Spotlight on Stem Cell Research

5 ISSN 1746-0751 10.2217/RME.09.84 © 2010 Future Medicine Ltd Regen. Med. (2010) 5(1), 5–6 “To further the advancement of responsible stem cell research, the Canadian Stem Cell Foundation ... released the Stem Cell Charter in September 2009 ... The promulgation and promotion of this Charter aims to prospectively frame stem cell research and to serve as a benchmark for the guidance of international and national initiatives in both scientific research and policymaking.” Bartha Maria Knoppers Author for correspondence: Director, Centre of Genomics & Policy, Faculty of Medicine, Department of Human Genetics, McGill University, 740 Dr. Penfield Avenue, Suite 5214, Montreal, Quebec, H3A 1A4 Canada Tel.: +1 514 398 8866; Fax: +1 514 398 8954; bartha.knoppers@mcgill.ca

Human embryonic stem (hES) cell research, a burgeoning area of medical inquiry, has been lauded by scientists, patient advocates, and members of the general public for its potential to cure many of today’s most dreaded diseases. Cynthia Fox’s Cell of cells: the global race to capture and control the stem cell presents the travails of stem cell researchers the world round and the vicissitudes of the patients who depend on them. It is a travelogue that provides the background of the work, people, and places involved in what is an exciting race to be first to realize the promise of stem cell research. It is a well-written book with material for the casual reader wanting to know more about the subject as well as for those with a greater familiarity with the topic who prefer more scientific detail. The book provides an overview of the science and politics surrounding this topic. Since hES cell research requires the destruction of human embryos, it has divided the religious conservative and scientific communities. Scientists see the potential to treat many life-threatening diseases while conservatives argue that these cells are still the foundations of human life and therefore have a right to life. Right-to-life supporters have been able to politicize this issue and hence place restrictions on stem cell research in America that will likely result in America falling behind in this scientific area. The key attribute of hES cells that makes them critical weapons in the fight against debilitating diseases is their ability to regenerate any and all of the body’s myriad cells and tissues. From alleviating common ailments such as rheumatoid arthritis to treating feared killers, including cancer, stroke, and heart disease, stem cells have the potential to restore wellness. The reader travels around the world as Fox reports on the international race to use stem cells successfully — illustrating mundane problems such as sand in Petri dishes in the Sahara and describing an Israeli lab that narrowly escaped a terrorist bomb. Fox also demonstrates the often cooperative nature of this area of research, even when the scientists involved hold different and opposing religious and political beliefs. In her writing, Fox adds a human dimension to the topic of stem cells. While she covers the scientific aspects of stem cell research, she also depicts the people involved, their lives and hopes and struggles. They live in different societies, in different environments. One of the most eye-opening sections of the book, titled “Biopolis,” describes research in Singapore, where some of the world’s most talented scientists have been recruited to work in state-of-the-art laboratories. Singapore has reportedly spent $1.5 billion on national stem cell research initiatives. It is easy to feel the passion that this scientific race engenders. Fox also makes the subject of stem cell research exciting through her descriptions of the efforts to condition a patient so that a donor organ will be accepted rather than rejected. She reviews the status of cloning and how its useful applications are expanding. The author also addresses the rise and fall of Woo-Suk Hwang, the South Korean researcher who claimed astonishing advances in stem cell research with his publications in major scientific journals. His career came to an abrupt end when it was made public that he had fabricated many of his results and had breached ethical guidelines when he paid women to donate their eggs for research. Fox proves to be a good storyteller. The book is filled with narratives that serve to increase the reader’s interest in science. Fox keeps the scientific facts and jargon to a minimum yet still gives the reader relevant information. Her pictorial descriptions of foreign settings are wonderful. Fox paints extremely vivid (at times a bit too graphic) images of places and people, and the stories are often suspenseful. She attempts to provide a plethora of lab findings; however, peer-reviewed scientific research is reported alongside limited commentaries and rhetoric that have not yet been critiqued via traditional channels by the conventional scientific community. Unfortunately, Cell of cells does not add much that is new. However, it makes one think about the immense possibility science holds for society. It tells a great story, one that unfortunately has not yet ended with success. But the struggle is important; it makes scientific research exciting. Aspiring students of science would benefit from this book, both as stimulation and as an example of the kinds of approaches undertaken in this particular scientific endeavor. The restrictions placed on hES cell research by religious groups will only delay success (assuming that there will be success at the end of this road). Fox’s book is an excellent introduction to the field of stem cell research and makes for interesting and entertaining reading.

