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Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×

Appendix A

Study Approach

In response to a request by the U.S. Food and Drug Administration (FDA), 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) and whether these issues preclude FDA from moving forward with consideration of MRT clinical investigations.

COMMITTEE EXPERTISE

The IOM formed a committee of 12 experts to deliberate on and respond to the statement of task for the study (see Box 1-1 in Chapter 1). The committee was composed of members with expertise in bioethics, philosophy, law, policy, religion, mitochondrial biology and medicine, clinical investigations, and patient advocacy. Appendix C provides biographical information for each committee member.

MEETINGS AND INFORMATION-GATHERING ACTIVITIES

The committee held five in-person meetings in 2015 (January, March-April, May, July, and September). The January, March-April, and May meetings included portions open to the public; the agendas for these open sessions are included at the end of this appendix. The committee meetings in July and September were held only in closed session.

Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×

To inform its deliberations, the committee gathered information through a variety of mechanisms: (1) the 2-day public workshop held in conjunction with the March-April meeting, which included an open public comment session; (2) the open public comment session held during its May meeting; (3) systematic reviews of the literature on the ethical, social, and policy issues associated with MRT, as well as pertinent scientific background and research (see below and Appendix B); (4) solicitation and consideration of written statements from stakeholders and members of the public through the committee’s Current Projects System (CPS) website and committee email; and (5) personal communication among committee members, staff, and individuals who have been directly involved in or have special knowledge of the issues under consideration.

During the 2-day public workshop held March 31-April 1, 2015, in Washington, DC, the committee gathered input from experts in academia, policy, clinical medicine, and government on a wide range of topics related to the study charge, including (1) ethical, social, and policy implications of MRT; (2) germline modification; (3) policy analogues; and (4) mitochondrial science and medicine. As was the case during the May meeting, the committee held open public comment sessions during which it invited input from any interested parties. 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 mitochondrial replacement techniques (MRT)?
    • Should MRT be considered germline modification?
    • Is MRT different, from an ethical and social perspective, from modification of nuclear DNA?
  • Should there be a distinction between genetic modification for therapeutic/prevention purposes and genetic modification for enhancement purposes? If so, how should this distinction be defined and implemented?
  • What are the ethical and social issues that arise if a child is born with genetic material from three individuals?
  • How should the current availability of alternative approaches—adoption and oocyte donation—factor into the assessment of allowing MRT investigations to proceed?
  • What are the ethical and social ethical issues if MRT clinical investigations were to proceed?
    • Ethical and social issues in providing “consent”
    • Ethical and social issues in first-in-human investigation in women and for the creation of children
Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×
  • Other aspects of enrollment and tracking during a clinical investigation

The committee also solicited and considered written statements from stakeholders, members of the public, and other interested parties through its CPS website and email. In response, the committee received 35 written comments from a variety of individuals and organizations, including domestic and international academic researchers and scholars, mitochondrial DNA (mtDNA) disease patients, parents of children with mtDNA disease, mtDNA disease patient advocacy representatives, public advocacy groups, and others. Staff collected and compiled all comments for the committee’s review, calling particular attention to recurring and cross-cutting themes and unique perspectives. 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). Other targeted literature reviews were conducted as novel issues arose throughout the committee’s deliberations.

Science and Medicine Literature

Search parameters:

  • Date range: all years
  • International, English only

Databases:

  • PUBMED Medline
  • Scopus
  • Web of Science
  • Grey literature (U.S. Food and Drug Administration [FDA], National Institutes of Health [NIH], Human Fertilisation and Embryology Authority [HFEA], Nuffield Council on Bioethics)
Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×

Search strategy:

