Dec. 8, 2015

Academies Consensus Study on Human Gene Editing Begins; First Data-Gathering Meeting Feb. 11-12, 2016

WASHINGTON -- Following the Dec. 1-3 International Summit on Human Gene Editing, the National Academy of Sciences and National Academy of Medicine are now moving forward with the second component of the Academies Human Gene Editing Initiative: a comprehensive study of the scientific underpinnings of human gene-editing technologies, their potential use in biomedical research and medicine -- including human germline editing -- and the clinical, ethical, legal, and social implications of their use.

The study committee will be co-chaired by Alta Charo, the Warren P. Knowles Professor of Law and Bioethics at the University of Wisconsin, Madison, and Richard Hynes, the Daniel K. Ludwig Professor for Cancer Research at the Massachusetts Institute of Technology and Howard Hughes Medical Institute Investigator. Hynes and Charo served on the committee that developed the Academies 2005 guidelines on stem cell research.

The new study committee began its information-gathering process by attending the December summit. Over the next year, it will perform its own independent, in-depth, and comprehensive review of the science and policy of human gene editing by reviewing the literature and holding data-gathering meetings in the U.S. and abroad to solicit broad input from researchers, clinicians, policymakers, and the public. The committee will also monitor in real-time the latest scientific achievements of importance in this rapidly developing field. Finally, while informed by the statement issued by the organizing committee for the international summit, the study committee will have broad discretion to arrive at its own findings and conclusions, which will be released in a peer-reviewed consensus report. Expected to be completed late in 2016, the report will represent the official views of the NAS and NAM.

The study committee has been tasked with addressing the following questions:

1. What is the current state of the science of human gene editing, and what are possible future directions and challenges to further advances in this research?

2. What are the potential clinical applications that may hold promise for the treatment of human diseases? What alternative approaches exist?

3. What is known about the efficacy and risks of gene editing in humans, and what research might increase the specificity and efficacy of human gene editing while reducing risks? Will further advances in gene editing introduce additional potential clinical applications while reducing concerns about patient safety?

4. Can or should explicit scientific standards be established for quantifying off-target genome alterations and, if so, how should such standards be applied for use in the treatment of human diseases?

5. Do current ethical and legal standards for human subjects research adequately address human gene editing, including germline editing? What are the ethical, legal, and social implications of the use of current and projected gene-editing technologies in humans?

6. What principles or frameworks might provide appropriate oversight for somatic and germline editing in humans? How might they help determine whether, and which applications of, gene editing in humans should go forward? What safeguards should be in place to ensure proper conduct of gene-editing research and use of gene-editing techniques?

7. Provide examples of how these issues are being addressed in the international context. What are the prospects for harmonizing policies? What can be learned from the approaches being applied in different jurisdictions?

The NAS/NAM study committees report will provide a framework based on fundamental, underlying principles that may be adapted by any nation considering the development of guidelines for human gene-editing research, with a focus on advice for the U.S.

The committees next meeting is scheduled for Feb. 11-12, 2016, in Washington, D.C. It will include sessions open to the public. A committee roster follows. For more information, visit http://nationalacademies.org/gene-editing/consensus-study/index.htm.

The National Academy of Sciences and the National Academy of Medicine are private, nonprofit institutions that provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science and medicine. The Academies operate under an 1863 congressional charter to the National Academy of Sciences, signed by President Lincoln.

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Committee on Human Gene Editing: Scientific, Medical, and Ethical Considerations

R. Alta Charo (co-chair)

Warren P. Knowles Professor of Law and Bioethics

School of Law and School of Medicine and Public Health

University of Wisconsin

Madison

Richard O. Hynes (co-chair)

Investigator

Howard Hughes Medical Institute; and

Daniel K. Ludwig Professor for Cancer Research

Koch Institute for Integrative Cancer Research

Massachusetts Institute of Technology

Cambridge

David W. Beier

Managing Director

Bay City Capital

San Francisco

Juan Carlos I. Belmonte

Professor

Gene Expression Laboratories

Salk Institute for Biological Studies

La Jolla, Calif.

Ellen W. Clayton

Craig Weaver Professor of Pediatrics and

Professor of Law

Vanderbilt University

Nashville, Tenn.

Barry S. Coller

Physician-in-Chief

Rockefeller University Hospital; and

Vice President for Medical Affairs,

David Rockefeller Professor of Medicine, and

Head, Allen and Frances Laboratory of Blood and Vascular Disease

The Rockefeller University

New York City

John H. Evans

Professor of Sociology and Associate Dean of Social Sciences

University of California

San Diego

Rudolf Jaenisch

Professor of Biology

Whitehead Institute for Biomedical Research

Massachusetts Institute of Technology

Cambridge

Jeffrey Kahn

Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy

Berman Institute of Bioethics

Johns Hopkins University

Baltimore

Robin Lovell-Badge

Group Leader and Head

Division of Stem Cell Biology and Developmental Genetics

The Francis Crick Institute

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