ENGAGE Ethics Report for the 1st reporting period (1.1.2008-31.12.2008)
Dr Renate Gertz, University of Glasgow
Seen from an ethico-Iegal point of view, the ENGAGE project is a particularly challenging study due to its multi-national and multi-disciplinary character. Particularly noticeable and commendable is the establishment of a spirit of openness and collaboration between all consortium members. From an ethico-Iegal perspective, there are no specific concerns about the currently active science presented so far and no corrective measures are required.
What sets ENGAGE apart from other genetic studies is the fact that no new original data are being collected, rather, the data collected from various individual studies are collated and analysed. Thus, the first ethical issue to be considered concerns the information on the ethical issues associated with these studies. The consent forms of all the studies used for data analysis by ENGAGE were made available to me and I thus had the opportunity to consider them in detail. Issues to be covered by these forms extend from confidentiality to commercialisation. I was satisfied that all forms were indeed appropriate and satisfied the most stringent criteria.
The secondary use of data is always considered an ethico-Iegal challenge. Participants in a study are usually giving their consent for the use of their samples for certain specified reasons, or, in the case of a biobank-type study, for research conducted within the terms of the biobank. ENGAGE, however, analyses data obtained from these studies, thus processing the data in a way not covered by the original consent forms. WP8 have collected the ethics and consent forms from all the participating cohort studies to ensure compatibility of ENGAGE with the terms and conditions participants have signed up for originally.
As far as data protection issues are concerned, this is relatively unproblematic as the European data protection directive, which has been implemented into national law in most of the nations that are part of ENGAGE, only applies where the data still qualify as personal data. The data used for analysis by ENGAGE, however, has been sufficiently anonymised to ensure that the data protection law does no longer apply. The study by Homer et al. in PLoS Genet. 4, eIOOOI67 (2008) provided some unease among researchers regarding the degree of anonymisation required to extract data from the sphere of the data protection legislation. A lengthy discussion about the topic with several ENGAGE members of both the scientific and the ethico-Iegal area as well as the collaboration with P3G led to the resolution that the risk of individuals being actually identified, and even identifiable, were so small that no extra precautions needed to be taken. In fact, the collaboration between ENGAGE and projects such as P3G and BBMRI is particularly laudable, as it contributes to and promotes harmonisation efforts and an exchange of expertise.
As regards flagship projects, criteria for selection could be slightly more transparent. Laying out clear requirements for a project checklist would help to focus funding efforts on the activities with the highest potential impact for ENGAGE; provide an understandable filter for rejecting unsuitable projects; and encourage submission of new projects by partner though providing clarity on the scope of activities that would be appropriate for funding. This suggestion was made by the Scientific Advisory Board to, has been accepted by the Steering Board and will be implemented.
One of the most important ethico-legal issue ENGAGE had to contemplate so far was the data access policy. The Scientific Advisory Board deliberated and discussed this topic in considerable detail and gave recommendations to the Steering Board. The first draft of the policy has been written and opened for comments. The deposition of data into the European genome-phenome archive (EGA) is to be recommended as it will facilitate access to the data and ensure that the data are in a standard format. Data access among ENGAGE partners is also provided for separate from general access, as set out in the Consortium Agreement. While the data access policy is still very much a work in progress, the first draft is very encouraging and I am sure that the final policy document will be ethically and legally sound.
Overall, I am satisfied that the ENGAGE study is operating in an ethically and legally sound way.