Public Access Records Office
The National Academies
500 5th Street NW
Room KECK 219
Washington, DC 20001
Tel: (202) 334-3543
Email: paro@nas.edu
Project Information

Project Information


International Commission on the Clinical Use of Human Germline Genome Editing


Project Scope:

Clinical applications of germline genome editing are now possible and there is an urgent need to examine the potential of this new technology.  Many scientific and medical questions about the procedures remain to be answered, and determining the safety and efficacy of germline genome editing will be necessary but not sufficient conditions for future clinical usage. There is a need for a framework to inform the development of a potential pathway from research to clinical use, recognizing that components of this framework may need to be periodically revised in response to our rapidly evolving knowledge. In addition, other important discussions are ongoing internationally about the implications for society of human germline genome editing and include issues such as access, equity, and consistency with religious views.

An international commission will be convened with the participation of National Academies of Sciences and Medicine throughout the world to develop a framework for considering technical, scientific, medical, regulatory, and ethical requirements for germline genome editing, should society conclude such applications are acceptable.

The U.S. National Academies of Sciences and Medicine and the UK Royal Society will serve as the commission’s secretariat.

Specifically, the commission will:

1) identify the scientific issues (as well as societal and ethical issues, where inextricably linked to research and clinical practice) that must be evaluated for various classes of possible applications. Potential applications considered should range from genetic correction of severe, highly penetrant monogenic diseases to various forms of genetic enhancement;

2) identify appropriate protocols and pre-clinical validation for assessing and evaluating on-target and off-target events and any potential developmental and long-term side effects;

3) identify appropriate protocols for assessing and evaluating potential mosaicism and long-term implications;

4) identify ways to assess the balance between potential benefits and harms to a child produced by genome editing and to subsequent generations.

5) design appropriate protocols for obtaining consent from patients, for obtaining ethical approval from knowledgeable review committees, and for satisfying regulatory authorities;

6) identify and assess possible mechanisms for the long term monitoring of children born with edited genomes; and

7) outline the research and clinical characteristics developed in tasks 1-6 that would form part of an oversight structure, including defining scientific criteria for establishing where heritable genome editing might be appropriate, overseeing any human clinical use, and bringing forward concerns about human experiments.

The commission will hold three meetings and an international workshop. After the first meeting a call for public input will be issued. The results of this call will inform the second meeting and the international workshop. The third meeting will be used to develop the commission’s findings and recommendations.

A final report providing the commission’s findings and recommendations will be issued at the conclusion of the project.

Overseeing the commission will be an international oversight board (IOB), comprised of leaders from public and private sectors including representative leadership of academies of sciences and medicine.  The U.S. National Academies of Sciences and Medicine and The Royal Society will serve as the secretariat and manage the day-to-day operations of the both the IOB and the commission. 
At present, financial support for the Commission is being provided by the U.S. National Institutes of Health, Royal Society of the U.K., Cicerone Endowment Fund of the U.S. National Academy of Sciences, and NAM Initiatives Fund of the U.S. National Academy of Medicine.

Status: Current

PIN: PGA-PGA EO-19-01

Project Duration (months): 12 month(s)

RSO: Bowman, Katherine



Geographic Focus:
Global

Committee Membership



Committee Membership

No data present.


Events


Event Type :  
-

Description :   

This will be a conference call of the international commission developing a framework for considering technical, scientific, medical, regulatory, and ethical requirements for germline genome editing (should society conclude such applications are acceptable).  It will be closed in its entirety.


Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Dominic LoBuglio
Contact Email:  dlobuglio@nas.edu
Contact Phone:  -

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Kay Davies
Richard Lifton
Andy Greenfield
Dana Carroll
Hide Akutsu
Doug Turnbull
Michele Ramsay
Anna Wedell
BK Thelma
Haoyi Wang
Julie Steffann
Jeff Kahn
Susan Golombok
Jinsong Li
Bartha Knoppers
Rahman Jamal
Eric Lander
Rob Califf

The following topics were discussed in the closed sessions:

The Commission discussed its draft report

The following materials (written documents) were made available to the committee in the closed sessions:

None.

