While the clinical promise of much stem cell research remains largely theoretical, patients are nonetheless pursuing unproven stem cell therapies in jurisdictions around the world?a phenomenon referred to as ?stem cell tourism.? These treatments are generally advertised on a direct-to-consumer basis via the Internet. Research shows portrayals of stem cell medicine on such websites are overly optimistic and the claims made are unsubstantiated by published evidence. However, anecdotal evidence suggests that parents are pursing these ?treatments? for their children, despite potential (...) physical and financial risk. Physicians are in a unique position as they can be expected to be involved in, or privy to, such decisions. In this paper, we consider what duties physicians may have toward minor patients whose parents/guardians wish to engage in stem cell tourism on their behalf. We use the Canadian perspective to address the broadly relevant issues raised by this trend. (shrink)
Research involving minors has been the subject of much ethical debate. The growing number of longitudinal, pediatric studies that involve genetic research present even more complex challenges to ensure appropriate protection of children and families as research participants. Long-term studies with a genetic component involve collection, retention and use of biological samples and personal information over many years. Cohort studies may be established to study specific conditions (e.g. autism, asthma) or may have a broad aim to research a range of (...) factors that influence the health and development of children. Studies are increasingly intended to serve as research platforms by providing access to data and biological samples to researchers over many years. (shrink)
Somatic cell nuclear transfer (SCNT) remains a controversial technique, one that has elicited a variety of regulatory responses throughout the world. On March 29, 2005, Canada's Assisted Human Reproduction Act came into force. This law prohibits a number of research activities, including SCNT. Given the pluralistic nature of Canadian society, the creation of this law stands as an interesting case study of the policy-making process and how and why a liberal democracy ends up making the relatively rare decision to use (...) a statutory prohibition, backed by severe penalties, to stop a particular scientific activity. In this article, we provide a comprehensive and systematic legal analysis of the legislative process and parliamentary debates associated with the passage of this law. (shrink)
In the context of stem cell research, the promise of economic growth has become a common policy argument for adoption of permissive policies and increased government funding. However, declarations of economic and commercial benefit, which can be found in policy reports, the scientific literature, public funding policies, and the popular press, have arguably created a great deal of expectation. Can stem cell research deliver on the economic promise? And what are the implications of this economic ethos for the researchers who (...) must work under its shadow? (shrink)
Background Genetic databases are becoming increasingly common as a means of determining the relationship between lifestyle, environmental exposures and genetic diseases. These databases rely on large numbers of research subjects contributing their genetic material to successfully explore the genetic basis of disease. However, as all possible research questions that can be posed of the data are unknown, an unresolved ethical issue is the status of informed consent for future research uses of genetic material. Discussion In this paper, we discuss the (...) difficulties of an informed consent model for future ineffable uses of genetic data. We argue that variations on consent, such as presumed consent, blanket consent or constructed consent fail to meet the standards required by current informed consent doctrine and are distortions of the original concept. In this paper, we propose the concept of an authorization model whereby participants in genetic data banks are able to exercise a certain amount of control over future uses of genetic data. We argue this preserves the autonomy of individuals at the same time as allowing them to give permission and discretion to researchers for certain types of research. Summary The authorization model represents a step forward in the debate about informed consent in genetic databases. The move towards an authorization model would require changes in the regulatory and legislative environments. Additionally, empirical support of the utility and acceptability of authorization is required. (shrink)
There has been growing concern about the phenomenon of science hype, the tendency to exaggerate the value or near-future application of research results. Although this is a problem that touches every area of biomedicine, the topic of genetics seems to be particularly prone to enthusiastic predictions. The world has been told for over two decades-by the media, researchers, politicians, and the biotech industry-that a genome-driven health care revolution is just around the corner. And while the revolution never seems to arrive, (...) the hopeful rhetoric continues. It has been suggested that this unrelenting “genohype” is having a range of adverse social consequences, including misleading the public and hurting the long-term legitimacy of the field. While we need more good data on the nature and magnitude of these possible harms, few would argue with the proposition that sustained science hype is a bad thing. We all benefit from robust science and accurate public representations of biomedical research. But, to date, there has been very little consideration of the degree to which the scholarship on the related ethical, legal, and social issues has been hyped. Are the conclusions from ELSI scholarship also exaggerated? (shrink)
The BiDil story offers an ideal opportunity to explore the nature and tone of media representations of race and genetics. For example, was a biological view of race emphasized? Or was the notion of race presented in a critical fashion?
