fully accredited since 2006 April 15, 2014

eConsent for Research: Considerations in Implementation and IRB Review

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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

• 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

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THE QUORUM ADVANTAGE

• 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

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THE QUORUM ADVANTAGE

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

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ABOUT THE PRESENTERS

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

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WEBINAR OVERVIEW

INTRODUCTION TO eCONSENT

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• Where and how is the system be used?

• What is needed to run the system?

UNDERSTANDING THE ECONSENT APPROACH

Introduction to eConsent

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eCONSENT OPTIONS A 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

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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 requirements set 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, 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

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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 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

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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 WORLD Privacy and

Confidentiality

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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?

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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.”

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 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

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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.”

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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