Informed consent

Informed consent refers to a process for getting permission before conducting a healthcare intervention or for disclosing personal information. 

 

 

Informed consent uses  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 consequences of an action. 

Rooted in ethical principles of respect for patient autonomy and patient well-being.

Must be free from patient coercion, unfair persuasion or inducements.

The process  is rooted in respecting a person’s dignity.

Obtaining informed consent is not always required: individuals considered unable to give informed consent, another person is generally authorized to give consent on his behalf, such as parents or legal guardians of a child, and conservators for the mentally disordered, or consent can be assumed through the doctrine of implied consent, when an unconscious person will die without immediate medical treatment.

If an individual is provided insufficient information to form a reasoned decision, serious ethical issues arise. 

Informed consent is complex to evaluate: neither expressions of consent, nor expressions of understanding of implications, necessarily mean that full adult consent was in fact given.

There is a degree to which informed consent must be assumed or inferred based upon observation, or knowledge, or legal reliance. 

Explicit agreement by means of signature is normally relied on legally, regardless of actual consent, is the norm. 

Brief examples of each of the above:

A person may claim to understand the implications of some action, but in fact has failed to appreciate the possible consequences fully and may later deny the validity of the consent for this reason. 

If 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 usually legally overrides later denial of informed consent, unless obtained by misrepresentation).

To give valid informed consent, three components must be present: disclosure, capacity and voluntariness.

Disclosure requires  information necessary to make an autonomous decision and also to ensure that the subject adequate understands the information provided: a written  consent should be in the form of lay language suited for the comprehension skills of subject population, as well as assessing the level of understanding through conversation (to be informed.

The capacity of an individual pertains to their ability of the subject to understand the information provided and form a reasonable judgment  on the potential consequences of his/her decision.

A patient has the right to freely exercise decision making without being subjected to coercion, manipulation, or undue influence.

A waiver of the consent requirement may be applied where no foreseeable harm is expected to result, or when permitted by law, federal regulations, or if an ethical review committee has approved the non-disclosure of certain information.

If a patient is incapacitated due to injury or illness, it is still important that patients benefit from emergency experimentation.

Legislation 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.

When an individual agrees to a health intervention it is based on an understanding of it.

Consent includes giving permission.

Medicine in the United States, takes this patient-centric approach to informed consent.

Informed consent requires healthcare providers to disclose significant risks, as well as risks of particular importance to that patient.

The consent standard is only that the person understands, in general terms, the nature of and purpose of the intended intervention.

Minors are generally presumed incompetent to consent, but depending on their age and other factors may be required to provide Informed assent. 

In cases of incompetent minors, informed consent is usually required from the parent.

Research involving deception prevents subjects from exercising their basic right of autonomous informed decision-making.

Informed consent with children: the primary response is parental consent. 

A number of doctrines have developed that allow children to receive health treatments without parental consent.

Informed consent is part of clinical research:  one voluntarily confirms willingness to participate in a particular trial, 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.

Medical research is overseen by an ethics committee that oversees the informed consent process.

 

To give informed consent, the individual concerned must have adequate reasoning faculties and be in possession of all relevant facts. 

 

 

Impairments to reasoning and judgment that may prevent informed consent.

Patients must have the capacity to understand and the competence to make health care decisions.

Includes disclosure of information required to understand procedure including its nature and purpose associated well associated risks, benefits and alternatives.

Information of common complications should be given and described.

Patients recall only a small portion of information given preoperatively, with a range of 35% to 57% retention.

Informed consent for elective diagnostic cardiac catheterization with possible percutaneous coronary intervention was associated with an 88% rate of mistaken beliefs about the benefits of the procedure (Rothberg MB et al).

Recall of information for facial nerve paralysis is 93%.