Perceptions of legislation relating to the sharing of genomic biobank results with donors-a survey of BBMRI-ERIC biobanks

Abstract

Biobanks accumulate huge amounts of research findings, including participants' genomic data. Increasingly this leads to biobanks receiving research results that could be of clinical significance to biobank participants. The EU Horizon 2020 Project 'Genetics Clinic of the Future' surveyed European biobanks' perceptions of the legal and regulatory requirements for communicating individual research results to donors. The goal was to gain background knowledge for possible future guidelines, especially relating to the consent process. The Survey was implemented using a web-based Webropol tool. The questionnaire was sent at the end of 2015 to 351 European biobanks in 13 countries that are members of BBMRI-ERIC (Biobanking and Biomolecular Resources Research Infrastructure-European Research Infrastructure Consortium). Seventy-two biobanks responded to the survey, representing each of the 13 BBMRI Member States. Respondents were mainly individuals responsible for the governance of biobanks. The replies indicate that the majority of the respondents thought that their national legislation allowed them to contact participants to communicate results, and that research participants had the right to request their results. However, respondents' understanding of their national legislation varied even within member states. Our results indicate that legislation applied to biobanks in many countries may be scattered and difficult to interpret. In BBMRI-ERIC, there is an ongoing discussion about the need for European recommendations on sharing genomic biobank results with donors, which may pave the way for more coherent global guidelines. Our results form a basis for this work.

Fig. 1

Replies to the question “What type of a biobank do you represent?” (n = 72). The respondents were allowed to choose several options

Fig. 2

Replies to the question “Do your national laws and/or other regulations explicitly mention the possibility of sharing individual-specific results with participants in the biobank?”, between countries and internally (n = 72)

Fig. 3

Replies to the question “Do your national laws and/or other regulations allow biobanks to contact participants to inform them about results concerning their health?” (n = 32)

Fig. 4

Replies to the question “Do your national laws and/or other regulations oblige biobanks to give participants their results if they request them?” (n = 32)

Fig. 5

Replies to question “Do your national laws and/or other regulations stipulate whether biobank results may or may not be shared with third parties?” (n = 72)

Fig. 6

Replies to question “In the consent process of your biobank, do you discuss the option of re-contacting the participant?” (n = 72)

Fig. 7

Replies to question “In the consent process of your biobank, do you discuss the possibility of the participant requesting results from the biobank?” (n = 72)