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Appendix A: Study Approach
Pages 149-164

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From page 149... ... , the Institute of Medicine (IOM) of the National Academies of Sciences, Engineering, and Medicine convened the Committee on the Ethical and Social Policy Considerations of Novel Techniques for Prevention of Maternal Transmission of Mitochondrial DNA Diseases to consider the ethical, social, and policy issues raised by the development of mitochondrial replacement techniques (MRT) Read the entire page →
From page 150... ... For those unable to travel to the meetings, a conference call number was provided. During the public workshop and May public comment session, the committee requested that commenters specifically address the following questions in their remarks: • What ethical and social issues are raised by proposed mito chondrial replacement techniques (MRT) Read the entire page →
From page 151... ... All written information provided to the committee from external sources is available by request through the Academies' Public Access Records Office. LITERATURE AND PRESS REVIEW Academies staff conducted a systematic literature review on topics related to the ethical, social, and policy aspects of MRT, as well as foundational background research related to mitochondrial biology and genetics, mtDNA disease, and MRT research to date (see Appendix B for a selected compilation of this research) Read the entire page →
From page 152... ... • Mitochondrial replacement techniques − ST: ("maternal spindle transfer" OR "spindle transfer" M OR "spindle-chromosomal complex transfer") AND (mito chondria* Read the entire page →
From page 153... ... ) Ethics and Policy Literature Search parameters: • Date range: all years • International, English only Databases: • Scopus • LexisNexis • Grey literature reports (NIH, FDA, World Health Organization [WHO] Read the entire page →
From page 154... ... OR ("spindle- chromosomal complex transfer") OR ("germline modification" OR "germline manipulation" OR "inheritable genetic modifica tion" OR germline) Read the entire page →
From page 155... ... or (mitochondria! w/p germline therapy or germ-line therapy or germ line therapy) Read the entire page →
From page 156... ... 11:00 AM Opening remarks to public audience Jeffrey Kahn, Committee Chair, Johns Hopkins University 11:05 AM Delivery of Study Charge and Q&A/Discussion with Committee Objectives: • Receive study background and charge from FDA. • Discuss task with the sponsor and determine scope of committee's work (i.e., what is in and what is out) Read the entire page →
From page 157... ... 8:30 AM Welcome and overview of workshop Jeffrey Kahn, Committee Chair, Johns Hopkins University SESSION I: ETHICAL OR SOCIAL IMPLICATIONS OF MRT Session Objectives: • Highlight key characteristics of proposed MRT techniques raising ethical or social issues. • Discuss the distinctive ethical or social issues that would arise with MRT techniques. Read the entire page →
From page 158... ... Session Co-Chairs: Jeffrey Kahn, Committee Chair, Johns Hopkins University Vamsi Mootha, Committee Member, Harvard Medical School 10:35 AM Annelien Bredenoord, University Medical Center Utrecht Marcy Darnovsky, Center for Genetics and Society John Evans, University of California, San Diego John Harris, University of Manchester 11:15 AM Discussion with committee and workshop participants 11:45 AM Lunch (Cafeteria located on third floor) SESSION III: POLICY ANALOGUES Session Objective: • Discuss unique characteristics of MRT shared with similarly inno vative techniques throughout history, and how the policy debates and eventual formulation of policy for those techniques can be instructive for MRT. Read the entire page →
From page 159... ... use in children Lainie Ross, University of Chicago 1:50 PM Discussion with committee and workshop participants 2:10 PM Embryo and embryonic stem cell (hES) research Patricia King, Georgetown Law 2:20 PM Discussion with committee and workshop participants 2:40 PM Public comment period David McKeon, New York Stem Cell Foundation (3 min.) Read the entire page →
From page 160... ... 160 MITOCHONDRIAL REPLACEMENT TECHNIQUES 3:00 PM Data on attitudes of women with mtDNA mutations toward MRT Michio Hirano, Columbia University Medical Center 3:15 PM Discussion with committee and workshop participants 3:30 PM Patient perspective on MRT Kirah Fasano, Personal Representative 3:40 PM Discussion with committee and workshop participants 3:55 PM Scientific and ethical considerations of mtDNA segregation and the bottleneck phenomenon as it applies to MRT Eric Shoubridge, McGill University 4:10 PM Potential alternative to preventing transmission of mtDNA diseases: Heteroplasmy shift therapy Carlos Moraes, University of Miami 4:25 PM Haplogroup compatibility and how mtDNA can influence traits beyond disease Doug Wallace, The Children's Hospital of Philadelphia 4:40 PM Discussion with committee and workshop participants 5:00 PM Adjourn day one April 1, 2015 OPEN SESSION (8:30 AM-12:20 PM) 8:30 AM Welcome and recap of day one Jeffrey Kahn, Committee Chair, Johns Hopkins University Read the entire page →
From page 161... ... Session Co-Chairs: Alan DeCherney, Committee Member, National Institutes of Health Marni Falk, Committee Member, The Children's Hospital of Philadelphia 8:45 AM Practical challenges of implementing MRT and potential effects on outcomes Jacques Cohen, Reprogenetics, LLC 9:00 AM Discussion with committee and workshop participants 9:15 AM Consideration of potential epigenetic effects of MRT George Daley, Boston Children's Hospital 9:30 AM Discussion with committee and workshop participants SESSION V: CLINICAL INVESTIGATIONS Session Objectives: • Discuss the preclinical evidence base necessary to support first-in human MRT research. • Consider earlier precedents for the collection of safety and efficacy information for novel techniques (e.g., systematically collecting evidence in surgical innovation or IVF) Read the entire page →
From page 162... ... Food and Drug Administration 11:25 AM Discussion with committee and workshop participants 11:40 AM Toleration of uncertainty for new reproductive technologies such as MRT Aaron Kesselheim, Harvard Medical School/Brigham and Women's Hospital John Robertson, University of Texas, Austin 12:00 PM Discussion with committee and workshop participants 12:15 PM Public comment period Brendan Foht, The New Atlantis (3 min.) Rick Leach, World Food Program USA (3 min.) Read the entire page →
From page 163... ... May 19, 2015 OPEN SESSION (10:00-10:30 AM) 10:00 AM Opening Remarks to Public Audience Jeffrey Kahn, Committee Chair, Johns Hopkins University Pre-registered public commenters: David Prentice, Charlotte Lozier Institute Brian Niland, Personal Representative Jaycee Hanson, International Center for Technology Assessment Suzanne Scheller, Pope Paul VI Institute for the Study of Human Reproduction ~10:30 AM Adjourn open session May 19, 2015 CLOSED SESSION (10:30 AM-5:00 PM) Read the entire page →

From page 149...

... , the Institute of Medicine (IOM) of the National Academies of Sciences, Engineering, and Medicine convened the Committee on the Ethical and Social Policy Considerations of Novel Techniques for Prevention of Maternal Transmission of Mitochondrial DNA Diseases to consider the ethical, social, and policy issues raised by the development of mitochondrial replacement techniques (MRT)

Appendix A: Study Approach Pages 149-164

Appendix A: Study Approach
Pages 149-164