Bordet S., Knoppers B.M., "
L'humain, l'humanité et les biotechnologies",
L'humain, l'humanité et le progrès scientifique (eds. Hervé C, Jean MS, Molinari PA, Grimaud M-A , Laforêt E) (France: Dalloz, 2009)
Abstract: [Not available]
Bordet S., Nguyen T.M., Knoppers B.M., Isasi R., "
Use of Umbilical Cord Blood for Stem Cell Research", (2010) 32:1
JOGC,
58
Abstract: Umbilical cord blood (UCB), long treated as waste material, is today considered a valuable source of hematopoietic stem cells. UCB is used, mostly in children, for the treatment of blood malignancies and inherited blood and metabolic disorders. In addition to blood precursor cells, UCB also contains stem cells that can differentiate into other types, such as cartilage, fat, hepatic, cardiac, and neural cells, fuelling speculation about the use of cord blood stem cells for regenerative medicine. Further research is therefore needed to investigate the expanded potential of UCB and its therapeutic use in cell and tissue therapies. According to a recent survey, practices for the procurement of UCB for research vary widely across Canada, so this area may not yet be ready for uniform regulation. However, some harmonization of practices to increase the availability of UCB for research would be useful for Canadian investigators. In this article, we address several important ethical and legal issues relating to the use of UCB in research and recommend guidelines to serve as a source of useful information for researchers. While their legal acceptability may vary across Canada, it is hoped that these recommendations foster more harmonized UCB research practices.
Caulfield T., Zarzeczny A., McCormick J., Bubela T., Joly Y., Isasi R. et al, "
International stem cell environments: A world of difference", (2009)
Nature Reports Stem Cells, doi:10.1038/stemcells.2009.61
Abstract: [None available]
Caulfield T., Zarzeczny A., McCormick J., Joly Y., Isasi R. et al, "
The Stem Cell Research Environment: A Patchwork of Patchworks", (2009) 5:2
Stem Cell Rev. and Rep., 82
Abstract: Few areas of recent research have received as much focus or generated as much excitement and debate as stem cell research. Hope for the therapeutic promise of this field has been matched by social concern associated largely with the sources of stem cells and their uses. This interplay between promise and controversy has contributed to the important as we enter this new era of stem cell research.
The current progression towards translational and clinical
research among international collaborators serves as a
catalyst for identifying potential policy conflict and makes
it imperative to address jurisdictional variability in stem cell research environments. The existing patchworks seen in
contemporary stem cell research environments provide a
valuable opportunity to consider how variations in regulations and policies across and within jurisdictions influence research efficiencies and directions. In one sense, the stem cell research context can be viewed as a living experiment occurring across the globe. The lessons to be gleaned from examining this field have great potential for broad-ranging general science policy application.
Fortin S., Knoppers B.M., "
Secondary Uses of Personal Data for Population Research", (2009) 5:1
Genomics, Society and Policy, 60
Abstract: With accompanying infrastructures (databases and biobanks). Population-based research links samples and data from multiple sources often obtained for other purposes. The normative frameworks of many countries are largely based on 1980 OECD principles which limit the uses of personal data, especially for secondary purposes. These limits, now found in legislation, policies and research guidelines, pose major barriers to population-based research.
This text examines similarities and differences between epidemiology, public health research and genomics. It also distinguishes between primary and secondary uses of personal information. In a comparative and critical analysis of the normative landscapes of five countries, Québec (Canada), Germany, Australia, the United States and the United Kingdom, three barriers are identified: the impracticability of re-consent; the shortcomings of the review process (ethics and privacy) and certain multi-jurisdictional issues. Recommendations are proposed.
Joly Y., "
La biotechnology ouverte - Bilan de la rencontre de deux révolutions", (2009) 25 : 11
Médecine Sciences 957 - 961
Abstract: [Available only in French]
Joly, Y., Pham, C., Shorno, D., Knoppers, B.M., "
Down the Rabbit Hole: Technology Transfer in the Field of Stem Cell Research", (2008) 47
Revista da Faculta de Dereito de Universidade Federal do Parana 101
Abstract: This article posits that collaborative
models of technology transfer could be considered
for their remarkable ability to maintain or
increase the pace and quality of scientific
development in stem cell research rather than for
their potential to fix problems that do not
empirically exist. In light of this scientific field’s
logistical constraints and its current stage of
development, the open model appears to be a
particularly suitable collaborative method of
technology management for stem cell research.
