Informed consent is a basic principle that acknowledges the right of individuals to control how their bodies are used. The concept was expressed in the Nuremberg Code of 1947 within the context of human experimentation, but evolved over time as a result of social, ethical, political, and legal concerns. Today, consent is formalized in a process that requires signing of an informed consent form.
Human Experimentation and Informed Consent
Medical research requires human experimentation, as not every disease can be duplicated in animals (e.g., yellow fever, malaria). Drugs used in treatment also metabolize (i.e., break down) at different rates in animals than in human beings, so what is effective in one may be ineffective in the other. Thus, research on humans is necessary to improve health and medical care. In modern medicine, research is performed in the context of a clinical trial.
Although the idea of asking permission before starting research seems fundamental, the principle of informed consent is a recent phenomenon. Following the disclosure of National Socialist (Nazi) medical atrocities during World War II, the Nuremberg Military Tribunal felt compelled to establish ten principles for human experimentation. These principles are known as the Nuremberg Code (1947).
When is Consent Required?
The first Code principle states that voluntary consent is required before any experiment may begin. This principle is consistent with a long-held legal notion that people are the true owners of their own bodies and have the right to accept or to refuse treatment.
But informed consent is not confined solely to clinical trials. Some medical therapies and treatments also require permission. For example, consent is sought for surgical operations, genetic testing, human immunodeficiency virus (HIV) screenings, blood transfusions, and even elective procedures such as cosmetic surgery. Over time, the various applications of the informed consent principle were expanded into a formal process.
The Evolution of the Informed Consent Process
Since 1947, informed consent has evolved to include additional protections for research subjects. In the United States alone, the informed consent process has been refined continually to meet
- physician oaths and codes of medical ethics (Declaration of Geneva 1948; World Medical Association International Code of Medical Ethics 1949);
- international guidelines (Universal Declaration of Human Rights 1948);
- legislation (Consumer Bill of Rights 1962; Federal Food, Drug & Cosmetic Act 1962);
- ethical considerations (Declaration of Helsinki 1964);
- policy input (Belmont Report 1979); and
- Federal guidelines established by the U.S. Food and Drug Administration [21 Code of Federal Regulations (CFR) 50.20; 45 CFR 46.117].
The means of formalizing permission for medical treatment, or for participation in a clinical trial, is through an informed consent form.
What Does an Informed Consent Form Contain?
Informed consent forms may be simple one-page documents, or complex booklets that attempt to account for every possible medical contingency. In general, 21 CFR 50.25(a) recommends that every consent form must contain at least the following elements:
- A complete description of the treatment or experiment, including the reasons for the intervention, the methods proposed, and the requirements for participation.
- All known or probable risks and benefits of the proposed treatment or experiment.
- A statement that participation is voluntary and that withdrawal is allowed at any time and for any reason.
- The extent to which confidentiality of records and privacy is maintained.
- Written acceptance of the treatment or experiment.
Consent forms may also include statements about compensation offered for participation in an experiment (or for damages incurred as a direct result of treatment), any conflict of interest by the physicians or research investigators, and contact information where further information may be obtained.
How is Consent Assessed?
Signing a consent form alone is not sufficient to prove that informed consent has been achieved. The physician or research investigator must also perform an independent three-part assessment:
- The subject must be competent to make a decision. If the subject is incapacitated, consent may be obtained from a legally acceptable representative, such as a family member or an attorney.
- The subject must understand what is contained in the form. The more complex the form, the more difficult it is for the scientific and medical principles to be expressed in simple language. Most forms are written to a fifth-grade reading level, which is often inadequate to convey difficult concepts. In certain situations, the consent interview may be videotaped to record the questions asked and the answers given.
- The subject must give consent voluntarily. As UWSM (1998, 2008) acknowledges, subjects often feel vulnerable before an authority figure, and it is “easy for coercive situations to arise in medicine.” To ensure the integrity of the consent process, the subject should be made to feel part of the decision-making process and not simply signing a form.
Only when all three parts of the assessment have been confirmed is the informed consent process considered complete.
References
Food and Drug Administration (FDA). 2009. A guide to informed consent — information sheet. FDA website.
M. D. Anderson Cancer Center (MDACC). 2009. Participating in clinical trials. MDACC website.
University of Washington School of Medicine (UWSM). 1998, 2008. Informed consent. UWSM website.
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