  • Mitochondrial biology and genetics
    • MESH: Mitochondria/Anatomy and Histology/Chemistry/Embryology/Genetics/Growth and Development/Metabolism/Physiology (sort by relevance)
    • MESH: “Cell Division/genetics” AND (with the following MESH terms searched separately) “DNA, Mitochondrial,” “Genome, Mitochondrial,” “Genes, Mitochondrial,” “Mitochondria/genetics”
  • Complexities of mitochondrial biology
    • Mitochondria* AND bottleneck
    • Mitochondria* AND haplotype OR haplogroup
    • Mitochondria* AND mismatch OR incompatibility
    • Mitochondria* AND epigenetics
  • Mitochondrial/mtDNA disease
    • (“mitochondrial disease” OR “mitochondrial disorder”) AND etiology
    • (“mitochondrial disease” OR “mitochondrial disorder”) AND (pathophysiology OR pathology)
    • (“mitochondrial disease” OR “mitochondrial disorder”) AND subtype*
    • (“mitochondrial disease” OR “mitochondrial disorder”) AND diagnosis
    • (“mitochondrial disease” OR “mitochondrial disorder”) AND (treatment OR therapeutics OR pharmaceutical or “gene therapy”)
  • Mitochondrial replacement techniques
    • MST: (“maternal spindle transfer” OR “spindle transfer” OR “spindle-chromosomal complex transfer”) AND (mitochondria* OR “mitochondrial disease” OR “mitochondrial disorder”)
    • PNT: ((“pronuclear transfer” OR (karyotype OR karytype OR pronuclei) AND transfer)) AND (mitochondria* OR “mitochondrial disease” OR “mitochondrial disorder”)
    • PBT: (“polar body” OR “polar bodies”) AND (mitochondria* OR “mitochondrial disease” OR “mitochondrial disorder”)
  • Alternatives to MRT
    • PGD or prenatal screening: (“prenatal diagnosis” OR “prenatal screening” OR PND OR “preimplantation genetic diagnosis” OR PGD) AND (“mitochondrial disorder” OR “mitochondrial disease”)
    • Adoption: (Adoption AND (“mitochondrial disorder” OR “mitochondrial disease”))
Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×
  • Surrogacy: (Surrogacy AND (“mitochondrial disorder” OR “mitochondrial disease”))

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], International Society for Stem Cell Research [ISSCR], United Nations Educational, Scientific and Cultural Organization [UNESCO], World Medical Association [WMA])

Search strategy:

  • MRT as germline modification: (“germline modification” OR “germline manipulation” OR “inheritable genetic modification” OR germline) AND ((“mitochondria replacement”) OR (“mitochondria transfer”) OR (“mitochondrial manipulation”) OR (“mitochondrial gene replacement”) OR (oocyte modification) OR (“three-person embryo”) OR (“three-parent babies”) OR (“nuclear genome transfer”) OR (“pronuclear transfer”) OR (“spindle transfer”) OR (“three-person IVF”) OR (“3-person IVF”) OR (tri-parenthood) OR (“assisted reproductive therapy” AND “mitochondria”) OR (“spindle-chromosomal complex transfer”))
  • MRT/germline modification and informed consent: (consent OR “informed consent” OR “assumption of risk” OR permission) AND (“germline modification” OR “germline manipulation” OR “inheritable genetic modification” OR germline) AND ((“mitochondria replacement”) OR (“mitochondria transfer”) OR (“mitochondrial manipulation”) OR (“mitochondrial gene replacement”) OR (oocyte modification) OR (“three-person embryo”) OR (“three-parent babies”) OR (“nuclear genome transfer”) OR (“pronuclear transfer”) OR (“spindle transfer”) OR (“three-person IVF”) OR (“3-person IVF”) OR (tri-parenthood) OR (“assisted reproductive therapy” AND “mitochondria”) OR (“spindle-chromosomal complex transfer”)) AND (child* OR offspring OR descendant* OR progeny)
  • MRT/germline modification and notions of identity/kinship: (ethic* OR “social issue” OR personhood) AND (child* OR offspring OR
Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×
  • progeny) AND (“germline modification” OR “germline manipulation” OR “inheritable genetic modification” OR germline) OR ((“mitochondria replacement”) OR (“mitochondria transfer”) OR (“mitochondrial manipulation”) OR (“mitochondrial gene replacement”) OR (oocyte modification) OR (“three-person embryo”) OR (“three-parent babies”) OR (“nuclear genome transfer”) OR (“pronuclear transfer”) OR (“spindle transfer”) OR (“three-person IVF”) OR (“3-person IVF”) OR (tri-parenthood) OR (“assisted reproductive therapy” AND “mitochondria”) OR (“spindle-chromosomal complex transfer”)))
  • MRT/germline modification and notions of genetic engineering, slippery slope, designer children: (“slippery slope” OR “designer babies” OR “designer baby” OR “genetic engineering”) AND ((“mitochondria replacement”) OR (“mitochondria transfer”) OR (“mitochondrial manipulation”) OR (“mitochondrial gene replacement”) OR (oocyte modification) OR (“three-person embryo”) OR (“three-parent babies”) OR (“nuclear genome transfer”) OR (“pronuclear transfer”) OR (“spindle transfer”) OR (“three-person IVF”) OR (“3-person IVF”) OR (tri-parenthood) OR (“assisted reproductive therapy” AND “mitochondria”) OR (“spindle-chromosomal complex transfer”) OR (“germline modification” OR “germline manipulation” OR “inheritable genetic modification” OR germline))
  • Risks related to MRT: (“health problem” OR “health implication” OR harm* OR risk* OR safety OR efficacy OR epigenetic harm OR epigenetic OR carryover) and (“mitochondria replacement”) OR (“mitochondria transfer”) AND ((“mitochondria replacement”) OR (“mitochondria transfer”) OR (“mitochondrial manipulation”) OR (“mitochondrial gene replacement”) OR (oocyte modification) OR (“three-person embryo”) OR (“three-parent babies”) OR (“nuclear genome transfer”) OR (“pronuclear transfer”) OR (“spindle transfer”) OR (“three-person IVF”) OR “3-person IVF”) OR (tri-parenthood) OR (“assisted reproductive therapy” AND “mitochondria”) OR (“spindle-chromosomal complex transfer”))

