How do I draft a legally effective informed consent document?
Federal regulations require certain statements in a legally effective informed consent document. Because all projects are unique in their purposes and procedures, the specific wording in consent forms differs on a case-by-case basis. The HSC does provide a template for investigators to utilize as a starting point in drafting their consent forms which can be found at http://www2.kumc.edu/researchcompliance/hscforms.htm The general criteria for an informed consent document can be found at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.116. Additionally, the HSC website has a quick-reference Informed Consent Checklist consent, posted at: http://www2.kumc.edu/researchcompliance/hscadditionalresources.
Federal regulations require certain statements in a legally effective informed consent document. Because all projects are unique in their purposes and procedures, the specific wording in consent forms differs on a case-by-case basis. The HSC2 does provide a template for investigators to utilize as a starting point in drafting their consent forms which can be found on our Forms page. The general criteria for an informed consent document can be found at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.116. Additionally, the HSC2 website has a quick-reference Informed Consent Checklist consent, postedon our Resources page.
