This genomic research project aims to create the next generation of non-toxic pest-control methods. However, this project also raises important societal questions given that governments and industry have not yet addressed appropriate ways of regulating genomic technologies as applied to agriculture. Even though promising technologies are already upon us, the regulatory system and policy framework exhibit some degree of uncertainty when dealing with biotechnological innovation. Partly, this is because the Canadian public is often given conflicting messages as to what these technologies involve and how the regulatory system operates. The GE³LS research team aims to contribute to improving this situation by providing a thorough analysis of the Canadian regulatory landscape that pertains to biotechnology research.

First, the researchers are studying what types of intellectual-property models yield the most benefit for everyone concerned, including industry, government and the public at large. The objective is to identify effects of intellectual-property rights on research, compare intellectual-property rights and licensing policies among several designated countries and regions and recommend better ways of managing intellectual-property rights.  The research team is studying two closely related subjects: the ability of researchers to use the techniques of genomics for maximum societal benefit, and the development of policies to ensure sustainability and respect ethical values when exploiting the fruits of genomic research.

Second, the team is examining Canadian government policy and legislation regarding the regulation of genetically modified products and their place in agriculture.  They will examine current Canadian policy directions as well as several policy alternatives that may be better-suited for the aims of governments in harvesting the fruits of biotechnology.

Finally, they are conducting a study of material-transfer agreements among various research groups working in a multi-regional research project such as this one.

The project team has had success in the commercialization of a microbial consortium, called KB-1™, which is the only such consortium so far to gain approval through Environment Canada’s New Substances Notification Regulations. Unfortunately, the development of KB-1™ is a rare example of a successful Canadian bioremediation project. Its development and approval required a decade-long effort, not only of genomics, microbiology and engineering, but also of discussion with government agencies.  The GE³LS research team is using its experience with KB-1™ as the basis for developing a framework for the integration of scientific research and public policy analysis.  Barriers to the entry of new bioproducts to the marketplace often come down to a lack of familiarity by end users, governments and regulators.

Working with these groups, the aim is to lower barriers to entry by generating a comprehensive plan for introducing new bioproducts.  The team is integrating scientific, economic and policy data in studies that aim to provide comparisons of new technologies with old to help decision-making by regulators, industrial users, and policy makers. Much of this work is being carried out in collaboration with a new programme in Engineering and Public Policy at the University of Toronto, whose mandate is to promote studies at the intersection of public policy and technology so that sound policy judgments can be made on the basis of well-developed and quantitative science.

The research team is approaching this study in the following ways:

• First, the team will devise quantitative methods for assessing the environmental and resource impacts of new bioproducts compared to similar, petroleum-derived products;
• Second, they will use these methods to assess the relative merits of the new biological products and processes developed in this research project;
• Finally, they will model how sustainable bioproducts industries can be maintained by providing quantitative information on environmental-resource impacts and total production costs.

In order to ensure optimal data collection and informed choice, the GE³LS project team’s over-arching goal is to investigate how the understandings of terms used in genomics research by scientists, when translated into the scientists’ meanings on consent forms, information letters, surveys, and demographic forms, may or may not be consistent with the understandings of research participants and their meanings when they respond to such documents. The team will:

• perform a textual analysis of research grants, information letters and consent forms that are being used in clinical studies of this Genome Canada grant and others funded in the last Genome Canada competition. With interview ‘prompts’ from the results of this research, research participants and researchers involved in the clinical Themes of this Genome Canada grant will be interviewed to provide further insight into the meanings and understandings of terms used in genomics research, particularly related to copy number variations (CNVs);
• survey other key stakeholders’ views of genomic research (particularly related to CNV), such as health professionals’ (medical geneticists and counselors, physicians) perceptions of the clinical meaning of CNV results (what kinds of results should provoke duty to warn, and child protection obligations);
• examine the views and experiences of patients and their families as research participants towards furthering informed choice to participate in CNV research;
• explore the meanings and understandings of terms used in CNV research by studying issues revolving around the interpretation, management and communication of whole genome scanning (WGS) results to patients and their families; and
• consider the legal issues that are emerging from the methodologies of the aforementioned studies that explore the meanings and understandings of terms used in CNV research, including qualitative content analysis, interviews of researchers and research participants, and electronic surveys.

The team will systematically address the potential GE³LS issues stemming from the development and commercialization of the quantum dot (Qdot) diagnostic system, a high-throughput diagnostic system capable of detecting multiple global infectious disease threats at point-of-care; in 3 parts:

1. Public Engagement: The project team will develop and evaluate a public engagement tool for high school students and the general public that encompasses various emergent technologies and their application to infectious disease research.

2. Regulation of the Convergence of Genomics, Proteomics and Nanotechnology: The project team will identify regulatory issues related to convergent technologies and work with Canadian regulatory authorities to develop regimes and guidelines on implementation of any standards that may be developed. As such, they will a) survey Canadian and international regulatory regimes for each of the major technologies involved in the project; b) develop a database of cognate regulatory regimes; c) identify potential bottlenecks that are likely to slow down the development of convergent technologies; d) develop recommendations for the federal government on how to streamline the different regimes to develop “smart regulation” for convergent technologies; and e) work with Canadian regulatory authorities to develop regulatory regimes and guidelines on implementation of any future Canadian standards.

3. Monitoring of Risks and Benefits of Quantum Dots: The project team will monitor research on toxicity of Qdots and develop an annotated database of research publications and data on the potential risks of Qdots after exposure, and participate in policy discussions with the Canadian federal government on these issues.

Recent research advances mean that Research Ethics Boards (REBs) are now reviewing protocols that involve predictive genetic testing in children.

While issues surrounding predictive genetic testing are clear in adults, there remain significant problems regarding the ethics of predictive testing in children. Further information on the acceptability and impact of predictive testing in children and adolescents and their families is required so as to allow REBs to better quantify risks and benefits of such studies.

The objectives of this research study include:

• There is a high interest in predictive testing in both the diabetic and general community and that factors motivating predictive testing are different in adolescents than in adults.
• In adults, the major motivating factors are related to their personal health. There is indication that adults may modify their behaviour to reduce risk of T1D based on predictive testing outcomes.
• Adolescents tend to take predictive testing for altruistic reasons.
• Siblings have an excellent knowledge base of diabetes and they can readily describe the long and short term consequences associated with the disease.
• The child’s reaction to the affected sibling’s diagnosis was shock and emotional; they attempt to cope with a normalization process in describing their affected sibling and family life. These young people will also participate in caregiving and show more respect for their sibling with T1D.
• These adolescents think the decision for predictive genetic testing is ultimately theirs to make, even though parents do have the right to know and should sit down and discuss with the child.

This information will help guide investigators, REB members and research participants on the key elements that need to be included in consent forms for research in T1D that includes predictive testing. Many other childhood diseases, including asthma and Crohn’s disease, are now understood to involve genome-environment interactions. Information gained will be generalisable to many other disorders and will be very important as other large population-based predictive studies are undertaken.