Genetic research attracts significant attention from the popular press, and often these representations are less than ideal, skewing toward hyperbole and promises of near-future benefits. Indeed, revolutionary language has permeated public discourse since the start of the Human Genome Project in the early 1990s. If the near constant parade of enthusiastic headlines is to be believed, we have been in the midst of a "genetic revolution" for over three decades, yet, the promised revolutionary changes never fully materialize, at least not (...) to the extent envisioned by the proselytizers. The revolution is always just around the corner. Moreover, the nature and impact of the promised revolution is... (shrink)

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)

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 concept of medical necessity plays a central role in many healthcare systems, including Canada's, by helping determine which healthcare services will receive funding. Despite its significance in health policy frameworks, medical necessity has proven to be notoriously difficult to define and operationalise. A shift toward a more personalised and genetically‐informed approach to the provision of healthcare seems likely to heighten associated policy challenges. One of the stated goals of personalised medicine is to save healthcare systems money by facilitating the (...) use of less and more effective treatments. However, any cost saving potential may ultimately be thwarted by physicians' legal and ethical obligations, given that physicians will inevitably be required to implement and define the bounds of genetically‐informed medical necessity for their patients. (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)

Policy arguments in support of stem cell research often use economic benefit as a key rationale for permissive policies and increased government funding. Economic growth, job creation, improved productivity, and a reduction in the burden of disease are all worthy goals and, as such, can be used as powerful rhetorical tools in efforts to sway voters, politicians, and funding agencies. 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)

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)

The obligation to maintain the privacy of patients and research participants is foundational to biomedical research. But there is growing concern about the challenges of keeping participant information private and confidential. A number of recent studies have highlighted how emerging computational strategies can be used to identify or reidentify individuals in health data repositories managed by public or private institutions. Some commentators have suggested the entire concept of privacy and anonymity is “dead”, and this raises legal and ethical questions about (...) the consent process and safeguards relating to health privacy. Members of the public and research participants value privacy highly, and inability to ensure it could affect participation. Canadian common law and legislation require a full and comprehensive disclosure of risks during informed consent, including anything a reasonable person in the participant or patient’s position would want to know. Research ethics policies require similar disclosures, as well as full descriptions of privacy related risks and mitigation strategies at the time of consent. In addition, the right to withdraw from research gives rise to a need for ongoing consent, and material information about changes in privacy risk must be disclosed. Given the research ethics concept of “non-identifiability” is increasingly questionable, policies based around it may be rendered untenable. Indeed, the potential inability to ensure anonymity could have significant ramifications for the research enterprise. (shrink)

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 extent to which society utilises the law to enforce its moral judgments remains a dominant issue in this era of embryonic stem cell research, preimplantation genetic diagnosis, and human reproductive cloning. Balancing the potential health benefits and diverse moral values of society can be a tremendous challenge. In this context, governments often adopt legislative bans and prohibitions and rely on the inflexible and often inappropriate tool of criminal law. Legal prohibitions in the field of reproductive genetics are not likely (...) to reflect adequately the depth and diversity of competing stakeholder positions. Rather, a comprehensive and readily responsive regulatory policy is required. Such a policy must attend to the evolving scientific developments and ethical considerations. We outline a proposal for effective, responsive, and coherent oversight of new reproductive genetic technologies. (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)

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)

Numerous social, economic and academic pressures can have a negative impact on representations of biomedical research. We review several of the forces playing an increasingly pernicious role in how health and science information is interpreted, shared and used, drawing discussions towards the role of narrative. In turn, we explore how aspects of narrative are used in different social contexts and communication environments, and present creative responses that may help counter the negative trends. As traditional methods of communication have in many (...) ways failed the public, changes in approach are required, including the creative use of narratives. (shrink)

Genetic testing technologies are rapidly moving from the research laboratory to the market place. Very little scholarship considers the implications of private genetic testing for a public health care system such as Canada’s. It is critical to consider how and if these tests should be marketed to, and purchased by, the public. It is also imperative to evaluate the extent to which genetic tests are or should be included in Canada’s public health care system, and the impact of allowing a (...) two-tiered system for genetic testing. A series of threshold tests are presented as ways of clarifying whether a genetic test is morally appropriate, effective and safe, efficient and appropriate for public funding and whether private purchase poses special problems and requires further regulation. These thresholds also identify the research questions around which professional, public and policy debate must be sustained: What is a morally acceptable goal for genetic services? What are the appropriate benefits? What are the risks? When is it acceptable that services are not funded under health care? And how can the harms of private access be managed? (shrink)

There is currently little evidence that the information provided by personal genomics companies—such as 23andMe and Navigenics—on a direct-to-consumer (DTC) basis, has any real health value. To be...