Press Search and Alerts

Database: LexisNexis

Search parameters:

  • All English language news
Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×
  • All available dates
  • Alerts received on a daily basis

Search strategy:

((mitochondria! replacement) or (mitochondria! manipulation) or (oocyte modification) or (three-person embryos) or (three-parent babies) or (nuclear genome transfer) or (pronuclear transfer) or (maternal spindle transfer) or (mitochondria! disease and oocyte and manipulation or replacement or modification) or (mitochondria! w/p germline therapy or germ-line therapy or germ line therapy) or (assisted reproduct! and mitochondria!) or (mitochondria! and oocyte and FDA))

Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×

COMMITTEE MEETING AGENDAS

Meeting 1: January 27-28, 2015

The National Academies
Keck Center—Rooms 100 and 201
500 Fifth Street NW
Washington, DC 20001

January 27, 2015
CLOSED SESSION (8:30-11:00 AM)

January 27, 2015
OPEN SESSION (11:00 AM-12:30 PM)

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).
  • Clarify issues identified by the committee and seek answers to questions.
  • Discuss report audience and expected products.
 

Celia Witten, Director, Office of Cellular, Tissue, and Gene Therapy, Center for Biologics Evaluation and Research (CBER)/U.S. Food and Drug Administration (FDA)

 

FDA Panelists:

 

Deborah Hursh, Senior Investigator, Division of Cell and Gene Therapy, CBER

Wilson Bryan, Director, Division of Clinical Evaluation and Pharmacology/Toxicology, CBER

Lei Xu, Medical Officer, Division of Clinical Evaluation and Pharmacology/Toxicology, CBER

12:30 PM

Adjourn open session

Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×

January 27, 2015
CLOSED SESSION (12:30-4:00 PM)

January 28, 2015
CLOSED SESSION (8:30 AM-5:00 PM)

Meeting 2: March 30-April 1, 2015

The National Academies
Keck Center—Room 208
500 Fifth Street NW
Washington, DC 20001

March 30, 2015
CLOSED SESSION (1:30-5:00 PM)

March 31, 2015
OPEN SESSION (8:30 AM-5:00 PM)

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.

Session Co-Chairs:

R. Alta Charo, Committee Member, University of Wisconsin–Madison

Laurie Strongin, Committee Member, Hope for Henry Foundation

9:00 AM

Heather Ward, Personal Representative

  Kevin FitzGerald, Georgetown University
  Thomas Murray, The Hastings Center
  Laurie Zoloth, Northwestern University
  Hugh Whittall, Nuffield Council on Bioethics
Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×
9:50 AM Discussion with committee and workshop participants

10:20 AM

Break

SESSION II: GERMLINE MODIFICATION

Session Objectives:

  • Discuss whether the manipulation of mitochondrial content raises social and ethical issues related to genetic germline modification, and whether the issues raised are similar to or different from those raised by modification of nuclear DNA.
  • Discuss the historical prohibitions on germline genetic modification, the social and ethical considerations that shaped these restrictions, and whether they should be revisited.
  • Consider whether it is advisable to establish controls to distinguish between genetic modification for therapeutic/prevention purposes and for enhancement purposes. What controls could be effective at maintaining this distinction?

