Introduction While the history of U.S. and international research ethics is well documented, little has been written on the formation of Canadian policy and practice. (2) Most commentary on Canadian policy has centred on content, particularly on gaps and shortcomings. (3) This is an unfortunate situation with both practical and intellectual implications. If Canadians are to understand and assess our policies and practices in this area, it is vital to have a sound historical understanding of our situation. Otherwise policy-making is likely to be erratic and ineffective. Intellectually the history of research ethics has become a subject in its own right. Beyond Canada the lack of a good Canadian history adds to the misperception that all national policies are clones of Belmont. It is vital, then, to have a sound intellectual history of key periods in Canadian research ethics policy. My intention is to provide a sketch of the formation of the 1998 Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans (TCPS). (4) My primary focus will be on process and contextual elements with less emphasis on content issues. This is in part due to space limitations--each of the multiple content issues deserve detailed treatment in their own right. However, I also believe that what is most lacking at this stage is a discussion of process and context. I have several reasons for focussing on TCPS. The TCPS is now Canada's policy for research ethics in most of the public research sector even though other policies (particularly ICH-GCP) are also relevant. (5) Moreover, issues arising during the TCPS process continue to this day. This history may also have particular relevance as a new formulation of the TCPS is being advanced for fall 2008, (6) and the Sponsors' Table continues its deliberations on research governance. (7) The formation of any policy for advancing ethical practice is a complex matter requiring a context sensitive balancing of matters of principle with practical considerations. The challenge is to balance these in a realistic and ethical way. Locating our situation historically helps answer the question of whether a good balance has been struck. In this paper I will first address two questions: what were the circumstances that led to the creation of the TCPS and how was the TCPS created? In the final section I will draw some lessons from this history. This paper draws on my experience as a member and deputy chair of the Tri-Council Working Group on Ethics (TCWG)--the group that drafted the document (the Code) that led to the TCPS. I draw also on the subsequent work that my colleagues and I for the Law Commission of Canada (LCC) and on a CIHR-sponsored study on Canadian governance of ethical health research involving humans and a comparison of US and Canadian governance. (8) As part of the latter, Dr. Fern Brunger (MUN) interviewed key participants (n=9) in the formation of TCPS. I have also drawn on documentation from the TCWG period and afterwards. 1. Circumstances Leading to the TCWG Prior to the TCPS, the key Canadian policies for governing research involving humans were the 1987 Medical Research Council Guidelines on Research Involving Human Subjects (9) and the 1979 Social Sciences and Humanities Research Council Guidelines (10) which originated with Canada Council in 1976. Guy Rocher, who was involved in the Canada Council process, says that the SSHRC Guidelines did not have much influence on social sciences and humanities researchers, the majority of whom were unaware of their existence, including members of the research ethics committees of Canadian universities. (11) The third federal research council, the Natural Sciences and Engineering Research Council (NSERC), had no guidelines in this area even though it funded research in such sensitive areas as experimental psychology and biomedical devices. (12) Closely connected to the MRC and its Guidelines was the National Council on Bioethics in Human Research (NCBHR). …
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This research is conducted by the Intellectual Property and Policy Research Group at the W. Maurice Young Centre for Applied Ethics at the University of British Columbia. It is part of the GE3LS (ethical, environmental, economic, legal and social issues related to genomics research) component of the Genome Canada Project "Dissecting Gene Expression Networks in Mammalian Organogenesis," MORGEN, which is located principally at the British Columbia Cancer Agency, Vancouver, British Columbia, Canada. The project is involved in upstream, basic genomic research. Part of this work includes the characterization of gene regulatory mechanisms governing organogenesis with a special focus on the heart, liver and pancreas. This paper serves as an introduction to both the MORGEN case study and the role of alternative mechanisms, such as open source. We discuss interim research results as they relate to our broader study of the relationship between open science, commercialization and technology transfer offices. The role of technology transfer offices (TTO) is central to our analysis and is viewed as a key factor in implementing Genome Canada policies and principles associated with IP and commercialization.
The goal of this paper is to begin to tease out the complexity of the relationship between policymaking and consultations in the U.S. and Canada. We do this in the context of genetically modified (GM) salmon, which involves a particularly entangled set of regulatory regimes. In exploring this relationship, we seek to lay the groundwork for demonstrating that the design, implementation, interpretation, and evaluation of public consultations need to take account of the policy arena. We use the term “policy” broadly here to refer to both legislative and administrative regimes designed to manage or implement a technology. We do not posit here that the policy regime should determine the public consultation. Rather, just as the underlying science is important to the design of the public consultation, so too is the policy regime. Thus, we think it necessary to take account of the policy arena they aim to influence in the same manner that designers of public consultation take some account of the science underlying the issues.
Surveys and focus groups are well known methods for ascertaining public perceptions and opinion. The general view is that such tools provide reasonably accurate reflections of public values, and that the norms employed by people to make decisions are fixed. But what about issues where the public needs to consider novel choices where no prior experience can be drawn on? Do their preferences and beliefs change when presented with new options and new information? Recent evidence suggests they do and this paper describes an alternative way of gathering data, which takes into account the dynamic nature of social norms in response to new technologies and their applications. It also discusses the problem with traditional methods of generating information about public opinion and offers a possible solution. Our interdisciplinary research team, NERD (Norms Evolving in Response to Dilemmas), has developed a web-based survey instrument that is designed to bridge the gap between perceived and actual public opinion, which traditional surveys and focus groups are unable to capture. This paper will present some of our preliminary findings from the results of our first survey on the topic of Human Health and Genomics. We have found that there are differences in the way respondents answer which has not yet been accounted for in other participatory processes. If new technologies demand new methods for creating policies, then it is imperative to find solutions that the older, more traditional methods currently face.
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