Date of posting of Closed Session Summary:
June 26, 2020
Publication(s) resulting from the event:

-

Event Type :  
TeleConference

Description :   

This will be a conference call of the international commission developing a framework for considering technical, scientific, medical, regulatory, and ethical requirements for germline genome editing (should society conclude such applications are acceptable).  It will be closed in its entirety.


Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Dominic LoBuglio
Contact Email:  dlobuglio@nas.edu
Contact Phone:  -

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Kay Davies
Richard Lifton
Andy Greenfield
Bartha Knoppers
Rob Califf
Dana Carroll
Doug Turnbull
Eric Lander
Jeff Kahn
Jinsong Li
Julie Steffann
Michele Ramsay
BK Thelma
Rahman Jamal
Haoyi Wang
Susan Golombok

The following topics were discussed in the closed sessions:

The commission discussed its draft report.

The following materials (written documents) were made available to the committee in the closed sessions:

None.

Date of posting of Closed Session Summary:
June 19, 2020
Publication(s) resulting from the event:

-

Event Type :  
TeleConference

Description :   

This will be a conference call of the international commission developing a framework for considering technical, scientific, medical, regulatory, and ethical requirements for germline genome editing (should society conclude such applications are acceptable).  It will be closed in its entirety.


Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Dominic LoBuglio
Contact Email:  dlobuglio@nas.edu
Contact Phone:  -

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Kay Davies
Richard Lifton
Bartha Knoppers
Dana Carroll
Jinsong Li
Andy Greenfield
Hide Akutsu
Doug Turnbull
Haoyi Wang
Julie Steffann
Anna Wedell
Michele Ramsay
Jeff Kahn
BK Thelma
Eric Lander
Susan Golombok

The following topics were discussed in the closed sessions:

The Commission discussed its draft report.

The following materials (written documents) were made available to the committee in the closed sessions:

None.

Publication(s) resulting from the event:

-

Event Type :  
TeleConference

Description :   

This will be a conference call of the international commission developing a framework for considering technical, scientific, medical, regulatory, and ethical requirements for germline genome editing (should society conclude such applications are acceptable).  It will be closed in its entirety.


Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Dominic LoBuglio
Contact Email:  dlobuglio@nas.edu
Contact Phone:  -

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Kay Davies
Richard Lifton
Bartha Knoppers
Dana Carroll
Hide Akutsu
Andy Greenfield
Jeffrey Kahn
Anna Wedell
Susan Golombok
Doug Turnbull
Rahman Jamal
Julie Steffann
Haoyi Wang
BK Thelma
Eric Lander

The following topics were discussed in the closed sessions:

The Commission discussed its draft report.

The following materials (written documents) were made available to the committee in the closed sessions:

None.

Date of posting of Closed Session Summary:
June 08, 2020
Publication(s) resulting from the event:

-

Event Type :  
TeleConference

Description :   

This will be a conference call of the international commission developing a framework for considering technical, scientific, medical, regulatory, and ethical requirements for germline genome editing (should society conclude such applications are acceptable).  It will be closed in its entirety.


Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Dominic LoBuglio
Contact Email:  dlobuglio@nas.edu
Contact Phone:  -

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Kay Davies
Richard Lifton
Andy Greenfield
Anna Wedell
Dana Carroll
Susan Golombok
Hide Akutsu
Rahman Jamal
B.K. Thelma
Doug Turnbull
Bartha Knoppers
Eric Lander
Rob Califf
Haoyi Wang
Michele Ramsay
Julie Steffann

The following topics were discussed in the closed sessions:

The Commissioners discussed their draft report

The following materials (written documents) were made available to the committee in the closed sessions:

none.

Date of posting of Closed Session Summary:
April 24, 2020
Publication(s) resulting from the event:

-

Event Type :  
TeleConference

Description :   

This will be a conference call of the international commission developing a framework for considering technical, scientific, medical, regulatory, and ethical requirements for germline genome editing (should society conclude such applications are acceptable).  It will be closed in its entirety.


Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Dominic LoBuglio
Contact Email:  dlobuglio@nas.edu
Contact Phone:  -

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Kay Davies
Bartha Knoppers
Eric Lander
Dana Carroll
Andy Greenfield
Anna Wedell
Hide Akutsu
Julie Steffann
Jeff Kahn
Rahman Jamal
Haoyi Wang
Rob Califf
Doug Turnbull
Susan Golombok
Michele Ramsay
B.K. Thelma

The following topics were discussed in the closed sessions:

The Commissioners discussed their draft report.

The following materials (written documents) were made available to the committee in the closed sessions:

none.

Date of posting of Closed Session Summary:
April 24, 2020
Publication(s) resulting from the event:

-

Event Type :  
TeleConference

Description :   

This will be a conference call of the international commission developing a framework for considering technical, scientific, medical, regulatory, and ethical requirements for germline genome editing (should society conclude such applications are acceptable).  It will be closed in its entirety.


Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Dominic LoBuglio
Contact Email:  dlobuglio@nas.edu
Contact Phone:  -

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Kay Davies
Richard Lifton
Hide Akutsu
Dana Carroll
Susan Golombok
Andy Greenfield
Jeffrey Kahn
Bartha Knoppers
Eric Lander
Michele Ramsay
Julie Steffann
BK Thelma
Doug Turnbull
Haoyi Wang
Anna Wedell.

The following topics were discussed in the closed sessions:

The Commission discussed its draft report.

The following materials (written documents) were made available to the committee in the closed sessions:

none.

Date of posting of Closed Session Summary:
March 23, 2020
Publication(s) resulting from the event:

-

Event Type :  
TeleConference

Description :   

This will be a conference call of the international commission developing a framework for considering technical, scientific, medical, regulatory, and ethical requirements for germline genome editing (should society conclude such applications are acceptable).  It will be closed in its entirety.


Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Dominic LoBuglio
Contact Email:  dlobuglio@nas.edu
Contact Phone:  -

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Publication(s) resulting from the event:

-

Event Type :  
TeleConference

Description :   

This was a conference call of the international commission developing a framework for considering technical, scientific, medical, regulatory, and ethical requirements for germline genome editing (should society conclude such applications are acceptable).  It was closed in its entirety.


Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Dominic LoBuglio
Contact Email:  dlobuglio@nas.edu
Contact Phone:  -

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Hidenori Akutsu
Dana Carroll
Andy Greenfield
Jeffrey Kahn
Bartha Knoppers
Eric Lander
Michelle Ramsey
Julie Steffann
Haoyi Wang
Anna Wedell

The following topics were discussed in the closed sessions:

Draft report

Date of posting of Closed Session Summary:
February 28, 2020
Publication(s) resulting from the event:

-

Event Type :  
Meeting

Description :   

This was the third meeting of the international commission developing a framework for considering technical, scientific, medical, regulatory, and ethical requirements for germline genome editing (should society conclude such applications are acceptable).  The meeting was closed in it's entirety.


Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Dominic LoBuglio
Contact Email:  dlobuglio@nas.edu
Contact Phone:  -

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Kay Davies
Richard Lifton
Hidenori Akutsu
Robert Califf
Dana Carroll
Andy Greenfield
Susan Golombok
Rahman Jamal
Jeffrey Kahn
Bartha Maria Knoppers
Eric Lander
Jinsong Li
Michele Ramsay
Julie Steffann
B.K. Thelma
Doug Turnbull
Haoyi Wang
Anna Wedell

The following topics were discussed in the closed sessions:

Draft report.

The following materials (written documents) were made available to the committee in the closed sessions:

Draft report

Date of posting of Closed Session Summary:
February 28, 2020
Publication(s) resulting from the event:

-

Event Type :  
Meeting

Description :   

This was the second meeting of the international commission developing a framework for considering technical, scientific, medical, regulatory, and ethical requirements for germline genome editing (should society conclude such applications are acceptable).





