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 Why? one should give there attention to anything is a good question. The information provided here highlights common errors found in the informed consent process and offer plans for remediation, because . . . “One cannot . . .

What’s at stake? Subject safety and autonomy Study integrity Potential loss of data Non-compliance with FDA and institutional regulations If it is not documented – there is little reason to believe the safety and autonomy of the subject is being considered. The Informed Consent is the first important thing to get right/or wrong, in any research study – and it is the first impression given to those who audit your study An insufficient informed consent can rendering the collected data for that subject useless For obvious reasons researchers want to avoid findings of non-compliance with FDA, institutional regulations and local laws

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

Common Consent Form Errors Information Technology Services 10/7/2019 Common Consent Form Errors Expired form No IRB Stamp Incorrect version or study Altered approved consent form Missing/lost copy of original ICF Failure to reconsent when ICF is revised (C) Copyright, 2000 Yale University. All rights reserved.

Information Technology Services 10/7/2019 The ICF must be IRB date stamped and It must not be expired Know that you are actually using the correct study ICF and version – a revised ICF may have the same expiration date but different version date (C) Copyright, 2000 Yale University. All rights reserved.

Information Technology Services 10/7/2019 No written corrections, changes, cross outs, initial and date notes are allowed on a valid ICF copy (C) Copyright, 2000 Yale University. All rights reserved.

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

Lack of legible printed name of subject and/or Investigator Missing signatures, date and time by subject and Investigator (when applicable – time will be noted to ensure that no procedure, including screening takes place before consent was signed. Person Obtaining consent is not listed in the iStar study application – unauthorized to consent – the iStar application is documentation that those consenting possess all certifications necessary to conduct the consent.

Chart note of ICF process: ICF must be accompanied by the Investigators written note or signed statement describing the consent process was conducted. This note offers added protection against human error.

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

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

Sample 1: One sheet with study specific items and #4 ICF note included

Sample 2: Investigator ICF note sign off (top) incorporated into study visit with 2 consents and time sensitive sample collection

ICF – Study Master File One binder - all original signed ICFs – tabs: Subject 001 . . - organized – easy to see subject history in relation to study history and consent - helps avoids missing amendment reconsent as they accumulate 2) Subject identity remains separate from coded source documents 3) Makes an impressive statement to auditors – it is the first thing they want to see.

Educate New Study Staff YouTube: Informed Consent Process – Emory University https://www.youtube.com/watch?v=Vb7e_0Mw4ps A very easy 7 min video for anyone who has never provided consent to a subject.

Audit Standards: ALCOA Attributable Legible Contemporaneous Original Accurate Clinical Research acronym of 5 principles for proper verification of source documents to ensure data integrity, validity and subject safety Attributable - who is responsible and for which data point collections Legible – unreadable = useless Contemporaneous – documentation of collected data should be existing, occurring, or originating during the same time /documented at the time of which a measurement or action is taken *** Note to File – can be your best friend. Original – The original source documentation should be the source for that information and or data point Accurate – be accurate. Auditors look for trends of repeated errors or inconsistancies.

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