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An analysis, performed under the auspices of IASCR,
intended to evaluate how policy differences may affect the sharing of research materials and other
collaborative work has been published in Medical Research Law & Policy Report.
More...
- The last meeting of the IASCR was held September 9-10, 2008,
a in Baltimore, MD. A summary of the meeting will be available at a later date.
Please see the meeting agenda for the topics
scheduled ro be discussed.
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IASCR Participants
Participating States
Other Affiliates
Participating States
In November 2004, more than seven million Californians voted for the
California Stem Cell
Research and Cures Initiative, to establish the
California Institute for Regenerative Medicine
(CIRM). CIRM's mission is to allocate $3 billion in public bond funds for
scientific and medical research in California. CIRM is governed by the Independent
Citizens Oversight Committee (ICOC), a 29-member body appointed by elected officials
and university chancellors.
As of October 2007, CIRM has approved more than $205 million in research and training
grants. The CIRM
Scientific Strategic Plan outlines a 10-year funding strategy.
California has developed and adopted the most comprehensive set of regulations in the
United States with regard to the ethical
standards, grants administration
policy, and intellectual property
management rules that will apply to its grantees.
In addition to the specific rules governing CIRM grantees, California also has separate
legislation governing the conduct of non-CIRM funded hESC research within its borders.
Recent legislation indicated the Legislature's intent to harmonize stem cell research
regulations in California. State
guidelines have been developed pursuant to this legislation.
Contact for IASCR: Geoff Lomax, Dr.PH.,
Senior Officer for Medical and Ethical Standards, California Institute for Regenerative Medicine
As noted in the annual
report of the Connecticut Stem Cell Research Advisory Committee, "An Act Permitting Stem Cell
Research and Banning the Cloning of Human Beings" (the Act), was approved by the General Assembly
and signed by Governor M. Jodi Rell on June 15, 2005. The Act appropriated a total of 100 million
dollars over ten years for the purpose of grants-in-aid for conducting human embryonic or adult
stem cell research. The Act has been codified at Connecticut General Statutes §19a-32d through
§19a-32g, and §4-28e(c)(3).
Passage of the legislation positioned Connecticut as the third state in the nation in
providing public funding in support of human embryonic and adult stem cell research.
It mandated the establishment of the Connecticut
Stem
Cell Research Advisory and
Peer
Review Committees and required the Commissioner of Public Health as Chair of the Stem
Cell Research Advisory Committee to convene the first meeting by December 1, 2005.
Seventy applications were received in response to the Request for Proposals issued on May 10,
2006. On November 21, 2006, with the support of Connecticut Innovations and the Department of
Public Health, the Connecticut Stem Cell Research Advisory Committee directed the award of
$19.78 million in stem cell research funds to researchers from the University of Connecticut,
Wesleyan University and Yale University.
Applications for the ten million dollars available in FY 2008 are due on November 1, 2007,
with final decisions expected on or after April 2008. A priority for the Connecticut Stem
Cell Research Grants Program is to support research on hESC that is not currently eligible
for federal funding.
Contact for IASCR:
Warren Wollschlager, Chief, Office of Research
and Development, Connecticut Department of Public Health
By Executive Order in July 2005, Governor Blagojevich directed the Illinois Department of
Public Health (DPH) to create a program that awarded $10 million in grants to medical
research facilities for the development of stem cell treatments and cures early in 2006.
The Illinois Regenerative Medicine Institute
(IRMI) was located in the State Health Department and run by existing agency staff.
In 2006, the Governor provided an additional $5 million of funding to the IRMI for
disbursal to researchers.
The legislature did not appropriate additional funds for stem cell research for 2008,
and rejected the Governor's request for an additional $20 million dollars.
Legislation was passed in summer 2007 that establishes a regulatory framework for providing
funding and for oversight of stem cell research.