If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Dominic LoBuglio
Contact Email:  dlobuglio@nas.edu
Contact Phone:  -

Agenda
Agenda

Is it a Closed Session Event?
Some sessions are open and some sessions are closed

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Kay Davies
Richard Lifton
Hidenori Akutsu
Robert Califf
Dana Carroll
Andy Greenfield
Susan Golombok
Rahman Jamal
Jeffrey Kahn
Bartha Maria Knoppers
Eric Lander
Jinsong Li
Michele Ramsay
B.K. Thelma
Doug Turnbull
Haoyi Wang
Anna Wedell

The following topics were discussed in the closed sessions:

Meeting presentations and background materials, draft report, project timeline, next steps.

Date of posting of Closed Session Summary:
January 07, 2020
Publication(s) resulting from the event:

-

Event Type :  
TeleConference

Description :   

This was a conference call of the international commission developing a framework for considering technical, scientific, medical, regulatory, and ethical requirements for germline genome editing (should society conclude such applications are acceptable).  It was closed in its entirety.


Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Dominic LoBuglio
Contact Email:  dlobuglio@nas.edu
Contact Phone:  -

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Kay Davies
Richard Lifton
Hidenori Akutsu
Dana Carroll
Susan Golombok
Andy Greenfield
Rahman Jamal
Jeffrey Kahn
Eric Lander
Michelle Ramsay
Julie Steffann
BK Thelma
Doug Turnbull
Anna Wedell

The following topics were discussed in the closed sessions:

The Commissioners discussed the agenda and invited speakers for their upcoming meeting in London.

The following materials (written documents) were made available to the committee in the closed sessions:

agenda

Date of posting of Closed Session Summary:
October 23, 2019
Publication(s) resulting from the event:

-

Event Type :  
Webinar

Description :   

This webinar was an information gathering event for the international commission developing a framework for considering technical, scientific, medical, regulatory, and ethical requirements for germline genome editing (should society conclude such applications are acceptable). It featured invited speaker Jin-Soo Kim, Seoul National University. Following his presentation, commissioners engaged in a question and answer session.

Watch the video recording.


Registration for Online Attendance :   
https://webinar-on-validating-edits.eventbrite.com

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Dominic LoBuglio
Contact Email:  dlobuglio@nas.edu
Contact Phone:  -

Supporting File(s)
-
Is it a Closed Session Event?
No

Publication(s) resulting from the event:

-

Event Type :  
Webinar

Description :   

This webinar was an information gathering event for the international commission developing a framework for considering technical, scientific, medical, regulatory, and ethical requirements for germline genome editing (should society conclude such applications are acceptable). It featured invited speakers Shoukhrat Mitalipov, Oregon Health & Science University and Xiaoliang Sunney Xie, Peking University. Following speaker presentations, commissioners engaged in a question and answer session.

Watch the video recording.


Registration for Online Attendance :   
https://webinar-on-hdr-and-single-cell-genomics.eventbrite.com

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Dominic LoBuglio
Contact Email:  dlobuglio@nas.edu
Contact Phone:  -

Supporting File(s)
-
Is it a Closed Session Event?
No

Publication(s) resulting from the event:

-

Event Type :  
Webinar

Description :   

This webinar was an information gathering event for the international commission developing a framework for considering technical, scientific, medical, regulatory, and ethical requirements for germline genome editing (should society conclude such applications are acceptable). It featured invited speakers invited speakers Kathy Niakan, Francis Crick Institute and Kyle Orwig, Magee-Womens Research Institute. Following speaker presentations, commissioners engaged in a question and answer session.

