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Is informed consent required and if so, why?

Informed consent is a fundamental principle of conducting ethical research, and a federal requirement (45 CFR 46). To enable participants to give fully informed consent when deciding whether to:

(a) Participate in research or

(b) Allow their identifiable data to be used for research purposes. It is essential that researchers provide sufficient information about the proposed study so that participants can understand what is being asked of them before agreeing to participate.

The standard for sufficient information is what a reasonable person would want to know before agreeing to participate.

There are rare circumstances when informed consent can be waived. Click here to learn more about waivers of informed consent.