Ethical governance in biobanks linked to electronic health records.

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Abstract

In the last years an alternative to traditional research projects conducted with patients has emerged: it is represented by the pairing of different type of disease biobanks specimens with Electronic Health Records (EHRs). Even if informed consent remains one of the most contested issues of biobank policy, other ethical challenges still require careful attention, given that additional issues are related to the use of EHRs. In this new way of doing research harmonization of governance is essential in practice, with the aim to make the most use of resources at our disposal, and sharing of samples and data among researchers under common policies regulating the distribution and the use. A biobank-specific Ethics Committee could be seen as a new and type of Ethics Committee, that we suggest to be applied to each biobank, with possible different functions. In particular, considering the possible use of electronic health record data linked to biological specimens in biobanking research, this specific Ethics Committee could draft best practice and ethical guidelines for the utilisation of the EHRs as a tool for genetic research, addressing concerns on accessibility, return of results and privacy and help to educate patients and healthcare providers.