In August 2002, the Health & Human Services Secretary Tommy Thompson and National Institutes of Health (NIH) Director Elias Zerhouni announced the creation of a new NIH Task Force to advance stem cell research. The National Heart, Lung, and Blood Institute (NHLBI), with a long history of sponsored research programs for stem cell biology, is participating in the NIH Stem Cell Task Force to facilitate stem cell and embryonic stem (ES) cell research including programs to improve access to cell sources. Programs being implemented include infrastructure enhancement awards to develop eligible human ES cell lines into distribution-quality cell lines, grant supplements for human ES cell line research, an educational program to provide laboratory courses on human ES cell culture techniques, and a new training program to assist investigators wishing to re-direct their laboratories into stem cell research.

In 2003 it became legal to carry out human embryonic stem (hES) cell research in Denmark using embryos that are considered `spare' in connection with fertility treatment. The public debate preceding the change of the Fertility Act presented the `spare' embryo as a biological fact and discussed whether it was possible and morally acceptable to connect a given stock of `spare' embryos to the stem cell lab. This paper tells a different story. Based on ethnographic fieldwork in a fertility clinic in Copenhagen and among stem cell researchers, we argue that `spare' embryos are not straightforward biological facts. Rather, complex decision-making processes constitute embryos as `spare' and thus as possible objects of exchange between couples in fertility treatment, stem cell researchers and future citizens in need of regenerative medicine. The ongoing fact-making of the `spare' embryo in the fertility clinic reveals the network of relationships and conflicting responsibilities in which clinicians are positioned. Using the spatial metaphor of a moral landscape we explore how clinicians try out new moral pathways when seeking alternative ways to obtain and classify embryos as `spare'. We argue that changing moral landscapes and `spare' embryos are being co-produced in the development of hES cell research.

This chapter reviews the regulatory situation for clinical stem cell research in the People’s Republic of China since the early 2000s. The paper is structured in four parts. Part I examines the regulatory conditions for the donation of human gametes and embryos and their use in basic and preclinical research. This involves an overview of China’s regulatory rules for assisted reproductive technologies (ART) and its approach to the governance of human embryonic stem cell (hESC) research. Part II offers a summary of the regulatory and legal instruments that govern clinical trials and other forms of human subjects research in China. These instruments, most of which have been launched in the 1990s and early 2000s, do not specifically address stem cell research, but they influence clinical stem cell research as horizontal regulatory rules. Part III focuses more specifically to the regulation of clinical stem cell research and applications, including the regulation of experimental (for-profit) interventions with stem cells that do not classify as clinical trials or systematic forms of clinical research. This part documents the formation of a regulatory approach for clinical stem cell applications since the mid-2000s, which was still ongoing at the time of writing. The conclusions discuss open questions and the repercussions of China’s regulatory approach for stem cell research for domestic researchers, clinicians, and corporations in China, as well as for international clinical and corporate collaborations.

The emergence of stem cell research has undoubtedly brought a lot of hope to the medical field with the opportunities that regenerative medicine offers. Human embryonic stem cells can be manipulated to cure some of the most debilitating diseases of our times. The ability to transform somatic cells into pluripotent stem cells will ease the objections by some people towards the use of embryo derived stem cells. However, due to global differences of opinion on stem cell research, it is almost impossible to come up with standardised rules that will govern the research around the world. While there is rapid and continues progress in the field of stem cell research, Africa is lagging behind with respect to actively being involved in stem cell research, despite the fact that it stands to benefit greatly from the research. There are very few African countries that are actively involved in stem cell research. This review article examines the involvement of African countries in stem cell research. Some of the challenges that are affecting the progress of stem cell research in Africa are discussed. Because human embryonic stem cells are derived from human embryos, there are legislative frameworks that concern the rights of unborn embryos to life which have to be considered before undertaking research involving human derived embryos. This review discusses recommendations that can vigorously promote and expand stem cell research in Africa, especially in smaller and less scientifically active countries of the continent. In order to succeed in promoting stem cell research in Africa, there is a need to understand the ethical and moral issues that hinders the research. There is further need to enforce basic understanding of what stem cells are and how they function. Therefore, the general consensus is that to succeed in growing stem cell research in Africa, there is a need to first enhance education about stem cells among the ordinary people of the continent

