Informed Consent Form (ICF) - Human Subjects ：知情同意书（ICF）-人.ppt

Informed Consent Form (ICF) Health Insurance Portability and Accountability Act (HIPAA) Human Subject Protection Office UConn Health Center Monika Haugstetter, MHA, RN, MSN HSPO Website /hspo/index.html (bookmark to your desktop) Informed Consent Process Described in details in IRB application Special provisions Informed Consent Form (ICF) HIPAA Authorization Informed Consent Process Essentials Individual consenting must complete CITI training within last 3 yrs Current valid ICF signed dated copy provided to subject Certificate of Confidentiality Allows investigators to refuse disclosing individually identifiable research information in any legal proceedings unless… Informed Consent Process Essentials Storage (in accordance with ICF content protocol) Several options E.g. research records separate from ICF Revision Review carefully for content accuracy Requires submission for modification Links to protocol Requires re-consenting subjects Informed Consent Form (ICF) Essentials Formatting document: 1” margin for stamps scanning Font size – 12, easily readable font Clear section headings Sufficient white space Utilization of tables/charts/pictures to communicate a point Version number in the footer (change when revised) ICF Essentials Complete ICF: PI, PI Phone Number, All Co-Investigator(s), Title of Research Study, Expected Duration of Subject’s Participation, IRB Number, Name of Research Participants (consistency) Provide IRB number on continuation Include version of ICF Avoid redundancy (read documents) State risks clearly (bullets, tables, headings) NO HIPAA elements in ICF - separate form ICF Essentials Use consistently person/tense – no use of 1st person Include all required elements Be attentive to coercion/undue influence issues Apply IRB version of pregnancy language (if applicable) Subjects initials on each page optional ICF Required Elements – Checklist Always use ICF checklist Checklist contains: All regulatory requirements When eleme