Informed consent
Informed consent is the process by which a person voluntarily agrees to medical treatment or participation in research after understanding relevant information, risks, benefits and alternatives.
Overview
Informed consent is the process through which an individual makes a voluntary and informed decision to accept or refuse a proposed medical intervention, procedure or participation in research. It is both an ethical obligation and, in many places, a legal requirement intended to protect patient autonomy and promote transparent clinician–patient communication. The principle recognizes a person's right to receive adequate information and to decide what happens to their body.
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Core elements
Effective informed consent typically depends on several interrelated elements. Clinicians must provide clear disclosure of the diagnosis, the nature and purpose of the proposed treatment, foreseeable risks and benefits, reasonable alternatives (including the option of no treatment), and the likely outcomes of each option. The patient must understand this information, be competent to decide, and give consent voluntarily, without coercion. Documentation can be written, verbal, or implied depending on the situation and local law.
Historical and legal context
The modern practice of informed consent developed from ethical responses to abuses in medicine and research in the 20th century. International statements and codes such as those influenced by the Nuremberg principles and later guidelines emphasize voluntary participation in research. Many legal systems incorporate informed consent into tort, contract and human rights frameworks; however, statutory requirements and procedures vary across jurisdictions.
Applications and common situations
- Clinical care: routine procedures and major surgeries usually require explicit consent after discussion of alternatives and risks.
- Research: enrollment in clinical trials requires documented informed consent that explains study procedures, potential benefits, and unknowns.
- Special cases: emergencies, incapacity, minors, or impaired decision-making create exceptions or call for surrogate decision-makers and advance directives.
Distinctions and notable facts
Informed consent differs from implied consent (assumed from a person's actions) and from assent (agreement by individuals not legally able to give full consent, such as children). International human-rights instruments and disability rights frameworks recognize the importance of access to information and supported decision-making; for example, the Convention on the Rights of Persons with Disabilities emphasizes equal rights and reasonable accommodations. Medical ethics resources and professional guidance on communication and consent can be found under broader discussions of medical ethics.
While informed consent seeks to respect autonomy and reduce harm, practical challenges include ensuring true comprehension, language or cultural barriers, time pressures, and differing legal standards. Clinicians and institutions therefore combine clear communication, documentation, and respect for patients' values to uphold the principle.
Civil and criminal significance of consent.
According to Section 630d of the German Civil Code, the practitioner is obliged to obtain the patient's consent before carrying out a medical measure, in particular an intervention in the body or health. The practitioner must ask the patient expressly and unambiguously whether he or she consents to the measure, after having properly informed him or her in advance in an understandable manner.
Effective, i.e. informed, consent is the justification for the practitioner to inflict bodily harm associated with the treatment, so that the bodily harming treatment measures, insofar as they are covered by consent, do not give rise to criminal or tort liability on the part of the practitioner.
Informed consent in the sexual abuse debate
The term informed consent has been used since 1979 by the American author David Finkelhor as a justification for a general rejection of sex with children. Finkelhor formulated that children, and in some cases adolescents, can willingly consent to sexual acts, but in doing so they do not overlook the implications of such consent. Accordingly, they did not knowingly (informed) consent to the act, regardless of whom they were consenting to. Finkelhor's studies demonstrated dramatic harm in a large proportion of abuse victims, but not all. He thus found a developmental psychological argument against sexual acts with children that does not necessarily rely on proof of harm, thus sparing the victim humiliating investigations if necessary.
Informed consent has no relevance to the legal consideration of sex with children as sexual abuse; most states have an age of consent below which sexual activity is prohibited.
The concept of knowing consent was countered by proponents (advocates) of pedophilic relationships such as Walter Bärsch, Rüdiger Lautmann and Ernst Bornemann.
See also: paedophilia debate of the 1970s and 1980s and paedophilia debate 2013
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Author
AlegsaOnline.com Informed consent Leandro Alegsa
URL: https://en.alegsaonline.com/art/47313