What is an Informed Consent?

The Office for Human Research Protections (OHRP) states that, “…the informed consent process is the critical communication link between the prospective human subject and an investigator beginning with the initial approach of an investigator to the potential subject (e.g. through a flyer, brochure, or any advertisement regarding the research study) and continuing until the completion of the research study. […] The informed consent process involves three key features:

  1. disclosing to potential research subjects information needed to make an informed decision;
  2. facilitating the understanding of what has been disclosed; and
  3. promoting the voluntariness of the decision about whether or not to participate in the research.”4
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