The popular press plays an important role in science communication, both reflecting and shaping public attitudes about particular issues and technologies. It is a key source of health information and can help to frame public debates about science and health care controversies. Given this powerful role, there has long been a concern that media representations of genetics are overly simplistic and inappropriately deterministic in tone. If true, media representations may hurt collective deliberations about science issues and misinform the public regarding (...) the relevance of genetics in a variety of contexts — including the relevance of genetics and biology to the existing social categories of “race.”. (shrink)

At present there is an enormous discrepancy between our nanotechnological capabilities (particularly our nanobiotechnologies), our social wisdom, and consensus on how to apply them. To date, cost considerations have greatly constrained our application of nanotechnologies. However, novel advances in microsystem platform technologies are about to greatly diminish that economic constraint while developing new industries. Properly used in a solid legal and ethical framework, within an educated population, these advances will vastly enrich our quality of life without being intrusive. Improperly used, (...) these technologies could lead to a modern-day Luddism, social turmoil, or possibly even to emulating those societies described in the darkest of novels. These technologies must be developed in tandem with the social and legal frameworks needed to ensure that they improve both individuals and our society. To ensure that this occurs, we need to have the ethical, legal, scientific, and engineering experts working together and with the public. (shrink)

In the past few years, there have been a number of high profile incidents that have emphasized the issues associated with financial conflicts of interest. As a result, commentators and policy-makers throughout the world have been directing their attention to how financial conflicts should be addressed. Despite such activity, however, there are few policies that provide specific guidance addressing one of the most common forms of financial conflict-the provision of generous remuneration packages to clinical investigators.In this column, we explore the (...) conflict of interest issues that flow from the pharmaceutical industry paying community physicians to be investigators in clinical drug trials. In particular, we are interested in the challenges associated with the management of this complex issue by local research ethics boards. We suggest the need for more research on this topic and specific guidelines to empower these boards to address this growing concern. We recognize that this is one of many current conflict issues faced by policy-makers today. (shrink)

Stem cell tourism is a form of medical tourism in which patients travel to receive unproven or untested stem cell-based interventions for many different diseases and conditions. A few studies indicate that patients and the public have several reasons for seeking these treatments for themselves or for their loved ones. Among these are the feeling of not having any other clinical options left, distrust of or frustration with their home country’s health care system, and a perception that their home country (...) has a burdensome or sluggish regulatory system for the approval of novel stem cell therapies. These last two viewpoints may contribute to a certain sense of distrust of regulatory agencies governing the conduct of clinical research, and perhaps the perception of a health care system that seems unresponsive to the needs of patients suffering from severe conditions. (shrink)

The growth of consumer DNA ancestry testing has resulted in questions and critiques being raised in social and research contexts. This study examined individuals discussing their ancestry DNA testing results on YouTube by searching for the two most popular testing companies (23andMe; Ancestry) and the phrase “DNA results.” The finalized dataset consisted of 117 videos, on which directed content analysis was performed. In the videos, individuals used results to clarify, confirm, question, and re-evaluate their previously held conceptions of racial/ethnic identities. (...) Reactions were more positive than negative (88.1% vs. 8.1%), and results more commonly reaffirmed (77.8%) than re-conceptualized (40.0%) one’s racial/ethnic identity. Ancestry testing and personal social media accounts were commonly promoted, demonstrating biotechnological hype where promotion abounds and critiques are scarce. Questions persist around the impact of ancestry DNA testing in reifying a scientifically inaccurate conception of race and what impact YouTube videos might have on audiences. (shrink)

With 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. The 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. Surveyed 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. Our 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)

Les recherches scientifiques sur la COVID-19 sont à la fois menées et diffusées à une cadence effrénée. Bien qu’il soit inspirant de voir la communauté de la recherche répondre avec autant de vigueur à la crise causée par la pandémie, toute cette activité a par ailleurs engendré un chaos de mauvaises données, de résultats contradictoires et de manchettes exagérées. Alors que la polarisation, la déformation et la médiatisation des résultats scientifiques s’intensifient chaque jour, les inquiétudes se font de plus en (...) plus sentir quant à la perspective que la science pertinente soit présentée au public d’une manière qui puisse causer de la confusion, créer de fausses attentes et éroder la confiance du public. Dans cette note, nous explorons les principaux enjeux associés à la présentation de la science dans le contexte de la pandémie de la COVID-19. Plusieurs de ces enjeux ne sont pas nouveaux. Mais la pandémie de la COVID-19 a braqué les projecteurs sur le processus de la recherche biomédicale et a amplifié les ramifications néfastes des problèmes de communication publique. Nous devons faire mieux. À ce titre, nous conclurons ce rapport en formulant dix recommandations qui s’adressent aux acteurs clés qui interviennent dans la communication de la science sur la COVID-19, notamment les gouvernements, les bailleurs de fonds, les universités, les éditeurs, les médias et les communautés de recherche. (shrink)

