ENGAGE Ethics Report for the 4th reporting period (1.1.-31.12.2012)
Dr. Pascal Borry, K.U. Leuven, Belgium
ENGAGE is a particularly interesting project due to its large supranational framework for research into genetic and genomic epidemiology that has been created and due to its aim to accelerate the discovery of disease-susceptibility genes through analyses of multiple large-scale data sets. From an ethical-legal point of view, this specific multi-national perspective brings in a set of specific issues that had to be addressed within the research project. In this report, I aim to focus on some of the achievements that were realized in the last year of the project.
Firstly, as a general observation and as far as I can assess the activities of the ENGAGE consortium, all efforts have been done to assure that the scientific research could be done with the highest possible respect for the original informed consent and respect for governing national and local ethical and legal rules.
Secondly, ENGAGE has put a lot of attention towards the specific ethical issues raised by genotype-driven recruitment in which research participants are recruited based on genotype rather than phenotype or specific clinical outcome. Presentation of the specific ethical issues raised by this approach has already been done, and a manuscript is forthcoming.
Thirdly, I would like to underline the considerable efforts of various participants in ENGAGE to promote harmonization efforts and exchange of expertise. In this regards, the established collaboration with projects such as BioSHaRE, P3G, ISBER, BBMRI and ESBB are laudable. In this perspective, various initiatives were elaborated that helped develop capacity building in the field of the ethical, legal and societal implications of the translation of epidemiological results from genetic and genomic research to clinical practice. Especially, the organisation of the International Biobank Summit, the international course "Translational Genomics Pipeline: From populations to individuals," as well as the biobank special issue of the Norwegian journal Norsk Epidemiologi.
Fourthly, as far as data sharing, data release and intellectual property are concerned, the ENGAGE project has developed principles that address these issues. The principles have been elaborated with great caution and aim to emphasize that all sharing and releasing all types of data (both summary level data and individual level data) should be conducted according to the most relevant legal, ethical and security norms. In this last year, ENGAGE has put a lot of energy in identifying the challenges and experiences of researchers in datasharing activities. It has been able to identify practical aspects of data sharing and application of ENGAGE datasharing policy, to identify hurdles encountered (technical, legal, ethical, administratively, and financially), to identify concerns experienced (data privacy & security, IP property, publication rights,…); conflicts and to provide recommendations to facilitate data sharing.
Finally, ENGAGE has put a lot of efforts in ensuring that ENGAGE-generated data should become available to any bona fide researchers. ENGAGE identified also the lack of funding support to sustain the data maintenance and data access after the project funding ends as one of the possible hurdles for data access. As this becomes a common issue in large consortia such as ENGAGE, a European or international consortium with Data Access Committee function to assist data access for a project such as ENGAGE after its project lifetime is certainly an element of further consideration for funding agencies.