title: Genetic research on biospecimens poses minimal risk.
abstract: Genetic research on human biospecimens is increasingly common. However, debate continues over the level of risk that this research poses to sample donors. Some argue that genetic research on biospecimens poses minimal risk; others argue that it poses greater than minimal risk and therefore needs additional requirements and limitations. This debate raises concern that some donors are not receiving appropriate protection or, conversely, that valuable research is being subject to unnecessary requirements and limitations. The present paper attempts to resolve this debate using the widely-endorsed 'risks of daily life' standard. The three extant versions of this standard all suggest that, with proper measures in place to protect confidentiality, most genetic research on human biospecimens poses minimal risk to donors.
authors.affiliation: Department of Bioethics, NIH Clinical Center, Bethesda, MD, USA. Electronic address: dwendler@nih.gov.
authors.forename: David S
authors.initials: DS
authors.lastname: Wendler
authors.affiliation: Department of Social Science, Health & Medicine, King's College London, London, England, UK.
authors.forename: Annette
authors.initials: A
authors.lastname: Rid
mesh_terms: D000818:Animals; D035843:Biomedical Research; D036281:Genetic Research; D005820:Genetic Testing; D006801:Humans; D012307:Risk Factors
keywords: confidentiality; genetic research; minimal risk