Informed Consent
Informed Consent is a dynamic, iterative process, beginning with subject recruitment and continuing until the research study is closed.
The consent form serves as a written overview of the study procedures, associated risks of participation and identifies who to contact concerning research procedures and the subject's concerns about involvement in a research study.
In order ensure that study subject's consent is truly informed, researchers must convey understandable information and provide answers to all questions posed by the subject at any time during their participation in the study. A truly informed research subject will possess a thorough, demonstrable understanding of the study in which they consent to participate.
Templates
Effective July 1, 2009, the IRB allows investigators to have greater flexibility with informed consent form and assent form wording. The only exception to this flexibility pertains to the institutional research injury language, which must remain verbatim. Please ensure that all informed consent language is accurate for your study.
Note: The templates have not yet been updated and they have been removed from the website to reduce confusion about standard statements. For guidance on informed consent requirements, contact the IRB office.
Research Injury Language
Signature Templates
Informed consent checklist used by the IRB. This checklist is used by IRB reviewers to ensure that all federal and institutional elements are met.
Waiver of Consent / Authorization
Waiver of Informed Consent or Waiver of Documentation of Informed Consent (updated Sept 23, 2009)
Waiver of HIPAA Authorization (updated July 2007)