Background The regulation of human cloning continues to be a significant national and international policy issue. Despite years of intense academic and public debate, there is little clarity as to the philosophical foundations for many of the emerging policy choices. The notion of "human dignity" is commonly used to justify cloning laws. The basis for this justification is that reproductive human cloning necessarily infringes notions of human dignity. Discussion The author critiques one of the most commonly used ethical justifications for (...) cloning laws – the idea that reproductive cloning necessarily infringes notions of human dignity. He points out that there is, in fact, little consensus on point and that the counter arguments are rarely reflected in formal policy. Rarely do domestic or international instruments provide an operational definition of human dignity and there is rarely an explanation of how, exactly, dignity is infringed in the context reproductive cloning. Summary It is the author's position that the lack of thoughtful analysis of the role of human dignity hurts the broader public debate about reproductive cloning, trivializes the value of human dignity as a normative principle and makes it nearly impossible to critique the actual justifications behind many of the proposed policies. (shrink)
The recent Canadian lawsuit on patent infringement, filed by the Children’s Hospital of Eastern Ontario, has engendered a significant public debate on whether patenting genes should be legal in Canada. In part, this public debate has involved the use of social networking sites, such as Twitter. This case provides an opportunity to examine how Twitter was used in the context of this gene patent controversy.
A challenge in human genome research is how to describe the populations being studied. The use of improper and/or imprecise terms has the potential to both generate and reinforce prejudices and to diminish the clinical value of the research. The issue of population descriptors has not attracted enough academic attention outside North America and Europe. In January 2012, we held a two-day workshop, the first of its kind in Japan, to engage in interdisciplinary dialogue between scholars in the humanities, social (...) sciences, medical sciences, and genetics to begin an ongoing discussion of the social and ethical issues associated with population descriptors. (shrink)
Stem cell tourism is a growing industry in which patients pursue unproven stem cell therapies for a wide variety of illnesses and conditions. It is a challenging market to regulate due to a number of factors including its international, online, direct-to-consumer approach. Calls to provide education and information to patients, their families, physicians, and the general public about the risks associated with stem cell tourism are mounting. Initial studies examining the perceptions of patients who have pursued stem cell tourism indicate (...) many are highly critical of the research and regulatory systems in their home countries and believe them to be stagnant and unresponsive to patient needs. We suggest that educational material should include an explanation of the translational research process, in addition to other aspects of stem cell tourism, as one means to help promote greater understanding and, ideally, curb patient demand for unproven stem cell interventions. The material provided must stress that strong scientific research is required in order for therapies to be safe and have a greater chance at being effective. Through an analysis of educational material on stem cell tourism and translational stem cell research from patient groups and scientific societies, we describe essential elements that should be conveyed in educational material provided to patients. Although we support the broad dissemination of educational material on stem cell translational research, we also acknowledge that education may simply not be enough to engender patient and public trust in domestic research and regulatory systems. However, promoting patient autonomy by providing good quality information to patients so they can make better informed decisions is valuable in itself, irrespective of whether it serves as an effective deterrent of stem cell tourism. (shrink)
BackgroundWith a growing number of genetic tests becoming available to the health and consumer markets, genetic health care providers in Canada are faced with the challenge of developing robust decision rules or guidelines to allocate a finite number of public resources. The objective of this study was to gain Canadian genetic health providers' perspectives on factors and criteria that influence and shape resource allocation decisions for publically funded predictive genetic testing in Canada.MethodsThe authors conducted semi-structured interviews with 16 senior lab (...) directors and clinicians at publically funded Canadian predictive genetic testing facilities. Participants were drawn from British Columbia, Alberta, Manitoba, Ontario, Quebec and Nova Scotia. Given the