Stem Cells & ESCRO


Overview

Stem cell research holds much promise for a greater understanding of basic biology, human development, and disease progression and for the potential creation of therapies that rebuild or replace damaged cells.  Harvard University has a strong commitment to advancing, supporting and overseeing the ethical conduct of this research through the Harvard Stem Cell Institute, the Department of Stem Cell and Regenerative Biology and the Harvard University Embryonic Stem Cell Research Oversight ("ESCRO") Committee.

Founded in 2004, the Harvard Stem Cell Institute is a scientific collaborative that draws together the diverse resources at the University, the Medical School and 11 affiliated teaching hospitals and research institutions, and promotes opportunities for open communication and education and the development of new ways to fund and support research.

The Department of Stem Cell and Regenerative Biology is the first cross-school department located in both the Faculty of Arts and Sciences and Harvard Medical School.

The ESCRO Committee performs ethical and scientific reviews of all research involving the derivation and research use of embryos, human embryonic stem cells and certain activities involving non-embryonic stem cells, human neural stem cells, and human gametes.  Its scope includes use of anonymous materials that may not require consideration by an Institutional Review Board ("IRB").  Review and approval by the ESCRO Committee is required regardless of the source of the funding or the applicability of state or federal law.

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External Oversight

Federal

Stem cells are typically categorized by species of origin (e.g., mouse or human) and by whether they are derived from adult or embryonic sources.  Much weight in the political and ethical discourse concerning stem cell research is given to the distinction between adult stem cells and embryonic stem cells.  Continued research on both types of human stem cells is important, partly because at the present time the two types have not been proven to be equivalent in the scope of their developmental potential. While there is an abundance of research in mouse stem cells and human adult stem cells, this research is not generally subject to the same level of moral and regulatory scrutiny beyond that required for any other research involving animal or human subjects. Human embryonic stem cells were first isolated by a team of scientists in 1998.  Since that time, researchers have faced an ever-changing landscape of political controversy, ethical guidance and regulatory policy.  

Federal oversight of human stem cell research is limited to whether such research is eligible for federal funding.  After years of funding restrictions and uncertainty, the scope of human embryonic stem cell ('hESC") research eligible for federal funding expanded under President Obama pursuant to policies outlined in the NIH Guidelines for Human Stem Cells Research (the "NIH Guidelines").  Today, federal funding of hESC research is available, but a pending court case challenging the NIH Guidelines has once again created an uncertain funding future for hESC researchers.  A brief overview of recent activity and the history of federal funding policy:

Recent Activity:

August 23, 2010:  Federal Court determines that NIH funding policy violates Dickey-Wicker Amendment and enjoins NIH from funding hESC research.

August 30, 2010:  NIH issues a Notice to suspend all hESC funding activities pursuant to the NIH Guidelines.

September 9, 2010:  Appeals Court imposes stay of the Federal Court injunction, allowing NIH to resume hESC funding activities temporarily.

September 7, 2010:  Judge Lamberth of the Federal District Court denies HHS emergency motion to stay the preliminary injunction, and suggests that the preliminary injunction does not extend to Bush lines or previously funded research.

September 10, 2010:  NIH issues a Notice lifting its August 30th suspension of hESC funding activities pursuant to the NIH Guidelines.

September 13, 2010:  Senator Arlen Specter introduces the Stem Cell Research Enhancement Act of 2010, seeking to codify President Obama's stem cell policy.

September 28, 2010:  Appeals Court issues a durable stay of the Federal Court injunction, allowing NIH to resume hESC funding activities pending the outcome of the case.

History:

1996:   President Clinton signs the first appropriation bill containing the Dickey-Wicker Amendment.  The Dickey-Wicker Amendment is a rider to the annual Appropriations Act that has been renewed every year since 1996.  The Amendment prohibits the use of federal funds for:

(1) the creation of a human embryo or embryos for research purposes; or

(2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).

This amendment defines “embryo” as “any organism, not protected as a human subject under 45 CFR 46 [the human subjects regulations] as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.”

1999:  Harriet Rabb, President Clinton's General Counsel, issues an opinion stating that research involving human embryonic stem cells is not subject to the Dickey-Wicker funding restrictions, because human embryonic stem cells are not "embryos."

August 9, 2001:  President Bush issues policy statement limiting federal funding to human embryonic stem cell (“hESC”) lines existing prior to 2001.

July 19, 2006/June 19, 2007:  President Bush vetoes the Stem Cell Research Enhancement Acts of 2005 and 2007, which would have allowed federal funding of hESC research on new lines derived from discarded embryos created for fertility treatments.

June 20, 2007:  President Bush formalizes his policy statement limiting federal funding to already existing hESC lines into an Executive Order.

March 9, 2009:  President Obama signs an Executive Order rescinding President Bush’s policy statement and Executive Order limiting federal funding, and directing the NIH to issue new stem cell guidelines allowing for expanded federal support of hESC research.

July 7, 2009:   After notice and hearing, NIH publishes the NIH Guidelines allowing for expanded federal funding of human embryonic stem cell research.  The NIH Guidelines:

  • Allow federal funding for the use of existing hESC lines included on the NIH’s newly established “New Registry”
  • Include requirements that, going forward, must be met for the embryo collection process if resulting lines will be considered for federal funding
  • Prohibit the use of NIH funding for research involving:
    • the introduction of human Pluripotent Stem Cells (hPSC) into non-human primate blastocysts
    • the breeding of animals where the introduction of hPSC may contribute to the germ line
    • derivation of stem cells from human embryos (consistent with the Dickey Amendment)
    • hESCs derived from other sources, including somatic cell nuclear transfer (SCNT; often characterized in the political arena as “therapeutic cloning”), parthenogenesis, and IVF embryos created for research purposes.

August 19, 2009:  Two researchers working with adult stem cells, certain religious groups and others, file a lawsuit seeking to enjoin NIH funding of hESC research pursuant to the NIH Guidelines.

October 27, 2009:  Judge Lamberth of the Federal District Court dismisses the case for lack of standing.

State

States are informally categorized as having permissive, flexible, or restrictive stem cell policies. Massachusetts is considered a permissive state.

  • The Commonwealth of Massachusetts stem cell law allows for human embryonic stem cell research but prohibits:
    • Reproductive cloning
    • Creation of an embryo by the method of fertilization with the sole intent of donating the embryo for research. (SCNT, parthenogenesis, and other asexual means of embryo creation are permitted.)
  • The Commonwealth requires any institution conducting stem cell research in Massachusetts to obtain a Certificate of Registration. Harvard’s Certificate is valid for three years and covers the entire University (not including affiliates). Registration renewals are managed by the Office of the Vice Provost for Research.
Other

Ethical guidance regarding the derivation and use of hESC lines is also provided by organizations such as the National Academies of Science ("NAS") and the International Society for Stem Cell Research ("ISSCR").  NAS and ISSCR guidance  pre-date the NIH Guidelines and remain relevant, particularly with respect to hESC research ineligible for federal funding under the NIH Guidelines.

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Harvard Policies, Procedures & Guidance

The Harvard University Embryonic Stem Cell Research Oversight (ESCRO) Committee performs ethical and scientific reviews of all research within its domain. The ESCRO Committee reports to the Provost through the Vice Provost for Research.   All research involving the derivation of hESC lines must be reviewed and approved by the ESCRO Committee. This review does not preclude other approvals that may be required by law or institutional policy.

Further details are available on the ESCRO’s policy page or by contacting the ESCRO administrator (escro@harvard.edu).

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