Directive 95/46 of European data protection law requires that consent be both “specific” and “informed.” The law is currently under review, which has resulted in a proposed Data Protection Regulation that will replace the existing directive and redefine the relationship between biobanking and data protection in Europe.
Hallinan and Friedewald1 argue that an open consent biobank cannot reasonably meet legislative requirements for being “specific” and “informed.” Furthermore, they recommend a robust political discussion as to the feasibility of consent conditions existing in the context of biobanking at all.
In medical research requiring human subjects, researchers are required to gain consent for participation in advance. The participating individual gives consent to being involved in a particular research project that is outlined to them. It is finite. In the case of biobanks, this type of consent proves to be a challenge. Biobanks, by their very nature, store biological material for use in research. At the time of collection there may not be a specific use described for a given sample. Therefore, individuals are asked to give open consent, also known as broad or general consent. Essentially, this means that an individual gives permission for their sample to be used for unrestricted future research purposes. It also means that consent is only required on a single occasion, despite it potentially covering multiple applications.
The authors suggest that a biobank will struggle to be specific in the consent process in at least four areas:
- Samples are collected prospectively, and therefore at this stage the biobanks do not know the research future of the sample.
- Without specific information regarding future research uses, biobanks cannot be specific about future sample recipients.
- Many biobanks operate on an international level, and therefore cannot necessarily provide accurate information as to sample destination country.
- The amount of data able to be extracted from a given sample is infinite. We only know what we know now. In the future there may be additional data that can be extracted from a given sample, and therefore this cannot be specified at time of collection.
Hallinan and Friedewald argue that open consent must be regarded as legitimate in the context of biobanking in order to maximize future research while minimizing administrative burden. They therefore suggest that a political discussion should take place about Article 9(2) of the proposed regulation, and whether to add a specific set of conditions for biobanking to address the areas where they expect to see difficulties.
1. Hallinan, D. and Friedewald, M. (2015) “Open consent, biobanking and data protection law: Can open consent be ‘informed’ under the forthcoming data protection regulation?” Life Sciences, Society and Policy, 11(1), doi:10.1186/s40504-014-0020-9