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Electronic Informed Consent Affinity Group

Electronic Informed Consent Affinity Group. 12/6/2012. Agenda. Welcome , History, Background of the group (Jihad) Informatics perspective (Jihad) Regulatory and ethics perspective (Nick) Suggested future meeting agendas (Jihad) Open Discussion (All) Future Agenda Items,

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Electronic Informed Consent Affinity Group

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  1. Electronic Informed Consent Affinity Group 12/6/2012

  2. Agenda • Welcome, History, Background of the group (Jihad) • Informatics perspective (Jihad) • Regulatory and ethics perspective (Nick) • Suggested future meeting agendas (Jihad) • Open Discussion (All) • Future Agenda Items, • Review goals of the group • Opportunities for a face-to-face meeting (Nick) • Scheduling and other business

  3. Welcome and History • Established 1/12/12 • Recent hiatus • Group membership is open • The following groups might be interested: • Informatics • Ethics • Regulatory • Biobanking • Today N=60 (Jacqueline) • Membership contact CTSA_Informatics@CTSAC4.org

  4. Group Mission The goal of Electronic Informed Consent Affinity Group is to explore transformative mechanisms for collecting informed consents and research authorizations electronically. There are many aspects of electronic informed consents (EIC) that are being explored and tested, such as: • The impact of EIC on workflows for informed consents • The use of EIC for tissue banking initiatives, research registries or other scenarios • Using EIC to enhance the consent process with rich media • The need for revised terminologies and ontologies to accommodate EIC and EIC-collected information in research data marts. • The need for storage and retrieval of consent data and permissions as searchable attributes.

  5. Informatics Perspective(Jihad Obeid)

  6. The Case For Change Current Environment New Permissions Management • Electronic recording of consents and permissions • Access to permission decisions for research • Common permissions terminology • Facilitating research while enhancing compliance with patient wishes • Rich educational opportunities about the research process • Patients will have easy access to their permission decisions (patient portal) • Tracking of informed consent versions • Paper-based consents and permissions • Permissions data are unavailable for analysis • The number of patients who are generally favorable to research participation is unknown • Inconsistent process and semantics in obtaining permissions across multiple hospitals • Poor comprehension and satisfaction in subjects providing permission • Research volunteer subject lists are localized

  7. Permission as a Searchable Attribute Show me how many males with Diabetes over 65 have given permission to be contacted for research Other permissions include participation in: Biobank or Disease Registries, etc.

  8. RPMS version 2: KEY FEATURES • Includes RPMS Pilot functionality for patient registration • Added Informed Consent and HIPAA Authorizations • Design: Configurable, Extensible, Easy to Use • Includes Authoring Module/Form Designer for broad tool applicability • Ability to embed Rich Media content into forms (e.g. video) • Robust Architecture: Plug-in style and Ontology-based (graph database at its core) • Nodes and relationships are flexible, extensible • Handles large and complex datasets (scalable) • Indexes to transverse relationships (performance) • Published as Open Source product (Compared to custom developed application)

  9. Regulatory and Ethics Perspective(Nick Steneck)

  10. Regulatory Issues • Information ~ will IRBs approve providing information about studies electronically? • Documentation ~ is an electronic record stable/secure enough to create a permanent record of informed consent? • Signatures ~ are electronics signatures valid or must signatures be hard copy? • Audits ~ will electronic consent make audits easier or more difficult? • Collaboration ~ will the mode of consent impact collaborations, i.e. can paper and electronic consent subjects be combined in one study? • International ~ can electronic consent be used in international studies?

  11. Ethical issues • Understanding ~ does electronic consent provide sufficient (ethically appropriate) understanding? • Administration ~ are eTablets and/or the web sufficiently private and useable for ethically appropriate administration of informed consent? • Records management ~ will electronic consent information be as private and secure as hard copy? • Consent ~ will electronic consent change the willingness of subjects to participate in research in appropriate rather than inappropriate ways? • Use ~ will making consent information more readily available create ethical issues relating to the use of information and materials?

  12. eInformation vs. eConsent • UM BioLibrary project • Separate informfrom consent • One-page consent form • Information pamphlet • Validate comprehension • Sign consent • Semi-structured interview • Enroll / withdraw • Next stage, go electronic

  13. Hard-copy results Low enrollment Piloting Unethical Where to recruit? • 75% agree if getting blood drawn • Others, low enrollment • Pamphlet provides comprehension • Pamphlet not effective at recruiting Unethical Will electronic recruiting and consent work better?

  14. Suggested Topics for Future Meetings(order may vary) • Update on the Informed Consent Ontology from UCSD • Update on the Research Permissions Management System (RPMS) from MUSC • University of Florida’s experience with RPMS • University of Michigan’s iPad Consent Experience • Biotrust: Nick Anderson • Epic experience in consenting workflow (tbd)

  15. Discussion(all) • Future Agenda Items (review previous slide) • Review goals of the group (next slide) • Other discussion…

  16. Group Mission The goal of Electronic Informed Consent Affinity Group is to explore transformative mechanisms for collecting informed consents and research authorizations electronically. There are many aspects of electronic informed consents (EIC) that are being explored and tested, such as: • The impact of EIC on workflows for informed consents • The use of EIC for tissue banking initiatives, research registries or other scenarios • Using EIC to enhance the consent process with rich media • The need for revised terminologies and ontologies to accommodate EIC and EIC-collected information in research data marts. • The need for storage and retrieval of consent data and permissions as searchable attributes.

  17. Future Meetings • Scheduling update – doodle poll (Jacqueline): • Monthly 1st Thursdays 3 Eastern? • Opportunities for a face-to-face meeting (Nick) • Other business

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