Stem cell and tissue engineering (SC&TE) research remain controversial. Polemics are potential hurdles for raising public funds for research and clinical implementation. In view of future applications of SC&TE in perinatal conditions, we aimed to measure the background knowledge, perceptions or beliefs on SC&TE research among clinicians and academic researchers with perinatal applications on the department's research agenda. We polled three professional categories: general obstetrician gynecologists, perinatologists and basic or translational researchers in development and regeneration. The survey included questions on demographics, work environment, educational background, general knowledge, expectations, opinions and ethical reflections of the respondent about SC&TE. The response rate was 39%. Respondents were mainly female (54%) and under 40 years (63%). The general background knowledge about SC&TE is low. Respondents confirm that remaining controversies still arise from the confusion that stem cell research coincides with embryo manipulation. Clinicians assume that stem cell research has reached the level of clinical implementation, and accept the risks associated of purposely harvesting fetal amniotic cells. Researchers in contrast are more cautious about both implementation and risks. Professionals in the field of perinatology may benefit of a better background knowledge and information on current SC & TE research. Though clinicians may be less aware of the current state of knowledge, they are open to clinical implementation, whereas dedicated researchers remain cautious. In view of the clinical introduction of SC & TE, purposed designed informative action should be taken and safety studies executed, hence avoid sustaining needless polemics.

Turkey is in a parallel state to that of other countries for developments in stem cell research and practices. Nevertheless, Turkish law has no regulations for stem cell practices. To define a legal framework for stem cell research, rules of general content should be used as the starting point. In 2005 and 2006, a general regulation and guidelines on stem cell research were published by Turkish Ministry of Health. Thus, the ministry, based on this first general regulation, stopped "Embryonic Stem Cell Research", while allowing "Adult Stem Cell Research" by a second general regulation. The method of such research was regulated with the addendum of 'Guidelines for Clinical Research on Non-embryonic stem Cell'. With the latest regulation, clinical stem cell research in Turkey has been based on 'Regulations for Clinical Research', which was legislated in 2009. However, the aforementioned regulations by the ministry are still legally binding. In addition, other regulations such as Medical Deontology Regulations of 1960 and Patients' Rights Regulations of 1998 are to be consulted for stem cell research in Turkey. While it is especially important that research that is still at experimental level not provide an opportunity for trade of hope in patients and their relatives, ethics discussions are enlightening in developing regulations and critical evaluation of current practices.

Stem cell research: win, win, win by keeping politics out.

Increasing public support for stem cell researchers may increase their influence over science policy decisions and lead to more favorable policies regarding stem cell research. Yet, until recently there was little scholarship on public opinion about the roles stem cell researchers should play in crafting science policy. A national survey of US adults found that Americans are generally supportive of stem cell researchers as policy advisers but that support is uneven throughout the public. Specifically, attitudes about stem cell researchers as policy advisers depend on gender, political beliefs, age and religiosity. Surprisingly, familiarity with science has a negative effect on attitudes about stem cell researchers as policy makers. This suggests that rather than simply “teaching” the public more scientific facts, science outreach and communication may be most effective when it is narrowly tailored to the match the interests of specific social groups. It also suggests that attitudes about stem cell researchers are rooted in deeply-held cultural dispositions and that widespread changes in public opinion are likely to occur slowly.

