Principal applicant:	Dr. Janice E. Graham
Co-applicants:	Dr. Regna Darnell Dr. Christina Holmes Dr. Mavis Jones Dr. Fiona McDonald Dr. Vural Ozdemir

The four case studies selected for this project are:

This project will expand upon Graham’s CIHR research grant 'Risks and Regulation of Novel Therapeutic Products: A Case Study of Biologics and Emerging Genetic Technologies. That earlier project studied the regulatory practices and policies of the Health Products and Food Branch, the regulatory arm of Health Canada, as they confronted and negotiated the health, social, ethical, and technological implications of emerging products. Graham identified several critical faultlines arising from the intersection of regulatory policy and scientific practices – in public and private laboratories, industry and government policy arenas, and among citizens in diverse communities who elect to uptake, adapt or reject the emerging technologies and their often uncertain outcomes. These faultlines represent disjunctures when issues are framed from partial perspectives; when one perspective is arbitrarily allowed to dictate outcomes; or when the mandates of official decision-makers place their objectives in direct conflict.

1) Health Canada, as the central hub of regional, national, and international regulatory connections

2) The Human Proteomics Organization (HUPO), based in Montreal and regional sites of HUPO activity selected to observe the translation of standards into domains with diverse resource capacities (Latin America, Europe, and Australia/Oceania)

3) The Walpole Island First Nations in southwestern Ontario, concerned with health consequences of environmental contaminants while negotiating their future with petrochemical giant Shell

4) Burkina Faso, West Africa, where the World Health Organization and the Gates Foundation have supported the development and implementation of a new meningitis vaccine.

This project conceptualizes risk regulation as shaped by the practices and perspectives of diverse actors (user groups, stakeholders, policies, technologies) across diverse disciplines, levels of governance, and geographies of experience. We see the interplay of these actors and locations as comprising a system which through its diversity can have an impact upon outcomes in complex and sometimes unanticipated ways. We choose to extend the term 'regulomics' to refer to the application of a systems approach to understand regulatory activities and relationships: to reveal patterns in organization of networks in the generation of policies, legislation and other instruments in the governance of emerging health technology and environmental risks.

 
The proposed research will use multi-sited systems ethnography to 1) map and describe the socio-technical networks involved in regulatory decision-making while actively integrating science, law and policy and their effect on regulatory systems across national and international networks in four case studies; 2) in the course of mapping these networks, track the flow of interaction and co-production of socio-technical evidence between and across regulatory layers and fieldsites; and 3) use interdisciplinary insights gained from evaluating these maps and flows, to analyze how regulatory actors interpret, mediate and negotiate critical faultlines to frame problems and solutions in the management of risk.