community sampled was identified as being relatively small and challenging to access, purposive sampling coupled with snowball sampling methodologies were utilized.ResultsSurveyed lab directors and clinicians indicated that predictive genetic tests were funded provincially by one of two predominant funding models, but they themselves played a significant role in how these funds were allocated for specific tests and services. They also rated and identified several factors that influenced allocation decisions and patients' decisions regarding testing. Lastly, participants provided recommendations regarding changes to existing allocation models and showed support for a national evaluation process for predictive testing.ConclusionOur findings suggest that largely local and relatively ad hoc decision making processes are being made in relation to resource allocations for predictive genetic tests and that a more coordinated and, potentially, national approach to allocation decisions in this context may be appropriate. (shrink)
Background No two countries have adopted identical regulatory measures on cloning. Understanding the complexity of these regulatory variations is essential. It highlights the challenges associated with the regulation of a controversial and rapidly evolving area of science and sheds light on a regulatory framework that can accommodate this reality. Methods Using the most reliable information available, we have performed a survey of the regulatory position of thirty countries around the world regarding the creation and use of cloned embryos (see Table (...) 1). We have relied on original and translated legislation, as well as published sources and personal communications. We have examined the regulation of both reproductive cloning (RC) and non-reproductive cloning (NRC). Results While most of the countries studied have enacted national legislation, the absence of legislation in seven of these countries should not be equated with the absence of regulation. Senator Morin was not correct in stating that the majority of recent legislation bans both RC and NRC. Recent regulatory moves are united only with regard to the banning of RC. While NRC is not permitted in seventeen of the countries examined, it could be permitted in up to thirteen countries. Conclusions There is little consensus on the various approaches to cloning laws and policies, and the regulatory position in many countries remains uncertain. (shrink)
The increased use of human biological material for cell-based research and clinical interventions poses risks to the privacy of patients and donors, including the possibility of re-identification of individuals from anonymized cell lines and associated genetic data. These risks will increase as technologies and databases used for re-identification become affordable and more sophisticated. Policies that require ongoing linkage of cell lines to donors’ clinical information for research and regulatory purposes, and existing practices that limit research participants’ ability to control what (...) is done with their genetic data, amplify the privacy concerns. (shrink)
BackgroundThe increasing push to commercialize university research has emerged as a significant science policy challenge. While the socio-economic benefits of increased and rapid research commercialization are often emphasized in policy statements and discussions, there is less mention or discussion of potential risks. In this paper, we highlight such potential risks and call for a more balanced assessment of the commercialization ethos and trends.DiscussionThere is growing evidence that the pressure to commercialize is directly or indirectly associated with adverse impacts on the (...) research environment, science hype, premature implementation or translation of research results, loss of public trust in the university research enterprise, research policy conflicts and confusion, and damage to the long-term contributions of university research.SummaryThe growing emphasis on commercialization of university research may be exerting unfounded pressure on researchers and misrepresenting scientific research realities, prospects and outcomes. While more research is needed to verify the potential risks outlined in this paper, policy discussions should, at a minimum, acknowledge them. (shrink)
To the Editor: Last year I sent a vial of my spit to a prominent direct-to-consumer genetic testing company. The company's Web site promised that, in return, I would get genetic risk information that would allow me to "make life-style choices" and "make more informed decisions" about my health—in other words, personalize my health behaviors and medical care.When the results arrived I found little that was helpful. There was lots of fun and interesting information. It was, after all, information about (...) me—one of my absolute favorite topics. And the data were presented in a sophisticated and engaging manner that made them easy to understand. But was there any information that should or would nudge me toward adopting .. (shrink)