1. fully accredited since 2006
April 15, 2014
eConsent for Research:
Considerations in Implementation and IRB Review

2. 2

3. 3

4. 6
ABOUT QUORUM REVIEW IRB
Accredited
Fully accredited by AAHRPP through 2014
Fully compliant with FDA and OHRP requirements
Regulatory
Leadership
6 in-house licensed attorneys providing guidance and
thought-leadership
International
Boards available for the review of U.S. and Canadian
studies
Strong
Framework
One of the largest IRBs in the U.S. with ~180 employees
Certified IRB
Professionals
(CIP)
60% of Affiliated IRB members, 40% of Regulatory staff
and 20% of study management & study support positions

5. • 15 Board meetings each week
• 24-hour site turnaround, 36-hour amendment review,
and same day site changes
• One time CV and audit documentation submission
• Support available 8am-8pm ET
• Dedicated Study Manager
• Industry leading legal team
7
THE QUORUM ADVANTAGE

6. • Secure portal with SmartForms, status
reports, and approval documents
• Customized Phase I and Expeditable
Research processes
• Flexible, customized process for AMCs
– Over 800 Institutions work with Quorum
• 100% Quality Control on all documents
• Commitment to 6 Sigma Process Analysis
8
THE QUORUM ADVANTAGE

7. Quorum Review Regulatory Attorney
J. Claire Carbary, JD, CIP
IRB Experience
 Joined Quorum Review IRB in September 2009
 WIRB prior to Quorum
 CIP certification since 2010
 Member of the Northwest Association for
Biomedical Research (NWABR) and Public
Responsibility in Medicine and Research (PRIM&R)
Legal Background
 Juris Doctor from Seattle University
 Member of the Washington State Bar Association (WSBA)
 Member of the Health and Corporate Law Sections of the WSBA
9
ABOUT THE PRESENTERS

8. eConsent for Research: Considerations in
Implementation and IRB Review
Introduction to eConsent 11
IRB Review of eConsent 15
Documentation of Consent 16
Privacy and Confidentiality of Data 22
IRB Documentation of Review and Approval 26
Consent Process 30
10
WEBINAR OVERVIEW

9. INTRODUCTION TO eCONSENT
11

10. • Where and how is the system
be used?
• What is needed to run the system?
UNDERSTANDING THE
ECONSENT APPROACH
Introduction
to eConsent
12

11. eCONSENT OPTIONS
A Look at
eConsent
13

12. Questions to ask the provider of the
eConsent application:
QUESTIONS TO ASK
Which IRBs have you worked with?
What support/training do you offer the sites?
Is the software 21 CFR Part 11 compliant?
Has the software been used in FDA-regulated clinical studies?
How is system access controlled?
Is there a robust back-up process?
A Look at
eConsent
14

13. IRB REVIEW OF eCONSENT
15

14. DOCUMENTATION OF CONSENT
16

15. REQUIREMENT FOR
DOCUMENTATION OF CONSENT
Citation: 45 CFR 46.109(c); 21 CFR 56.109(c)
Documentation
of Consent
An IRB shall require documentation
of informed consent…”
FDA Guidance
17

16. 21 CFR Part 11 applies to records in
electronic form that are created, modified,
maintained, archived, retrieved, or
transmitted under any
records requirements
set forth in the FDA
regulations.
ELECTRONIC SIGNATURES
UNDER PART 11
Documentation
of Consent
18

17. FDA regulations, at 21 CFR Part 11 ,
establish the criteria for acceptance by FDA
of electronic records, electronic signatures, and
handwritten signatures executed to electronic
records as equivalent to
paper records and
handwritten signatures
executed on paper.
VALIDITY OF
ELECTRONIC SIGNATURES
Documentation
of Consent
19

18. PART 11 COMPLIANCE requires both procedure
controls (notification, training, SOPs, administration) and
administrative controls to be put in place in addition to the
technical controls that exist in the system.
These include:
 Each electronic signature shall be unique to one individual
and shall not be reused by, or reassigned to, anyone else
 The organization must verify the identity of an individual
before an electronic signature may be utilized
 Certification must be provided to FDA that the electronic
signature is intended to be the legally binding equivalent of a
traditional handwritten signature
ELECTRONIC SIGNATURES
UNDER PART 11
Citation: 21 CFR 11.200
Documentation
of Consent
FDA Guidance
20

19. Required Controls for ID Codes and Passwords:
ELECTRONIC SIGNATURES
UNDER PART 11
Citation: 21 CFR 11.200
Documentation
of Consent
Maintenance of unique combined ID codes and passwords
Periodic checking of code and passwords
(to cover password aging)
Loss management procedures to de-authorize lost, stolen,
missing or otherwise compromised passwords
Transaction safeguards to prevent unauthorized use of
passwords
Testing of devices that bear or generate ID code or password
information
FDA Guidance
21

20. PRIVACY & CONFIDENTIALITY OF DATA
22

21. PRIVACY & CONFIDENTIALITY
Citation: 45 CFR 46.111(7); 21 CFR 56.111(7)
Privacy and
Confidentiality
The IRB must determine that there are
adequate provisions to protect the
privacy of subjects and to maintain the
confidentiality of data.”
FDA Guidance
23

