Introduction to Returning of Individual Results Working Group - PowerPoint PPT Presentation

Introduction to Returning of Individual Results Working Group December 16, 2015

December 16, 2015 - Agenda Time Topic Presenters 8:00 – 8:15 Welcome and Introductions Rebecca Li 8:15 – 9:15 Scope and background on returning individual Barbara Bierer research results Definition of key terms Debra Mathews 9:15 – 10:30 Brainstorming: common institutional Sandy Prucka barriers/challenges (white board brainstorming Dave Pulford session) Barbara Bierer 10:30 – 10:45 Break 10:45 – 11:15 Discussion of workgroup logistics, workflow, timeline MRCT Center Outline of first deliverable(s) to address identified 11:15 – 12:15 Sandy Prucka barriers Dave Pulford Debra Mathews 12:15 – 1:00 Working lunch: Next steps and responsibilities

Current Working Group Members Co-Chairs: Kelly Coulbourne, AstraZeneca Sandra Prucka, Eli Lilly and Company Patrick Cullinan, Takeda Pharmaceuticals Debra Mathews, Johns Hopkins Berman Institute Felipe Dolz, Sanofi Nicole Hinton, Biogen Team members: Jaime Houde, EMD Serono Academic/Medical Center: Barbara Kress, Merck Carmen Aldinger, MRCT Center Sarah Larson, Biogen Barbara Bierer, MRCT Center Laurie Myers, Merck Juan Carmona, MRCT Center David Pulford, GlaxoSmithKline Alisa Donnelly, formerly Univ of Manchester Jessica Scott, GlaxoSmithKline Felicitas Holzer, Univ of Cambridge Institutional Review Boards: Rebecca Li, MRCT Center Linda Coleman, Quorum Review IRB Heather Marino, MRCT Center David Forster, WIRB Copernicus Group Ignacio Mastroleo, FLACSO Argentina Stephen Rosenfeld, Quorum Review IRB Ramadhani Abdallah Noor, Harvard Chan School Non-Profit: Usharani Pingali, Nizam's Institute of Medical Sciences Zachary Hallinan, CISCRP Wasana Prasitsuebsai, HIV-NAT, AIDS Research Ctr Ellie Okada, Boston Cancer Policy Institute Lynn Sleeper, Harvard Medical School Lauren Quattrochi, Sense About Science Clinical Research Organization: Patient Advocates: Jules Mitchel, Target Health Inc. Deborah Collyar, Patient Advocates In Research Government/Regulatory: Elizabeth Frank, Dana Farber/Harvard Cancer Ctr Ricardo Eccard da Silva, Braz. Health Surv. Ag. - Anvisa Cheryl Jernigan, Susan G. Komen Garbine Saruwatari Zavala – INMEGEN Jane Perlmutter, Gemini Group Industry: Research/Consulting Firms: Mary Ellen Allen, Genentech, Inc. Barbara Godlew, The FAIRE Company, LLC Karina Bienfait, Merck Wendy Sanhai, Exponent, Inc Karla Childers, Johnson & Johnson Patricia Teden, Teden Consulting LLC

Framing questions • The MRCT Center has developed guidance and tools for return of aggregate results of research to participants. Often, participants will ask, “What study arm was I on?” Do we, should we disclose? If yes, how do we ensure they have heard? • Beyond study arm assignment, in the past, individual research results were determined to be “actionable” or not, and only actionable results returned. Do individuals own or have a right to all or only some of their data? • Individuals increasingly are requesting access to their information; individuals are partners in research. • Do we, should we, respect participant autonomy rights? And if we do return results, what are our responsibilities to the participant? 4

Project statement: returning individual research results • Problem: Patients and advocacy groups desire to receive individual & aggregate research data from clinical studies in which they participated. While the MRCT Center has developed guidelines on the return of aggregate results, standard guidelines/criteria to facilitate the return of individual results are lacking, making it difficult to determine what, when, and how data are to be returned • Summary : This project will focus on returning individual results to study participants • Approach: Launch diverse workgroup comprised of multi-stakeholders coordinated and organized by MRCT Center that will provide guidance on return of individual-level data Individual-level results may include incidental findings (IFs), clinical and research laboratory results, pharmacogenomic/genomic results, and results of the study arm

