Study Assessment

Main Content

Informed Consent Form Design

Definition

  • Informed consent is a process by which a participant voluntarily confirms his or her willingness to participate in a particular study, after having been informed of all aspects of the study that are relevant to the decision to participate.
  • The Informed Consent Form (ICF) is the main source of information to those considering participation in a clinical research study and is used to document a participant’s informed consent.

Policies/guidelines

  • Effective informed consent must be obtained and documented using only the Institutional Review Board (IRB)-approved and stamped consent document(s) prior to participation in a clinical research study. 
  • The ICF and any other written information intended to be provided to participants should be revised whenever important new information becomes available that may be relevant to the participant’s consent. Any revised ICF or other written information intended to be provided to participants must receive the IRB's approval prior to use.
  • Guidelines of Investigator’s Responsibilities - Informed Consent 
  • Informed Consent Checklist - PDF (intranet)
  • Informed Consent Lay Terminology - PDF (intranet)

Templates/forms

  • UMMC Consent Template - Word (intranet)
  • UMMC Child Assent Template - Word (intranet)

Training