Standards Working Group Meeting

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2016 Annual Meeting of the
Scientific and Medical Accountability Standards Working Group
of The California Institute For Regenerative Medicine
Organized Pursuant To The
CALIFORNIA STEM CELL RESEARCH AND CURES ACT

 Date:   Thursday February 4, 2016

 

CIRM Scientific and Medical Accountability Standards Working Group Workshop on Human Gene Editing

This workshop took place on February 4, 2016
Click here to listen to an audio recording of the workshop [5 hours 47 minutes]

Background:
A series of science-policy initiatives have been undertaken to address the use of human genome editing technologies in biomedical research. These initiatives include:

These initiatives have sought to develop a framework for the application of human genome editing in biomedical research. Given these science-policy deliberations, CIRM will review its policies governing the funding and oversight of research involving human genome editing. 

Scientific & Policy Context: 

Understanding the biology of human embryos and germ line cells has been identified as a basic and pre-clinical research imperative provided protocols are subject to effective oversight. CIRM has the unique ability to fund research involving human embryos and gametes. CIRM’s Medical and Ethical Standards provide a comprehensive framework for the review and oversight of embryo and gamete research under the auspices of a Stem Cell Research Oversight Committee. Under this framework, CIRM-funded researchers have made important scientific contributions including the derivation of new hESC lines and insights into human development and the disease process.

Charge:

Pursuant to its mission, CIRM will continue to support groundbreaking stem cell treatments and technologies, including gamete and embryo research, from their inception to translation. In light of recent science-policy initiatives, the Scientific and Medical Accountability Standards Working Group is, specifically, being asked to review CIRM policies associated with gene editing of human germ cells and embryos. One objective of this review is to ensure CIRM research continues to be conducted under the highest medical and ethical standards.

Agenda (Subject to Change): 

1. Review of International Summit recommendations: David Baltimore 

Provide a summary of the International Summit Statement with an emphasis on recommendations relating to gene editing of human gametes and embryos.

2. Review of ISSCR Guidelines: Jonathan Kimmelman

Provide a summary of the ISSCR Guidelines with an emphasis on recommendations relating to the review and oversight of studies involving gene editing human gametes and embryos.

3. National Academies’ Human Gene Editing Initiative: Alta Charo 

4. Review of current CIRM policy: CIRM Team

Describe CIRM requirements for the review and oversight of gamete and embryo research and consider how these requirements align with International Summit and ISSCR recommendations.

5. Research directions in California: Invited California Researchers: Amander Clarke, Jacob Corn, Juan Carlos Belmonte

Describe current and possible research involving human genome editing that CIRM may be asked to support.

6. Considerations for CIRM Governance & Oversight of research involving human genome editing: Henry Greely, Charis Thompson 

Reflect on CIRM’s policies for scientific review and research oversight in light of its mission, International Summit and ISSCR recommendations for research involving human gene editing, research directions in California, and ethical considerations.

7. Public comments 

8. Discussion / deliberations: Standards Working Group & guest participants

Consider the adequacy of the CIRM policy framework in light of recent policy developments and emerging science.

9. Public comments

THE ORDER OF BUSINESS MAY BE CHANGED WITHOUT NOTICE. 

Additional Background Documents:

**NOTICE** 

The California Institute for Regenerative Medicine and its Independent Citizen’s Oversight Committee, and any subcommittees thereof, comply with the Americans with Disabilities Act (ADA) by ensuring that the meeting facilities are accessible to persons with disabilities, and providing  that this notice and information given to the Members of the Committee is available to the public in appropriate alternative formats when requested. If you need further assistance, including disability-­‐related modifications or accommodations, you may contact Douglas Guillen at the California Institute for Regenerative Medicine Douglas Guillen dguillen@cirm.ca.gov or (510) 340-9108 no later than the day prior to the meeting. 

Questions or requests for additional  information prior to the Scientific and Medical Research Funding Working Group meeting may be referred Geoffrey Lomax at the California Institute for Regenerative Medicine glomax@cirm.ca.gov or (510) 340-9146.

This meeting agenda is also available on the website for the California Institute for Regenerative Medicine at https://www.cirm.ca.gov. 

Date Published: January 12, 2016
Last Modified: February 25, 2016