Documenting Clinical Research Informed Consent Problems and Solutions

Documenting Clinical Research Informed Consent ֎ Problems and Solutions KATHERINE HAWTHORNE, BS, RN, CCRP PROGRAM MANAGER OFFICE FOR THE PROTECTION OF RESEARCH SUBJECTS (OPRS) UNIVERSITY OF SOUTHERN CALIFORNIA JUNE 6, 2019

“ Why should I care? ” THE WHO 1999 “One cannot know with certainty whether a consent is valid until a lawsuit has been filed and resolved” CALIFORNIA SUPREME COURT 2016

What’s at stake? Subject Study safety and autonomy integrity Potential loss of data Non-compliance with FDA and institutional regulations

Discussion Common Process consent form errors Please don’t Helpful solutions

Common Consent Form Errors Expired No form IRB Stamp Incorrect Altered version or study approved consent form Missing/lost Failure copy of original ICF to reconsent when ICF is revised

Common Process Errors Missing Signature/Missing Printed Name Incorrect/Unauthorized Missing/Incorrect Signatures Dates No documentation note of consent process No ICF copy given to subject

Chart note of ICF process:

Please don’t Alter the ICF Use a ICF copy without an IRB Stamp Sign the wrong version or study) Loose the original signed ICF (store pdf) Fail to reconsent subjects with revised ICF when necessary (date

Suggested Solutions ICF note template or checklist ICF – Study Master File Educate Know new study staff the Standard: ALCOA

ICF – Study Master File

Educate New Study Staff You. Tube: Informed Consent Process – Emory University https: //www. youtube. com/watch? v=Vb 7 e_0 Mw 4 ps

Audit Standards: ALCOA Attributable Legible Contemporaneous Original Accurate

Questions? Office for the Protection of Research Subjects (213) 821 -1154 oprs@usc. edu https. //oprs. usc. edu