Applying E-Consent to Studies. Presenters: Haemar Kin, MHA, Melissa Scotti, PhD, Lara Lechtenberg, MPH

Transcription

1 Applying E-Consent to Studies Presenters: Haemar Kin, MHA, Melissa Scotti, PhD, Lara Lechtenberg, MPH 1

2 CME Disclosure Statement Northwell Health adheres to the ACCME s new Standards for Commercial Support. Any individuals in a position to control the content of a CME activity, including faculty, planners, and managers, are required to disclose all financial relationships with commercial interests. All identified potential conflicts of interest are thoroughly vetted by Northwell Health for fair balance and scientific objectivity and to ensure appropriateness of patient care recommendations. Course Director and Course Planner, Kevin Tracey, MD and Tina Chuck, MPH, have nothing to disclose. Course Speakers, Haemar Kin, Melissa Scotti, and Lara Lechtenberg, have nothing to disclose. 2

3 Course Objectives Apply the use of E-Consent when conducting human subjects research. Understand how to set up a REDCap Survey to capture informed consent online. 3

4 Course Content Regulatory framework pertaining to e-consent Best practices when applying e-consent Differences between the traditional consent process and e-consent Special consideration when using e-consent, including limitation Different types of e-consent and how to utilize them in a study 4

5 econsent (electronic consent) econsent- obtain and record legally effective informed consent via an electronic method It does not replace the consent process Still subject to all federal, state, and institutional policies IRB approval for the use of econsent must be sought prior to implementation.

6 All Elements of Informed Consent Still Apply In Accordance with the Common Rule & FDA 45 CFR & 21 CFR : obtain legally effective informed consent of the subject or the subject s legally authorized representative (LAR) before involving the subject in research. provide the prospective subject or the LAR sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. given to the subject or the representative in a language understandable to the subject or the representative. The informed consent, whether oral or written, may not include any exculpatory language. Please click here for the combined OHRP and FDA guidance 12/2016

7 HIPAA Authorization HIPAA authorization for research purposes can be obtained electronically as long as it (1) constitutes a valid electronic signature and (2) the signature cannot be denied legally effective because of its electronic form (as outlined in HIPAA privacy rule, E-sign Act, and Public Law ). In addition, the subject (and/or parent or LAR) must be provided a signed copy of the econsent, including the HIPAA authorization. 7

8 Northwell Health Policies Policy GR089 (Research Consent) provides guidance on obtaining consent for research, including obtaining consent remotely via mail, , or fax The HRPP Manual refers back to GR089 for guidance on obtaining consent remotely The use of electronic media falls under the purview of other offices within the Health System, such as Research IT Clearance from these offices may also be needed before the IRB can verify the acceptability of the use of electronic media 8

9 Acceptable electronic media econsent and eassent for pediatric studies can employ one or more of the following: Text Graphics Audio Video Interactive websites Biological recognition devices REDCap 9

10 Acceptable electronic media econsent may also use interactive computerbased technology, such as: Diagrams, Images Graphics Video Technology Narration econsent can be used either on-site or remotely 10

11 Use of these features in REDCap surveys for econsents: Text Audio & Video Interactive websites Diagrams Images & Graphics Video Technology Narration for low vision participants Eg. Special thanks to Elena Kowalsky & Dorean Flores for allowing use of their econsent as the template for this example. 11

12 The econsent Approach The use of electronic signatures can be permitted if in compliance with regulations No specific method mandated, instead IRB determines appropriateness Encrypted digitized signature software, voice print, or finger print suggested IRB will need to review the econsent be prepared to provide a demo

13 If using REDCap, your IRB Manager may ask for a demo: Provide link to econsent for review. Eg. If using survey invitations through REDCap, invite your IRB Mgr to complete the consent: 13

14 The econsent Approach Before considering the use of econsent, the investigator must consider: where the consent process take place. The consent process may take place on-site or remotely. If the entire process takes place on-site, the investigator must: verify subject identity, the content of the econsent and answer any questions, and obtain a witness signature

15 The econsent Approach If any or all of the process takes place remotely: All responses must be documented without the ability to alter, There must be a process for answering questions prior to signing the econsent. Process of remote consent is nearly identical to in-person consent EXCEPT

16 Remote Consent Northwell s requirement for a Witness signature is waived by the IRB A PDF copy of the consent form is sent to the potential subject for signatures and returned back to the consenting investigator via , mail, or fax, OR REDCap survey After receipt, the consenting investigator signs the document and provides the subject with a copy of the signed consent form

