Consent form versus informational letters: What is the difference?
A consent form is a document signed by the participant that contains specific information so that he or she may make an informed decision as to whether to participate in the study or not. The following must be included: • Purpose of the Research • What is expected of the participant • Risks and/or Discomforts • Potential Benefits • Alternative Procedure or Treatment • Confidentiality Provisions • Liability statement • IRB Contact for Information • Voluntary Participation and Right to Discontinue without Penalty • Signature of Participant and Investigator An informational letter should contain all of the content from the aforementioned list so that he or she may make an informed decision as to whether to participate in the study or not; however, a signature of the participant is not required. Informational letters are often used with anonymous surveys. See the IRB website for a template to construct a consent form.
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