Informed consent is a process for getting permission before conducting a healthcare intervention on a person. A health care provider may ask a patient to consent to receive therapy before providing it, or a clinical researcher may ask a research participant before enrolling that person into a clinical trial. Informed consent is collected according to guidelines from the fields of medical ethics and research ethics.
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 a severe intellectual disability, severe mental illness, intoxication, severe sleep deprivation, Alzheimer’s disease, or being in a coma.
Some acts can 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 (though in this circumstance the child may be required to provide informed assent) and conservators for the mentally ill.
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.
Informed Consent Form Templates can be found on the World Health Organization Website for practical use.
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. This is the case with certain procedures, such as a “do not resuscitate” directive signed by a patient prior to their illness.
Elements of valid informed consent
For an individual to give valid informed consent, three components must be present: disclosure, capacity and voluntariness.
While Disclosure requires the researcher to supply the subject with the information necessary to make an autonomous decision, the investigators must ensure that subjects have adequate comprehension of the information provided. This latter requirement implies that the consent form be written in lay language suited for the apprehension skills of subject population, as well as assessing the level of understanding during the meeting.
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.
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.
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