17 REDCap for econsent: Providing a Signed Copy Future process: Easily copy of signed ICF to participants through REDCap, including investigator signature Current process: Participant reads, signs, submits econsent Study staff receive notification & edit survey to add their signature Staff download as PDF & securely PDF to participants (print if in person) After downloading & ing ICF, delete PDF or save in a secure ephi drive 17

18 Remote Consent Research procedures may not commence until after the fully executed consent form is sent back to the subject with all signatures. IRB approval is required prior to implementation of remote consent. To be HIPAA compliant s must be encrypted

19 The econsent Approach The investigator must decide: where and how the system will be used what is needed to run the system When considering system requirements, the investigator should: consider the regulatory framework that governs the study (i.e. OHRP, FDA, and HIPAA) as appropriate

20 Additional Requirements as per FDA Electronic system must include a method to ensure that the person electronically signing the informed consent is the subject who will be participating in the research study Examples: Verification of a state-issued identification Personal questions Biometric methods Other identifying documents Please note: Compliance with these additional FDA requirements when using REDCap may require different study procedures for obtaining econsent. 20

21 REDCap Examples of Identity Verification: Ask subjects to electronically submit copy of identity verification (state ID, etc.), much like they would in person: 21

22 REDCap Examples of Identity Verification: Do initial eligibility screen and verify identity. Capture personal info that can then be used in the Survey Login feature to verify identity before unlocking econsent: 22

23 Pediatric Considerations Language and presentation of information must be understandable to the child For FDA-regulated clinical investigations Child may lack the documentation necessary to verify their identity for the purposes of preventing fraudulent use of electronic signatures It may be reasonable for the parent to initially document the child s assent, which can then be verified by the investigator upon the first study visit 23

24 econsent Options: The New Approach PDFs or Paper Consent: PDF consent documents contain built-in logic Interaction occurs via computer software Electronic Forms (Ex. REDCap) Completely online consent forms Interaction occurs online or an app Flexibility (econsent to paper) econsent becomes untenable Re-consent is required

25 econsent Options: The New Approach Interactive Features Consents with built in education curriculums, including videos, pictures, audio and other interactive features. Participant quizzes and feedback tools.

26 Utilizing REDCap surveys for Interactive econsent: 26

27 Examples of IRB Considerations for econsent Is the study population appropriate for econsent use? ( e.g., age, language, comprehension, technological savvy) Is there an audit trail? What systems are in place to verify the electronic signature? How will the consent process be undertaken? How will econsent be documented (e.g., software program, app, etc.)? How will a copy of the executed consent form be provided to subjects? 27

28 Examples of IRB Considerations for econsent (cont.) Is the system HIPAA compliant? What is the involvement of the PI in the consent process? Where will consenting take place? If re-consent is required, what mechanisms are in place to ensure that consent is obtained? Are there any specific state laws pertaining to econsent? 28

29 Benefits of econsent Enhance understanding of the research by using interactive technology to facilitate comprehension Customizable consent easily made appropriate for a specific culture/population There may be the ability to provide real-time updates to sponsors & CROs regarding enrollment The potential for remote monitoring of the informed consents 29

30 econsent Hurdles Initial start-up cost and/or any maintenance costs Staff training to manage econsent platform Not appropriate for all subject populations (e.g., those who are not technologically savvy). May pose a challenge to manage with site specific changes in multi-site studies. There may be additional delays when an informed consent is revised. Hardware considerations Readability/Font Size Amount of memory required to run the software Signature capture Touch screen; PC or Mac Security considerations 30

31 Barriers to Adopting econsent Regulatory Uncertainty FDA and OHRP emphasized that requirements of econsents should mirror the processes of paper consents Security and privacy concerns are two of the biggest barriers to adopting econsent Lack of confidence Market instability With competing vendors, it would not be ideal to start an econsent platform just to have another vendor take over and have to start over again 31

32 REDCap econsent Tour from Start to Finish eicf project #1 (basic): eicf project #2 (Survey Login for verifying identity for FDA regs): 32

33 REDCap econsent Options covered in this demo: Contents of econsent: Text Audio & Video Links to external websites Narration for low vision participants Interactive options/quizzes Verifying identity when required by FDA (#2) Providing a demo to the IRB Providing signed copy of ICF to pt 33

34 REDCap questions? Survey options can be overwhelming. econsent can be too. Contact for questions! 34

35 Thank you 35