State regulation of oocyte donation in the context of human embryonic stem cell (hESC) research has increased since California’s landmark passage of Proposition 71 and the establishment of the first state-funded stem cell agency, the California Institute for Regenerative Medicine (CIRM). Scholarship has largely focused on California’s regulation of stem cell research as a patchwork of private sector and state regulations, reflecting major debates about the social contract for science. Given California’s political exceptionalism, how does examining alternative state histories, political structures, and institutions at the state level illuminate the ways that bio-innovation is being regulated in a federal regulatory vacuum? Examining state management of oocyte donation in the context of hESC research, this article considers New York and California as comparative sites of stem cell science regulation, which enriches our understanding of how regulation of stem cell science arises out of an engagement with representative politics and the private sector in the United States. Employing a process tracing of policy development in New York and California, this article highlights alternative democratic pathways to the management of oocyte donation in research contexts: given differences in direct democratic action, legislative representation, executive leadership, and publicly funded state stem cell research institutions, distinct regulatory outcomes occur with important bioethical implications for publics and participants in stem cell science at the state level.

View of Volume 66, Special Issue, September 2021 Over the years, numerous ethical implications in stem cell research have been identified. Consequentially, there is a need to anticipate, prevent and/or mitigate these implications. In literature and in the guidelines of the International Society for Stem Cell Research some of these implications have been reframed into (moral) responsibilities. What exactly is meant by responsibility and which notions of responsibility are important often remains unclear. As a consequence, this encumbers the possibility to deal with these responsibilities in a systematic way. Therefore, the goal of this paper is to discuss how the concept of responsibility in stem cell research could best be understood. This paper addresses which notions of responsibility are relevant for the field of stem cell research. This will be done by first distinguishing between backward-looking and forward-looking notions of responsibilities, where backward-looking responsibilities are about reactive attitudes and forward-looking responsibilities are about what could be expected from someone to prevent ethical implications. Subsequently, ethical implications of and wrongdoings in stem cell research will be categorized in these notions of responsibility. Taking one step back and looking at the different notions of responsibility could help to identify gaps in responsibilities as well as to distinguish obligatory and supererogatory responsibilities. Consequentially, this informs how to prioritize, distribute and delegate responsibilities over the different stakeholders in stem cell research. This paper concludes by discussing the distribution of responsibilities and different strategies to promote responsibility in stem cell research.

Redox Regulation in Hematology and Stem Cell Research

Many states in the U.S. have adopted policies regarding human embryonic stem cell (hESC) research in the last few years. Some have arrived at these policies through legislative debate, some by referendum, and some by executive order. New York has chosen a unique structure for addressing policy decisions regarding this morally controversial issue by creating the Empire State Stem Cell Board with two Committees--an Ethics Committee and a Funding Committee. This essay explores the pros and cons of various policy arrangements for making public policy decisions about morally controversial issues in bioethics (as well as other issues) through the lens of Deliberative Democracy, focusing on the principles of reciprocity, publicity, and accountability. Although New York's unique mechanism potentially offers an opportunity to make policy decisions regarding a morally controversial subject like hESC research in accord with the principles of Deliberative Democracy, this essay demonstrates its failure to do so in actual fact. A few relatively simple changes could make New York's program a real model for putting Deliberative Democracy into practice in making policy decisions regarding controversial bioethical issues.

Few science and technology–related issues have sparked as much survey attention as the public controversy ov er human embryonic stem cell research and therapeutic cloning. Interest groups, advocates, and policymakers on both sides of the debate have taken advantage of poll results to support their claims that the public backs their preferred policy outc omes, and the competing camps have staged ongoing public communication campaigns in an effort to shape public opinion. Journalists have also highlighted the results of these surveys, using poll figures to complement their coverage of who is ahead and who is behind in the competition to decide stem cell–and cloning-related policy (Nisbet, Brossard, and Kroepsch 2003). The study of survey trends detailing public responses to genetic engineering and biotechnology is not new. For example, Singer, Corning, and Lamias (1998) reviewed poll trends specific to genetic testing, gene therapy, and early public reactions to animal and human reproductive cloning. Shanahan, Scheufele, and Lee (2001) examined trends related to agricultural biotechnology, and the National Science Foundation’s Science and Engineering Indicators surveys have tracked public opinion about genetic engineering (broadly defined) since the 1980s (for an overview, see Miller and Kimmel 2001). These previous analyses, however, have not focused speci fically on surveys measuring public reactions either to stem cell or therapeutic cloning research.