Final Report Summary - ELSPBSBBE (Ethical, Legal, Social and Practical Barriers to Sharing between Biobanks in Europe) PROJECT AIM: A great deal of time, effort and money has been dedicated to building and maintaining biobanks of human biological samples and associated data in Europe. Biobanks are meant to serve as a resource for researchers in many different areas of biomedical research. Their full research potential, however, has not yet been reached due to, among other issues, existing barriers to sharing samples and data with researchers. The overall objective of this project was to study the barriers to sharing human biological samples and data in the context of biobanks in Europe. In a second instance, we also wanted to study possible solutions to these barriers.SUMMARY OF WORK CARRIED OUT AND MAIN RESULTSFirstly we conducted a descriptive review of the academic literature to identify what authors stated as being the barriers to sharing data and samples. We found that relatively few academic articles dealt explicitly with the issue of barriers to sharing beyond a general call for increased harmonization and/or standardization. Furthermore, we found that most articles that dealt with this topic were commentaries or theoretical articles as opposed to articles presenting empirical data. Our literature search identified 17 barriers, including among others, logistical, ethical and legal issues; the top two most cited barriers in the literature were those related to lack of standard operating procedures (SOPs) and those related to legal issues. We provided a description of all barriers, discussed key themes, and conclude that empirical research is required to determine the full extent of the problems underlined but not fully addressed in the literature. Secondly, we conducted empirical research by interviewing European stakeholders in biobanking about their experiences and opinions regarding barriers to sharing biological samples and data with other biobanks and/or researchers. Part of this research focused on stakeholders in Switzerland while the research fellow was hosted at a Swiss university during the first year of the fellowship. Important themes raised by stakeholders from this country included the issue of publication credit, consent, (especially for secondary use of samples), and the role of ethics committees in imposing limitations to sharing samples. A second set of the interviews were conducted with stakeholders all over Europe, including countries such as Spain, France, and Sweden while the fellow was at a host institution in France (year 2). Preliminary results of these interviews suggest that the specific type and contextual situation of each biobank, including whether it is a population biobank or one for rare disorders, the country of location, and how the biobank has a priori decided to share samples and data are all factors that may affect the barriers to sharing encountered by different biobanks and stakeholders. Furthermore, these contextual issues may also affect how stakeholders perceive or define an aspect as being a barrier. Important barriers raised by stakeholders include the lack of will of researchers to share samples in the first place, the practical issues surrounding sending samples to distant countries, and obtaining proper consent from participants.Thirdly, with a focus on possible solutions to the barriers to sharing, we conducted a survey of European stakeholders in genetics research to find out their awareness and opinion of the Bioresource Research Impact Factor (BRIF) initiative. The BRIF is a work in progress, currently developing a framework for creating a tool for calculating the research impact of bioresources (similar to a journal impact factor) based on a metric and a unique digital resource identifier. It also aims to assess requirements for standardising bioresource citation. It is meant to be a practical instrument to increase research data and sample sharing from biobanks. Specifically it is conceived to overcome the barriers to sharing of reluctant researchers or biobankers because they feel their contribution will not be adequately recognized. Since the BRIF is a tool that will only work if stakeholders in biobanking accept it and want to use it, we undertook a survey to find out if stakeholders are aware of this tool and to ask them their views on its usefulness. Our results show that the large majority of respondent stakeholders (89%) are not aware of the BRIF. Despite the low previous awareness of the BRIF, a majority of 63% of respondents thought a tool like the BRIF would be useful, while 35% had no opinion and 2% said they did not think it would be useful. An important aspect of the process of setting up the BRIF to be a functional tool is to let stakeholders know about it and to have them provide feedback. Given that presently only a small minority of stakeholders as users of bioresources are aware of the BRIF, it will be important to invest time and money in increasing awareness and increasing discussion about the BRIF with a wider group of stakeholders. Finally, we also took the opportunity to study an emerging phenomenon in biobanking, namely biobanks set up by companies that sell genetic testing directly to consumers (DTC). Some DTC genetic testing companies performing genome-wide testing are also conducting research with consumer data and as such are creating a type of biobank for research like those traditionally found in the academic, associative or pharmaceutical companies settings. In particular we addressed the issue of patenting (which was raised as a barrier to sharing in our literature review) and how it relates to trust, transparency and consent of participants (also issues raised in our earlier research). We concluded that the positioning of these companies’ activities outside the traditional health care system yet offering tests related to health, and their dual role as biobankers/researchers have placed them in a type of “no-man’s-land”, where stakeholders have been hesitant to, or simply have not be able to agree on how to deal with their biobank research activities. Furthermore, as with the academic research community, in order to recruit participants in an ethical manner, and merit and maintain participants’ confidence and trust, DTC genetic testing companies should strive to obtain ethically sound informed consent from participants and they should be transparent about their research activities and goals. IMPACT A great deal of time, effort and money has been dedicated to building and maintaining biobanks of human biological samples and associated data in Europe. Their full research potential, however, has not yet been reached due to, among other issues, barriers to sharing samples and data. The impact of the work we have conducted regarding the identification of current specific barriers to sharing samples in biobanking is therefore an important step in helping biobanks to solve these problems. The results will allow the development of ethical solutions such that the research potential of (and investments in) biobanks in Europe can be maximized. In particular, the data can now be used by biobank stakeholders and policy makers to start working on implementing solutions above and beyond the general call for harmonization or standardization. Our study of the BRIF, a potential solution to the barrier where researchers or biobanks do not want to share due to the fear that they will not be properly recognized, reveals that stakeholders do support this initiative. Thus, funding bodies should be attentive to this and be willing to provide additional financial resrouces to allow this tool to be fully developed.
