Glossary / Lexicon

Informed consent refers to a person's expressed willingness to participate in a Research study, based on his/her understanding of the nature of the research, the potential risks and benefits involved, the expected outcomes, and possible alternatives.

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Other /More definition:
Informed consent refers to an ethical principle requiring that research participants be told enough information to enable them to choose whether they wish to participate; it is an ethical requirement of social scientific research which specifies that research subjects will be informed as to the nature of the research about to be conducted, their anticipated role in it, and the uses to which the data they provide will be put ; a legal procedure to ensure that a patient or client knows all of the risks and costs involved in a treatment. The elements of informed consents include informing the client of the nature of the treatment, possible alternative treatments, and the potential risks and benefits of the treatment. Participants must read, understand and sign it, indicating that they have been informed and consent to participate.

Informed consent is a legal doctrine that has been developed by the courts over a number of years. The doctrine of informed consent may have been derived from the Nuremberg Code (1947), which required that doctors obtain the voluntary informed consent of the subject prior to conducting research, and/or treatment. The Informed Consent Doctrine requires that doctors or therapists provide a consumer with all relevant information about a proposed procedure or treatment prior to obtaining the consent of the consumer to carry out the procedure or treatment. Four (4) items of information that must be provided are:

1. the nature of the treatment or procedure
2. the risks
3. the benefits
4. the alternatives

Informed consent protects consumers by providing him/her with complete information on which to make an informed decision. Informed consent usually also protects the doctor/therapist from liability, but with exceptions provided that the treatment is properly dispensed according to the prevailing standard of care and without negligence. The adult consumer's power to consent is very broad. Inadequate provision of information, however, may invalidate the consent.
In order for informed consent to be considered valid, the client must be competent and the consent should be given voluntarily.

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Other /More definition:
informed consent refers to ethical requirement whereby research subjects agree to participate in a study only after they receive full disclosure about the nature of the study and their own role in it.