Neglected ethical issues in biobank management: Results from a U.S. study.

R Jean Cadigan,Ian Conlon,Dragana Lassiter,Kaaren Haldeman,Erik Reavely,Gail E Henderson

doi:10.1186/2195-7819-9-1

Abstract

The empirical literature on the ethical, legal, and social implications (ELSI) of biobanking has almost entirely relied on the perspectives of those outside of biobanks, such as the general public, researchers, and specimen contributors. Little attention has been paid to the perspectives and practices of those who operate biobanks. We conducted a study of U.S. biobanks consisting of six in-depth case studies and a large online survey (N = 456), which was developed from the case study results. The case studies included qualitative interviews with a total of 24 personnel. Both interview and survey questions focused on how biobanks operate, and what policies and practices govern their relationships with specimen contributors and the researchers who use the specimens. Analysis revealed unexpected ethical dilemmas embedded in those policies and practices that highlight a need for practical planning. In this paper, we review three issues seldom explored in the ELSI literature: 1. the discrepancy between biobankers’ hope that the bank will exist “permanently” and the fact that funding is limited; 2. the lack of planning for what will happen to the specimens if the bank closes; and 3. the concern that once collected, specimens may be underutilized. These dilemmas are missing from current public representations of biobanks, which instead focus on the intrinsic value in storing specimens as essential to the advancement of translational research. We argue that attention to these issues is important for biobanking, and that greater transparency of these policies and practices will contribute to promoting public trust in biobanks.

Highlights

As biobanks have proliferated in number and size over the past decade or more (Hoeyer 2012), they, and the “biobank research system” (Wolf et al 2012), are often heralded as critical to the advancement of translational research
Empirical data on ELSI concerns in biobanking have been gathered from various stakeholders including genome researchers, IRBs, specimen contributors, and the general public (Cadigan and Davis 2009; Capron et al 2009; Dressler et al 2012; Kaufman et al 2009; Brothers et al 2011)
We present three issues that emerged from our interview and survey data that we argue warrant further discussion in the ELSI literature and in the burgeoning literature on biobanking policies and practices

Summary

Introduction

As biobanks have proliferated in number and size over the past decade or more (Hoeyer 2012), they, and the “biobank research system” (Wolf et al 2012), are often heralded as critical to the advancement of translational research. Legal, and social issues (ELSI) of biobanking has correspondingly proliferated over the past decade as researchers suggest policies and practices that preserve respect for the individuals who contribute specimens to the biobank while promoting research (Fullerton et al 2010; Kaye 2012; Mitchell et al 2011; Mongoven and Solomon 2012; Trinidad et al 2011). Empirical data on ELSI concerns in biobanking have been gathered from various stakeholders including genome researchers, IRBs, specimen contributors, and the general public (Cadigan and Davis 2009; Capron et al 2009; Dressler et al 2012; Kaufman et al 2009; Brothers et al 2011). The perspectives of biobankers in this country have yet to be adequately incorporated into discussions of the ELSI of biobanking

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