What is the regulatory framework governing pharmacogenomics in Canada?
• Similar to the FDA in the United States, Health Canada has developed a guidance document, Submission of Pharmacogenomic Information, concerning the voluntary submission of pharmacogenomic data. This document suggests that separate consent should be obtained when a pharmacogenomic study takes place in the context of a clinical trial. • In addition to explaining the pharmacogenomic study, consent forms must also inform participants “that pharmacogenomic testing will be conducted and the research aim, the sample and data coding strategy, and the storage, destruction and security measures used around sample and data preservation.” Other requirements may be outlined by the ethics review committee reviewing the research.
• Similar to the FDA in the United States, Health Canada has developed a guidance document, Submission of Pharmacogenomic Information (2007), concerning the voluntary submission of pharmacogenomic data. This document suggests that separate consent should be obtained when a pharmacogenomic study takes place in the context of a clinical trial. • In addition to explaining the pharmacogenomic study, consent forms must also inform participants “that pharmacogenomic testing will be conducted and the research aim, the sample and data coding strategy, and the storage, destruction and security measures used around sample and data preservation.” Other requirements may be outlined by the ethics review committee reviewing the research.
