors. It can be evident in the presence of various phenomena, such as inappropriate so ...
. Finally, the code requires a debriefing session in which the experimenter both tells the subject about the deception and gives subject the option of withdrawing the data.
Abortion
In some U.S. states, informed consent laws (sometimes called "right to know" laws) require that a woman seeking an elective
abortion
Abortion is the termination of a pregnancy by removal or expulsion of an embryo or fetus. An abortion that occurs without intervention is known as a miscarriage or "spontaneous abortion"; these occur in approximately 30% to 40% of pregn ...
receive information from the abortion provider about her legal rights, alternatives to abortion (such as
adoption
Adoption is a process whereby a person assumes the parenting of another, usually a child, from that person's biological or legal parent or parents. Legal adoptions permanently transfer all rights and responsibilities, along with filiation, from ...
), available public and private assistance, and other information specified in the law, before the abortion is performed. Other countries with such laws (e.g.
Germany
Germany,, officially the Federal Republic of Germany, is a country in Central Europe. It is the second most populous country in Europe after Russia, and the most populous member state of the European Union. Germany is situated betwe ...
) require that the information giver be properly certified to make sure that no abortion is carried out for the financial gain of the abortion provider and to ensure that the decision to have an abortion is not swayed by any form of incentive.
Some informed consent laws have been criticized for allegedly using "loaded language in an apparently deliberate attempt to 'personify' the fetus," but those critics acknowledge that "most of the information in the
egally mandatedmaterials about abortion comports with recent scientific findings and the principles of informed consent", although "some content is either misleading or altogether incorrect."
From children
As children often lack the decision-making ability or legal power (competence) to provide true informed consent for medical decisions, it often falls on parents or legal guardians to provide ''informed permission'' for medical decisions. This "consent by proxy" usually works reasonably well, but can lead to ethical dilemmas when the judgment of the parents or guardians and the medical professional differ with regard to what constitutes appropriate decisions "in the best interest of the child". Children who are
legally emancipated, and certain situations such as decisions regarding sexually transmitted diseases or pregnancy, or for unemancipated minors who are deemed to have medical decision making capacity, may be able to provide consent without the need for parental permission depending on the laws of the jurisdiction the child lives in. The
American Academy of Pediatrics
The American Academy of Pediatrics (AAP) is an American professional association of pediatricians, headquartered in Itasca, Illinois. It maintains its Department of Federal Affairs office in Washington, D.C.
Background
The Academy was founded ...
encourages medical professionals also to seek the assent of older children and adolescents by providing age appropriate information to these children to help empower them in the decision-making process.
Research on children has benefited society in many ways. The only effective way to establish normal patterns of growth and metabolism is to do research on infants and young children. When addressing the issue of informed consent with children, the primary response is parental consent. This is valid, although only legal guardians are able to consent for a child, not adult siblings.
Additionally, parents may not order the termination of a treatment that is required to keep a child alive, even if they feel it is in the best interest.
Guardians are typically involved in the consent of children, however a number of doctrines have developed that allow children to receive health treatments without parental consent. For example, emancipated minors may consent to medical treatment, and minors can also consent in an emergency.
Consent to research
Informed consent is part of the ethical
clinical research
Clinical research is a branch of healthcare science that determines the safety and effectiveness ( efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatm ...
as well, in which a human subject voluntarily confirms his or her willingness to participate in a particular
clinical trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...
, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form.
In
medical research
Medical research (or biomedical research), also known as experimental medicine, encompasses a wide array of research, extending from "basic research" (also called ''bench science'' or ''bench research''), – involving fundamental scientif ...
, the
Nuremberg Code
The Nuremberg Code (german: Nürnberger Kodex) is a set of ethical research principles for human experimentation created by the court in '' U.S. v Brandt'', one of the Subsequent Nuremberg trials that were held after the Second World War.
Tho ...
set a base international standard in 1947, which continued to develop, for example in response to the ethical violation in the
Holocaust
The Holocaust, also known as the Shoah, was the genocide of European Jews during World War II. Between 1941 and 1945, Nazi Germany and its collaborators systematically murdered some six million Jews across German-occupied Europe; a ...