COVID science is being both done and circulated at a furious pace. While it is inspiring to see the research community responding so vigorously to the pandemic crisis, all this activity has also created a churning sea of bad data, conflicting results, and exaggerated headlines. With representations of science becoming increasingly polarized, twisted and hyped, there is growing concern that the relevant science is being represented to the public in a manner that may cause confusion, inappropriate expectations, and the erosion (...) of public trust. Here we explore some of the key issues associated with the representations of science in the context of the COVID-19 pandemic. Many of these issues are not new. But the COVID-19 pandemic has placed a spotlight on the biomedical research process and amplified the adverse ramifications of poor public communication. We need to do better. As such, we conclude with ten recommendations aimed at key actors involved in the communication of COVID-19 science, including government, funders, universities, publishers, media and the research communities. (shrink)

An increasing number of community physicians are involved in clinical research.Indeed, 60 of industry-funded research is now spent on community based trials. This surge in community based clinical trials has increased the number of clinical trials applications submitted to the drug regulatory agencies by pharmaceutical sponsors. Many have argued that the commercial interests connected to the conduct and outcome of these trials also increases the potential for conflicts of interest for participating physicians. The context in which these trials take place (...) increases the potential for a host of practices that infringe on ethical, legal and clinical obligations of physicians For example, financial recruitment incentives may lead to violations of the inclusion criteria and the consent process. It may result in inappropriate recruitment of patient participants and a blurring of the ethically significant distinctions between treatment and research. In some cases, it may be hard to distinguish research from the marketing of new products and attempts to influencing prescribing patterns. (shrink)

This article outlines the data about the nature of public representations of neuroimaging. Drawing on research from related domains, particularly genetics, it considers social issues associated with media representations—with an emphasis on the concerns of determinism and fatalism. It discusses some of the key forces that are shaping the direction of trends in this area. This analysis is particularly timely given the current prominence of neuroscience, and neuroimaging in particular, in the public eye. Ideally it will also contribute to the (...) growing discourse surrounding emerging biomedical technologies and how they are framed in public representations. These advances in neuroscience and related research are occurring in an era increasingly characterized by quick and easy access to information, including information about health, medical options, and scientific developments. (shrink)

The marketing of unproven direct-to-consumer stem cell interventions is becoming widespread in Canada. There is little evidence supporting their use and they have been associated with a range of harms. Canada has been slower to act against clinics offering these interventions than other jurisdictions, including the United States. Here, we outline the regulatory and policy tools available in Canada to address this growing problem. Health Canada’s regulations governing cell therapies are complex, but recent statements make it clear that Health Canada (...) believes it has jurisdiction over many of the currently marketed stem cell interventions. Still, further regulatory clarity is needed from Health Canada, as are increased directed enforcement efforts on interventions that fall within their scope. The Competition Bureau, via the Competition Act, prohibits advertisers from making materially false or misleading promotional representations. The Competition Bureau could collaborate with the scientific community to analyze the claims of existing clinics in Canada, and impose sanctions upon those who breach the established standard. Professional regulators, including provincial colleges of physicians and surgeons, have considerable power over what products and services their members can offer. Every college of physicians in Canada requires, via policy and codes of ethics, that doctors maintain evidence-based practices. This requirement is incompatible with offering many unproven stem cell interventions. Litigation may be another tool, including the use of fraud, misrepresentation and/or negligence claims for failing to meet the required standard of care. Finally, political pressure on federal and provincial lawmakers could encourage changes to marketing, cell therapy and professional regulations that would allow a more comprehensive response. In sum, there are many existing tools that can be used to protect the public from unproven stem cell interventions. Increased bureaucratic will and grassroots efforts are needed in order to effect a positive policy response. (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)

Artificial intelligence (AI) is increasingly being developed and implemented in healthcare. This presents privacy issues since many AIs are privately owned and rely on data sharing arrangements for mass quantities of patient health information. We investigated the Canadian legal and policy framework focusing on regulation relevant to the potential for inappropriate use or disclosure of personal health information by private AI companies. This included analysis of federal and provincial legislation, common law and research ethics policy. Our evaluation of the various (...) regulatory frameworks found that together they require private AI companies and their partners in healthcare implementation to meet high standards of privacy protection that prioritize patient autonomy, with limited exceptions. We found that healthcare AI systems are required to be consistent with the rules and foundational ethical norms enshrined in law and research ethics, even if this poses challenges to implementation. Data sharing arrangements must focus on tight integration with high levels of data security, strong oversight and retention of patient control over data. (shrink)

