Biobanks are repositories of human biological materials collected for biomedical research. There are over 300 million stored specimens in the United States, and the number grows by 20 million per year. In the post-genome world of high throughput gene sequencing and computational biology, biobanks hold the promise of facilitating large-scale research studies. New organizational and operational models of research repositories also raise complex issues of big science, big business, and big ethical concerns.

Biobanks are repositories of human biological materials collected for biomedical research. There are over 300 million stored specimens in the United States, and the number grows by 20 million per year. In the post-genome world of high throughput gene sequencing and computational biology, biobanks hold the promise of facilitating large-scale research studies. New organizational and operational models of research repositories also raise complex issues of big science, big business, and big ethical concerns.

Repositories of tissues, cell lines, blood samples, and other biological specimens are crucial to genomics, proteomics, and other emerging forms of biomedical research. Creation of these repositories by individual researchers and their affiliated organizations, commercial entities, and even governments has been labeled “biobanking” in the bioethics literature. Biobanking as a metaphor for the collection, transfer, and use of these specimens suggests a framework for the legal response to conflicts that may arise - one embedded in principles of contract law and (...) property ownership with an overlay of legislatively authorized regulation of the “industry.”. (shrink)

There has been extensive discussion in research ethics literature surrounding the appropriate form of informed consent for biobanking, whether with adapted content, or adapted forms such as broad or tiered consent. These discussions presuppose that it is possible to disclose adequate information at the outset to facilitate an informed choice to donate to a biobank. I will argue that informed consent cannot be achieved because in the biobanking context, we are either consenting to an enterprise that is not research or (...) to future research. Nor is the solution to abandon the idea that informed consent ethically requires the disclosure of a certain minimal amount of information to make an informed choice by misleadingly identifying broad, blanket or even tiered consent as forms of ‘informed’ consent. Rather, we should abandon the idea that informed consent for research can be adapted to the type of endeavor that biobanking is, and understand the goal as to develop alternatives not as alternative forms of informed consent, but rather alternatives to informed consent. (shrink)