Academic Medical Center Security and Privacy Conference (AMCSP)

Size: px

Start display at page:

Download "Academic Medical Center Security and Privacy Conference (AMCSP)"

Leslie Casey
6 years ago
Views:

1 Academic Medical Center Security and Privacy Conference (AMCSP) econsent Guidance and Use Cases JUNE 27, 2016 Colleen Lawrence, PhD, CCRP, Research Services Consultant, Vanderbilt University Medical Center Jody Power, MS, MBA, CIP Executive Director of IRB, Duke

2 Disclosures/Disclaimers C. Lawrence I am not an IRB analyst. I have never written my own consent document. I have never had to consent a patient. The IRB has final say with regards to all procedures and processes related to consent documents and the consent process.

3 Today you will learn Regulatory framework for using econsent IRB processes for using econsent at Vanderbilt and Duke Use cases: REDCap platform Vanderbilt Various platforms and media Duke Challenges for econsent

4 econsent: What is it? Electronic informed consent refers to using electronic systems and processes that may employ multiple electronic media (e.g. text, graphics, audio, video, podcasts and interactive Web sites, biological recognition devices and card readers) to convey information related to the study and to obtain and document informed consent. - FDA Draft Guidance for Industry Use of Electronic Informed Consent in Clinical Investigations ; March 2015

5 45 CFR 46 & OHRP Guidance 45 CFR 46 - Does not address electronic consent, only the general requirements for informed consent OHRP guidance- Yes, electronic signatures may be used to document consent. No specific method of signature mandated Defers to local laws for validity of electronic signature

6 IRB Policy IRB Policies & Procedures- Echo the federal regulations i.e. all elements of consent must be present and participants must receive a copy Nothing explicitly stated against electronic consent and signature

7 FDA Part 11 & Draft Guidance CFR 21 Part 11 applies to electronic records of source documents FDA Draft Guidance: Use of Electronic Informed Consent in Clinical Investigations

8 Use Case 1: REDCap econsent The econsent model is implemented in REDCap, a secure, web-based application that allows users to build and manage online surveys and databases quickly and securely. REDCap was built with an emphasis on data security, userfriendly design, and study-specific adaptability and meets standards for HIPAA- compliant data collection. The template REDCap data dictionary for a standard health sciences consent is available for download

10 Assessing Comprehension

11 How is version control handled in the econsent model? Include a revision date in the survey instructions for version control.

12 How is version control handled in the econsent model? Include a revision date in the survey instructions for version control.

13 How is the signature process handled in the econsent model? Patients can sign their consents by typing in their name, signing their name via stylus/finger, or study coordinators may also consider assigning PIN numbers to prospective participants to aid in the signature process.

14 * The development work to incorporate the signature functionality into REDCap was done by Rob Taylor.

15 E-Sign Act, Uniform Electronic Transactions Act & Tennessee Law E-Sign- Electronic Signatures in Global and National Commerce (Public Law ) UETA- adopted by forty-seven states and gives electronic signature the same legal effect as manual signature TCA addresses Uniform Electronic Transactions in Tennessee and the validity of electronic signature

16 The Privacy Rule for Research The Privacy Rule- Requires that participants are provided with a copy of their signed authorization to access PHI (private health information) for research purposes

17 ICH-GCP Requirements International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Requires that participants are provided with a copy of their signed consent document

18 What are my options for providing patients with their consent form? When a protocol states that it will follow Good Clinical Practice (GCP) or if PHI is being utilized in the study, patients must be provided with a signed copy of their consent form. These patients can have their consent converted to a pdf and printed in the clinic or an address can be provided and the consent can be mailed to the participant. For non-hipaa related or non-gcp studies, the appropriate version of the consent document can be housed on a shared resource site (i.e. ROCKET) and patients can be issued business cards or brochures with the web link to the version of the consent form they signed. Participants not seen in the clinic could choose to provide their address to be mailed a hard copy of their consent. In the near future, participants will be able to provide a cell phone number to receive a text containing the link to their consent document.

19 Future Directions - Technology Develop a library of IRB approved videos for of the most commonly consented procedures. The library will be available for Vanderbilt investigators to include in their e-consent materials. Embed videos within REDCap for a more fluid/user friendly interface

20 Embedding Videos Listen to audio files (e.g. welcome, instructions, etc.) View/play videos embedded from VIMEO or YouTube

21 Future Directions Patient Comprehension Conduct community engagement studio to have collect feedback from potential users regarding the usability/understandability of e- Consent (work with Meharry Vanderbilt Community Engaged Research Core) Collaborate with the Vanderbilt Enhanced Health Literacy Core to develop a set of best practices for: 1.) developing e-consent forms and 2.) how to ask quality questions to assess patient comprehension

22 Use Case 2: econsent at Duke Platforms for econsent at Duke include: In house program(s) developed by the DCRI Innovations Group Apple s Research Kit Commercially available econsent platforms The DUHS IRB is part of a School of Medicine team working to license or create econsent tools for the research community.

23 Approaches Utilized at Duke Traditional Consent on an ipad Standard Consent template Consenter (study coordinator) holds the ipad and goes through the document with the potential subject Consent via a signature pad Signed copy via printer or secure Combination of video and econsent

24 The PLATFORM Study at Duke Dr. Robin Matthews, PI; Vincent Miller, study coordinator Sponsors: AHRQ, Gilead, Hartford Foundation PLATFORM is a cardiology-based study designed to investigate the effect of customized health education and reminders on patient adherence to medical/lifestyle programs. Eligible subjects are adults who have experienced a Myocardial Infarction. Video with e-signature Video on YouTube.com Video sections consistent with Consent form subheadings Potential subject moves sequentially through video and can flag sections for which he/she has questions or needs additional information Signature using his/her finger on tablet

25 Advantages from the Subject s Point of View Progress through the consent process at individual speed Can indicate at any point when the coordinator is needed to answer questions The combination of video and econsent provides visual reference for the study activities described in the consent document

26 Advantages from the Research Team s Point of View Study Coordinator s presence is not required throughout the entire consent process Early indications suggest that the inclusion of video enhances the subject s understanding of the study Embedded milestones in the econsent process where the subject can halt and summon the study coordinator for further explanation. This mechanism provides feedback to the study team on sections of the consent document that may benefit from revision

27 Challenges Significant cost of video production Cost of ipads dedicated to the consent process No communication between eirb and econsent platform. Revised consents do not automatically download to platform. Minimal risk studies and remote econsent How can questions prior to consent be submitted When will study team members be available to address submitted questions?

28 Review Process at Duke Consultation With DUHS IRB Study Submitted To IRB IRB Approval Video Taping Completed Study Initiated 1) econsent and Video Text 2) Secure Transmission

29 Future Plans The DUHS IRB is leading efforts to create resources within the School of Medicine (SOM) that researchers can contract for videotaping. These resources would be heavily subsidized by the SOM. Using the argument that it will greatly facilitate enrollment at lower total cost to the institution regarding facilities and personnel, the DUHS IRB has suggested to SOM leadership that a general research fund for ipads be established. Use would be restricted to federal/non-profit funded research studies.

30 References 45 CFR 46 IRB Policy & Procedure IV.A & IV.B OHRP Informed Consent FAQs atoryinformation/guidances/ucm pdf

4.1. Accurate: The information is a true reflection of the original observation.

4.1. Accurate: The information is a true reflection of the original observation. SOP #: DOC-101 Page: 1 of 7 Effective Date: 1. POLICY STATEMENT: The Principal Investigator and research team members are required to prepare and maintain adequate and accurate case histories designed