Journal of Clinical Research & Bioethics

Abstract

Consenting for Current Genetic Research: Views of Canadian Institutional Review Board Members

Iris Jaitovich Groisman, Beatrice Godard

The widespread use of next generation sequencing (NGS) technologies in genetic research protocols creates a need for sequencing material that has been already collected, be it for similar or different purposes, in addition to increasing the need for sharing both material and the genetic generated data to enrich study results. Along with this comes the need to recontact participants for a variety of reasons where consent for unanticipated use and obtaining additional health information are only some examples. Following an earlier content analysis on a sample of Canadian Institutional Review Boards (IRB) consent form templates and accompanying guidelines, and IRB-approved consent forms, we developed an online survey addressing the opinions and experiences of Canadian IRB members on the use of NGS in research. We report herein the results pertaining to secondary use, sharing of material and data and recontacting participants. Participants in our survey agree with the need for clear identification on the matter of secondary use on consent form documents as well as the importance of differentiating use of material from the generated data. Our responders seem to be unsure how these separate options could affect the research enterprise. Respondents to our study agree with study participants opinions obtained elsewhere about the importance of providing options when it comes to share their data. While all responders agree on the importance of increasing grounds for recontacting, not all accept a clause allowing researchers to contact participants by default and giving always the possibility to refuse any further communication at time of recontact. Furthermore, our survey allowed us to make connections between the information stated on consent documents resulting from our earlier analysis with member’s views of said Boards. Adapting to new modalities of research is a challenging endeavour for IRB members. Continuous empirical research will allow the ethical oversight of research projects to keep pace with technological changes, simultaneously ensuring protection of human participants.