1. 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

2. “ Why should I care?” The WHO “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 . . .

3. 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

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

5. 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.

6. 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.

7. 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.

8. 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

9. 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.

10. 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.

11. 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

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

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

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

15. ICF – Study Master File
One binder - all original signed ICFs – tabs: Subject
- 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.

16. Educate New Study Staff
YouTube: Informed Consent Process – Emory University
A very easy 7 min video for anyone who has never provided consent to a subject.

17. 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.

18. Office for the Protection of Research Subjects
Questions?
Office for the Protection of Research Subjects
(213)
https.//oprs.usc.edu