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Informed consent

Informed consent is the most important issue in human trials. It means participants must be told of the aims and risks of an experiment or a clinical trial before taking part in it.

In medicine, human experiments are often used to test new medicines and techniques. Before the late 1940s, doctors who ran these experiments did not have to tell their patients what they were doing. Soldiers, inmates in prisons and asylums, and ethnic minorities were often used.

This changed after the Nuremberg trials and the introduction of the Nuremberg Code. Any experiment must be explained to a patient or test subject, who must understand it and agree to participate. Once the experiment’s aims, procedures and risks are explained, this agreement from a patient is called ‘informed consent’.

Pharmaceutical companies test most of their new products in developing countries. However, there is controversy over how much informed consent these participants give.

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Bibliography

J H Jones, Bad Blood: the Tuskegee syphilis experiment (New York: Free Press, 1993)

J W Berg et al (eds.), Informed consent: Legal theory and clinical practice (Oxford: OUP, 2001)

L Doyal and J S Tobias, Informed Consent in Medical Research (London: BMJ, 2001)

K Getz and D Borfitz, Informed Consent: A Guide to the Risks and Benefits of volunteering for Clinical Trials (Boston: CenterWatch, 2002)

A Petryna, When Experiments Travel: Clinical Trials and the Global Search for Human Subjects (Princeton: Princeton University Press, 2009)

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