Throughout your research study (from recruitment to the end of a participant’s involvement), it is the responsibility of the researcher to have an open and ongoing dialogue with research participants. This is to provide them information and answer their questions about the research in language that is clear and easily understood by the participant. How you consent your participants, including the process itself and document or script used, will vary according to the research and the population, but the requirement to obtain Informed Consent is the cornerstone of human subjects protection.

Office of Human Research Protections: 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. Informed consent must be legally effective and prospectively obtained. HHS regulations at 45 CFR 46.116 and 45 CFR 46.117 describe the informed consent requirements. HHS Frequently Asked Questions.