ENGAGE Ethics Report for the 2nd reporting period (1.1.2009-30.06.2010)

Ethics Report

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.

Firstly, as ENGAGE makes use of genetic and phenotypic data for which informed consent was obtained before the ENGAGE project was conceived, particular attention had to be given to assess the consent mechanisms that were provided at the inclusion in previous studies. It was reported that all participating cohort studies in ENGAGE had received local research ethics commmittee approval, and that all research participants included in the various cohort studies had received an information sheet describing the research and/or an informed consent at the time of recruitment. WP8 of the ENGAGE research project has collected all information leaflets and consent forms from the participating cohort studies to ensure the compabitility of the original consent forms with the goal and objectives of the ENGAGE research work. Their work on this issue was reported not only within the ENGAGE Project, but was also shared with the wider scientific community through the publication Retrospectice access to data : the ENGAGE consent experience (European Journal of Human Genetics 18 (2010), 741-745) WP8 reported about some incompabilities between the original consent forms and the aims of the ENGAGE research studies, which resulted in some data collected by some cohorts not to be used in ENGAGE. All participating cohorts had to check before participation that their data would be used in accordance with the consent given by the research participants, or that the relevant local procedure were followed (e.g. approval from a local research ethics committee or data inspectorate) 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. Therefore, no corrective measures are required. The plan of WP8 to develop a consent template, which aim is to focus on core elements to be included in an informed consent form which could be used as a first step towards creating bridges between clinically-based biobanks and population biobanks seems to be a valuable objective. It will help harmonize international collaboration and data exchange and sharing in the future.

Secondly, as fars as data protection issues are concerned, the data used for analysis by ENGAGE should in principle not allow for identification of the research participants. The study of Holmer (PLOS Genetics (2008) has led a discussion within the ENGAGE project (see ethics report 2009) about the identification of research participants. I agree with the decision taken that at this moment the risk of individuals being actually identified, and even being identifiable, are so small that no extra preacautions need to be taken.

Thirdly, 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. No specific adaptations are requested.

Finally, 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 P3G, BBMRI and the Centre for Society and Genomics are laudable. Moreover, the four-day intensive course Genetics, Ethics and Clinical Consultation is an excellent initiative to 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.