Contact for IASCR: Marilyn Thomas,
Chief Counsel and Ethics Officer, Illinois Department of Public Health
The Maryland Stem Cell Research Act of 2006 (the Act) established and funded a
Stem Cell Research Fund to
promote state-funded stem cell research and cures through grants and loans to public
and private entities in the State. The fund is a special, nonlapsing fund that is not
subject to the State Finance and Procurement Article. Funding to date is $38 million
(FY2007 and FY2008). Additional funding is dependent upon State appropriations.
The Maryland Stem Cell Research
Commission is an independent body whose members include the Attorney General or designee,
patient advocates, individuals with experience in biotechnology, scientists from the University
System of Maryland and Johns Hopkins University, and bioethicists. The Commission adopts
regulations that ensure that adult stem cell and stem cell research financed by the Fund
complies with State law; develops criteria, standards, and requirements for the initial review
of grant applications; establishes procedures and guidelines to be used by an independent
Scientific Peer Review Committee
(SPRC); determines what types of grants or other forms of funding to award, as well as the
size, duration, objectives and terms of all such grants; and makes the decisions about which
grants should be recommended for awards, based on both the scientific rankings of the SPRC for
grants and on certain broader policy considerations set forth in Maryland's Stem Cell Act.
The Commission functions within the Maryland Technology
Development Corporation (TEDCO). TEDCO, created by the State legislature in 1998, is a
public instrumentality of the State. Governed by a 15-member Board appointed by the Governor
with the advice and consent of the Senate, the Board is comprised of leaders in the State's
technology community and contains representatives from the private, university, non-profit,
and public sectors.
Grants have been awarded for the FY2007 and FY2008; for the list of awardees, please
visit http://www.mscrf.org/content/awardees/index.cfm.
Contact for IASCR: Dan Gincel, Ph.D.,
Director, Maryland Stem Cell Research Fund
In May of 2007, Governor Patrick unveiled a $1.25 billion life sciences package.
This life sciences package involves $1 billion in state funding over 10 years,
some borrowed through bond issues, plus $250 million in matching money from private
business. The money would provide grants for university and hospital scientists,
establish special research centers, and train workers for biotechnology businesses
while also establishing a stem cell bank in Massachusetts. The Governor's proposed
bill amends Chapter 23A to create a new Life Sciences Sector Investment Program,
which allows life sciences businesses to apply to the Department of Business
Development for certification as a "certified life sciences project," eligible
for certain tax incentives. Further, the bill seeks to expand the purposes of the
Massachusetts Life Sciences Center Fund to include: providing fellowships and grants,
providing for workforce training grants to prepare individuals for life sciences careers;
and allowing funds to be spent in furtherance of the purposes set forth in the act.
Additionally, in October of 2007, the Massachusetts Department of Public Health
rescinded Romney-era regulations viewed by the research community as restricting
embryonic stem cell research in the Commonwealth.
Contact for IASCR: Melissa Lopes,
Deputy General Counsel, Massachusetts Department of Public Health
New Jersey was the first state in the country to fund human embryonic stem cell research.
The state awarded $5 million in research grants to 17 research teams in November 2005,
including hESCR proposals. This was followed in June 2007 by awards totaling $10,470,000
for 16 individual research projects and 2 larger core facilities projects. Its program is
multifaceted and administered by the New Jersey Commission on Science and Technology's
Stem Cell Research Program (the Commission). The Commission on Science and Technology
will begin accepting proposals in January of 2008 for the $10.7 million Stem Cell Research
Program in fiscal year 2008.
New Jersey has also approved the expenditure of $150 million for the construction of the
Stem Cell Institute of New Jersey at a cost of $150 million, which will be administered by
the New Jersey Economic Development Authority. The Stem
Cell Institute of New Jersey was created by a memorandum of understanding between Rutgers
University and the University of Medicine and Dentistry of New Jersey in response to the state's
need and desire to make significant advancements in stem cell research. The Institute will provide
the facilities, equipment and resources for research that will result in cures for devastating
diseases and injuries.
