Get Section 5. Informed Consent

The informed consent form consists of two parts: the information sheet and the consent certificate.

The informed consent process involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research.

The Joint Commission requires documentation of all the elements of informed consent "in a form, progress notes or elsewhere in the record." The following are the required elements for documentation of the informed consent discussion: (1) the nature of the procedure, (2) the risks and benefits and the procedure, (3) ...

The Elements of Informed Consent. Literature of bioethics often analyzes informed consent in terms of the following elements: (1) disclosure; (2) comprehension; (3) voluntariness; (4) competence; and (5) consent (see U.S. National Commission, 1978, U.S. President's Commission, 1982; Meisel and Roth, 1981).

The Elements of Informed Consent. Literature of bioethics often analyzes informed consent in terms of the following elements: (1) disclosure; (2) comprehension; (3) voluntariness; (4) competence; and (5) consent (see U.S. National Commission, 1978, U.S. President's Commission, 1982; Meisel and Roth, 1981).

There are 4 components of informed consent including decision capacity, documentation of consent, disclosure, and competency. Doctors will give you information about a particular treatment or test in order for you to decide whether or not you wish to undergo a treatment or test.

The consent form must include: A statement that the study involves research. ... Purpose of the research. ... Procedures. ... Risks or discomforts to the subject. ... Benefits of the research to the subject. ... Treatment Alternatives. ... Costs of Participation. ... Confidentiality.

The consent form must identify the subject's alternatives to participation in the protocol and should offer a discussion of their relative advantages and disadvantages. It is usually not necessary to provide a full account of the risks and benefits of alternative treatments in the research consent form.