Consenting for current genetic research: is Canadian practice adequate?

Background In order to ensure an adequate and ongoing protection of individuals participating in scientific research, the impacts of new biomedical technologies, such as Next Generation Sequencing (NGS), need to be assessed. In this light, a necessary reexamination of the ethical and legal structures framing research could lead to requisite changes in informed consent modalities. This would have implications for Institutional Review Boards (IRBs), who bear the responsibility of guaranteeing that participants are verifiably informed, and in sufficient detail, to understand the reality of genetic research as it is practiced now. Current literature allowed the identification of key emergent themes related to the consent process when NGS was used in a research setting. Methods We examined the subjects of secondary use, sharing of materials and data, and recontacting participants as outlined in the Canadian Informed Consent templates and the accompanying IRB instructions for the conduct of genetic research. The research ethics policy applied by the three Canadian research agencies (Tri-Council Policy Statement, 2 nd Edition) was used to frame our content analysis. We also obtained IRB-approved consent forms for genetic research projects on brain and mental health disorders as an example of a setting where participants might present higher-than-average vulnerability. Results Eighty percent of documents addressed different modalities for the secondary use of material and/or data, although the message was not conveyed in a systematic way. Information on the sharing of genetic sequencing data in a manner completely independent of the material from which it originated was absent. Grounds for recontacting participants were limited, and mainly mentioned to obtain consent for secondary use. A feature of the IRB-approved consent documents for genetic studies on brain and mental health disorders using NGS technologies, offered a complete explanation on sharing material and data and the use of databases. Conclusions ...