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E consent for research: Considerations in Implementation and IRB Review


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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 …

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.

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  • 1. June 18 & 20, 2013eConsent for Research:Considerations in Implementation and IRB Review
  • 2. 2
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  • 4. • Questions & Answers• Feel free to submit questions at any pointduring the webinar using the chat box on yourwebinar dashboard• Responses will be sent by the presentersfollowing the presentation4WEBINARHOUSEKEEPING
  • 5. • Recording & Slide Deck• The webinar recording and slide deck will beposted on our website within 5 business days• We will email you a link to view the recordingas soon as it is available• Feel free to share the link with your staffand/or colleagues5WEBINARHOUSEKEEPING
  • 6. 6ABOUT QUORUM REVIEW IRBAccreditedFully accredited by AAHRPP through 2014Fully compliant with FDA and OHRP requirementsRegulatoryLeadership6 in-house licensed attorneys providing guidance andthought-leadershipInternationalBoards available for the review of U.S. and CanadianstudiesStrongFrameworkOne of the largest IRBs in the U.S. with ~180 employeesCertified IRBProfessionals(CIP)60% of Affiliated IRB members, 40% of Regulatory staffand 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 Manager7THE QUORUM ADVANTAGE
  • 8. • Secure portal with SmartForms, statusreports, and approval documents• Customized Phase I and Post-Marketingprocesses• Flexible, customized process for AMCs• 100% Quality Control on all documents8THE QUORUM ADVANTAGE
  • 9. Quorum Review Regulatory AttorneyJ. Claire Carbary, JD, CIPIRB Experience Joined Quorum Review IRB in September 2009 WIRB prior to Quorum CIP certification since 2010 Member of the Northwest Association forBiomedical Research (NWABR) and PublicResponsibility 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 WSBA9ABOUT THE PRESENTERS
  • 10. ConsentSolutions President & CEOSusan G. Brink, DrPHConsentSolutions, Inc. Founded by Dr. Brink in 2005 To further the development of media-basedapproaches to informed consent Grew out of Phase II SBIR NCI funding for thedevelopment of an online informed consent processfor clinical trialsDr. Brink’s Background Served as PI on the grant for the SBIR NCI funding Authored articles on patient experience, the need for eConsent, andpathways to implementation Has presented on electronic consent at DIA, PRIM&R, ACRP, and SoCRA10ABOUT THE PRESENTERS
  • 11. eConsent for Research: Considerations inImplementation and IRB ReviewConsiderations in Implementing eConsent 12 Introduction to eConsent 13 Paper-based vs. eConsent 17 Initiating eConsent 22 A Look at eConsent 26IRB Review of eConsent 30 Documentation of Consent 31 Privacy and Confidentiality of Data 37 IRB Documentation of Review and Approval 41 Consent Process 4511WEBINAR OVERVIEWPart IPart II
  • 14. How to get there:PAPER TO eCONSENT:GETTING UP AND RUNNINGPick an eConsent approachCoordinate closely with the IRBMake sure your sites are on boardIntroductionto eConsent14
  • 15. Sites Acceptance ofsystem Understandingof procedures Understandingof whateConsent doesfor them Versiontracking PatienttrackingPatient Education Knowledge Understanding Consent Language Audio LiteracyRegulatoryCompliance ―Formalizedstaff trainingwith certificate‖ Signatures Access ControlBudgetConsiderations Remotemonitoringaudits Devices Internet/Cellular ConsentChanges Try a PilotWHAT IS MOSTIMPORTANT TO YOUR STUDY?Introductionto eConsent15
  • 16. • Where and how can the systembe used?• What is needed to run the system?E-INFORMED CONSENTIntroductionto eConsent16
  • 18. COMPARISON:PAPER-BASED VS. eCONSENTSignatureSite StaffInvolvementPaper-basedvs. eConsentComparisonPaper-basedeConsentResearchers want to find out moreabout an investigational drugcalled XYZ. An investigationaldrug is a drug that is being testedand is not approved for sale in theUnited States by the U.S. Foodand Drug Administration (FDA).IRB-approvedLanguageSignatureSite StaffInvolvementIRB-approvedLanguage18
  • 19. SECURE CONSENT COMPONENTSTrial StaffDashboardManage patients andsubjectsReaderfor PatientsRead the consentdocument, acknowledge understanding,review with trialstaff, and signconsentAdministrationCreate electronicconsent documentsand manage trialsPaper-basedvs. eConsentComparison19
