Consent Procedures

What is Informed Consent?

Consent by a patient to a surgical or medical procedure or participation in a clinical study after achieving an understanding of the relevant medical facts and the risks involved.

This is the method by which fully informed, rational persons may be involved in choices about their health care.

Informed consent stems from the legal and ethical right an individual has to decide what is done to his or her body, and from the researcher's ethical duty to make sure that individuals are involved in decisions about their own health care.

Why Have Informed Consent?

History

The idea to protect people who take part in medical research has developed over the last half century. Some major milestones:

The Nuremberg Code

In 1947, the Nuremberg Code was developed in response to the Nuremberg Trials of Nazi doctors who performed unethical experimentation during World War II. It made voluntary consent a requirement in clinical research studies, emphasizing that consent can be voluntary only if: participants are able to consent; they are free from coercion (i.e., outside pressure); and they comprehend the risks and benefits involved.

Tuskegee experiments

In the 1940s, a series of research abuses started in Tuskegee, Alabama. In one study on the natural history of untreated syphilis, poor, black males are uninformed of their disease and denied treatment even after a treatment is found in 1947. The abuses were revealed in 1972.

Belmont Report

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research publishes The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research -- a guide for U.S. research with human subjects.

Parts of Informed Consent

The process of securing informed consent has three phases, all of which involve information exchange between researcher and participant and are part of patient education.

Parts of Informed Consent

First, in words an individual can understand, the researcher must disclose the details of the planned research, its potential benefits and serious risks, any feasible alternatives and the most likely outcomes of the research.

Parts of Informed Consent

Second, the researcher must evaluate whether or not the person has understood what has been said, must determine that the risks have been accepted, and that the patient is giving consent to proceed with the research with full knowledge and understanding.

Parts of Informed Consent

Finally, the individual must sign the consent form, which documents the major points of consideration.

Consent Forms You Will Administer

1. Consent form for the cancer patient

2. Consent form for the support person