The University of Iowa

Manuals

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 
 
 

University of Iowa Guidance:

Follow the links below for documents, instructions, and community resources.

English version of the Short Form and Instructions for Use  

Translated versions of the Short Form     

List of Community Translators

Short Form Policy November 2013