. Nowadays, medical research is overseen by an
ethics committee
An ethics committee is a body responsible for ensuring that medical experimentation and human subject research are carried out in an ethical manner in accordance with national and international law.
Specific regions
An ethics committee in the E ...
that also oversees the informed consent process.
As the medical guidelines established in the Nuremberg Code were imported into the ethical guidelines for the
social science
Social science is one of the branches of science, devoted to the study of societies and the relationships among individuals within those societies. The term was formerly used to refer to the field of sociology, the original "science of soc ...
s, informed consent became a common part of the research procedure. However, while informed consent is the default in medical settings, it is not always required in the social science. Here, research often involves low or no risk for participants, unlike in many medical experiments. Second, the mere knowledge that they participate in a study can cause people to alter their behavior, as in the
Hawthorne Effect
The Hawthorne effect is a type of reactivity in which individuals modify an aspect of their behavior in response to their awareness of being observed. The effect was discovered in the context of research conducted at the Hawthorne Western Electri ...
: "In the typical lab experiment, subjects enter an environment in which they are keenly aware that their behavior is being monitored, recorded, and subsequently scrutinized."
In such cases, seeking informed consent directly interferes with the ability to conduct the research, because the very act of revealing that a study is being conducted is likely to alter the behavior studied. List exemplifies the potential dilemma that can result: "if one were interested in exploring whether, and to what extent, race or gender influences the prices that buyers pay for used cars, it would be difficult to measure accurately the degree of discrimination among used car dealers who know that they are taking part in an experiment." In cases where such interference is likely, and after careful consideration, a researcher may forgo the informed consent process. This is commonly done after weighting the risk to study participants versus the benefit to society and whether participants are present in the study out of their own wish and treated fairly. Researchers often consult with an ethics committee or institutional review board to render a decision.
The birth of new online media, such as social media, has complicated the idea of informed consent. In an online environment people pay little attention to Terms of Use agreements and can subject themselves to research without thorough knowledge. This issue came to the public light following a study conducted by
Facebook Inc. in 2014, and published by that company and
Cornell University
Cornell University is a private statutory land-grant research university based in Ithaca, New York. It is a member of the Ivy League. Founded in 1865 by Ezra Cornell and Andrew Dickson White, Cornell was founded with the intention to teach an ...
. Facebook conducted a study where they altered the Facebook News Feeds of roughly 700,000 users to reduce either the amount of positive or negative posts they saw for a week. The study then analyzed if the users status updates changed during the different conditions. The study was published in the Proceedings of the National Academy of Sciences.
The lack of informed consent led to outrage among many researchers and users. Many believed that by potentially altering the mood of users by altering what posts they see, Facebook put at-risk individuals at higher dangers for depression and suicide. However, supports of Facebook claim that Facebook details that they have the right to use information for research in their terms of use. Others say the experiment is just a part of Facebook's current work, which alters News Feeds algorithms continually to keep people interested and coming back to the site. Others pointed out that this specific study is not along but that news organizations constantly try out different headlines using algorithms to elicit emotions and garner clicks or Facebook shares. They say this Facebook study is no different from things people already accept. Still, others say that Facebook broke the law when conducting the experiment on user that didn't give informed consent.
The Facebook study controversy raises numerous questions about informed consent and the differences in the ethical review process between publicly and privately funded research. Some say Facebook was within its limits and others see the need for more informed consent and/or the establishment of in-house private review boards.
Conflicts of interest
Other, long-standing controversies underscore the role for
conflicts of interest
A conflict of interest (COI) is a situation in which a person or organization is involved in multiple wikt:interest#Noun, interests, finance, financial or otherwise, and serving one interest could involve working against another. Typically, t ...
among medical school faculty and researchers. For example, coverage of University of California (UC) medical school faculty members has included news of ongoing corporate payments to researchers and practitioners from companies that market and produce the very devices and treatments they recommend to patients.
[Petersen, Melody. (2014, May 25). UC system struggles with professors' outside earnings. Orange County Register. Retrieved from https://www.ocregister.com/2014/05/27/uc-system-struggles-with-professors-outside-earnings/] Robert Pedowitz, the former chairman of UCLA's orthopedic surgery department, reported concern that his colleague's financial conflicts of interest could negatively affect patient care or research into new treatments.
