Informed consent is a legal condition whereby a person can be said to have given consent based upon an appreciation and understanding of the facts and implications of an action. The individual needs to be in possession of all of his faculties, such as not being mentally retarded or mentally ill and without an impairment of judgment at the time of consenting. Impairments include illness, intoxication, drunkenness, using drugs, and other health problems.

Some acts cannot legally take place because of a lack of informed consent. In other cases, consent of someone on behalf of a person not considered able to give informed consent is valid. Examples of this include the parents or legal guardians of a child and caregivers for the mentally ill.

[edit] Issues surrounding assessment of consent

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. Many times consent is implied within the usual subtleties of human communication, rather than explicitly negotiated verbally or in writing. In some cases consent is legally prevented from ever being possible, even if the person protests they do indeed understand and wish.

There is thus 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 which may normally be relied upon legally, regardless of actual consent, is the norm.

Brief examples of each of the above:

1. A person may verbally agree to something from fear, perceived social pressure, or psychological difficulty in asserting their true feelings, and the person requesting the action may honestly be unaware of this and believe it is genuine, and rely upon it. Consent is expressed, but not internally given.
2. A person may state they understand the implications of some action, as part of their consent, but in fact not have appreciated the possible consequences fully and later deny the validity of their consent for this reason. Understanding needed for informed consent is stated to be present but is in fact (through ignorance) not present.
3. A person below the age of consent may agree to sex, know all the consequences, but their consent is deemed invalid as they are deemed (regardless of the reality) to be a child unaware of the issues and thus incapable of being informed consent. Individual is barred from legally giving informed consent, despite what they may feel (1)
4. A person signs a legal release form for a medical procedure, and later feels they did not really consent. Unless they 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 will usually legally override later denial of informed consent (unless obtained by misrepresentation)

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. The doctrine of informed consent also has significant implications for medical trials of new medications.

[edit] Competency

The ability to give informed consent will be 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, informed consent--from the patients or from their families--is not required. Rather, the medical practitioner must simply act in the patient's best interests in order to avoid negligence liability.

By contrast, 'minors' (which may be defined differently in different jurisdictions) are generally presumed incompetent to consent. 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 order may apply (allowing the court to dispense with parental consent in cases of refusal).

While children may be able to give consent, a more complex question applies in terms of informed consent: whether children are developmentally and otherwise able to give informed consent, in particular to an adult, bearing in mind power relationships, maturity, experience and mental development. For this and other reasons most states have an age of consent under which a child is deemed unable to give consent. As evaluation of maturity, mental maturity, child development, child communication, and child intelligence are further explored, this may be based on psychological and medical evaluation of status for sexual activity instead of chronological age.

[edit] Research

Informed consent is also important in social research. For example in survey research, people need to give informed consent before they participate in the survey. In medical research the Nuremberg Code has set a base standard since 1947, and most research proposals are reviewed by ethics committees, otherwise knows in the USA as IRBs in the 21st Century.

[edit] See also

• Online Research Ethics
• IRB FAQ

[edit] References

Page title: Informed consent
Revision ID: 3242
Date accessed: Thursday, September 2, 2010
Stable URL: http://lo-wiki.acor.org/index.php/Informed_consent
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