Forms, Policies & Procedures

Documentation Consent Process Form and Log

Informed consent is a process and involves providing a potential subject with adequate information about the research to allow for an informed decision about the subject’s voluntary participation in a research study. Informed consent is a process. Documenting informed consent occurs after explaining the research, addressing any questions, and assessing participant comprehension.

• Documentation of informed consent requires the signature of informed consent by the research participant (or their legally authorized representative or parent(s), as applicable) unless a waiver of that signature has been approved by the IRB.
• The forms here are two different suggested templates that can be used so that the person obtaining consent notates the following: current and IRB-approved informed consent forms were used, that he/she explained the research to the participant, ensured that the participant understood the research and that the participant freely agreed to enroll.
• These forms should be utilized at the beginning of the study and throughout the study, when updates and revisions to the consent form(s) require re-consent.
• The templates herein provide a framework for documenting the consent discussion and process with each potential study participant and should be customized to different studies as applicable.
• Modify the form as needed/desired to add or remove any additional consent information, such as:
  • If a legally authorized representative is present

  Information related to signatures as applicable