Liability and the legal duty to inform in research

Abstract

Section 12.2 of this chapter will discuss the duty to inform as enunciated in international normative documents that frame medical research. Although the duty to inform is often linked with the notion of consent, it should be noted that these two concepts are not synonymous, and should be considered as interrelated but ultimately separate. While consent is seen to crystallize the duty to inform, the latter encompasses a number of additional elements. These elements will be presented through a review of regional and national laws and regulations.In order to provide a concrete illustration of the principles examined in section 12.2, section 13.2 will examine how Canadian case law has dealt with the duty to inform in the context of research. Finally, section 12.4 will address the increasingly blurred lines between the clinical and research settings through a succinct overview of recent developments in genomic research. More precisely, this section will discuss emerging issues of liability that researchers face in the fulfillment of their duty to inform.