- Compliance Committees
- IRB (Humans)
- Is IRB Approval Required?
- IRB Process Training
- IRB Training
- Good Clinical Practice (GCP) Training
- Informed Consent Templates
- Participant Information
- Review Process
- Post-Approval Monitoring
- Policies and Guidance
- Committee & Meeting Info
- Multi-Site Research & sIRB
- 2018 Revised Common Rule Information
- IACUC (Animals)
- IBC (Biohazards)
- RSC (Radiation)
- IRB (Humans)
- About Us
- Reporting Concerns
- Why Comply?
- How to Comply
- Responsible Conduct of Research
- ClinicalTrials.gov Registration
Informed Consent Templates
Informed Consent Document Templates
Using one of these templates will help ensure that all of the consent elements required by the regulations are included in your document. The template is only a guide and you may modify the document to meet the needs of your research. However, it is very important that you include all of the consent elements in your document unless your study falls into one of the categories of exempt research.
Informed consent documents should use an 11pt. font or larger. Please do not include titles such as Attachment or Appendix on the consent form, as the approved document will be stamped with the IRB approval stamp. Please leave a 1 1/2-inch margin at the top of the document to accommodate the stamp.
The stamped document should then be copied for use in your study to assure that the current IRB-approved document is being used. The IRB stamp will also serve as a reminder of the approval date of the consent document and will assure participants that the study has been reviewed by the IRB.
Elements of Informed Consent (UPDATED: 1-21-19)
Informed Consent Addendum Template--use for re-consenting or to inform participants of new information (NEW: 11-5-19)
Informed Consent Document Template--Q & A Format (UPDATED: 4-16-19)
Informed Consent Document Template--Standard Format (UPDATED: 4-16-19)
Parental Informed Consent Document Template--Q & A Format (UPDATED: 4-16-19)
Parental Informed Consent Document Template--Standard Format (UPDATED: 4-16-19)
Note: For student submissions, the major Supervising Investigator's contact information must be included on the consent form.
Under some circumstances, requirements for informed consent can be waived by the IRB. See Information about Waiver or Alteration of Informed Consent. Researchers will be prompted to provide justification for consent-related waivers in the IRB application.