eConsent for Research


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eConsent for Research

  1. 1. fully accredited since 2006 April 15, 2014 eConsent for Research: Considerations in Implementation and IRB Review
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  4. 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. 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. 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. 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. 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
  10. 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. 11. eCONSENT OPTIONS A Look at eConsent 13
  12. 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
  15. 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. 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. 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. 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. 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
  21. 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. 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. 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
  25. 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. 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. 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. 28. CONSENT PROCESS 30
  29. 29. IRB REVIEW OF THE CONSENT PROCESS Citation: FDA Information Sheet, “A Guide to Informed Consent”, available at: 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. 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: 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. 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. 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. 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. 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. 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. 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. 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. 38. CONNECT WITH QUORUM! 2192707896902777 @quorumreview quorumreview quorum-review 40 QuorumReview QcustomerR