Presented by Quorum Review Regulatory Attorney J. Claire Carbary, JD, CIP, and Consent Solutions President and CEO Susan G. Brink, DrPH, this presentation discusses considerations in the review and approval of eConsent processes, meeting the requirements related to documentation of IRB review and approval, the decision to use an eConsent, how an eConsent system may impact IRB process, and questions regarding what the IRB should consider when evaluating the use of eConsent for a given study. With the adoption of EHRs and electronic data collection, researchers, trial sponsors and IRBs are looking toward possible adoption of electronic consent processes and systems. The use of an eConsent process has many advantages. However, early consideration, planning and close coordination at the IRB review stage is important before implementation.

1. June 18 & 20, 2013
eConsent for Research:
Considerations in Implementation and IRB Review

2. 2

3. 3

4. • Questions & Answers
• Feel free to submit questions at any point
during the webinar using the chat box on your
webinar dashboard
• Responses will be sent by the presenters
following the presentation
4
WEBINAR
HOUSEKEEPING

5. • Recording & Slide Deck
• The webinar recording and slide deck will be
posted on our website within 5 business days
• We will email you a link to view the recording
as soon as it is available
• Feel free to share the link with your staff
and/or colleagues
5
WEBINAR
HOUSEKEEPING

6. 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

7. • 14 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
7
THE QUORUM ADVANTAGE

8. • Secure portal with SmartForms, status
reports, and approval documents
• Customized Phase I and Post-Marketing
processes
• Flexible, customized process for AMCs
• 100% Quality Control on all documents
8
THE QUORUM ADVANTAGE

9. 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

10. ConsentSolutions President & CEO
Susan G. Brink, DrPH
ConsentSolutions, Inc.
 Founded by Dr. Brink in 2005
 To further the development of media-based
approaches to informed consent
 Grew out of Phase II SBIR NCI funding for the
development of an online informed consent process
for clinical trials
Dr. Brink’s Background
 Served as PI on the grant for the SBIR NCI funding
 Authored articles on patient experience, the need for eConsent, and
pathways to implementation
 Has presented on electronic consent at DIA, PRIM&R, ACRP, and SoCRA
10
ABOUT THE PRESENTERS

11. eConsent for Research: Considerations in
Implementation and IRB Review
Considerations in Implementing eConsent 12
 Introduction to eConsent 13
 Paper-based vs. eConsent 17
 Initiating eConsent 22
 A Look at eConsent 26
IRB Review of eConsent 30
 Documentation of Consent 31
 Privacy and Confidentiality of Data 37
 IRB Documentation of Review and Approval 41
 Consent Process 45
11
WEBINAR OVERVIEW
Part I
Part II

12. CONSIDERATIONS IN
IMPLEMENTING eCONSENT
Part I
12

13. INTRODUCTION TO eCONSENT
13

14. How to get there:
PAPER TO eCONSENT:
GETTING UP AND RUNNING
Pick an eConsent approach
Coordinate closely with the IRB
Make sure your sites are on board
Introduction
to eConsent
14

15. Sites
 Acceptance of
system
 Understanding
of procedures
 Understanding
of what
eConsent does
for them
 Version
tracking
 Patient
tracking
Patient
 Education
 Knowledge
 Understanding
 Consent
 Language
 Audio
 Literacy
Regulatory
Compliance
 ―Formalized
staff training
with certificate‖
 Signatures
 Access Control
Budget
Considerations
 Remote
monitoring
audits
 Devices
 Internet/
Cellular
 Consent
Changes
 Try a Pilot
WHAT IS MOST
IMPORTANT TO YOUR STUDY?
Introduction
to eConsent
15

16. • Where and how can the system
be used?
• What is needed to run the system?
E-INFORMED CONSENT
Introduction
to eConsent
16

17. PAPER-BASED VS. eCONSENT
17

18. COMPARISON:
PAPER-BASED VS. eCONSENT
Signature
Site Staff
Involvement
Paper-based
vs. eConsent
Comparison
Paper-based
eConsent
Researchers want to find out more
about an investigational drug
called XYZ. An investigational
drug is a drug that is being tested
and is not approved for sale in the
United States by the U.S. Food
and Drug Administration (FDA).
IRB-approved
Language
Signature
Site Staff
Involvement
IRB-approved
Language
18

19. SECURE CONSENT COMPONENTS
Trial Staff
Dashboard
Manage patients and
subjects
Reader
for Patients
Read the consent
document, acknowled
ge understanding,
review with trial
staff, and sign
consent
Administration
Create electronic
consent documents
and manage trials
Paper-based
vs. eConsent
Comparison
19

