History of Informed Consent

The need for informed consent arose in reaction to what are now considered unethical practices by researchers and clinicians in the early to mid-20th century and before.

Historically, the relationship between a healthcare professional and their patient or research subject was more unequal than it is now. There was little expectation, on both sides, that a patient should question their doctor’s decisions. Unfortunately, in some research, such as the infamous Tuskegee syphilis study begun in the 1930s, some healthcare professionals have used people as research subjects without their informed consent. In this study, researchers tracked the progress of the disease in subjects over many years, withholding penicillin that might have helped or even cured them. The horrors of the experimental practices used by the ‘Nazi Doctors’ during World War II led to creation of the Nuremburg Code, which has as its first statement, “The voluntary consent of the human subject is absolutely essential.”

As society changed in the second half of the 20th century, individuals claimed more responsibility for their own lives and rights, as evidenced by the civil rights movement, feminism, and activism by minority communities, such as those suffering from HIV/AIDS or particular disabilities. This rise in autonomy as a human right has reinforced the importance of the informed consent process.

Several criteria have been suggested for the informed consent process to be valid. The person must be able to understand the information presented to them and be able to make a decision. The person must be given enough information and at a sufficiently understandable level so that, based on it, they can make a decision. The person must understand the consequences of their decision. The person must be able to make their decision without being coerced. Finally, the person must give some indication of their consent, such as a verbal agreement or by signing a consent form. One way of thinking about the consent process may be like this:

C – You are Competent to make your decision
O – You are Open to making the decision
N – You have the Necessary background information to make the decision
S – You have the Steps to be followed if you agree or disagree
E – You understand the Explanation of those steps
N – You make your decision and Notify someone
T – You Tick the boxes and sign the form

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