Articulating Standards: translating the practices of standardizing health technologies

The construction, development and consistent use of biomedical standards to regulate health risks (standardization) are essential to the health and safety of Canadians. We aim to investigate how different types of engagement affect knowledge translation when stakeholders come together to create and negotiate standards. Our interdisciplinary team proposes to study how knowledge is communicated in the negotiation of standards in three case studies: 1) the international Human Proteomics Organization (HUPO) and its Proteomics Standards Initiative (PSI) which creates human proteomes research standards for the development of personalised medicines; 2) the implementation of global vaccine safety standards and their uptake in a developing country; and 3) negotiations for biomedical standards that will recognize the environmental and health consequences of pollutants in the Walpole Island First Nation. Using qualitative ethnographic methods including interviews, observations and document analysis, this comparative study represents the continuum of standards development and stakeholder engagement from lab to public: before a biotechnology reaches society-wide application and is integrated into public discourse (HUPO); during the implementation of global vaccine safety standards; and after technical standards of health risks have failed and been challenged in public discourses (Walpole Island). We will evaluate knowledge translation between scientists, clinicians, industry, regulators and communities, producing accounts of systematic patterns of communication and mis-communication between stakeholders engaged in standardization. Targeted areas will be identified to facilitate more effective engagement and knowledge translation between stakeholders in future, and produce a model of participation in biomedical standardization which will aid regulators, policy makers, researchers and practitioners involved in assessing and implementing new standardized health technologies.