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.

Contents

• The National Academies of SCIENCES • ENGINEERING • MEDICINE
• COMMITTEE ON THE ETHICAL AND SOCIAL POLICY CONSIDERATIONS OF NOVEL TECHNIQUES FOR PREVENTION OF MATERNAL TRANSMISSION OF MITOCHONDRIAL DNA DISEASES
• Reviewers
• Preface
• Abstract
• Summary
  • STUDY CHARGE AND APPROACH
  • ETHICAL, SOCIAL, AND POLICY CONCERNS SURROUNDING MRT
  • INITIAL INVESTIGATIONS AND GOVERNANCE OF MRT RESEARCH IN HUMANS
• 1. Introduction
  • STUDY BACKGROUND AND CONTEXT
  • STUDY APPROACH
  • ORGANIZATION OF THE REPORT
  • REFERENCES
• 2. Science and Policy Context
  • INTRODUCTION TO REPRODUCTIVE BIOLOGY AND MEDICINE
  • INTRODUCTION TO MITOCHONDRIAL BIOLOGY AND GENETICS
  • MRT RESEARCH TO DATE
  • RISKS RELATED TO MRT: SCIENTIFIC COMPLEXITIES AND TECHNICAL UNKNOWNS AND UNCERTAINTIES
  • POLICY CONTEXT
  • REFERENCES
• 3. Do Ethical, Social, and Policy Considerations Preclude MRT?
  • DEMAND FOR MRT
  • GENETIC MODIFICATION OF GERM CELLS AND THE GERMLINE
  • UNINTENDED DOWNSTREAM SOCIAL IMPLICATIONS OF MRT
  • DNA CONTRIBUTION OF TWO WOMEN
  • MANIPULATION OF EMBRYOS
  • CONCLUDING DISCUSSION
  • REFERENCES
• 4. Regulation and Oversight of MRT in Humans
  • ASSESSMENT OF BENEFITS AND RISKS
  • PRECLINICAL EVIDENCE TO SUPPORT MRT
  • CONDITIONS FOR CLINICAL INVESTIGATIONS
  • RESEARCH IN HUMAN OOCYTES AND EMBRYOS
  • PRINCIPLES AND PRACTICES TO GUIDE CLINICAL INVESTIGATIONS
  • EXTENSION OF MRT RESEARCH TO FEMALE EMBRYOS
  • INFORMED CONSENT
  • GUIDING PRINCIPLES FOR OVERSIGHT
  • REFERENCES
• Appendixes
  • Appendix A. Study Approach
  • Appendix B. Summary of MRT Research
  • Appenddix C. Biosketches of Committee Members

Suggested citation:

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.