An increasing research trend is to pool collections of biological samples in international scientific studies, thereby amplifying their potential scientific value. The pooling of samples in such ‘biobanks’ poses several ethical and legal challenges, which various authors have attempted to meet by proposing guidelines for researchers (see G. Helgesson et al. Nature Biotechnol. 25, 973-976; 2007). One suggestion made by these authors is that “when the study is not particularly sensitive, and on the condition that (i) strict coding procedures are maintained, (ii) secrecy laws apply to any handling of sensitive information and (iii) vital research interests are at stake …that genetic analyses of identifiable samples should be permitted without (new) consent.”
Bjørn M Hofmann takes issue with this view in the September issue of Nature Biotechnology (26, 979-980; 2008), arguing that the earlier proposals would be “detrimental to the public’s trust”. He writes: "If one applies a lax interpretation of “not particularly sensitive” research, any study can be justified as long as it serves research interests. Their lax interpretation of consent to “future cancer research” as being consent to any kind of future research endorses this. For the above reasons, instead of minimizing risk to research participants, the framework they suggest actually enhances the risk by not addressing basic challenges with biobank research."
In the same issue of the journal (Nature Biotechnol. 26, 980-981; 2008), Helgesson replies that there is no risk of direct physical harm to research subjects once biobank samples have been collected, because “a core characteristic of biobank research is that it is the inappropriate distribution of information that has a potential to harm research subjects. This is why we stressed the importance of strict routines for coding, storage and use of biobank samples and related data as the first central feature of our ethical framework for research on previously collected samples.”
The core of the debate is the fact that “some people might be included in biobank research who would have said no if they had been informed and asked”, writes Helgesson. Although it is important to exclude people who do not wish to participate, excessively cautious informed-consent procedures might cause many more peple to drop out and hence to reduce the quality of the research.
Further information: World Medical Association Helsinki Declaration on ethical principles for medical research involving human subjects.