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 innovative techniques throughout history, and how the policy debates and eventual formulation of policy for those techniques can be instructive for MRT.
Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×

Session Chair:

Jeffrey Kahn, Committee Chair, Johns Hopkins University

12:30 PM

In vitro fertilization (IVF) (including donor gametes)

Nick Hopwood, University of Cambridge (via WebEx)

Rene Almeling, Yale University

12:50 PM

Discussion with committee and workshop participants

1:10 PM

Gene transfer in pediatric populations

Benjamin Wilfond, Seattle Children’s Hospital

1:20 PM

Discussion with committee and workshop participants

1:40 PM

Human growth hormone (hGH) 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.)

2:43 PM

Break

SESSION IV: SCIENCE AND MEDICINE

Session Objective:

  • Discuss key scientific questions regarding MRT and their ethical or social implications.

Session Co-Chairs:

Alan DeCherney, Committee Member, National Institutes of Health

Marni Falk, Committee Member, The Children’s Hospital of Philadelphia

Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×

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

Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×

SESSION IV: SCIENCE AND MEDICINE

Session Objective:

  • Discuss key scientific questions regarding MRT.

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-inhuman 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).
  • Discuss what an ethical clinical investigation of MRT might look like, and consider the decision milestones that would occur across the evaluation of MRT.

Session Chair:

Jeffrey Botkin, Committee Member, University of Utah

9:45 AM

Preclinical evidence base to support an IND for MRT

     Wei Liang, U.S. Food and Drug Administration
     John Gearhart, University of Pennsylvania
     Insoo Hyun, Case Western Reserve University
Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×
10:15 AM Discussion with committee and workshop participants

10:30 AM

Designing a systematic investigation of MRT techniques

Steven Goodman, Stanford Medical School (via WebEx)

Doug Turnbull, University of Newcastle upon Tyne (via WebEx)

10:50 AM Discussion with committee and workshop participants

11:05 AM

Designing an ethically acceptable investigation of MRT in the United States

Rebecca Dresser, Washington University in St. Louis

Robert Nelson, U.S. 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.)

12:21 PM Adjourn open session/committee convenes in closed session

April 1, 2015
CLOSED SESSION (12:20-5:00 PM)

Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×

Meeting 3: May 18-20, 2015

The National Academies
Keck Center—Room 103
500 Fifth Street NW
Washington, DC 20001

May 18, 2015
CLOSED SESSION (8:30 AM-5:00 PM)

May 19, 2015
CLOSED SESSION (8:30-10:00 AM)

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)

May 20, 2015
CLOSED SESSION (8:00-11:00 AM)

Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×

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Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×
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Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×
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Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×
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Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×
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Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×
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Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×
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Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×
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Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×
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Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×
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Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×
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Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×
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Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×
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Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×
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Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×
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Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×
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Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.
×
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Mitochondrial replacement techniques (MRTs) are designed to prevent the transmission of mitochondrial DNA (mtDNA) diseases from mother to child. While MRTs, if effective, could satisfy a desire of women seeking to have a genetically related child without the risk of passing on mtDNA disease, the technique raises significant ethical and social issues. It would create offspring who have genetic material from two women, something never sanctioned in humans, and would create mitochondrial changes that could be heritable (in female offspring), and therefore passed on in perpetuity. The manipulation would be performed on eggs or embryos, would affect every cell of the resulting individual, and once carried out this genetic manipulation is not reversible.

Mitochondrial Replacement Techniques considers the implications of manipulating mitochondrial content both in children born to women as a result of participating in these studies and in descendants of any female offspring. This study examines the ethical and social issues related to MRTs, outlines principles that would provide a framework and foundation for oversight of MRTs, and develops recommendations to inform the Food and Drug Administration’s consideration of investigational new drug applications.

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