The Top 10 Myths of eConsent

1. …and the journey that makes “going electronic”
the only path for industry leaders
There are some concerns about eConsent and its validity, effectiveness, and security, but most of
these concerns are myths. Take a ride with CRF Health to learn about the misconceptions of eConsent
and why industry leaders are taking this route over all others when it comes to informed consent.
about Electronic Informed Consent
(eConsent)
about Electronic Informed Consent
(eConsent)
The Top10 MythsThe Top10 MythsThe Top10 Myths
about Electronic Informed Consent
(eConsent)
The process of creating and executing
informed consent is not improved with eConsent.
Consents developed electronically increase quality and consistency:
Provides timely identification of
consenting issues (rather than
discovery a er the fact)
Reduces audit and inspection
findings for incorrect versions,
missing signatures, etc.
Enables study teams to review
sections that are not well understood
1
based on each participant's needs
Improves management of overall
consent tracking (e.g., re-
consenting, consent withdrawal)
eConsent:
Digital signatures generate a
permanent electronic trail
which substantially reduces the
costs of storing paper-based
4
documents
#1
MYTH
There is no regulatory support for eConsent because it
isn't secure.
Identity of the person who is providing consent can be confirmed in several
3
ways: digital signature, username and password, or biometrics.
Participants can and do have the right to access and obtain information
related to their identity (EU Data Protection regulation)
Regulatory officials require eConsent vendors to ensure security and integrity
when using electronic signatures based upon use of identification codes in
combination with passwords (e.g., to ensure that no two combinations are the
same) (1.14 FDA 21 CFR Part 11, Controls for identification codes/passwords)
The FDA's 2016 guidance document for eConsent, Use of Electronic Informed Consent,
emphasizes informed consent is more effective when presented electronically
4
Digital signatures generate a permanent electronic trail which is very important in cases of the regulatory audit
eConsent complements risk-based monitoring of studies by enabling risk assessment through central and
1
remote monitoring of consent activities
The FDA encourages users of eConsent systems to include validation as part of their preparations to ensure
accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records (1.8
FDA 21 CFR Part 11 1.8.1 Sec. 11.10 controls for closed systems 1.9)
The following regulators have all provided guidance for obtaining electronic signatures
and protecting health information:
All Protected Health Information (PHI) must be securely encrypted due to Health Insurance Portability and
Accountability Act (HIPAA) regulations
According to FDA 21 CFR Part 11, (1.11.2 sec 11.70), electronic and handwritten signatures executed to
electronic records shall be linked to their respective electronic records to ensure that the signatures
cannot be excised, copied, or otherwise transferred to falsify an electronic record by any means
eConsent is not
used and won't be
accepted outside of
the United States.
3
becoming more apparent
countries have had eConsent submissions (to
6
HAs and/or IRB/IECs)
eCOA compliance rates are 3x greater than paper,
as high as 97% (based on CRF Health research)
The industry thought that Electronic
Clinical Outcome Assessment (eCOA)
solutions wouldn't be accepted either,
but data shows compliance rates are better.
Industry subject matter experts suggest
eConsent is headed in the same
direction, with regulatory support
Pharmaceutical
organizations are not
adopting eConsent.
29
#7MYTH
3x
Sites prefer paper. eConsent is too difficult.
1
eConsent reduces burden on sites
Providing information about the
participant's understanding
during the consent process
Time spent resolving consent form
issues is reduced
2 2/10 informed consent forms
have an issue that takes on
average 2-3 hours to resolve.
10minutes less
eConsent can significantly
reduce the number of issues,
reducing the time spent per
5
consent down to 10 minutes.
85 85% of sites believe eConsent
10
is useful for their role
#6MYTH
Participant experience is not improved with eConsent.
3
eConsent o en includes multimedia, such
as graphics or video, about essential study
features that may increase understanding
3
of the study. By offering various methods
to comprehend the information, eConsent
caters to all learning styles and serves a
wider range of participants
Built-in quizzes assess comprehension
and correct misunderstandings of key trial
features, eliminating confusion and
frustration that can cause participants to
3
refuse consent
Participant compliance is improved with eConsent
A legally authorized representative (LAR) can support elderly,
children, and seriously ill patients. According to the HIPAA
Privacy Rule (1.21 HIPAA – US CFR 160 and 164), the individual
or LAR must sign a HIPAA authorization for a clinical trial,
outlining what PHI can be used and disclosed (and to whom)
Family members can help elderly, children, and seriously ill
patients who need help using an eConsent
“We've found as far as using the
tablet, even elderly subjects
were very comfortable holding
and using the tablet and
scrolling through the pages
with very little instruction
needed, and that really
surprised me.” (Giga Smith,
CCHC, “Electronic Informed
Consent – 2017 Industry Survey
Results from Clinical Sites”
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Webinar)
The elderly are tech savvy and
able to use eConsent
eConsent is less
efficient than paper.
eConsent enables the improved quality and
efficiency of clinical trials through insight into
the patient experience, improved data quality,
and a fully electronic system.
TransCelerate Biopharma
10th grade is the average reading level of
health communication materials, but 5th
grade is the average reading level of American
1
adults. The use of video, pictures, and other
multimedia tools supplement text in an
eConsent format, enabling better participant
comprehension
Comprehension is improved with eConsent.
