Documenting Informed Consent
One of the primary ethical requirements underpinning research with human subjects is informed consent. Informed consent follows the ethical principle of respect for persons, outlined in the Belmont Report, and it is a federal requirement of research with human subjects. Unless waived by the IRB, informed consent from subjects must be obtained freely and without coercion and/or undue influence. A subject’s consent is considered “informed” when they have adequate comprehension of what participation in the research entails, including potential risks.
The following templates provide investigators with resources and guidance to document informed consent:
When written informed consent is appropriate, a consent form should be presented to potential research subjects and the investigator should ensure the subject reads and understands the information presented in the form.
Federal regulations require that all consent form statements describe the nature of the research and the request for human subjects’ participation in language that is understandable to each potential subject. Consent forms should avoid technical jargon or terminology that is not defined. The title should be descriptive and not overly technical. The forms should also adjust for educational backgrounds, mental abilities, and the ages of the intended subjects.
Additionally, subjects should be presented with a consent document or consent script in a language that is understandable to them. If subjects do not speak or read English then consent documents must be translated into a language they can understand.
Researchers may also review the guidelines for Informed Consent.