Informed Consent

Participant Informed Consent

Every research project has one or more unique feature and requires a suitably customized informed consent document. Use the Examples under Downloadable Forms to customize your consent document to meet your specific project requirements. Adult informed consent forms for general populations should be written at an 8th-grade level to the extent possible, so that all prospective participants can understand the elements of the research well enough to give truly informed consent to participate.

For specially selected research populations who may be educationally disadvantaged, cognitively impaired, or even uniformly well-educated, different assumptions about the right level of complexity may be appropriate. Assent forms for minors (under 18 years of age) should be written in language that is developmentally appropriate to the age of the children. High School students should be able to understand the adult version. All research using minors require Parental Consent as well as Child Assent and require review of the full IRB at a convened meeting with the exception of anonymous surveys.

Broad consent

Broad consent is permitted as an alternative to the informed consent requirements for the storage, maintenance, and secondary research uses of identifiable private information and identifiable biospecimens (collected for either research studies other than the proposed research or nonresearch purposes). If the subject is asked to provide board consent, additional information must be included on the Informed Consent form. Refer to the Informed Consent Guidelines.

Downloadable Forms