Spectrum of results to return to participants: • Aggregate research results Easiest • Assignment to and results of study arm • Routine clinical results performed in the course of research – USA: CLIA-approved or – unapproved laboratories and processes – What is global standard for trustworthiness and does it matter? • Incidental findings discovered in the course of a clinical trial (mass on an MRI done for research purposes) – Of potential clinical significance – Of uncertain significance • Research results – Of likely or uncertain significance – Of potential proprietary importance Hardest – Genetic/genomic results • Other results

Source of data Data types • Clinical CLIA (or equivalent) laboratory results • Clinical non-CLIA laboratory results • Research results (e.g. biomarkers, experimental, proprietary) • Imaging results – Routine – Experimental • Genetic/Genomic results • Other: biometric, social/behavioral, etc. Sources of data • Clinical trials • Secondary research • Research using samples obtained from biobanks 1/22/2016 7

In the context of biobanking: Definitions Wolf et. Al., specifically addressing biobanking policies, defined: • Incidental Finding (IF): “a finding concerning an individual research participant ... that has potential health or reproductive importance and is discovered in the course of conducting research but is beyond the aims of the study.” • Individual Research Results (IRR): “a finding concerning an individual contributor that has potential health or reproductive importance and is discovered in the course of research on the focal variables under study in meeting the stated aims of the research project.” Wolf SM, Crock, BN, Van Ness, B, et al. Managing incidental findings and research results in genomic research involving biobanks and archived data sets. Genet Med, 2012;14:361 – 384 1/22/2016 8

In Biobanking, 4 key responsibilities: CARR: Clarifying, Analyzing, Re-identifying, Recontacting • C larifying the criteria to determine what kind of findings are returnable, and the roster of returnable IFs and IRRs; • A nalyzing a particular finding to decide whether it should be offered to the individual contributor; • R e-identifying that contributor (or contributors, if more than one is affected by the finding); and • R econtacting the contributor(s) to offer the finding and genetic or other appropriate counseling. (in this context, contributor is donor or participant. Possible for contributor to be another investigator) Wolf SM, Crock, BN, Van Ness, B, et al. Managing incidental findings and research results in 1/22/2016 9 genomic research involving biobanks and archived data sets. Genet Med, 2012;14:361 – 384

Definition of key terms Incidental Findings • Are previously undiagnosed medical or psychiatric conditions that are discovered unintentionally and are unrelated to the current medical or psychiatric condition which is being treated or for which tests are being performed. Note: primarily directed to clinical care but applicable to research and DTC

Presidential Commission for the Study of Bioethical Issues Recommendations : The Bioethics Commission offered specific recommendations for handling incidental and secondary findings in clinical, research and direct-to- consumer settings. There are, however, some ethical principles and duties that span all three contexts for which the Bioethics Commission made five broad recommendations. I. Practitioners should inform potential recipients, in any setting, about the possibility of incidental or secondary findings, and if and how those findings will be disclosed, before the start of a test or procedure. Informed consent and open communication between providers and potential recipients is essential. II. Professional representative groups should develop guidelines that categorize findings likely to arise from each diagnostic modality, and develop best practices for managing them. See more at: http://bioethics.gov/node/3186#sthash.stxRzbWm.dpuf (emphasis added)

Presidential Commission for the Study of Bioethical Issues (continued) Federal agencies and other interested parties should fund research to keep III. abreast of the rapidly evolving types and frequency of findings; potential costs, benefits, and harms; and recipient and practitioner preferences about incidental and secondary findings. Public and private entities should prepare materials and enhance education of all IV. stakeholders, including practitioners, institutional review boards, and potential recipients about the ethical, practical, and legal considerations raised by incidental and secondary findings. There is a need – based on justice and fairness – not just for a privileged few but V. for all individuals to have access to information and the guidance needed to make informed choices about what tests to undergo, what kind of information to seek, and what to do with information once received. Affordable access to care and quality information about incidental and secondary findings, before and after testing, can be potentially lifesaving. - See more at: http://bioethics.gov/node/3186#sthash.stxRzbWm.dpuf (emphasis added)