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MedicalDevice版 - informed consent
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Informed consent
From Wikipedia, the free encyclopedi
"Informed Consent" redirects here. For the House episode, see Informed
Consent (House). For the website, see Informed Consent (website).
Scales of justice
Tort law
Part of the common law series
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v · d · e
Informed consent is a phrase often used in law to indicate that the consent
a person gives meets certain minimum standards. As a literal matter, in the
absence of fraud, it is redundant. An informed consent can be said to have
been given based upon a clear appreciation and understanding of the facts,
implications, and future consequences of an action. In order to give
informed consent, the individual concerned must have adequate reasoning
faculties and be in possession of all relevant facts at the time consent is
given. Impairments to reasoning and judgment which may make it impossible
for someone to give informed consent include such factors as basic
intellectual or emotional immaturity, high levels of stress such as PTSD or
as severe mental retardation, severe mental illness, intoxication, severe
sleep deprivation, Alzheimer's disease, or being in a coma. This term was
first used in a 1957 medical malpractice case by Paul G. Gebhard.
Some acts cannot legally take place because of a lack of informed consent.
In cases where an individual is considered unable to give informed consent,
another person is generally authorized to give consent on his behalf, e.g.,
parents or legal guardians of a child and caregivers for the mentally ill.
However, if a severely injured person is brought to a hospital in an
unconscious state and no-one is available to give informed consent, doctors
will give whatever treatment is necessary to save their life (according to
the Hippocratic oath), which might involve major surgery, e.g., amputation.
In cases where an individual is provided insufficient information to form a
reasoned decision, serious ethical issues arise. Such cases in a clinical
trial in medical research are anticipated and prevented by an ethics
committee or Institutional Review Board.
Contents
[hide]
1 Assessment of consent
2 Medical procedures
2.1 Competency
2.2 Abortion
2.3 Vaccines
3 Sex
4 No-victim laws
5 Research
6 See also
7 Footnotes
8 Bibliography
9 External links
[edit] 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. 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.
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:
A person may verbally agree to something from fear, perceived social
pressure, or psychological difficulty in asserting his true feelings. The
person requesting the action may honestly be unaware of this and believe the
consent is genuine, and rely upon it. Consent is expressed, but not
internally given.
A person may state he understands the implications of some action, as
part of his consent, but in fact has failed to appreciate the possible
consequences fully and later deny the validity of his consent for this
reason. Understanding needed for informed consent is stated to be present
but is in fact (through ignorance) not present.
A person may move from friendship to sexual contact on the basis of body
language and apparent receptivity, but very few people on a date that
results in sexual contact have explicitly asked the other if his or her
consent is informed, if he does in fact fully understand what is implied,
and all potential conditions or results. Informed consent is implied (or
assumed unless disproved) but not stated explicitly.
A person below the age of consent may agree to sex, knowing all the
consequences, but his or her consent is deemed invalid as he is deemed 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)
In some countries (notably the United Kingdom), individuals may not
consent to injuries being inflicted upon them, and so a person practicing
sadism and masochism upon a consenting partner may be deemed to have caused
actual bodily harm without consent, actual consent notwithstanding.
Individual is barred from legally giving informed consent, despite what they
may feel (2). See also Spanner case and 'consensual non-consensuality'.
A person signs a legal release form for a medical procedure, 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 will usually legally override later denial of informed
consent (unless obtained by misrepresentation)
A person or institution (e.g., a school or childcare professional)
exposes a minor to non-age-appropriate material, in any media format,
without the expressed informed consent of the minor's parent or legal
guardian. Informed consent in this instance goes to the argument of
competency on the part of the minor. An example would be the showing of an R
rated movie to a 12-year-old by an educational institution without the
informed consent of the parent or legal guardian.
[edit] 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, breach of the duty, and causation English law).
In the United Kingdom and countries such as Malaysia and Singapore, informed
consent requires proof as to the standard of care to be expected as a
recognised standard of acceptable professional practice (the Bolam Test),
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."
In the United States, Australia, and Canada, a more patient-centered
approach is taken and this approach is usually what is meant by the phrase "
informed consent." Informed consent in these jurisdictions requires that
significant risks be disclosed, as well as risks which would be of
particular importance to that patient. This approach combines an objective (
the 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. 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).
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.
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.
[edit] Abortion
In some U.S. States, informed consent laws (sometimes called "Right To Know"
laws) require that a woman seeking an elective abortion be given factual
information by the abortion provider about her legal rights, alternatives to
abortion (such as adoption), available public and private assistance, and
medical facts (some of which are disputed—see fetal pain), before the
abortion is performed (usually 24 hours in advance of the abortion). Other
countries with such laws (e.g. Germany) require that the information giver
not be affiliated with the abortion provider, to avoid giving an economic
incentive for handing out faulty information.[citation needed]
Some informed consent laws have been criticized for allegedly using “loaded
language in an apparently deliberate attempt to 'personify' the fetus,”[1]
but those critics acknowledge that abortion information provided pursuant
to informed consent laws “most of the information in the materials about
abortion comports with recent scientific findings and the principles of
informed consent, some content is either misleading or altogether incorrect.
