The Ethics of Repurposing Previously Collected Research Biospecimens in an Infectious Disease Pandemic
Ethics & Human Research, Vol. 43, early view online (Feb. 23, 2021)
17 Pages Posted: 23 Mar 2021
Date Written: 2021
In the early days of a pandemic, repurposing bio-specimens from established research projects could prove to be extraordinarily useful in achieving substantial and timely public health benefits. Nonetheless, there are potential ethical and regulatory uncertainties that may impede access to those valuable bio-specimens. In this article, we argue that there should be a presumption in favor of using previously collected identifiable research bio-specimens without reconsent to directly address an infectious disease pandemic, assuming certain conditions are met. This argument fills a unique yet critical gap in decision‐making where the specific consent accompanying the identifiable bio-specimens would not otherwise permit repurposing. Further, it suggests that even if gaining reconsent is feasible, doing so in a fast‐moving crisis is not necessary. This analysis also attempts to address the ethical concerns of public health authorities who already may have the power to use such specimens but are reluctant to do so.
Funding Statement: This research was supported in part by the NIH Clinical Center and the Intramural Research Program of the National Human Genome Research Institute.
Declaration of Interests: No competing interests.
Keywords: human subjects research, human research ethics, pandemic, infectious disease pandemic, bio-specimen research, identifiable research bio-specimens, informed consent
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