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Federal Guidance:
45 CFR 46.116 and 21 CFR 50.20 – General requirements for informed consent
45 CFR 46.117 and 21 CFR 50.27 – Documentation of informed consent
Food and Drug Administration (FDA) Guidance - A Guide to Informed Consent –Information Sheet Non-English Speaking Subjects
Office of Human Research Protections (OHRP) Guidance – OPRR Memo,1995 Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English
University of Iowa Guidance:
Follow the links below for documents, instructions, and community resources.
English version of the Short Form and Instructions for Use
Short Form Policy November 2013