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Biomedical subjects

T Caulfield

Publications and source records attributed to T Caulfield.

At least 19 recordsLinked to original sources

Law and policy in the era of reproductive genetics.

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.

Attitude to Health↗

Tissue banking, patient rights, and confidentiality: tensions in law and policy.

The collection, storage and analysis of tissue samples, including genetic data, has become an increasingly common part of biomedical research. Though there are many scientific justifications for the creation of tissue and DNA databanks, the storage and use of human tissue continues to create legal dilemmas. In this paper, the impact and relevance of existing common law principles are reviewed. It is noted that the Canadian common law rules covering consent and confidentiality may create challenges for the research community. Emerging health information legislation does, however, create a somewhat more lenient research environment, largely because these laws allow, in some circumstances, research on identifiable health information without consent. Nevertheless, conflicts between existing common law, research ethics policy and new health information legislation illustrate profound policy dilemmas created by research involving storage and use of tissue and genetic material.

Biomedical Research↗

Creating needs? A review of survey data and concerns relevant to the commercialization of genetic testing.

An increasing number of genetic tests are moving from the laboratory to the clinical setting. It seems an appropriate time to assess the interest and receptivity of the public toward genetic testing services. This is particularly so given the concerns that have been expressed about the commercialization of genetic testing technologies. To this end, the paper begins with an overview of the concerns and benefits associated with commercialization. This is followed by a review of a selection of survey data relevant to the potential 'genetic testing market' (i.e., the attitudes, perceptions and knowledge of the public, patients and professionals). We conclude that although emerging data and past experience suggest that the actual uptake of genetic tests may fall short of expectations, the strong public interest and perceived right of access disclosed in the survey research indicate a future potential for a large testing market. As such, the concerns associated warrant careful consideration.

Advertising↗

Clones, controversy, and criminal law: a comment on the proposal for legislation governing assisted human reproduction.

In the past few years there has been a tremendous amount of regulatory conflict and social controversy in the area of reproductive genetics. The Canadian government has recently released a proposal for legislating in this complex arena. Although the proposed Bill contains many positive elements, it is argued that the use of the criminal law as a regulatory mechanism is neither warranted nor appropriate. The author suggests a more flexible and responsive system of moratoriums and licenses that would enable review and adjustment to the realities of emerging reproductive technologies is a better approach.

Canada↗

Patenting human genetic material: refocusing the debate.

The biotechnology industry has become firmly established over the past twenty years and gene patents have played an important part in this phenomenon. However, concerns have been raised over the patentability of human genetic material, through public protests and international statements, but to little effect. Here we discuss some of these concerns, the patent authorities' response to them, and ways in which to address these issues and to move the debate forward using current legal structures.

Bioethics↗

Underwhelmed: hyperbole, regulatory policy, and the genetic revolution.

Rapid advances in the field of genetics in recent years have caused some commentators to suggest the emergence of a "genetic revolution." Such advances have been both praised as the "future of medicine" and condemned for encouraging the acceptance in society of laissez-faire eugenics. Yet the effect of technological advances flowing from the science of genetics appear somewhat overstated as few products of the genetic revolution, particularly in the areas of gene therapy and genetic testing, have managed to satisfy scientists' expectations to date. Furthermore, misdirected regulation of such advances can exacerbate the social, legal, and ethical problems associated with genetics, particularly in the context of health care, where issues of human cloning and the use of premature genetic testing technologies dominate current public debate. In this article, the author criticizes the hyperbolic rhetoric surrounding the genetic revolution and calls for a more balanced and informed approach to the development of genetic policies and regulations. Such an approach should include substantial interdisciplinary debate and an active role on the part of government in the identification and communication of accurate information relating to the effects of recent technological advances in the field of genetics.

Biotechnology↗

Regulating the genetic revolution.

The rapid pace of scientific breakthroughs that are flowing from genetic research seem to be matched only by the intensifying perception that some form of social control is required. As exemplified by the call to 'regulatory action' that was elicited by the prospect of human cloning, increased formal government oversight of human genetic research appears to be inevitable. Although there are certainly many valid social and ethical concerns worthy of a regulatory response, legislating genetic policy will not be easy.

Cloning, Organism↗

The commercialization of human genetics: profits and problems.

Private-sector funding is becoming increasingly important to genetic scientists and clinicians, and the number of academic-industry collaborations is growing rapidly. Furthermore, genetics has become an important tool for the healthcare industry, as the genomes of humans and other organisms are mined for new diagnostic tests and drug leads. Potentially, this is a win-win situation: academic research gets a funding boost; industry benefits from academic research; and humankind benefits from the products of these liaisons. But these benefits do not come without cost. This article explores these costs and examines whether the commercialization of academic research is compromising academic freedom, progress in clinical research, and our attitudes to normal good health.

Attitude to Health↗

Notifying patients exposed to blood products associated with Creutzfeldt-Jakob disease: integrating science, legal duties and ethical mandates.

The issue of notifying people who have been exposed to blood products that have been associated with Creutzfeldt-Jakob disease (CJD) has arisen at a time when the Canadian blood system is under intense scrutiny. As a result, the Canadian Red Cross Society issued a recommendation to health care institutions that recipients of CJD-associated blood products be identified, notified and counselled. Although Canadian jurisprudence in the realm of informed consent may support a policy of individual notification, a review of the scientific evidence and the applicable ethical principles arguably favours a policy of a more general public notification. Indeed, situations such as this require a unique approach to the formation of legal and ethical duties, one that effectively integrates all relevant factors. As such, the authors argue that individual notification is currently not justified. Nevertheless, if a system of general notification is implemented (e.g., through a series of public health announcements), it should provide, for people who wish to know, the opportunity to find out whether they were given CJD-associated products.

Beneficence↗