Watch video recording


Registration for Online Attendance :   
https://webinar-on-embryo-and-germ-cell.eventbrite.com

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Dominic LoBuglio
Contact Email:  dlobuglio@nas.edu
Contact Phone:  -

Supporting File(s)
-
Is it a Closed Session Event?
No

Publication(s) resulting from the event:

-

Event Type :  
Webinar

Description :   

This webinar was an information gathering event for the international commission developing a framework for considering technical, scientific, medical, regulatory, and ethical requirements for germline genome editing (should society conclude such applications are acceptable). It featured invited speakers Ellen Clayton, Venderbilt University and Robert Klitzman, Columbia University. Following the presentations, ommissioners engaged in a question and answer session.

Watch video recording


Registration for Online Attendance :   
https://informed-consent-webinar.eventbrite.com

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Dominic LoBuglio
Contact Email:  dlobuglio@nas.edu
Contact Phone:  -

Supporting File(s)
-
Is it a Closed Session Event?
No

Publication(s) resulting from the event:

-

Event Type :  
Meeting

Description :   

This was the first meeting of the international commission developing a framework for considering technical, scientific, medical, regulatory, and ethical requirements for germline genome editing (should society conclude such applications are acceptable).

View video at: https://vimeo.com/showcase/6229550

(Closed captioning available by clicking on the "CC")


Registration for Online Attendance :   
https://germlinegenomeediting.eventbrite.com

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Dominic LoBuglio
Contact Email:  dlobuglio@nas.edu
Contact Phone:  -

Agenda
Agenda

Is it a Closed Session Event?
Some sessions are open and some sessions are closed

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Kay Davies
Richard Lifton
Hidenori Akutsu
Robert Califf
Dana Carroll
Susan Golombok
Rahman Jamal
Jeffrey Kahn
Bartha Maria Knoppers
Eric Lander
Jinsong Li
Michele Ramsay
B.K. Thelma
Doug Turnbull
Haoyi Wang
Anna Wedell

The following topics were discussed in the closed sessions:

The commission discussed information gathered so far, its further information gathering needs, and its work plan for the fall.

The following materials (written documents) were made available to the committee in the closed sessions:

none.

Date of posting of Closed Session Summary:
August 19, 2019
Publication(s) resulting from the event:

-

Event Type :  
TeleConference

Description :   

This was a conference call of the international commission developing a framework for considering technical, scientific, medical, regulatory, and ethical requirements for germline genome editing (should society conclude such applications are acceptable).  It was closed in its entirety.


Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Dominic LoBuglio
Contact Email:  dlobuglio@nas.edu
Contact Phone:  -

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Kay Davies
Richard Lifton
Robert Califf
Dana Carroll
Susan Golombok
Andy Greenfield
Rahman Jamal
Jeffrey Kahn
Bartha Knoppers
Eric Lander
Jinsong Li
Michele Ramsay
Julie Steffann
B.K. Thelma
Doug Turnbull
Haoyi Wang
Anna Wedell

The following topics were discussed in the closed sessions:

The commission discussed topics to be covered in addressing its statement of task, as well as preparations for upcoming commission calls and meetings.

Date of posting of Closed Session Summary:
July 19, 2019
Publication(s) resulting from the event:

-

Event Type :  
TeleConference

Description :   

This was a conference call of the international commission developing a framework for considering technical, scientific, medical, regulatory, and ethical requirements for germline genome editing (should society conclude such applications are acceptable).  It was closed in its entirety.


Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Dominic LoBuglio
Contact Email:  dlobuglio@nas.edu
Contact Phone:  -

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Kay Davies
Richard Lifton
Hidenori Akutsu
Robert Califf
Dana Carroll
Susan Golombok
Andy Greenfield
Rahman Jamal
Jeffery Kahn
Bartha Knoppers
Eric Lander
Julie Steffann
B.K. Thelma
Doug Turnbull
Haoyi Wang
Anna Wedell.

The following topics were discussed in the closed sessions:

The commission discussed its task and composition.

The following materials (written documents) were made available to the committee in the closed sessions:

Statement of task and provisional roster for the commission.

Date of posting of Closed Session Summary:
June 10, 2019
Publication(s) resulting from the event:

-

Publications

  • Publications having no URL can be seen at the Public Access Records Office
Publications

No data present.