Ethical Legal and Social Issues of Biobanking: Past, Present, and Future

Abstract

The past 15 years has seen considerable changes in the research environment. These changes include the development of new sophisticated genetic and genomic technologies, a proliferation of databases containing large amount of genotypic and phenotypic data, and wide-spread data sharing among many institutions, nationally and internationally. These changes have raised new questions regarding how best to protect the participants of biobanking research. In response to these questions, best practices for addressing the legal, ethical, and social issues of biobanking have been developed. In addition, new ethical guidelines related to biobanking have been established, as well as new regulations regarding privacy and human subject protections. Finally, changes in the science and the research environment have raised complex ethical issues related to biobanking, such as questions about the most appropriate consent models to use for biobanking research, commercial use and ownership issues, and whether and how to return individual research results to biobank participants. This article reviews some of the developments over the past 15 years related to the ELSI of biobanking with a look toward the future.

Assessing the stability of biobank donor preferences regarding sample use: evidence supporting the value of dynamic consent

“…Consideration of dynamic consent is timely as several new DNA biobanks, including the All of Us Research Program [ 4 ], are recruiting very large numbers of sample donors and are considering how best to manage these important collections over time. Although dynamic consent has been proposed as a strategy for addressing the limitations of traditional, broad consent for biobank participation [ 5 – 9 ], it is unclear whether biobank participants would have reasons to use a dynamic consent mechanism to adjust their sample use preferences. Little data exists to suggest whether biobank donors’ sample use preferences evolve or remain stable after participants enroll in a DNA biobank.…”

The ISBER 2019 Awards

“…She continues to offer her leadership, strong voice, and insights in the realm of biobanking, especially on ethical, legal, and social issues challenges. 2 For her work, she received the ISBER distinguished leadership and services award in 2012. In 2011 she was instrumental in recognizing the need for a forum to provide ISBER's membership with a voice in shaping the evolving regulations and policies affecting biobanking and biospecimen use across the globe.…”

“…Eastern Virginia Medical School, Norfolk, Virginia 2. Chair, ISBER Education and Training Committee 3.…”

Help, hope and hype: ethical considerations of human microbiome research and applications

“…For example, how to determine and select healthy donors, how to manage and interpret the unprecedented amount of biological data when the relevance to disease is unknown, how to externalize and collaborate with other banks and clinics nationally and internationally, should volunteers be rewarded financially for giving stool samples to incentivize stool donation (Bolan et al, 2016 ; Terveer et al, 2017 ; Paramsothy et al, 2015 ). Ethical issues in biobank are mainly focused on privacy, informed consent, ownership of samples and information, secondary use of biological specimens, benefit sharing, rules and governance (Cambon-Thomsen, 2004 ; Bledsoe, 2017 ). We will mainly review two issues below:…”