Regulating biobank research: new book


Biobank research and genomic information are changing the way we look at health and medicine. So how can we regulate it? A recent book published by Springer shows us how the regulatory systems work and raises a critical voice.

Genomics has a way of challenging our values with its promise of tailored medical treatments and pharmacogenomics somewhere in the future. Genomic research has always been difficult to regulate, but now the borders between medical research and clinical practice are becoming blurred. Sequencing platforms for research suddenly have a potential diagnostic value for actual patients. So what do we do now?

Deborah Mascalzoni is Senior Researcher at CRB and the editor of Ethics, Law and Governance of Biobanking that was recently published by Springer. According to her, we can't keep clinical applications and research separate anymore. But when we start blurring the lines we start challenging existing regulations and ethical frameworks. The book gives an overview of the existing regulatory landscape for biobank research in the Western world. But it also raises some critique of how regulations and ethical frameworks are developed and work.

"There are many questions that still need resolving, for example how researchers should share samples and data across borders. But we also need to figure out some of the basics. Like how we design an ethical informed consent. These are some of the questions that this book addresses", Deborah Mascalzoni explains.

Right now, there are some international efforts to build systems that meet these challenges, but according to some of the authors, perhaps it is time to stop and think for a moment before writing more policy.
In one of the chapters, Jennifer Viberg, PhD student at CRB, has looked at arguments for and against disclosure of incidental findings in biobank research. According to her, we need more empirical research to find out what people actually want to know. But we also need some critical reflection on the concept of genetic risk before we start disclosing information:

"It is difficult to compare genetic risk to actual disease. The predictive value of incidental findings is not always clear. That is why I believe there is more reflection needed before we start designing policy", says Jennifer Viberg.

Deborah Mascalzoni believes that biobank researchers have a moral responsibility put their work in relation to the norms and values we share as a society. According to her, research ethics isn't just about bioethicists that write guidelines for professionals to follow. Ethics is something that we practice both through discourse and regulatory frameworks.

"If ethics is a part of public discourse, ethical review becomes an arena where researchers can discuss their projects instead of a burden and a bureaucratic exercise", says Deborah Mascalzoni.

About the book

Ethics, Law and Governance of Biobanking offers a reivew of existing biobank regulation in Western countries. It introduces new theoretical developments for biobanking from both ethics and law. The book also develops tailored governance practices.

The list of authors includes, among others Jennifer Viberg, Mats G. Hansson, Pär Segerdahl, Linus Johnsson, Stefan Eriksson, Jane Reichel and Anna-Sara Lind from CRB.

Mascalzoni D (ed), Ethics, Law and Governance of Biobanking, Springer, National, European and International Approaches Series: The International Library of Ethics, Law and Technology, Vol. 14 2015, VI, 277 p.

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