20. Paper Consent
Page numbers
No education
Must be read by patients, or
read aloud by staff to patient
Handwritten signature, dated by
signer
eConsent System
Presented by section
Just-in-time Media-based
education accessible during
consent
Audio track of exact consent text
Digital handwritten signature,
system assigns date and time
APPROACHES - DIFFERENCES
Paper-based
vs. eConsent
Comparison
20

21. Paper Consent
Black box as to what patient does
Version control can be minimal
Maintained in paper files/scanned
to EMR
Electronic Secure Consent System
Timeline by date and time of all
actions; analytics on patient
consent actions
Robust Version control/revision
tracking and management
Stored on server; can
accommodate transfer of consent
information to other systems
COMPARISON
Paper-based
vs. eConsent
Comparison
21

22. INITIATING eCONSENT
22

23. Have the eConsent contractor review
draft consent before sending to IRB
(maybe even before internal compliance)
ENGAGE WITH
eCONSENT PROVIDER EARLY
Initiating
eConsent
Moving from an unstructured to structured system
Changing consent/approval workflow
Embedded education takes time
IRB education and review take time
23

24. What are the special characteristics
for the study? Trial population?
SPECIAL CHARACTERISTICS
Initiating
eConsent
Ask eConsent
Provider
Ask Your Team
Which sites are open to an eConsent process?
Which device(s) will the sites use?
What do we want to assure patient knows?
What are the constraints on the system?
24

25. IRB PROCESS
Initiating
eConsent
Does the IRB already have the process
in place for review of eConsents?
Yes No
What does the eConsent
provider need to do?
Who will talk with the IRB?
What does our preferred IRB
need to know?
Who do they talk to at the
IRB?
What does the IRB require?
Do they have guidelines for
eConsent submission?
25

26. A LOOK AT eCONSENT
26

27. Staff Dashboard
 Patient list
 Single patient
timeline
Patient Interface
 Consent section
 Signature page
EXAMPLES OF eCONSENT
A Look at
eConsent
27

28. • Dashboard with
list of patients
• Individual Timeline
• Monitor view
during study
• FDA view during
inspection/audit
MONITORING AND AUDITING
A Look at
eConsent
28

29. 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
29

30. IRB REVIEW OF eCONSENT
Part II
30

31. DOCUMENTATION OF CONSENT
31

32. 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
32

33. 21 CFR Part 11 applies to records in
electronic form that are
created, modified, maintained, archived, retri
eved, or transmitted under any
records requirements
set forth in the FDA
regulations.
ELECTRONIC SIGNATURES
UNDER PART 11
Documentation
of Consent
33

34. 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
34

35. 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
35

36. 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
36

37. PRIVACY & CONFIDENTIALITY OF
DATA
37

38. 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
38

39. 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
39

40. 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?
40

41. IRB DOCUMENTATION
OF REVIEW AND APPROVAL
41

42. 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
42

43. 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
43

44. 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
44

45. CONSENT PROCESS
45

46. 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
46

47. 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
47

48. 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
48

49. 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
49

50. 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
50

51. 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
51

52. 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
52

53. • 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
53

54. • 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
54

55. • You may submit questions during our webinar
survey, or
• You may email your questions to:
clientrelations@quorumreview.com
• We will do our best to follow-up individually or
answer your questions in the Q&A we post on
our website
55
ADDITIONAL QUESTIONS

56. • The webinar Recording, Slide Deck, and Q&A
will be posted on our website
• We will email you a link to view these items
as they become available
• We value your opinion – please take our
SURVEY and provide us with feedback
56
WEBINAR FOLLOW-UP

57. ConsentSolutions is a developer of internet-
based multimedia systems for informed
consent in the clinical trial industry.
To learn more, contact ConsentSolutions at:
 info@consentsolutions.com
 240-575-1918
 www.consentsolutions.com
CONSENTSOLUTIONS
57

58. CONNECT WITH QUORUM!
plus.google.com/10505
2192707896902777
@quorumreview
youtube.com/
quorumreview
linkedin.com/company/
quorum-review
58
facebook.com/
QuorumReview
slideshare.net/
QcustomerR
www.QuorumReview.com

59. THANK YOU FOR ATTENDING!
59

60. June 18 & 20, 2013
eConsent for Research:
Considerations in Implementation and IRB Review