fully accredited since 2006

June 18 & 20, 2013

eConsent for Research: Considerations in Implementation and IRB Review

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• 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

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WEBINAR HOUSEKEEPING

• 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

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WEBINAR HOUSEKEEPING

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ABOUT QUORUM REVIEW IRB

Accredited Fully accredited by AAHRPP through 2014

Fully compliant with FDA and OHRP requirements

RegulatoryLeadership

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 IRBProfessionals

(CIP)

60% of Affiliated IRB members, 40% of Regulatory staff and 20% of study management & study support positions

• 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

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THE QUORUM ADVANTAGE

• 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

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THE QUORUM ADVANTAGE

Quorum Review Regulatory AttorneyJ. 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

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ABOUT THE PRESENTERS

ConsentSolutions President & CEOSusan 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

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ABOUT THE PRESENTERS

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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

WEBINAR OVERVIEW

Part I

Part II

CONSIDERATIONS IN IMPLEMENTING eCONSENT

Part I

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INTRODUCTION TO eCONSENT

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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

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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

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• Where and how can the system be used?

• What is needed to run the system?

E-INFORMED CONSENTIntroduction to eConsent

Internet Specific Devices

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PAPER-BASED VS. eCONSENT

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COMPARISON: PAPER-BASED VS. eCONSENT

SignatureSite Staff

Involvement

Paper-based vs. eConsent

ComparisonPaper-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

SignatureSite Staff

InvolvementIRB-approved

Language

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SECURE CONSENT COMPONENTS

Trial Staff Dashboard

Manage patients and subjects

Reader for Patients

Read the consent document, acknowledge understanding, review with trial staff, and sign consent

Administration

Create electronic consent documents and manage trials

Paper-based vs. eConsent

Comparison

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Paper Consent

Page numbers

No education

Must be read by patients, orread 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 - DIFFERENCESPaper-based vs. eConsent

Comparison

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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

COMPARISONPaper-based vs. eConsent

Comparison

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INITIATING eCONSENT

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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

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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?

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IRB PROCESSInitiating

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?

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A LOOK AT eCONSENT

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Staff Dashboard Patient list Single patient

timeline

Patient Interface Consent section Signature page

EXAMPLES OF eCONSENT

A Look at eConsent

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• Dashboard with list of patients

• Individual Timeline

• Monitor view during study

• FDA view during inspection/audit

MONITORING AND AUDITINGA Look at eConsent

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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

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IRB REVIEW OF eCONSENT

Part II

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DOCUMENTATION OF CONSENT

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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

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21 CFR Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any

records requirementsset forth in the FDA regulations.

ELECTRONIC SIGNATURES UNDER PART 11

Documentation of Consent

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FDA regulations, at 21 CFR Part 11 , establish the criteria for acceptance by FDA of electronic records, electronic signatures, andhandwritten signatures executed to electronic

records as equivalent to paper records and handwritten signatures executed on paper.

VALIDITY OF ELECTRONIC SIGNATURES

Documentation of Consent

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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

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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 passwordsPeriodic checking of code and passwords (to cover password aging)Loss management procedures to de-authorize lost, stolen, missing or otherwise compromised passwordsTransaction safeguards to prevent unauthorized use of passwordsTesting of devices that bear or generate ID code or password information

FDA Guidance

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PRIVACY & CONFIDENTIALITY OF DATA

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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

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Evaluating Privacy and Confidentiality in the Paper World

How are records stored and protected?

Who has access to the records?

THE PAPER WORLDPrivacy and

Confidentiality

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Evaluating Privacy & Confidentiality Protections with eConsent:

PROTECTIONS WITH eCONSENTPrivacy 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?

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IRB DOCUMENTATION OF REVIEW AND APPROVAL

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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

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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

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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

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CONSENT PROCESS

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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.”

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FDA Guidance

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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 interviewThe timing of obtaining informed consent (any waiting period between informing and obtaining consent)The amount of time a patient is given to consider participationAdditional agreements they are asked to sign (Terms of Use)

Consent Process

FDA Guidance

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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

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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

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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

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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

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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.”

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Consent Process

FDA Guidance

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• 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

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• 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

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• 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

ADDITIONAL QUESTIONS

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• 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

WEBINAR FOLLOW-UP

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

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www.QuorumReview.com

THANK YOU FOR ATTENDING!

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fully accredited since 2006

June 18 & 20, 2013

eConsent for Research: Considerations in Implementation and IRB Review