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Informed Consent

Obtaining informed consent is a basic ethical obligation and a legal requirement for researchers.

This requirement is founded on the principle of respect for persons, one of the 3 ethical principles governing human subject research described in the  Belmont Report . The principle of respect for persons requires that individuals be treated as autonomous agents and that the rights and welfare of persons with diminished autonomy be appropriately protected.  The requirement for informed consent is one of these central protections defined by the:

  • Department of Health & Human Services (HHS) regulations at  45 CFR part 46

Potential subjects must be provided with information about the research that is understandable and that permits them to make an informed and voluntary decision about whether or not to participate. The amount of information and the manner of presentation will vary depending on the complexity and risk involved in the research study.  Informed consent is an ongoing educational interaction between the investigator and the research participant that continues throughout the study.

You must describe your process for obtaining informed consent for participation in human research.  The process you employ for obtaining informed consent will depend on the research setting and your participant population.  An  in-depth description of the Process to Obtain Informed Consent  has been provided for reference as you write the study protocol.

Types Of Consent

To assist you in choosing the right type of consent process for your study, read the descriptions of the types of consent, parental permission and child assent on the FORMS PAGE .  Upload the proposed consent document(s) in section 4.1 of Initial Review Submission Packet.