Assessing The Medical Risks Of Human Oocyte Donation For Stem Cell Research

It is widely understood that stem cell treatments have the potential to revolutionize medicine. Because of this potential, in 2004 California voters approved Proposition 71 to set up a 10-year, $3 billion program to fund research on stem cells. Under the direction of the California Institute for Regenerative Medicine, this program will pay to build facilities for stem cell research and will fund doctors and scientists to carry out research with the ultimate goal of helping to develop therapies based on stem cells. For this research to move forward, however, will require a steady supply of stem cells, particularly human embryonic stem cells. Those stem cells are collected from developing human embryos created from eggs-or oocytes-harvested from the ovaries of female donors. Thus much of the promise of stem cells depends on women choosing to donate oocytes to the research effort. The oocyte donation process is not without risk, however. Donors are given doses of hormones to trigger the production of more eggs than would normally be produced, and this hormone treatment can have various side effects. Once the eggs have matured in the ovary, they must be retrieved via a surgical procedure that is typically performed under anesthesia, and both the surgery and the anesthesia carry their own risks. Furthermore, given the very personal nature of egg donation, the experience may carry psychological risks for some women as well. With this in mind, in 2006 the California Institute for Regenerative Medicine contracted with the National Academies to organize a workshop that would bring together experts from various areas to speak about the potential risks of oocyte donation and to summarize what is known and what needs to be known about this topic. The Committee on Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research was formed to plan the workshop, which was held in San Francisco on September 28, 2006. This report is a summary and synthesis of that workshop.

Since 1998, the volume of research being conducted using human embryonic stem (hES) cells has expanded primarily using private funds because of restrictions on the use of federal funds for such research. Given limited federal involvement, privately funded hES cell research has thus far been carried out under a patchwork of existing regulations, many of which were not designed with this research specifically in mind. In addition, hES cell research touches on many ethical, legal, scientific, and policy issues that are of concern to the public. This report provides guidelines for the conduct of hES cell research to address both ethical and scientific concerns. The guidelines are intended to enhance the integrity of privately funded hES cell research by encouraging responsible practices in the conduct of that research.

The Committee was appointed in March 2001 to examine the issues arising from the Human Fertilisation and Embryology (Research Purposes) Regulations 2001. These regulations extended the legal grounds for research on human embryos to include the increase of knowledge about the development of embryos or serious disease, or to enable such knowledge to help in the development of treatments for serious diseases. The Committee's report analyses the potential of stem cell research to generate new therapies, and assesses the relative scientific advantages and disadvantages of research on embryonic and adult stem cells. It considers the ethical concerns about the use of early human embryos for research purposes and the implications of developments in cell nuclear replacement and reproductive cloning. The report discusses the current regulatory regime and the scope for future legislation, including the issue of informed consent and the creation of stem cell banks. Overall, the Committee finds that there is a strong scientific and medical case for continued research on human embryonic stem cells in order to realise the full therapeutic potential of stem cell research. Adult stems cell research holds the promise of future therapies which might make further research on embryonic cells unnecessary, although this is unlikely in the foreseeable future. In the meantime, to ensure maximum medical benefit, it is necessary to keep both routes to therapy open since neither alone is likely to meet all therapeutic needs. The role of the Human Fertilisation and Embryology Authority is crucial to the effective regulation of research and maintenance of public confidence.

"Stem Cell Century provides a very clear analysis of the policy issues around cloning and stem cells in biomedicine, on the basis of a sound scientific understanding of the underlying biology." Ian Wilmut, director, Edinburgh University Centre for Regenerative Medicine, and creator of "Dolly" the lamb, the world's first cloned mammal. From the bookjacket.

Mitochondrial replacement techniques (MRTs) are designed to prevent the transmission of mitochondrial DNA (mtDNA) diseases from mother to child. While MRTs, if effective, could satisfy a desire of women seeking to have a genetically related child without the risk of passing on mtDNA disease, the technique raises significant ethical and social issues. It would create offspring who have genetic material from two women, something never sanctioned in humans, and would create mitochondrial changes that could be heritable (in female offspring), and therefore passed on in perpetuity. The manipulation would be performed on eggs or embryos, would affect every cell of the resulting individual, and once carried out this genetic manipulation is not reversible. Mitochondrial Replacement Techniques considers the implications of manipulating mitochondrial content both in children born to women as a result of participating in these studies and in descendants of any female offspring. This study examines the ethical and social issues related to MRTs, outlines principles that would provide a framework and foundation for oversight of MRTs, and develops recommendations to inform the Food and Drug Administration's consideration of investigational new drug applications.

Michele Goodwin and a group of contributing experts examine the ways in which Westerners create families through private, market processes.

This book teaches researchers how to resolve the ethical dilemmas that can arise at any stage in clinical research. In addition to explaining pertinent regulations and laws, Dr. Lo helps investigators understand the gaps and uncertainties in regulations, as well as situations in which merely complying with the law may not fulfill ethical responsibilities. Most chapters include real-life examples that the author walks through, discussing the salient issues and how to approach them. This book can be used in courses on research ethics that are required or encouraged by major National Institutes of Health grants in academic health centers.

The great hurry to realise promised cures in stem cell research requires regulation to guarantee bioethical research practices. Yet, increasingly similar national guidelines for stem cell research yields a range of diverging research practices. This book shows how the different rationale of regulation affects stem cell research practices in Asia. In low- and medium income countries such as India and China the advancement of science has a different weight on the national agenda, and the evaluation of scientific research is measured with a different yardstick, depending on the political and national research environment. For developing countries the question of research funding into stem cell research, healthcare, and the donation of embryos, foetuses and oocytes entail different considerations compared to in affluent welfare societies. Moreover, research institutions have different cultural and political histories, so that the meaning of formal guidelines, legislation and social rules may differ according to their various institutional settings. This volume discusses the informal cultures, social conventions and traditions that are crucial to the way in which stem cell research takes place in Asia. This book was originally published as a special issue of New Genetics and Society.