Contact for IASCR: Peter Reczek, Ph.D.,
Executive Director, New Jersey Commission on Science and Technology
Enactment of Public Health Law Title5-A in 2007 established the Empire
State Stem Cell Research Fund and Board. The Board consists of two
committees, the funding committee and the ethics committee. The first
meeting of the board is planned for October 22, 2007. $100 million was
committed to the fund initially with an additional $50 million promised
each year for 10 years. Information regarding the statute, board, and
funding opportunities will be available at <stemcell.ny.gov> Funding
options, criteria for peer review and the ethical standards for conduct of
funded research is in development as of this writing October 2007.
The Empire State Stem Cell Board has drafted a framework for how New York
State's $600 million commitment to stem cell research may best accelerate
scientific discoveries into novel prevention and treatment strategies.
At its May 13, 2008, meeting the Board approved a draft strategic plan for posting and public comment.
The Empire State Stem Cell Board's Strategic Plan may be accessed at
http://www.stemcell.ny.gov/plan_comment_form.php,
along with an electronic form for submitting comments up to
June 13, 2008. The Board will consider submitted comments at its June 27,
2008 meeting.
Contact for IASCR: Judy Doesschate, Esq.,
Bureau of House Counsel, New York State Department of Health
There is no Rhode Island law that specifically restricts the use of human adult or
embryonic stem cells for research purposes. The Rhode Island law that does restrict
some uses of human cells explicitly permits research as long as the research is not
for the purposes of cloning an entire human being—which is not part of stem cell
research.
Starting in 2003 and continuing every year thereafter, bills were introduced that would
have explicitly allowed all forms of stem cell research and created a procedure for
unused embryos as a result of in vitro fertilization treatments to be donated for the
purpose of stem cell research. These bills were sponsored in the House by Representative
Edith Ajello, and in the Senate by Senator Rhoda Perry. A 2007 version of the bill,
2007 H-6082,
was introduced again but failed to pass.
In 2006, a resolution
sponsored by Representative Eileen Naughton was passed, creating a special House commission
to promote and develop a nationally recognized cord blood program for the future of disease
management in Rhode Island. That commission began meeting in February of 2007. In 2007, a
resolution
sponsored by Representative Naughton was passed creating the Rhode Island House of
Representatives Regenerative Medicine and Research Advisory Study Commission.
In 2007, Lt. Governor Elizabeth Roberts released a report entitled Discovering Rhode Island's
Stem Cell Future: Charting the Course Toward Health and Prosperity, outlining the potential
that stem cell research holds for reducing human suffering and supporting economic growth
in Rhode Island.
Contacts for IASCR: Adriana Thomas,
Policy Analyst, Rhode Island House of Representatives,
and Eli Zupnick,
Policy Analyst, Office of the Lt. Governor
In April 2006, the Governor directed the Department of Commerce to spend up to $5 million
to recruit new stem cell research companies, and in May 2007 the Governor awarded $1 million
from a biotechnology and small business seed fund to the new hES cell company, Stemina.
However, this financial investment has not been accompanied by any legislative support.
Specifically, the legislature has twice passed bills that would criminalize SCNT research
(both times vetoed by the Governor), and has never passed a bill authorizing additional hES
cell research funding beyond that within executive discretion. Thus, the overall legal
landscape is characterized by an absence of law. All stem cell research is therefore legal,
and regulated only to the extent that it is subject to federal regulation by the FDA,
federal restrictions where NIH funds have been used, or voluntary restrictions adopted by
individual universities as companies. While he previously announced funding a $750 million
public-private partnership in the broad area of biotechnology, the amount of public funding
that will support hESCR is not known at this time. No specific state funding programs have
been made available to academic and non-profit research institutes in Wisconsin. The
primary focus has been to encourage development of businesses that commercialize services
and products based on human embryonic stem cell technology.
