Humans: Institutional Review Board (IRB)
Informed Consent Templates
Informed consent is a cornerstone principal of ethical human subjects research. 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 (i.e., 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. Templates can 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.
An IRB-approval stamp will be applied to approved consent forms. Please leave a 1 ½ inch margin at the top of the document to accommodate the stamp. Avoid including unnecessary headings (e.g., Attachment or Appendix) on the consent form. Researchers are strongly advised to copy/print the stamped consent form for use during the study—doing so assures the current IRB-approved version is used and assures participants that the study has been reviewed by the IRB.
Informed Consent Form Template–Standard Format (UPDATED: 1.24.22)
Parental Informed Consent Form Template–Q & A Format (UPDATED: 1.24.22)
Parental Informed Consent Form Template–Standard Format (UPDATED: 1.24.22)
Informed Consent Addendum Template–use for re-consenting or to inform participants of new information (UPDATED: 3.22.22)
For additional guidance about informed consent, see the following:
Consent Process – guidance on developing a meaningful informed consent process
Assent Process – guidance on obtaining assent from children
Elements of Informed Consent – a detailed description of required consent elements and consent form considerations
Waivers or Alterations of Consent – guidance on when consent requirements can be altered or waived
Retention of Signed Consent Forms – guidance on retention of consent forms
Informed Consent for Exempt Research
Use of a formal informed consent form containing all the elements of consent is not required for research under exempt review. However, researchers are ethically obligated to obtain the voluntary agreement of prospective participants before including them in research. For more information and examples of consent forms appropriate for exempt research see Informed Consent for Exempt Studies.