”[2]
[edit] Vaccines
Except for during clinical trials, there is no Federal requirement in the
United States for providing informed consent regarding the administration of
vaccines. [1]
[edit] Sex
Ambox question.svg
The text in this section may be incoherent or very hard to understand,
and should be reworded if the intended meaning can be determined. The talk
page may have details. (March 2011)
This section does not cite any references or sources.
Please help improve this section by adding citations to reliable sources.
Unsourced material may be challenged and removed. (March 2011)
The question of whether informed consent needs to be formally given before
sexual intercourse or other sexual activity, and whether this consent can be
withdrawn at any time during the act, is an issue that is currently being
discussed in the United States regarding rape and sexual assault legislation
. For example, people who perform sexual acts on sleeping people are not
given consent unless the initiator have given prior informed consent to the
act within a reasonable recency,[citation needed] and are assumed to be
consenting during the act and to not prosecute for it when waking up. This
is also an issue in rape fantasy enaction which is often discussed by a "
ravishment community" of participants (a subset of the BDSM community) who
advocate extensive prior negotiation and planning.
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.
Animals are not usually considered able to give informed consent in a legal
sense (although advocates and some ethologists argue they have the
capability to agree and strongly solicit such activity),[citation needed]
and partly for this reason, but more usually due to concerns for morality,
bestiality is illegal in many jurisdictions.
[edit] No-victim laws
It may not be legally possible to give consent to certain activities in
certain jurisdictions; see the Operation Spanner case for an example of this
in the UK which involved sadomasochistic activities such as branding. There
are currently several legal challenges underway to address these issues of
legality in several nations.[verification needed]
Further information: Victimless crime
[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 set a base international
standard in 1947, and research proposals involving human subjects have
developed since then. Most modern research is overseen by an ethics
committee that also oversees the informed consent process.
[edit] See also
World Medical Association
Human experimentation
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use
Declaration of Geneva
Declaration of Helsinki
Belmont Report
Human experimentation in the United States
Safe, sane and consensual
Informed consent in sociocratic decision-making
Consent (BDSM)
Consent (criminal law)
Consensual crime
Parental consent
Minors and abortion
Informed refusal
Mature minor doctrine
[edit] Footnotes
^ Gold, Rachel and Nash, Elizabeth.State Abortion Counseling Policies
and the Fundamental Principles of Informed Consent, Guttmacher Policy Review
, Fall 2007, Volume 10, Number 4.
^ Richardson, Chinue and Nash, Elizabeth. “Misinformed Consent: The
Medical Accuracy of State-Developed Abortion Counseling Materials”,
Guttmacher Policy Review Fall 2006, Volume 9, Number 4.
[edit] Bibliography
Text document with red question mark.svg
This article includes a list of references, related reading or external
links, but its sources remain unclear because it lacks inline citations.
Please improve this article by introducing more precise citations where
appropriate. (July 2007)
Atkinson, J. (2006) Private and Public Protection: Civil Mental Health
Legislation, Edinburgh, Dunedin Academic Press
Druml C., Informed consent of incapable (ICU) patients in Europe:
existing laws and the EU Directive, Curr Opin Crit Care. 2004 Dec;10(6):570-
3.
Dunn LB, Nowrangi MA, Palmer BW, Jeste DV, & Saks ER, Assessing
decisional capacity for clinical research or treatment: A review of
instruments. Am J Psychiatry, 163(8):1323-1334.
Fisher, JA., Procedural Misconceptions and Informed Consent: Insights
from Empirical Research on the Clinical Trials Industry, Kennedy Institute
of Ethics Journal. 2006; 16(3): 251-268.
Holmes-Rovner M, Wills CE., Improving informed consent: insights from
behavioral decision research, Med Care. 2002 Sep;40 (9 Suppl):V30-8.
Solomon RC., Ethical issues in medical malpractice, Emerg Med Clin North
Am. 2006 Aug;24(3):733-47.
Wang CE, Huch MH., Protecting human research subjects: an international
perspective, Nurs Sci Q. 2000 Oct;13(4):293-8.
Informed Consent: Legal Theory and Clinical Practice by Jessica W. Berg,
Paul S. Appelbaum, Lisa S. Parker, and Charles W. Lidz, Oxford University
Press, 2001
A History and Theory of Informed Consent by Ruth Faden and Thomas
Beauchamp
[edit] External links
Informed Consent (University of Washington School of Medicine)
A Guide to Understanding Informed Consent (National Cancer Institute,
USA)
Informed Consent and Clinical Research(Johns Hopkins University)
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发帖数: 2823
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this is very good to know
thanks for sharing
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