Writing an Informed Consent Document

1. Checklist of required informed consent elements per ICH-GCP Guidelines (to be modeled after the Providence Healthcare Research Institute form)
   (http://www.providencehealthcare.org/research/documents/ICHConsentElementsCheckListMarch2008.doc)
2. Tips on Preparing Understandable Informed Consent Documents (adapted from the University of Michigan Medical School)
   (http://www.med.umich.edu/irbmed/guidance/tips.htm)
3. Glossary: Simplification Guide to Medical terms (from the University of Michigan Medical School)
   (http://www.med.umich.edu/irbmed/guidance/guide.htm)