Streamlining Review of Research Involving Humans: Canadian Models

Abstract

Biomedical research post sequencing of the first human genome is increasingly eroding a traditional ecology of individualist science. It is, furthermore, normalising collective innovation and shared scientific discovery. Achieving sound statistical power in a genome-wide association study, for example, can often be well beyond the scope of any one researcher’s capacity. For this reason and others, the scientific imperative of research collaboration can be more pronounced in the ‘omics’ disciplines, where millions of data points are needed to make global inferences about links between the human genome and disease. From the scientific necessity to adequately power a study through research collaborations is also born an ethical imperative to do so. That is, the anticipated benefits and harms of a particular study are justified based on the researchers’ sound predictions about potential outcomes and contributions to knowledge. Either underestimating or overestimating translational possibilities can disturb the benefit–harm balance due largely to insufficient statistical power.