  • 20. Paper ConsentPage numbersNo educationMust be read by patients, orread aloud by staff to patientHandwritten signature, dated bysignereConsent SystemPresented by sectionJust-in-time Media-basededucation accessible duringconsentAudio track of exact consent textDigital handwritten signature,system assigns date and timeAPPROACHES - DIFFERENCESPaper-basedvs. eConsentComparison20
  • 21. Paper ConsentBlack box as to what patient doesVersion control can be minimalMaintained in paper files/scannedto EMRElectronic Secure Consent SystemTimeline by date and time of allactions; analytics on patientconsent actionsRobust Version control/revisiontracking and managementStored on server; canaccommodate transfer of consentinformation to other systemsCOMPARISONPaper-basedvs. eConsentComparison21
  • 23. Have the eConsent contractor reviewdraft consent before sending to IRB(maybe even before internal compliance)ENGAGE WITHeCONSENT PROVIDER EARLYInitiatingeConsentMoving from an unstructured to structured systemChanging consent/approval workflowEmbedded education takes timeIRB education and review take time23
  • 24. What are the special characteristicsfor the study? Trial population?SPECIAL CHARACTERISTICSInitiatingeConsentAsk eConsentProviderAsk Your TeamWhich 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 PROCESSInitiatingeConsentDoes the IRB already have the processin place for review of eConsents?Yes NoWhat does the eConsentprovider need to do?Who will talk with the IRB?What does our preferred IRBneed to know?Who do they talk to at theIRB?What does the IRB require?Do they have guidelines foreConsent submission?25
  • 26. A LOOK AT eCONSENT26
  • 27. Staff Dashboard Patient list Single patienttimelinePatient Interface Consent section Signature pageEXAMPLES OF eCONSENTA Look ateConsent27
  • 28. • Dashboard withlist of patients• Individual Timeline• Monitor viewduring study• FDA view duringinspection/auditMONITORING AND AUDITINGA Look ateConsent28
  • 29. Questions to ask the provider of theeConsent application:QUESTIONS TO ASKWhich 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 ateConsent29
  • 32. REQUIREMENT FORDOCUMENTATION OF CONSENTCitation: 45 CFR 46.109(c); 21 CFR 56.109(c)Documentationof ConsentAn IRB shall require documentationof informed consent…”FDA Guidance32
  • 33. 21 CFR Part 11 applies to records inelectronic form that arecreated, modified, maintained, archived, retrieved, or transmitted under anyrecords requirementsset forth in the FDAregulations.ELECTRONIC SIGNATURESUNDER PART 11Documentationof Consent33
  • 34. FDA regulations, at 21 CFR Part 11 ,establish the criteria for acceptance by FDAof electronic records, electronic signatures, andhandwritten signatures executed to electronicrecords as equivalent topaper records andhandwritten signaturesexecuted on paper.VALIDITY OFELECTRONIC SIGNATURESDocumentationof Consent34
  • 35. PART 11 COMPLIANCE requires both procedurecontrols (notification, training, SOPs, administration) andadministrative controls to be put in place in addition to thetechnical controls that exist in the system.These include: Each electronic signature shall be unique to one individualand shall not be reused by, or reassigned to, anyone else The organization must verify the identity of an individualbefore an electronic signature may be utilized Certification must be provided to FDA that the electronicsignature is intended to be the legally binding equivalent of atraditional handwritten signatureELECTRONIC SIGNATURESUNDER PART 11Citation: 21 CFR 11.200Documentationof ConsentFDA Guidance35
  • 36. Required Controls for ID Codes and Passwords:ELECTRONIC SIGNATURESUNDER PART 11Citation: 21 CFR 11.200Documentationof ConsentMaintenance of unique combined ID codes and passwordsPeriodic checking of code and passwords(to cover password aging)Loss management procedures to de-authorizelost, stolen, missing or otherwise compromised passwordsTransaction safeguards to prevent unauthorized use ofpasswordsTesting of devices that bear or generate ID code or passwordinformationFDA Guidance36
  • 38. PRIVACY & CONFIDENTIALITYCitation: 45 CFR 46.111(7); 21 CFR 56.111(7)Privacy andConfidentialityThe IRB must determine that there areadequate provisions to protect theprivacy of subjects and to maintain theconfidentiality of data.”FDA Guidance38
  • 39. Evaluating Privacy and Confidentialityin the Paper World How are records storedand protected? Who has access tothe records?THE PAPER WORLDPrivacy andConfidentiality39
  • 40. Evaluating Privacy & ConfidentialityProtections with eConsent:PROTECTIONS WITH eCONSENTPrivacy andConfidentialityIs 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