22. Evaluating Privacy and Confidentiality
in the Paper World
 How are records stored
and protected?
 Who has access to
the records?
THE PAPER WORLD
Privacy and
Confidentiality
24

23. Evaluating Privacy & Confidentiality
Protections with eConsent:
PROTECTIONS WITH eCONSENT
Privacy and
Confidentiality
Is the system Part 11 Compliant?
What type of hardware and platform will be used?
Is the technology Web-based or app-based?
If web-based what type of encryption is used?
Does it interface with existing EHR?
How do users get access?
Does the technology use location or other tracking features?
25

24. IRB DOCUMENTATION
OF REVIEW AND APPROVAL
26

25. IRB RECORDS &
DOCUMENTING APPROVAL
Citation: 45 CFR 46.115(a), 46.109(d) & 21 CFR 56.115 & 56.109(e)
IRB
Documentation
The IRB is required to…
“Prepare and maintain adequate documentation of
IRB activities, including…copies of all…approved
sample consent documents.”
“Notify investigators…in writing of its decision to
approve…the proposed research activity.”


FDA Guidance
27

26. The IRB must consider compatibility
for both storage and access:
 Screenshots
 Video files of consent presentation
 Archived web-pages
DOCUMENTATION OF
APPROVED eCONSENT
IRB
Documentation
28

27. DOCUMENTATION OF
APPROVED eCONSENT
 Stamp a screenshot
 Refer to the version, date, of the
electronic version in approval
letters or documentation
IRB
Documentation
In the paper world the
IRB places a “stamp”
of approval on the
finalized paper copy
In the electronic
world, what do
you stamp?
Paper World Electronic World
OPTIONS
29

28. CONSENT PROCESS
30

29. IRB REVIEW OF
THE CONSENT PROCESS
Citation: FDA Information Sheet, “A Guide to Informed Consent”, available at:
http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm.
Consent
Process
The informed consent process is more
than just a signature… it is a process of
information exchange… IRBs, clinical
investigators, and research sponsors all share
responsibility for ensuring that the informed
consent process is adequate… the consent
document should be the basis for a
meaningful exchange between the
investigator and the subject.”
FDA Guidance
31

30. The IRB should be aware of:
REQUIREMENTS FOR CONSENT
PROCESS AND IRB REVIEW
Citation: FDA Information Sheet, “A Guide to Informed Consent,” available at:
http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm.
Who will conduct the consent interview
The timing of obtaining informed consent (any waiting period
between informing and obtaining consent)
The amount of time a patient is given to consider participation
Additional agreements they are asked to sign (Terms of Use)
Consent
Process
FDA Guidance
32

31. IRB REVIEW OF
THE CONSENT PROCESS
Citation: 45 CFR 46.116; 21 CFR 50.20
An investigator shall seek…consent
only under circumstances that provide the
prospective subject or the representative
sufficient opportunity to consider
whether or not to participate…”
Consent
Process
FDA Guidance
33

32. IRB REVIEW OF
THE CONSENT PROCESS
Citation: 45 CFR 46.116; 21 CFR 50.20
NO informed consent, whether oral or
written, may include any exculpatory
language through which the subject or the
representative is made to waive or
appear to waive any of the subject’s legal
rights, or releases or appears to release the
investigator, the sponsor, the institution, or
its agents from liability for negligence.
Consent
Process
FDA Guidance
34

33. A copy of the consent must be
provided to subjects:
 FDA & HHS do not require a signed copy
be provided to subjects (or LAR)
 ICH does require a signed and dated copy
be provided to subjects (or representative)
REQUIREMENTS FOR CONSENT
PROCESS AND IRB REVIEW
Citations: 45 CFR 46.117(a); 21 CFR 50.27(a); ICH E6 4.8.11
Consent
Process
FDA Guidance
35

34. COMPLYING WITH CONSENT
PROCESS REQUIREMENTS
Who will be obtaining the consent?
What is the involvement of the PI?
Where will the consenting take place?
Are subjects asked to sign a Terms of Use or other type of
agreement?
How will copies be provided? (Electronic vs. Paper)
Consent
Process
36

35. FDA, HHS, and ICH require the consent
(where appropriate) to indicate that—
REQUIREMENT TO
PROVIDE NEW INFORMATION
Citation: 45 CFR 46.116(b)(5); 21 CFR 50.25(b)(5)
significant new findings developed
during the course of the research which may
relate to the subject’s willingness to continue
participation will be provided to the
subject.”
Consent
Process
FDA Guidance
37

36. • Flexibility is important if information
may need to be given to subjects
immediately
(A hybrid paper and e-process may be needed)
• A web-based eConsent
could deliver content
faster than paper
UPDATING THE eCONSENT
Consent
Process
38

37. • There will be a learning curve when first
submitting an electronic consent to IRBs for
review
• Propose a meeting with staff and/or
Board members prior to review to discuss
how things should be submitted, talk about
what the review process will entail, and get
information about the review timeline
• Refer to Quorum’s List of eConsent
Questions for an IRB to assist with the
process
SUMMARY
39

38. CONNECT WITH QUORUM!
plus.google.com/10505
2192707896902777
@quorumreview
youtube.com/
quorumreview
linkedin.com/company/
quorum-review
40
facebook.com/
QuorumReview
slideshare.net/
QcustomerR
www.QuorumReview.com

39. THANK YOU FOR ATTENDING!
41