Minimal risk and large-scale biobank and cohort research.
Health Law Review › Vol. 17 Nbr. 2-3, March 2009
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Extract
Minimal risk and large-scale biobank and cohort research.
Introduction
Minimal risk is a core concept in research ethics, but its proper role in the regulation of large-scale biobank and cohort research is unsettled. By framing a project as posing only minimal risk to research participants, researchers may be afforded a degree of latitude in the design and implementation of consent procedures. In the context of large-scale population biobank and cohort studies, whether and to what degree of specificity one is required to seek informed consent from study participants is a critical issue. (1) Large-scale population biobank and cohort studies are best understood as research platforms rather than discrete research projects. They may involve very large numbers of research participants. The UK Biobank, for example, is aiming to recruit 500,000 participants and, as of December 2008, the project already has more than 200,000 individuals enrolled. (2) They may be designed to run for decades and encompass a great number of separate research projects over their lifespan. While it is generally recognized that researchers have an obligation to seek the informed consent of research participants, the complexity of large-scale biobank and cohort studies poses a significant challenge to obtaining informed consent for each research project...See the full content of this document
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