Genes, cells, and biobanks: Yes, there's still a consent problem.

Timothy Caulfield,Blake Murdoch

doi:10.1371/journal.pbio.2002654

Abstract

From a research perspective, the interest in biobanking continues to intensify. Governments and industry have invested heavily in biobanks, as exemplified by initiatives like the United Kingdom Biobank and United States' Precision Medicine Initiative. But despite this enthusiasm, many profound legal and ethical challenges remain unresolved. Indeed, there continues to be disagreements about how best to obtain consent and the degree and nature of control that research participants retain over donated samples and health information. Emerging social trends—including concerns about commercialization and perceived rights of continuing control (“biorights”)—seem likely to intensify these issues.

Highlights

Driven by advances in genetics, information technology, and cell-line research, interest in the collection and analysis of human biological material continues to intensify
Over the past few decades, there has been a proliferation of biobanks—both large and small [1]—that link tissue and genetic information to a host of other forms of health and personal data
There are emerging social trends and technological developments—several of which we review below—that have heightened the need for increased clarity in the context of consent policy

Summary

Introduction

Driven by advances in genetics, information technology, and cell-line research, interest in the collection and analysis of human biological material continues to intensify. A 2017 revision of the US Common Rule, the country’s national research ethics guideline, explicitly endorses the use of broad consent in specific situations [17,18,19], but this policy change does not resolve debate about whether such an approach is appropriate; as noted by a commentator, “potential subjects cannot be informed of the specific risks and benefits of research because the biobanks do not know what those risks or benefits may be” [20].

Results

Conclusion