What is an informed consent document? How does it differ from an information sheet?

An informed consent document is a document that records a subject's voluntary participation in a research study and which provides the subject with a description of the study, the risks and benefits of the study to the subject and society, and contact information.

Usually subjects are asked to provide written consent to participate in the study by signing the informed consent document, but there are times when written consent is not needed (e.g., if the data collected are to be anonymous). In those cases, a subject can be “consented” through consent discussion and be provided with an information sheet which provides a description of the study and contact information. If verbal consent is to be obtained the researcher should provide a script for the IRB to review.

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