About Stem Cells

Stem Cell Research: Ethics and Policy

Stem cell research is a focus for hope, activity, discussion and sometimes controversy throughout the world. The promise this research offers to healthcare is great: repair of tissues and organs with one’s own cells, without the need to find a matched donor and endure lifelong anti-rejection therapy. Cell-based therapies open up the prospect of not just treatments but cures for currently untreatable diseases. In addition, embryonic stem cell research may lead to rapid, reliable methods of screening new drugs for toxicity and efficacy without having to do these tests in human beings.

At Children’s Hospital Boston, we are excited about this promise, because we see children every day who are fighting to stay alive, and for whom we don’t have good treatment options now. At the same time, Children’s has led in voicing concerns about premature and inappropriate use of stem cells in patients. We also recognize that people hold differing philosophical and moral views about the ethics of stem cell research, particularly embryonic stem cell research involving embryos and eggs (see The facts: What happens to eggs and embryos in stem cell research?). This section is meant to be a resource for people interested in delving further into these issues.

George Q. Daley, MD, PhD, testifies to the Committee of Health, Education, Labor, and Pensions (HELP), January 19, 2007. Photo courtesy of HELP Web site.

Ethical review at Children’s:
From its beginnings, the Stem Cell Program at Children’s Hospital Boston has been deeply engaged in the public dialogue about research ethics. Early on, Children’s developed internal standards for the ethical conduct of stem cell research that are widely followed by scientists in the field today, and many of which are reflected in the stem cell research guidelines issued by the National Institutes of Health in 2009. Our engagement in ethical and policy discussions continues in pace with the rapid scientific advances in the field.

Training in Children’s stem cell laboratories includes discussion groups and other forums for exploring the ethics of scientific investigation. Topics in medical ethics, such as consent, privacy, beneficence, personal autonomy, and research integrity/honesty are thoughtfully considered. Members of the Stem Cell Program actively publish papers on research ethics (see Stem cell ethics and policy: Information and resources).

In 2007, the International Society for Stem Cell Research released Guidelines for the Conduct of Human Embryonic Stem Cell Research, a set of principles for self-governance and ethical conduct. George Q. Daley, MD, PhD, Principal Investigator, chaired the ISSCR task force that developed these guidelines, which have been adopted by virtually all research institutions worldwide that work with stem cells. The donor consent form developed at Children’s was used by the ISSCR as a benchmark.

Children’s also helped author the ISSCR’s 2008 Guidelines for the Clinical Translation of Stem Cells, developed to address the problem of unproven, potentially risky stem cell therapies being marketed directly to patients.

Review procedures:
In addition to the ISSCR’s guidelines, as well as guidelines from the National Academy of Sciences, scientists at Children’s and most other institutions who do research involving human embryonic stem cells must submit their protocols for internal review by several bodies:

  • An Institutional Review Board, which protects the rights of human subjects. Children’s IRB is composed of staff from a broad range of clinical and administrative areas, representatives from the Children’s patient/family population and from the community. If there are partners in the research, those institutions’ IRBs must grant approval as well. For more information on Children’s IRB, click here.
  • An Embryonic Stem Cell Research Oversight committee, as recommended by the National Academy of Sciences. ESCRO committees include public representatives and members with expertise in developmental biology, stem cell research, molecular biology, assisted reproduction and ethical and legal issues in human embryonic stem cell research. If there are partners in the research, those institutions’ ESCROs must grant approval as well.
  • The Institutional Animal Care and Use Committee, which reviews and oversees all research conducted in laboratory animals. It is made up of scientists, non-scientists and biosafety staff at Children’s, a non-affiliated community member, and veterinarians. Children’s animal care and use program is accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International.
  • Stem Cell research at Children’s also complies with Massachusetts stem cell research legislation, passed in 2005.

Criteria for embryonic stem cell research:
The multi-layered regulatory framework outlined above is meant to ensure that human embryonic stem cell research:

  • meets strict standards for obtaining explicit informed consent from people donating their eggs and/or embryos for research purposes
  • ensures that individuals and couples don’t feel pressured to donate eggs or embryos, and that the decision to donate IVF embryos is completely separate from the decision not to keep them
  • does not involve payment for eggs or embryos (egg donors may receive reimbursement for expenses).
  • has a compelling scientific rationale, and has the potential to make a true scientific and social contribution
  • does not allow early embryos to develop beyond the blastocyst stage
  • makes materials readily accessible to the biomedical research community

For further information, click on the links below:
Embryonic stem cell research: the facts
Stem cell ethics and policy – a timeline
Further information and resources
hESC Research Review Process



  • A great day for stem cell research

    On July 7, 2009, the National Institutes of Health issued new policy guidelines for federal funding of human embryonic stem cell research. Soon after, in December 2009, the NIH announced its approval of 13 new stem cell lines
    for funding, including 11 lines developed at Children’s Hospital Boston. M. William Lensch, PhD, from the Stem Cell Program at Children’s applauds the NIH’s decision in this blog post.

  • A new era

    In these videos made in spring, 2009, George Q. Daley, MD, PhD, and Leonard Zon, MD of the Stem Cell Program at Children’s Hospital Boston discuss what the loosening of some funding restrictions on embryonic stem cell research will mean.

  • One family’s story

    Andres Treviño, whose son has a rare immune disorder, explains why he and his wife donated embryos to stem cell research.

  • Embryonic stem cell research: the facts

    What happens to eggs and embryos
    in stem cell research? Learn more.

  • Senate Testimony

    Read a transcript of the testimony Daley gave in 2007 and 2005, offering his perspective on embryonic stem cell research as a scientist and a hematologist seeking better cures for his patients. He explains why alternative forms of adult stem cell research cannot substitute for the study of embryonic stem cells.