[Terhune, Chad (2014, April 25). More scrutiny for UCLA's School of Medicine. Los Angeles Times. Retrieved from http://www.latimes.com/business/la-fi-ucla-outside-money-20140426-story.html#ixzz30BvcCJIV] In a subsequent lawsuit about whistleblower retaliation, the university provided a $10 million settlement to Pedowitz while acknowledging no wrongdoing.
Consumer Watchdog, an oversight group, observed that University of California policies were "either inadequate or unenforced...Patients in UC hospitals deserve the most reliable surgical devices and medication…and they shouldn't be treated as subjects in expensive experiments."
Other UC incidents include taking the eggs of women for implantation into other women without consent and injecting live bacteria into human brains, resulting in potentially premature deaths.
[The Sacramento Bee. (2013, August 25). UC Davis surgeons resign after bacteria-in-brain dispute. Retrieved from ]
See also
*
Anti-Psychiatry
Anti-psychiatry is a movement based on the view that psychiatric treatment is often more damaging than helpful to patients, highlighting controversies about psychiatry. Objections include the reliability of psychiatric diagnosis, the questionabl ...
*
Belmont Report
The ''Belmont Report'' is a report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its full title is the ''Belmont Report: Ethical Principles and Guidelines for the Protection of Human ...
*
Consent (BDSM)
Consent within BDSM is when a participant gives their permission for certain acts or types of relationships. It bears much in common with the concept of informed consent and is simultaneously a personal, ethical and social issue. It is an iss ...
*
Consent (criminal law)
*
Consensual crime
A consensual crime is a public-order crime that involves more than one participant, all of whom give their consent as willing participants in an activity that is unlawful. Legislative bodies and interest groups sometimes rationalize the criminali ...
*
Declaration of Geneva
The Declaration of Geneva was adopted by the General Assembly of the World Medical Association at Geneva in 1948, amended in 1968, 1983, 1994, editorially revised in 2005 and 2006 and amended in 2017.
It is a declaration of a physician's dedicati ...
*
Declaration of Helsinki
The Declaration of Helsinki (DoH, fi, Helsingin julistus, sv, Helsingforsdeklarationen) is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA) ...
*
Dynamic consent
Dynamic consent is an approach to informed consent that enables on-going engagement and communication between individuals and the users and custodians of their data. It is designed to address the many issues that are raised by the use of digital t ...
*
Free, prior and informed consent
Free, prior and informed consent (FPIC) is aimed to establish bottom-up participation and consultation of an indigenous population prior to the beginning of development on ancestral land or using resources in an indigenous population's territory. ...
*
Human experimentation
*
Informed assent
The term informed assent describes the process whereby Minor (law), minors may agree to participate in clinical trials. It is similar to the process of informed consent in adults, however there remains some overlap between the terms.
Background
...
*
Informed refusal
*
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
*
Minors and abortion
Many jurisdictions have laws applying to minors and abortion. These parental involvement laws require that one or more parents consent or be informed before their minor daughter may legally have an abortion.
Minors and abortion in law Australia ...
*
Parental consent
Parental consent laws (also known as parental involvement laws) in some countries require that one or more parents consent to or be notified before their minor child can legally engage in certain activities.
Parental consent may refer to:
*A pa ...
*
Patient safety
Patient safety is a discipline that emphasizes safety in health care through the prevention, reduction, reporting and analysis of error and other types of unnecessary harm that often lead to adverse patient events. The frequency and magnitude of ...
*
Safe, sane and consensual
The fundamental principles for the exercise of BDSM require that it be performed with the informed consent of all parties. Since the 1980s, many practitioners and organizations have adopted the motto safe, sane and consensual, commonly abbreviated ...
*
World Medical Association
The World Medical Association (WMA) is an international and independent confederation of free professional medical associations representing physicians worldwide. WMA was formally established on September 18, 1947 and has grown to 115 national ...
*
Therapeutic misconception
References
{{Authority control
Consent
Medical ethics
Human subject research
Clinical research ethics
Concepts in ethics
Clinical trials
University of California
Medical sociology