Across Borders: The Challenges of Harmonisation

© Springer Science+Business Media Dordrecht 2015
Deborah Mascalzoni (ed.)Ethics, Law and Governance of BiobankingThe International Library of Ethics, Law and Technology1410.1007/978-94-017-9573-9_10

Biobanking Across Borders: The Challenges of Harmonisation

A Short Comment

Ruth Chadwick  and Heather Strange 

Cardiff University, Cardiff, UK



Ruth Chadwick (Corresponding author)


Heather Strange

1 Introduction

The development of national initiatives in biobanking in countries such as Iceland, Estonia, and the UK, has given rise to a great deal of social, legal and ethical discussion over the past decade and more. It is the possibilities of exchange at the international level, however, that have now moved centre stage. They have led, first to arguments for the desirability of exchange of samples and data, and second to issues about standardisation and harmonisation to make this possible.

The argument for exchange goes as follows. Population wide biobank research is of potentially very great importance for future health care—for example, by finding out the genetic basis underlying the variation influencing our susceptibilities to common diseases and to adverse drug responses. To maximise its effectiveness, however, and achieve sufficient statistical power, collaboration between different initiatives is required.

There are, however, obvious hurdles to collaboration. If data cannot be compared between different biobanks, because information is collected in a different way, then comparison may not be possible. In order to exchange information readily, something analogous to the USB stick is required—a standard which facilitates the exchange of data.

When we turn to ethics, there may also be barriers to meaningful collaboration—for example, if completely different norms operate in different contexts about what people have consented to, it may not be possible to compare results from one context to another. To a certain extent this is addressed by harmonisation in law, regulation and governance, for example in the EU context. There are ethical issues outside the remit of law, however, hence the search for ethical standards. There is a question, however, over what would count as a standard in ethics, or whether harmonisation is the concept of choice: is there an ethical equivalent of the USB stick?

In 2009 we published an article on harmonisation and standardisation (Chadwick and Strange 2009), which based our argument on a musical analogy, taking our inspiration from the following entry in the Oxford Companion to Music:

It seems natural and right that music which is … harmonious, should be highly regarded in civilised societies … there is a clear correspondence between the concept of society as a mutually supportive commonwealth, and those manifestations of concert and theatre music which attract the collective approbation ‘civilized’. Collective performance, as in singing the same text to different but interdependent vocal lines, can be regarded as the musical correlate of civilised democracy (Whittall 2002).

It was this idea of different voices singing the same text to different vocal lines that seemed to us to hold an important insight—that harmonisation in ethics is best understood as a process, and not as an end point. Standards, or ‘texts’ can be produced, for example in ethical guidelines, but the process of harmonisation in relation to these texts is something different. There may be, and indeed is, variation in interpretation of guidelines (which may of course occur in relation to law too, but we are not addressing that here)—the important question is, what is the acceptable scope for variation in relation to the text?

That there must be some limits to variation is clear: although in ethics agreement is not readily to be found on some issues, morality has a certain core. This gives a clue as to a potential response to possible criticism of the musical analogy, namely how one deals with those who are completely out of tune, or tone deaf. This raises deeper issues relating to the problem of the failure to accept moral reasoning at all: the individual who can see no answer to the ‘Why should I be moral?’ question, as opposed to disagreement on particular issues, and we will not attempt to deal with that in this short article—it is a problem for ‘end point’ views as well as our process approach.

When we turn to the ‘text’, or standard, in this context a standard is a rule established to have action-guiding force. Busch (2013) has pointed out that an important (ethical) dimension here is who has the power to set standards? If we look at another context the issues of power become obvious: in pictures of meetings between international leaders, for example, we can see that despite the different cultural backgrounds of the participants, a common standard of dress has been adopted: the western business suit. What does this say about the power to set standards? Where one leader adopts a different style of dress, it really stands out—a statement is being made. In some contexts, where power lies to set standards may not be traceable: in ethics in general, and in the context of biological and biomolecular resources in particular, however, transparency may be assumed to be a prerequisite.

In the 2009 article we proceeded to identify three potential areas

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