Abstract
BackgroundIn 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.MethodsWe 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, 2nd 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.ResultsEighty 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.ConclusionsThe results of our work show that in Canada, many NGS research needs are already dealt with. Our analysis led us to propose the addition of well-defined categories for future use, adding options on the sharing of genetic data, and widening the grounds on which research participants could consent to be recontacted.
Highlights
In order to ensure an adequate and ongoing protection of individuals participating in scientific research, the impacts of new biomedical technologies, such as Generation Sequencing (NGS), need to be assessed
Units of analysis were comprised of individual forms or a combination of forms, much as they would be presented to a potential research participant
In this article we present the categories of future use, recontact of participants and data sharing in relation to future use because of the way they were linked in terms of implementation and the provision of informed consent
Summary
In order to ensure an adequate and ongoing protection of individuals participating in scientific research, the impacts of new biomedical technologies, such as 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. Another example is the “Informed Cohort” model in which there is continuous interaction between researchers and participants when providing and receiving genetic results, entailing the active use of educational tools [7] These changes impel Institutional Review Boards (IRBs) to adapt their ethical reviews to a new language and entertain novel concepts in order to better safeguard research participants’ rights without hindering expected scientific advancements. IRBs may need to see if their current recommendations to researchers, offered in the form of templates and guiding documents, are apt to offer research participants information that truly reflect the state of genetics research as well as the paths it may yet follow
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