Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research


Book Description

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.




Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research


Book Description

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.




Stem Cells in Reproductive Medicine


Book Description

Stem cell science has the potential to impact human reproductive medicine significantly - cutting edge technologies allow the production and regeneration of viable gametes from human stem cells offering potential to preciously infertile patients. Written by leading experts in the field Stem Cells in Reproductive Medicine brings together chapters on the genetics and epigenetics of both the male and female gametes as well as advice on the production and regeneration of gene cells in men and women, trophoblasts and endometrium from human embryonic and adult stem cells. Although focussing mainly on the practical elements of the use of stem cells in reproductive medicine, the book also contains a section on new developments in stem cell research. The book is essential reading for reproductive medicine clinicians, gynecologists and embryologists who want to keep abreast of practical developments in this rapidly developing field.




Mitochondrial Replacement Techniques


Book Description

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.




Heritable Human Genome Editing


Book Description

Heritable human genome editing - making changes to the genetic material of eggs, sperm, or any cells that lead to their development, including the cells of early embryos, and establishing a pregnancy - raises not only scientific and medical considerations but also a host of ethical, moral, and societal issues. Human embryos whose genomes have been edited should not be used to create a pregnancy until it is established that precise genomic changes can be made reliably and without introducing undesired changes - criteria that have not yet been met, says Heritable Human Genome Editing. From an international commission of the U.S. National Academy of Medicine, U.S. National Academy of Sciences, and the U.K.'s Royal Society, the report considers potential benefits, harms, and uncertainties associated with genome editing technologies and defines a translational pathway from rigorous preclinical research to initial clinical uses, should a country decide to permit such uses. The report specifies stringent preclinical and clinical requirements for establishing safety and efficacy, and for undertaking long-term monitoring of outcomes. Extensive national and international dialogue is needed before any country decides whether to permit clinical use of this technology, according to the report, which identifies essential elements of national and international scientific governance and oversight.




Clinical Labor


Book Description

Forms of embodied labor, such as surrogacy and participation in clinical trials, are central to biomedical innovation, but they are rarely considered as labor. Melinda Cooper and Catherine Waldby take on that project, analyzing what they call "clinical labor," and asking what such an analysis might indicate about the organization of the bioeconomy and the broader organization of labor and value today. At the same time, they reflect on the challenges that clinical labor might pose to some of the founding assumptions of classical, Marxist, and post-Fordist theories of labor. Cooper and Waldby examine the rapidly expanding transnational labor markets surrounding assisted reproduction and experimental drug trials. As they discuss, the pharmaceutical industry demands ever greater numbers of trial subjects to meet its innovation imperatives. The assisted reproductive market grows as more and more households look to third-party providers for fertility services and sectors of the biomedical industry seek reproductive tissues rich in stem cells. Cooper and Waldby trace the historical conditions, political economy, and contemporary trajectory of clinical labor. Ultimately, they reveal clinical labor to be emblematic of labor in twenty-first-century neoliberal economies.




Principles of Oocyte and Embryo Donation


Book Description

The versatility of oocyte and embryo donation has proven to be extremely valuable to both patients and doctors engaged in reproductive medicine. Originally thought to be applicable only to a rather small subset of infertile women, today busy practices commonly recommend the procedure and it is estimated that nearly all of the 400 or more IVF programs in the United States provide these services. Oocyte and embryo donation has established itself as a mainstay procedure within assisted reproductive care, and the breadth, depth and complexity of practice is deserving of focused attention. Much has changed within the field of oocyte and embryo donation since the publication of the first edition of Principles of Oocyte and Embryo Donation in 1998, thus the need for a completely updated and more expansive text. The second edition of this book provides an overview of the major issues affecting men and women engaged in the practice of oocyte and embryo donation. A primary emphasis has been placed on defining the standards of practice that have evolved over the past 30 years, clearly stating the outcomes expected from adhering to these established protocols. Details of both the basic science and the clinical medicine are presented together and attention is also focused on the non-reproductive aspects inherent to this unique method of assisted reproduction that involves opinions from lawyers, ethicists, mental health care professionals and theologians. Oocyte and embryo donation requires a working knowledge of the medicine, the law and the ethics that underlies its foundation. This book is intended to serve as a complete and comprehensive reference for all health care professionals that provide services related to egg donation, reproductive endocrinologists, obstetrician- gynecologists, and fellows and residents entering the fertility field.




Baby Markets


Book Description

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




Ethical Issues in Clinical Research


Book Description

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.




Stem Cell Research in Asia


Book Description

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.