The National Academies of Sciences, Engineering and Medicine
HUMAN GENE-EDITING INITIATIVE

Frequently Asked Questions

Why are the National Academy of Sciences and National Academy of Medicine studying human gene editing? 
Gene-editing technologies hold great promise for advancing science and improving human health.  Powerful new tools, such as CRISPR-Cas9, allow researchers with basic knowledge of molecular biology to precisely modify the genetic makeup of any living organism. The possible applications for such technologies are many.  In humans, the technologies could offer a cure to often devastating genetic diseases such as Huntington’s disease and sickle cell anemia, and help improve understanding and treatment of many other illnesses.

However, these new avenues of research also present many complex challenges, both to the scientific and medical communities and to society as a whole.  The availability of new technologies has intensified debate among scientists and physicians about such research.  We are at a critical juncture in genetic research.  What is needed now is guidance -- guidance that is based on an in-depth review of the science underlying gene editing and an understanding of the potential benefits as well as the valid concerns raised by this research.  This is exactly the type of leadership for which the Academies are known. 

Toward that end, the National Academy of Sciences and the National Academy of Medicine announced a major initiative on gene-editing research. Through the initiative’s consensus study, the Academies stand prepared to marshal the best available expertise to help Congress and the nation obtain a thorough understanding of gene editing and its potential benefits and risks, which will provide a solid foundation for informed decisions and sound policies on this research. 

What is the goal of this study?
The study will examine the scientific underpinnings as well as the clinical, ethical, legal, and social implications of the use of human genome editing technologies in biomedical research and medicine. The committee will address these questions and prepare a report that contains its findings and recommendations. The report will focus on advice for the United States, and provide a framework based on fundamental, underlying principles that may be adapted and adopted by any nation that is considering the development of guidelines. 

How are committee members chosen?
The National Academies of Sciences, Engineering, and Medicine issue calls for nominations for committee members, seeking recognized experts from diverse disciplines and backgrounds.   Each committee must include the full range of expertise and experience needed to address the study’s statement of task.  The overall composition of the committee is evaluated to make sure that points of view are reasonably balanced so that the committee can carry out its charge objectively and credibly. A provisional slate is posted for a 20-day comment period.  Once approved by the President of the National Academy of Sciences, all committee members are screened for conflict of interest. Read more about the Academies’ policies on committee composition and conflicts of interest. You may also comment on the composition of the committee here.

How does the committee gather information before it assembles a report?
Study committees typically gather information through: 1) meetings that are open to the public and that are announced in advance through the National Academies of Sciences, Engineering, and Medicine website; 2) the submission of information by outside parties; 3) reviews of the scientific literature; and 4) the investigations of the committee members and staff. In all cases, efforts are made to solicit input from individuals who have been directly involved in, or who have special knowledge of, the issue under consideration.

Who reviews the report before it is published?
As a final check on the quality and objectivity of the study, all Academies reports must undergo a rigorous, independent external review by experts whose comments are provided anonymously to the committee members. The National Academies of Sciences, Engineering, and Medicine recruit independent experts with a range of views and perspectives to review and comment on the draft report prepared by the committee. 

The review process is structured to ensure that each report addresses its approved study charge and does not go beyond it, that the findings are supported by the scientific evidence and arguments presented, that the exposition and organization are effective, and that the report is impartial and objective. 

After all committee members and appropriate officials from the Academies have signed off on the final report, it is transmitted to the sponsor of the study and is released to the public. 

When will the study be completed?
The study is projected to be completed in early 2017. 

Can I attend committee meetings?
Yes - all meetings in which the committee gathers information are open to the public. Meetings that are open to the public will be announced in advance on this website. After the meetings, any presentations shared with the committee will also be posted here. 

Can I provide comments to the committee?
Yes - at most information-gathering meetings, members of the public can present comments to the committee. Some public comment sessions may need to limit the number of speakers or require advance sign-up, which will be announced on the meeting webpage in advance of the information-gathering meeting. In addition, you may submit written statements and relevant information to the committee at any time. This helps ensure that the committee hears about important issues from interested parties. All submissions may be reviewed by members of the Committee. By submitting input, you agree that all information shared with the Committee, including your name and email address, will be recorded in the Public Access File and may be quoted in whole or in part in the Committee's report with attribution. Submitted information may also be made available to the public upon request.

Can I see the comments that have been submitted?
Written materials submitted to a study committee by external sources are listed in the project’s Public Access File and can be made available to the public upon request. Contact the Public Access Records Office (PARO) for a copy of the list and to obtain copies of the materials. Copies of materials are free to the press and government employees. Please send an email or call PARO to make a request or an inquiry. Normal business hours for PARO are 9:00 am to 5:00 pm, Monday through Friday. 

Public Access Records Office
The National Academies of Sciences, Engineering, and Medicine
500 5th Street NW
Washington DC 20001
Tel: 202.334.3543
FAX: 202.334.2158
Email: paro@nas.edu 

Will the results of the study be made available to the public?
Yes – upon completion of the study, an electronic version of the final report will be available to download for free from the National Academies Press. 

Who is sponsoring the study?
This study is sponsored by the U.S. Food and Drug Administration, the Greenwall Foundation, Wellcome Trust, MacArthur Foundation, and the Defense Advanced Research Projects Agency. 

Are the Academies currently studying similar topics, like the application of gene editing technologies to agriculture?
Yes - the Academies are working on several related studies

Have the Academies released other reports on genetic research?
Yes – the Academies have published several reports on genetic research. 

Where can I get more information?
You can subscribe for updates to the study or direct inquiries to geneediting@nas.edu.

 


 

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