Feb.

4, 2015

Geoffrey Lomax Dr.PH

Review of CIRM Policy
Senior Officer
Governing Embryo ResearchCalifornia Institute for Regenerative Medicine

esentation Objectives
CIRMs mission & program areas
Clinical restrictions on use of genetically
modified embryos
Review and oversight requirements for
gamete and embryo research
Regulatory impact

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esentation Objectives

BER Workshop 3A, May 5, 2015

CIRM Mission Program Areas

CIRM supports the exploration of new,

potentially groundbreaking stem cell
based treatments from inception to
translation
CIRM supports research that is not

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Restrictions on Use of Genetically Modified Em

CIRM MES Regulations were adopted in
2006
The regulations apply to all research
funded by CIRM
Rules on clinical use of gametes and
embryo are consistent with the statement
from the International Summit on Human
Gene Editing and the Draft ISSCR
Guidelines

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vities Not Eligible for CIRM Funding

Section 10030: The following activities are
not eligible for CIRM funding
(f) The transfer to a uterus of a genetically
modified human embryo
The record support the SWGs intent was to
allow for in-vitro use of human embryos for
research while prohibiting reproductive use.

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araphrasing the SWG

It would seem logically that one could

manipulate [embryos] in any fashion and
that the only real concern is that you make
sure that in the end that embryo is not
transferred to a uterus, whether it is the
result of cloning or some other manipulation
because your concern is in a newborn child
down the road nine months later who could
suffer harm.
SWG 1.31.2006 p. 216.

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M Review and Oversight of Research

Scientific Review: All CIRM research awards
are first subject to peer review by the Grants
Working Group (GWG). GWG is comprised of
international subject-area experts.
Representative review criteria include:
Scientific impact: will it increase the
likelihood of new therapy discovery?
Scientific rationale: is the project sound?
Design: is the project appropriately
planned and designed?
Feasibility: is the team qualified and are
the aims feasible?

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ew and Oversight of Gamete & Embryo Researc

Section 10070(a-b): Research involving
procurement of human gametes or embryos
is subject to review and approval by a Stem
Cell Research Oversight Committee.
Comprehensive consent from all gamete
donors
Gamete and embryo use is well justified
including number of gametes or embryos
required
Team has demonstrated scientific
expertise

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egulatory Impact
All major CIRM grantees have a
designated SCRO committee
SCRO committees have established
written procedures and policies consistent
with CIRM regulatory requirements
The designated SCRO committee
membership includes a non-scientist
member and a patient advocate

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