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.

Keywords: and social issues; best practices; biobanking; ethical; informed consent; legal; regulations.