Pragmatic clinical trials are a relatively new methodological approach to the execution of clinical research that can increase research efficiency and provide access to unique data. Some have suggested that the costs and delays associated with obtaining informed consent could make PCTs difficult or even impossible to execute. Alternative consent models have been proposed, some of which lower standards of disclosure, delay consent, or waive it altogether. We analyze the permissibility of changes to informed consent in the context of Canadian (...) research ethics policies, legislation, common law, professional codes of ethics, and professional standards of practice. We find that Canadian law and policy relating to informed consent clearly applies to any clinician who might be involved in a PCT. In addition, existing consent norms seem unable to accommodate alternative consent models for pragmatic research if such models would involve lowering the standard of disclosure. The strong emphasis on the primacy... (shrink)

When a minor research participant reaches the age of majority or the level of maturity necessary to be granted legal decision-making capacity, reconsent can be required for ongoing participation in research or use of health information and banked biological materials. Despite potential logistical concerns with implementation and ethical questions about the trade-offs between maximising respect for participant agency and facilitating research that may generate benefits, reconsent is the approach most consistent with both law and research ethics.Canadian common law consent requirements (...) are expansive and likely compel reconsent on obtaining capacity. Common law doctrine recognises that children are entitled to decision-making authority that reflects their evolving intelligence and understanding. Health consent legislation varies by province but generally either compels reconsent on obtaining capacity or delegates the ability to determine reconsent to research ethics boards. These boards largely rely on the Canada’s national ethics policy, the Tri-Council Policy Statement, which states that, with few exceptions, reconsent for continued participation is required when minors gain capacity that would allow them to consent to the research in which they participate. A strict interpretation of this policy could require researchers to perform frequent capacity assessments, potentially presenting feasibility concerns. In addition, Canadian policy and law are generally consistent with the core principles of key international ethical standards from the United Nations and elsewhere.In sum, reconsent of paediatric participants upon obtaining capacity should be explicit and informed in Canada, and should not be presumed from continued participation alone. (shrink)

BackgroundPrivate umbilical cord blood banking is a for-profit industry in which parents pay to store blood for potential future use. Governments have noted the tendency for private banks to oversell the potential for cord blood use, especially in relation to speculative cell therapies not yet supported by clinical evidence. We assessed the regulatory landscape governing private cord bank marketing in Canada.Main bodyBecause the problematic marketing of private cord blood banking for future use often relates to speculative future cell therapies that (...) do not exist and are not being advertised for current clinical use, most private blood bank marketing seems to fall outside Health Canada’s regulatory scope. However, this problematic marketing is regulated by the Competition Bureau pursuant to the Competition Act. While representations relating to future hypothetical treatments may not always be subject to the legal requirement for claim substantiation, the law also prohibits individuals and companies from knowingly or recklessly making representations that are “false or misleading in a material respect.” A representation is materially false or misleading when it could “influence a consumer’s behavior or purchasing decisions,” and consumers are likely to be considered to be “credulous and inexperienced” for the purposes of assessing an advertisement’s general impression. Because all of the potential benefit of the banking is derived from the potential future use of the biological material for health interventions directed toward the customers and their relatives, and because we know the best available medical evidence indicates a very low probability of utility in this context, we can say with confidence that some private cord blood banking claims are materially misleading. Moreover, to the extent that medical professionals are involved in private bank interactions with customers or hold ownership stakes in private banks, they are subject to professional codes, standards of practice, and potentially fiduciary obligations that further prohibit misleading marketing.ConclusionsPrivate cord blood bank marketing that advertises hypothetical future treatments can be misleading and may influence consumer behaviour. This marketing may breach existing advertising law. Regulatory bodies should enforce the law in order to help prevent public health and personal financial harm. (shrink)

The rapid advances made in genetic research and technology over the last few decades have led to a host of important discoveries that have allowed for the detection (and hopefully soon the treatment) of a number of genetic conditions and diseases. Not surprisingly, these advances have also raised numerous ethical concerns about how result­ ing technologies will be implemented, and the impact they will have on different com­ munities. One particular concern is the enormous costs involved in conducting genetic research (...) and the fact that the private sector has become heavily involved; the desire to commercialize the results and technology derived from genetic research is considered problematic. In September 1998, the Second International Conference on DNA Sampling, titled "The Commercialization of Genetic Research: Ethical, Legal and Policy Issues," was held of the conference, and of this book, was to in Edmonton, Alberta, Canada. The goal facilitate an interdisciplinary discussion of the legal, ethical, and policy implications arising from the commercialization of genetic research. We solicited contributions for the book from authors in fields as diverse as ethics, law, medicine, health policy, and the social sciences. The papers included, while based on presentations given at the conference, have been substantially expanded and enhanced by the commentary received and discussions held at the conference. (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)

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)