Kirby É., Lévesque E., Avard D., "
Reducing Fears of Participating in Research Involving Genetic Testing", (2009) 1 : 6
MIREC Newsletter 8
Abstract: [None available]
Knoppers B.M., "
Challenges to Ethics Review in Health Research", (2009) 17:2-3
Health Law Review, 47
Abstract: [None available]
Knoppers B.M., Avard D., "
'Principled' personalized medicine?", (2009) 6:6
Personalized Medicine, 663
Abstract: The advent of both population genomic studies and direct-to-consumer personal genetic testing raises ethical challenges for researchers and physicians alike. Quality and solidarity can now be added to traditional ethical principles, such as autonomy and privacy. There is no doubt that genetic information is going 'public'. Information technologies allow for greater accessibility and integration, but can researchers and physicians handle the challenges? Are ethics committees equipped to handle this shift towards greater openess and towards a conflation of research and traditional medical ethics?
Knoppers B.M., Kharaboyan L., "
"Deconstructing" Biobank Communication of Results", (2009) 6:3
SCRIPTed, 677
Abstract: Biobanks have been troubled by a history of confusion and controversy around certain key concepts such as “broad consent”, and, more recently, “return of results”. This article analyses the return of results only as it pertains to the participation of (presumably healthy) volunteers in the creation of longitudinal biobank infrastructures for future unspecified research. Limiting ourselves to the
trajectory of a typical protocol then that begins with: the arrival of volunteers at assessment centres for the collection of blood and the filling-in of extensive
questionnaires on lifestyle, socio-demographic factors and family history; followed by long term storage; and finally the use by researchers accessing such biobanks (it is evident that it is necessary to distinguish between the different obligations that may arise at distinct moments in this trajectory). We posit that there are five types of
communication, and we explore the best means of protecting the privacy of those involved in such biobanks, concluding that international policies are converging towards an ethical duty to return individual genetic research results to subjects, provided there is proof of validity, significance and benefit.
Knoppers B.M., Nguyen T.M., "
Prenatal and Preimplantation Diagnosis: International Policy Perspectives", in Milunsky, A. (ed.)
Genetic Disorders and the Fetus, (London: Wiley-Blackwell, 2009)
Abstract: None available
Lévesque E., "
Les banques de matériel biologique utilisées en recherche : préférer une évaluation globale afin de décider du meilleur moyen de protéger la confidentialité", (2009) 43:3
R.J.T., 773-800
Abstract: [Available only in French]
Tassé A.M., Godard B., "
L'internationalisation des services génétiques: Analyse comparative des normes de gouvernance canadiennes, américaines, britanniques et australiennes", L'internationalisation des services génétiques: Analyse comparative des normes de gouvernance canadiennes, américaines, britanniques et australiennes (Montréal: Thémis, 2009)
Abstract: [None available]
Tassé A.M., Godard, B., "
Analyse éthique de l’internationalisation des services de laboratoires génétiques", (2009) 6:3
Éthique & Santé 152, online:
URL
Abstract: Since the discovery of the double helix structure of DNA in 1953, knowledge in genetics has grown exponentially. The decoding of the human genome suggests the creation of an impressive array of new diagnostic tests. Nevertheless, a large number of genetic disorders are rare, and required tests are sometimes available only in specialized laboratories. For this reason, many samples must be sent abroad to be tested. However, a comparative analysis shows that most countries have different frameworks governing genetic laboratories and patient rights. The internationalization of genetic services is an undeniable reality, creating important ethical and legal issues for the health professionals required to send samples abroad for genetic analysis. An analysis of these issues, using three major ethical perspectives, principlism, utilitarianism and deontology, demonstrates prima facie evidence of the ethics of the internationalization of genetic services. However, this analysis also raises several issues created by the coexistence of different national frameworks governing genetic laboratory services.
Zarzeczny A., Scott C., Isasi R. et. al., "
iPS Cells: Mapping the Policy Issues", (2009) 139:6
Cell, 1032, online:
URL
Abstract: Given the explosion of research on induced pluripotent stem (iPS) cells, it is timely to consider the various ethical, legal, and social issues engaged by this fast-moving field. Here, we review issues associated with the procurement, basic research and clinical translation of iPS cells.