  • 42. IRB RECORDS &DOCUMENTING APPROVALCitation: 45 CFR 46.115(a), 46.109(d) & 21 CFR 56.115 & 56.109(e)IRBDocumentationThe IRB is required to…“Prepare and maintain adequate documentation ofIRB activities, including…copies of all…approvedsample consent documents.”“Notify investigators…in writing of its decision toapprove…the proposed research activity.”FDA Guidance42
  • 43. The IRB must consider compatibilityfor both storage and access: Screenshots Video files of consent presentation Archived web-pagesDOCUMENTATION OFAPPROVED eCONSENTIRBDocumentation43
  • 44. DOCUMENTATION OFAPPROVED eCONSENT Stamp a screenshot Refer to the version, date, of theelectronic version in approvalletters or documentationIRBDocumentationIn the paper world theIRB places a ―stamp‖of approval on thefinalized paper copyIn the electronicworld, what doyou stamp?Paper World Electronic WorldOPTIONS44
  • 46. IRB REVIEW OFTHE CONSENT PROCESSCitation: FDA Information Sheet, ―A Guide to Informed Consent‖, available at: informed consent process is morethan just a signature… it is a process ofinformation exchange… IRBs, clinicalinvestigators, and research sponsors all shareresponsibility for ensuring that the informedconsent process is adequate… the consentdocument should be the basis for ameaningful exchange between theinvestigator and the subject.”FDA Guidance46
  • 47. The IRB should be aware of:REQUIREMENTS FOR CONSENTPROCESS AND IRB REVIEWCitation: FDA Information Sheet, ―A Guide to Informed Consent,‖ available at: will conduct the consent interviewThe timing of obtaining informed consent (any waiting periodbetween informing and obtaining consent)The amount of time a patient is given to consider participationAdditional agreements they are asked to sign (Terms of Use)ConsentProcessFDA Guidance47
  • 48. IRB REVIEW OFTHE CONSENT PROCESSCitation: 45 CFR 46.116; 21 CFR 50.20An investigator shall seek…consentonly under circumstances that provide theprospective subject or the representativesufficient opportunity to considerwhether or not to participate…‖ConsentProcessFDA Guidance48
  • 49. IRB REVIEW OFTHE CONSENT PROCESSCitation: 45 CFR 46.116; 21 CFR 50.20NO informed consent, whether oral orwritten, may include any exculpatorylanguage through which the subject or therepresentative is made to waive orappear to waive any of the subject’s legalrights, or releases or appears to release theinvestigator, the sponsor, the institution, orits agents from liability for negligence.ConsentProcessFDA Guidance49
  • 50. A copy of the consent must beprovided to subjects: FDA & HHS do not require a signed copybe provided to subjects (or LAR) ICH does require a signed and dated copybe provided to subjects (or representative)REQUIREMENTS FOR CONSENTPROCESS AND IRB REVIEWCitations: 45 CFR 46.117(a); 21 CFR 50.27(a); ICH E6 4.8.11ConsentProcessFDA Guidance50
  • 51. COMPLYING WITH CONSENTPROCESS REQUIREMENTSWho 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 ofagreement?How will copies be provided? (Electronic vs. Paper)ConsentProcess51
  • 52. FDA, HHS, and ICH require the consent(where appropriate) to indicate that—REQUIREMENT TOPROVIDE NEW INFORMATIONCitation: 45 CFR 46.116(b)(5); 21 CFR 50.25(b)(5)significant new findings developedduring the course of the research which mayrelate to the subject’s willingness to continueparticipation will be provided to thesubject.”ConsentProcessFDA Guidance52
  • 53. • Flexibility is important if informationmay need to be given to subjectsimmediately(A hybrid paper and e-process may be needed)• A web-based eConsentcould deliver contentfaster than paperUPDATING THE eCONSENTConsentProcess53
  • 54. • There will be a learning curve when firstsubmitting an electronic consent to IRBs forreview• Propose a meeting with staff and/orBoard members prior to review to discusshow things should be submitted, talk aboutwhat the review process will entail, and getinformation about the review timeline• Refer to Quorum’s List of eConsentQuestions for an IRB to assist with theprocessSUMMARY54
  • 55. • You may submit questions during our webinarsurvey, or• You may email your questions• We will do our best to follow-up individually oranswer your questions in the Q&A we post onour website55ADDITIONAL QUESTIONS
  • 56. • The webinar Recording, Slide Deck, and Q&Awill be posted on our website• We will email you a link to view these itemsas they become available• We value your opinion – please take ourSURVEY and provide us with feedback56WEBINAR FOLLOW-UP
  • 57. ConsentSolutions is a developer of internet-based multimedia systems for informedconsent in the clinical trial industry.To learn more, contact ConsentSolutions at: 240-575-1918 www.consentsolutions.comCONSENTSOLUTIONS57
  • 60. June 18 & 20, 2013eConsent for Research:Considerations in Implementation and IRB Review