To further encourage private sector activity in the state, in September 2006 the Doyle
administration reached an agreement with the Wisconsin
Alumni Research Foundation (WARF), which holds patents and royalty rights on some of the
stem cell lines. Under this agreement, all companies conducting research at non-profit and
academic institutions located in Wisconsin will receive a free non-exclusive research license
under the stem cell patents held by WARF for that sponsored research. In other words, they
will not have to pay royalty fees to WARF for that research that would be required if the
research was conducted in another state.
WiCell Research Institute was established in 1999 at
the request of UW-Madison to ensure that UW faculty have a place to perform hESC research
in Wisconsin. This was done in a period of uncertainty about the permissibility of
conducting hESC research on a campus that has federal research funds. The policy has
since been clarified such that federal funding is available for hESC research, but deriving
new hESC lines in a federally funded laboratory is still impermissable. WiCell, in
addition to providing support to UW-Madison researchers and hosting the
National Stem Cell Bank, also maintains a
privately funded facility that may be used to derive new hESC lines or conduct research on
those cell lines ineligible for federal research funding.
Governor Doyle announced the WARF patent agreement as part of an incentive package designed
to attract stem cell research and development to Wisconsin. In addition to this agreement,
the Governor's stem cell incentive package also includes:
- Stem cell companies that locate or expand in Wisconsin will be eligible for up to $250,000
in grants.
- All licensed companies in Wisconsin will receive free distribution on the lines that WARF
holds patents on and personnel of all licensed companies will be eligible for free stem cell
training courses offered by WARF.
- Wisconsin will certify early-stage stem cell companies as eligible for angel and venture
capital investment tax credits.
- There will be a new stem cell development specialist in the Wisconsin Entrepreneur's Network
to support companies that wish to start or locate in Wisconsin.
- The state will assist companies with accessing the Wisconsin Angel Network and identifying
incubators with wet lab space.
- Wisconsin and WARF will also work with other organizations to ensure that this initiative is
part of statewide economic development efforts.
Contacts for IASCR:
- University of Wisconsin:
Sue Gilbert, Coordinator, UW-Madison Stem Cell &
Regenerative Medicine Center
- WiCell Research Institute: Erik J. Forsberg, Ph.D.,
Executive Director, and Jeffrey M. Jones, Ph.D., HCLD(ABB),
Director of the Derivation Laboratory
Any state that supports the mission and goals
of the IASCR is welcome to request that it be allowed to become a
participating state in the
organization. Please contact Geoff Lomax
or Warren Wollschlager
if you are interested.
Other Affiliates
Until March 2002, Canada had no laws to govern stem cell research, nor were
there any guidelines for researchers, research ethics boards, or funding
agencies on how stem cells may be derived and used. Recognizing the urgent need
for clear guidelines that would allow for response to rapidly evolving science
and shifting public opinion, and to ensure ethical and scientific oversight, the
Canadian Institutes
of Health Research (CIHR) announced guidelines for human pluripotent stem cell research in March 2002.
The federal granting agencies, the Canadian Institutes of Health Research (CIHR), the
Natural Sciences and Engineering Research Council (NSERC) and the Social Sciences and
Humanities Research Council (SSHRC) ("the Agencies") subsequently adopted interim
Tri-Agency stem cell measures, agreeing that no research with human pluripotent stem
cells would be funded without the prior review and approval of the Stem Cell Oversight
Committee (SCOC) in conformity with the CIHR guidelines. The measures incorporate adherence to the
Guidelines as a condition of Agency-funded research, and were adopted to afford time
to integrate the Guidelines into the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans,
in a manner consistent with the developing federal regulatory regime for human embryonic stem
cell research.
