Biobank Research Ethics: An examination of consent, commercial use and return of research results in the realm of population-based biobanks

Abstract

Population-based biobank research is a phenomenon which has evolved over the past two decades. This development has received extensive ethical scrutiny because it requires large numbers of research participants, involves genetic analysis, and its activities do not fit the mould of traditional medical research ethics. Thus the aim of this study was to analyse, explore and further develop ethical arguments on the following three issues pertaining to population-based biobank research: consent, commercial use and return of research results.

The work included in this thesis was carried out as part of the project: “In Genes We Trust? Biobanks, commercialization and everyday life”. It was funded by the Research Council of Norway by the framework addressing ethical, legal and social issues (ELSI) within functional genomics research – the FUGE program (The Research Council of Norway 2009). This effort has resulted in 11 papers published in national and international peer-reviewed journals or reviewed academic anthologies, where five of these works are included in this thesis.

Four of the papers presented are grounded in theoretical normative analysis; they are partly descriptive and partly argumentative, and are based on bioethical inquiry of the topic addressed. In addition, one paper presents an empirical study using focus group interviews. This strategy was used to explore lay peoples’ intuitions on commercial involvement in biobank research; subsequently they were drawn on in the normative analysis of this topic.

The two papers pertaining to consent first of all contribute to understanding the legitimacy of broad consent. Here previous arguments and notions are articulated and explained and broad consent is argued as a valid consent. In addition, the proposal of dynamic consent, suggested as a unique and morally superior form of consent to use in biobank research, is critically examined and compared to the broad form of consent.

The two works included about commercial actors’ involvement in publicly funded population-based biobank research, support an understanding that some forms of commercial use can be acceptable. Governance frameworks, including ethical reviews,public contribution fees and separating the donation setting from the realms of the marketplace, were strategies that could help render commercial use sound. However, unjust handling of the resources and unfair distributions of profits can hamper such opportunities.

The last paper addresses the increased call for a return of research results to individuals. Its appeal is based on respect for individuals’ autonomy, potential beneficence and reciprocity for specific individuals as well as a potential strategy to commit lay persons to and involve them in biobank research. This issue is currently receiving substantial scholarly attention, based both on theoretical debates of justification, and on evaluations of practical implementations. Although arguments for such strategies are strong, there are also substantial arguments against a general duty to return research results to individual research participants.

On a whole, this thesis contributes to build a platform to understand why ethical inquiries into issues in biobank research are embarked upon. It also shows how complex and interrelated all the ethical issues in biobank research are. Although working separately with these issues, the complexity of their political and social meaning in addition to their role in biomedical research are underlying reasons why these discussions are still on-going. Further bioethical work in this field is needed as none of the practical ethical challenges are fully met.

As the nature of biobank research is longitudinal, it will continuously meet developments in society and technologies which provide novel opportunities. Therefore ethical issues in biobank research will and should re-emerge and be readdressed on a regular basis.