Genetic research on biospecimens poses minimal risk

• There is continuing debate over whether genetic research on biospecimens poses minimal risk or greater than minimal risk to donors.
• Resolving this debate is important for determining when genetic research on biospecimens is ethically appropriate and when it should be subject to additional requirements and limitations.
• With standard protections in place, the risks of most genetic research are no greater than the risks of daily life, the risks of routine examinations, and the risks of charitable activities.
• The risk level of most genetic research on biospecimens, therefore, qualifies as minimal on the three extant definitions of minimal risk.

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.