Through automated edit checks that track participant completeness,
alerts to the sponsor in case of errors, version control, and a central
1
location for all processes related to the consent form
Electronic processes reduce the burden on sponsors.
Paper informed consent forms (ICFs) have increased in length and
due to this, study personnel require an excessive amount of time to
appropriately review the ICF. This o en creates obstacles in
4
enrollment of adequate numbers of subjects in the clinical trial.
Paper is lengthy and requires time.
Regulators won't approve
eConsent because it doesn't
provide source data.
Attributable
Legible
Contemporaneous
Original
Accurate
Regulations require source data to uphold ALCOA principles
(ICH GCP E6 Section 4.9.0 Investigator Adequate Documentation)
Therefore, eConsent does meet source data standards (e.g., typed
data is more legible than handwritten data)
How does your informed consent process measure up?
Does it create unnecessary burden on stakeholders?
Are you optimizing your consent approach to make it easy for sponsors,
sites, and participants?
Consider the options for your next trial.
Keeping your process the same is not worth the risk of failing to get
approval on a study treatment that can change or save lives.
About CRF Health
CRF Health is the leading provider of patient-centered eSource for the life sciences industry. With experience in more than 800 clinical trials,
over 100 languages and across 74 countries, CRF Health’s TrialMax® platform consistently demonstrates the industry’s highest data accuracy,
patient and site compliance, and patient retention. The integrated TrialMax platform includes eCOA solutions for collecting PROs (Patient
Reported Outcomes), ObsROs (Observer Reported Outcomes), ClinROs (Clinician or Rater Reported Outcomes), and PerfOs (Performance
Outcomes), and features TrialConsent®, an electronic solution for collecting and managing informed consent in clinical trials. CRF Health’s
eSource solutions improve trial engagement by making the patient the center of the clinical trial process.
© CRF Health. All rights reserved.
www.crfhealth.com
Phone: +1 267 498 2300
Email: hello@crfhealth.com
Effectively obtaining
consent is a non-issue.
Paper informed
consents do not
promote consistent
quality dialogue and
informed decision-
1
making
Improves the consent
experience
Increases quality
Reduces regulatory
1
inspection findings
vs.



FDA
EMA
HIPAA
OHRP
E-SIGN
ACT
User interface matters to participants
Most studies have shown that participants' recall of
key facts about a study is better with the use of
interactive eConsent features than with paper forms
#8MYTH
#9MYTH
Click to view the resources referenced in this document.
I can't afford eConsent.
Can you afford to lose critical data from patients who weren't consented properly? Failure to enroll a sufficient number of research participants in an
4
adequate period of time magnifies the cost of clinical trials. (Indian Journal of Pharmacology)
5
Cost Analysis Examples (based on CRF Health interviews with industry experts)
~20% of eligible patients do not enroll due to a lack of understanding
regarding study specifics
20
eConsent improves patient understanding via tiered information delivery,
multimedia, knowledge checks and interactivity, and enables studies to
recruit at least ~25% of these patients. Faster recruitment reduces study
duration, which reduces trial costs and brings drugs to market faster
25
~5% of eligible patients drop out due to misunderstood expectations. To
put this into context, in a study with 1,000 patients, it could mean 50
patients drop out, which could be 5 less sites for a study5
eConsent ensures patients have clear expectations
about the study, (timeline, procedures, etc.)
reducing the drop-out rate and the total number of
patients needed to be recruited. Recruiting less
patients reduces study duration, which reduces
trial costs and enables sponsors to bring
treatments to market faster
Initial development of an
eConsent process can be costly,
but reuse of templates can save
3
money in subsequent studies
Digital signatures generate a
permanent electronic trail which
substantially reduces the costs of
4
storing paper-based documents
Paper Consent Electronic Consent
#2MYTH
#3MYTH
Electronic signatures are secure in an eConsent
Personal identity is secure in eConsent
Many regulators support eConsent
#4
MYTH
#5MYTH
100%
of Top 10 Pharma
companies have an
eConsent initiative
9
in place
88%
of the Top 25
Pharma companies
have implemented
9
eConsent
66%
of the Top 50 Pharma
companies are engaged
or planning an eConsent
9
in the near future
eConsent Advantage Site Benefit
Automatically providing a
glossary of terms, automated
reminders, etc.
Automatically alerting sites
about issues
Sites can focus on their targeted
questions and areas of concern
Reduces the amount of time sites
must spend answering questions
or explaining things to participants
Enables them to resolve
problems faster
0#1MYTH
Timely re-consent notification
linked to protocol amendments
and safety updates
Fewer transcription errors (e.g.,
ICF date copied automatically
into the electronic data capture
1
[EDC] system)
Data validity and protection (e.g.,
access controls and passwords)
Quick, easy, remote follow-up on
errors
Identification and prevention of
recurring errors (e.g., version
control)
Paper informed consent documents focus on legal and
institutional needs rather than facilitating participants'
2
understanding.
Paper consents use overly complex language and are too
2
lengthy and confusing for many participants
eConsent increases comprehension and retention of
information compared to lengthy and complex paper
documents. (Complex procedures or study treatments
1
can be shown visually)
Use
Archival
Monitoring and Oversight
Development