Forms and Templates
When developing an informed consent process, an important component is the documentation of that consent. A good informed consent document clearly describes to the potential subject information that they need to know to decide if they want to participate in the study. Researchers must ensure prospective participants receive information about the study, sufficiently detailed to facilitate a truly informed choice, in a manner that facilitates voluntary consideration of whether to participate. This ethical obligation exists for all research—exempt and non-exempt.
Federal regulations outline informed consent requirements for non-exempt research, including a list of information participants must receive (elements of informed consent). Using one of the templates below helps ensure that your consent form includes these elements. The templates are only a guide, and should be adapted to fit the study plans and needs of prospective participants. However, all of the consent elements must be included in your consent form unless your study is eligible for exempt review.