TY - JOUR
T1 - The Ethics of Repurposing Previously Collected Research Biospecimens in an Infectious Disease Pandemic
AU - Berkman, Benjamin E.
AU - Mastroianni, Anna C.
AU - Jamal, Leila
AU - Solis, Coleman
AU - Taylor, Holly A.
AU - Hull, Sara Chandros
N1 - Publisher Copyright:
© 2021 by The Hastings Center. All rights reserved
PY - 2021/3/1
Y1 - 2021/3/1
N2 - In the early days of a pandemic, repurposing biospecimens 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 biospecimens. In this article, we argue that there should be a presumption in favor of using previously collected identifiable research biospecimens 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 biospecimens 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.
AB - In the early days of a pandemic, repurposing biospecimens 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 biospecimens. In this article, we argue that there should be a presumption in favor of using previously collected identifiable research biospecimens 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 biospecimens 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.
KW - biospecimen research
KW - human research ethics
KW - human subjects research
KW - identifiable research biospecimens
KW - infectious disease pandemic
KW - informed consent
KW - pandemic
UR - http://www.scopus.com/inward/record.url?scp=85101724155&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85101724155&partnerID=8YFLogxK
U2 - 10.1002/eahr.500083
DO - 10.1002/eahr.500083
M3 - Article
C2 - 33620774
AN - SCOPUS:85101724155
SN - 2578-2363
VL - 43
SP - 2
EP - 18
JO - Ethics and Human Research
JF - Ethics and Human Research
IS - 2
ER -