Revolutionizing Informed Consent: Best Practices that Leverage Innovation and Technology

Transcription

1 Conference Agenda Thursday, July 23, 2015_v22 Bell Harbor International Conference Center 2211 Alaskan Way, Pier 66, Seattle, WA Revolutionizing Informed Consent: Best Practices that Leverage Innovation and Technology Target Audience The conference agenda and offered professional education will be relevant to the following audiences: IRB chairs, members, administrators, and staff Medical doctors, registered nurses, and other staff involved in clinical research Regulatory affairs and compliance oversight personnel, scientists, and ethicists Sponsors and contract research organization staff involved in developing, managing, or administering informed consent Educational Objectives Highlight informed consent best practices that leverage innovation and technology. Review emerging models, trends, and regulatory requirements when informing the research participant. Summarize agency recommendations for improving informed consent. Discuss informed consent models. Discuss how emerging technologies are shaping the consent process. Analyze how IRBs, institutions, and sponsors impact what is required in consent forms. Describe the auditing of the consent process from the sponsor, institution, IRB, and agency perspective. Discuss informed consent involving data and tissue repositories. Identify special considerations related to diverse and vulnerable populations and the consent process.

2 Track A Track B 07:00 08:00 08:00 08:15 Registration Topic: Welcome and Introduction Cheryl Weaver President, Board of Directors, NWABR, Seattle, WA Ken Gordon Executive Director, NWABR, Seattle, WA 08:15 08:45 08:45 10:15 Keynote: Informing the Research Participant Emerging Models, Trends, and Regulatory Requirements Topic: Recommendations for Improving Informed Consent Recent Agency Guidance and Hot Topics Cami Gearhart CEO Quorum Review IRB, Seattle, WA; Cambridge, MA; Vancouver, BC Kevin Hudziak Emergent Strategy Consultant Eli Lilly & Company Indianapolis, IN Leonard V Sacks Associate Director for Clinical Methodology, Office of Medical Policy/ CDER at Food and Drug Administration Washington, DC Cheryl Grandinetti Health Science Policy Analyst, Office of Medical Policy/CDER at Food and Drug Analyze key forces shaping the health care industry and how they will influence clinical trials and the informed consent process. Identify models, trends, and regulatory requirements regarding informed consent. Highlight informed consent best practices that leverage innovation and technology. Summarize agency recommendations regarding informed consent and use of econsent tools. Review CICSCRP and SACHRP recommendations for improving informed consent.

3 Administration Washington, DC Zachary Hallinan Director, Patient Communication and Engagement Programs, Center for Information & Study on Clinical Research Participation (CISCRP) Boston, MA 10:15 10:45 10:45 12:15 BREAK Topic: Consent Models - Tiered Consent - Dynamic Consent - Front Door Consent - Global Consent - Community Consent - Simplified Consent - Short Form Consent - econsent - Other Informed Consent Approaches David Borasky Vice President, Quality Management Copernicus Group IRB Durham, NC; Co-Chair, SACHRP Advisory Committee, Washington, DC John R. Baumann Assistant Vice President for Research Compliance Office of Research Compliance Office of Vice President for Research Indiana University Kevin Hudziak Emergent Strategy Consultant Eli Lilly & Company Indianapolis, IN Stephen Schmechel Associate Professor, Department of Pathology, University of Washington; Director, Northwest BioTrust, Seattle, WA Discuss the practicability of the traditional informed consent process in light of emerging trends in research. Identify new and emerging informed consent approaches. Topic: Special Considerations Regarding Adults and Pediatric Populations Douglas Diekema Director of Education Treuman Katz Center for Pediatric Bioethics; Chair, Institutional Review Board Committee, Seattle Children s, Seattle, WA David Forster Chief Compliance Officer, Office of Compliance, WIRB- Copernicus Group RIB, Olympia, WA Ran Goldman IRB Board Member, Quorum Review IRB; Professor of Pediatrics, University of British Columbia; Director of Pediatric Research in Identify special considerations related to diverse populations and the consent process Discuss pediatric decision-making considerations and challenges.

4 Abigail Echo-Hawk Tribal Liaison UW Partnership for Native Health and Institute for Translational Medicine, Seattle, WA Emergency Therapeutics & Division Head, Translational Therapeutics, BC Children s Hospital Anthony Costello CEO Mytrus, Inc. Davis, CA 12:15 01:30 01:30 02:15 LUNCH Topic: How IRBs, Institutions, and Sponsors Impact What is Required in Consent Forms John R. Baumann Assistant Vice President for Research Compliance Office of Research Compliance Office of Vice President for Research Indiana University Stephen Rosenfeld IRB Chair Quorum Review IRB, Seattle, WA; Cambridge, MA; Vancouver, BC Discuss stakeholder issues related to consent requirements Analyze consent form issues based on regulatory and organizational requirements. Topic: Informed Consent and Research Involving Data and Tissue Repositories Stephen Schmechel Associate Professor, Department of Pathology, University of Washington; Director, Northwest BioTrust, Seattle, WA Identify the ethical, legal and social policy implications relating to the collection, storage and use of biospecimens. Review special considerations related to informed consent involving data and tissue repositories. Marta Fields Senior Director, Compliance and Quality Systems at Seattle Genetics, Seattle, WA 02:15 03:00 Charlotte Shupert Compliance Domain Analyst, Compliance Solutions Evisions Portland, OR Continued See Above Continued Topic: Auditing the Consent Process The Sponsor, Institution, and IRB Perspectives Phillip Coran Senior Director, Quality & Regulatory Identify the auditing of the consent process

5 Affairs, Medidata, New York, NY Linda Coleman Director of Regulatory Affairs & General Counsel, Quorum Review IRB,, Seattle, WA; Cambridge, MA; Vancouver, BC from the perspective of the sponsor, Institution, and agency perspective. Review best practices related to auditing the consent process. 03:00 03:30 03:30 05:00 BREAK Topic: Emerging Trends in Research - mhealth - econsent - Internet Research - Social Media - Research Kits John Wilbanks Chief Commons Officer, Sage Bionetworks Charlotte Shupert Compliance Domain Analyst, Compliance Solutions Evisions Portland, OR Analyze key forces shaping health care industry and how they will influence clinical trials and informed consent Discuss how emerging technologies are shaping the consent process. Demonstration: Smart Form Wizard for Exempt or Excused Research Alayne Lehman Director, Clinical Operations, C.R. Bard, Inc.; Irvine, CA Jane A. McCutcheon Associate Professor, Department of Basic Sciences, College of Dentistry, Faculty Liaison for Compliance, Office of the Senior Vice Provost for Research, New York University, New York, NY Discuss a smart form (wizard) that will allow investigators to selfdetermine minimal risk research projects that meet the review category of exempt or excused research. Stephen Rosenfeld IRB Chair Quorum Review IRB, Seattle, WA; Cambridge, MA; Vancouver, BC Eric Delente Managing Director Enforme Interactive, Inc. Frederick, MD

6 05:00 05:05 Topic: Closing Remarks