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Orientation to Research with Human Subjects

Informed Consent: "What does informed mean?" Examples

Proof of Understanding

Rhiannon Albatrosa, a graduate student in Kinesiology and Physical Education, wants to investigate the differences between sustained and intermittant high-impact aerobics. She will be using an electrocardiograph, a sphygmomanometer, and exercise CD's by a local pop/rock group. She has listed these instruments in her Informed Consent document. Does she need to provide any additional information?

Rhiannon has two choices. She can give the technical and plain language names of her equipment, explain what the instruments are and how they are used in the consent form, or she can follow up a brief presentation of information for consent with a little quiz of her subjects, asking them if they know what the device does and how it is used on the human body. Also the term "high impact" should be explained in the consent or the proof-of-understanding quiz. Rhiannon should understand that it is unusual for young persons to have had experience with electrocardiography. Everyone has had their blood pressure taken, yet most do not know the name of the instrument that is typically used.

Researchers should avoid the use of highly technical language and maintain a sensitivity to the vocabulary and general level of understanding of their subjects. Doing so will reduce or eliminate the necessity for double-checking whether the subjects actually understand what is going to happen and why.

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