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

See all articles by Benjamin Berkman

Benjamin Berkman

Department of Bioethics, National Institutes of Health

Anna C. Mastroianni

University of Washington - School of Law; University of Washington, Dept. of Health Services, School of Public Health; University of Washington, Dept. of Pediatrics and Department of Bioethics and Humanities, School of Medicine

Leila Jamal

National Institutes of Health, Department of Bioethics

Coleman Solis

National Institutes of Health, Department of Bioethics

Holly A. Taylor

National Institutes of Health, Department of Bioethics

Sara Chandros Hull

National Institutes of Health, Department of Bioethics

Date Written: 2021

Abstract

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.

Note:
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

Suggested Citation

Berkman, Benjamin and Mastroianni, Anna C. and Jamal, Leila and Solis, Coleman and Taylor, Holly A. and Hull, Sara Chandros, The Ethics of Repurposing Previously Collected Research Biospecimens in an Infectious Disease Pandemic (2021). Ethics & Human Research, Vol. 43, early view online (Feb. 23, 2021), Available at SSRN: https://ssrn.com/abstract=3792561

Benjamin Berkman

Department of Bioethics, National Institutes of Health ( email )

9000 Rockville Pike
Bethesda, MD 20892
United States

Anna C. Mastroianni (Contact Author)

University of Washington - School of Law ( email )

William H. Gates Hall
Box 353020
Seattle, WA 98105-3020
United States

HOME PAGE: https://www.law.washington.edu/directory/profile.aspx?ID=144

University of Washington, Dept. of Health Services, School of Public Health ( email )

Seattle, WA 98103
United States

University of Washington, Dept. of Pediatrics and Department of Bioethics and Humanities, School of Medicine ( email )

Seattle, WA 98195
United States

Leila Jamal

National Institutes of Health, Department of Bioethics ( email )

9000 Rockville Pike
Bethesda, MD 20892
United States

HOME PAGE: http://https://bioethics.nih.gov/people/jamal-bio.shtml

Coleman Solis

National Institutes of Health, Department of Bioethics ( email )

9000 Rockville Pike
Bethesda, MD 20892
United States

HOME PAGE: http://https://www.bioethics.nih.gov/people/solis-bio.shtml

Holly A. Taylor

National Institutes of Health, Department of Bioethics ( email )

9000 Rockville Pike
Bethesda, MD 20892
United States

HOME PAGE: https://www.cc.nih.gov/meet-our-doctors/htaylor.html

Sara Chandros Hull

National Institutes of Health, Department of Bioethics ( email )

9000 Rockville Pike
Bethesda, MD 20892
United States

HOME PAGE: https://www.bioethics.nih.gov/people/hull-bio.shtml

Do you have a job opening that you would like to promote on SSRN?

Paper statistics

Downloads
8
Abstract Views
80
PlumX Metrics