Canadian researchers have been pioneers in the area of stem cell research and continue to
lead the way using animal models. With the introduction of these
Guidelines,
Canadian researchers are now able to move forward and remain at the forefront of their
field while conducting their research according to explicit ethical standards. Funding
agencies, Research Ethics Boards, and universities now have a framework to guide their
evaluation and approval decisions. Canadians can be assured that the research made
possible by federal public funds will be undertaken within a well-defined ethical and
legal framework.
Contact for IASCR: Cheryl Rogers, Ph.D.,
Trade Commissioner, Consulate of Canada, San Diego
The International Society for Stem Cell
Research (ISSCR) is an independent, nonprofit organization established to promote
and foster the exchange and dissemination of information and ideas relating
to stem cells, to encourage the general field of research involving stem cells
and to promote professional and public education in all areas of stem cell
research and application.
Contacts for IASCR: Jonathan Auerbach, Ph.D.,
Chair, ISSCR Standards Group, and President, GlobalStem, Inc., and
Heather Rooke, Ph.D., Science Editor, ISSCR
The National Academy of Sciences,
National Academy of Engineering, Institute
of Medicine, and National Research
Council make up the National Academies.
They are private, nonprofit institutions that provide science, technology, and health
policy advice under a congressional charter. The Research Council is the principal
operating agency of the National Academy of Sciences and the National Academy of
Engineering.
The National Academies released Guidelines for Human Embryonic Stem Cell Research
in 2005 with subsequent amendments in 2007. Click here for
information about the National Academies' Guidelines.
Contact for IASCR: Fran Sharples, Ph.D.,
Director, Board on Life Sciences
The United Kingdom has been a leader in stem cell science from the
beginning. UK scientists have been involved in regenerative medicine since
its inception of the field in the early 1980s. In 2001 the UK was one of
the first countries to introduce specific legislation banning any attempt
to carry out reproductive cloning.
The UK's regenerative medicine legislation is largely based on the Human
Fertilisation and Embryology (HFE) Act of 1990. Under the terms of the
Act, scientists are allowed to use human embryos for a restricted range of
research, provided they gain a license from the HFE Authority (HFEA).
In 2001, the Act was modified to allow the licensing and derivation of
stem cell lines from surplus embryos created during IVF treatments, for
both IVF and therapeutic cloning, as well as additional areas of research.
The International
Stem Cell Forum's 2004 review of global ethics and regulations in stem
cell research provided the foundation for the 2004 Human Tissue Act which reflects scientific
advances in the field.
Today the UK permits research with adult and embryonic stem cells and is
one of the very few countries to allow therapeutic cloning, all within a
clear, comprehensive regulatory framework that is supportive of
responsible research within well defined and closely monitored parameters.
The UK government is fully supportive of regenerative medicine and has
consistently provided substantial funding. In 2005 it established the UK Stem Cell Initiative, charged with formulating a
ten-year stem cell vision for the UK, and creating a platform for
coordinated public and private funding. In the same year the Pattison Report provided 11 recommendations for the
government to take stem cell research forward.
Outside of central government a range of organisations support
regenerative medicine research. Key players are the United Kingdom
Research Councils (RCUK), the Medical Research Council (MRC) and the Biotechnology and
Biological Sciences Research Council (BBSRC), as well as charities
such as the Wellcome
Trust.
The UK sees international collaboration and knowledge sharing essential
for successful research. Examples of initiatives that foster such
knowledge exchange are:
The UK government is currently revising its legislation governing assisted
reproduction and embryo research, taking into account developments in science
and society over the last 18 years. The Human Fertilisation and Embryology Bill covers a number of
issues related to embryonic stem cell research. This link provides a factsheet on
some of the key issues addressed in the draft legislation which is expected to
complete its passage through Parliament in the next few weeks.
Contacts for IASCR: Theresa
Djirbandee (Western USA), Acting Vice Consul, Science and Innovation, British Counsulate-General
San Francisco and Stefan Winkler,
Ph.D. (Eastern USA), Consul and Chief Science Officer, British Consulate-General Boston,
Science and
Innovation, British Consulate-General
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