B1MG WP2 - Recommendation of minimal standards for feedback provision of general results of research studies conducted with data provided through 1+MG to data subjects - version for the 1+MG Framework
Creators: name: Rebers, Susanne
Publisher: name: Zenodo
Year: 2023
Subjects: B1MG
Beyond 1 Million Genomes
1+MG
1 Million Genomes Initiative
Minimal standards
ELSI

description: This policy recommendation covers general feedback of the general results of research studies conducted with data provided through 1+MG to data subjects. The 1+MG policy covers: ● what information should and should not (necessarily) be shared with data subjects (and potentially other people interested in 1+MG, i.e. the general public); ● how this information should be shared (e.g. through which medium and in which language(s)). The 1+MG policy only applies to analyses conducted in the context of 1+MG data sharing. Data uses addressed in the primary data collection context should be covered by local policies. In an analysis of current guidelines and best practices, we identified four important principles to provide feedback of general research results to data subjects: transparency, accountability, privacy, and the fair distribution of benefits. Providing feedback towards data subjects about general research results contributes to transparency, and as a result, accountability, about conducted studies with health data. Factors that contribute to the need for transparency and accountability, both towards data subjects and the general public, are the use of public funding to set up the infrastructure, collect the data, and conduct the studies. Moreover, it is often difficult in observational research to provide a detailed account of the exact studies that will be conducted with the data at the moment the data subject is informed about participation. In the long run, providing feedback may add to the (prolonged) trust of data subjects and the broader society in 1+MG and health research in general. Importantly, providing feedback towards data subjects about general research results should adhere to the principle of privacy. First, the contents of the general research results should be anonymous. Second, data subjects should only be actively informed about these general research results if they indicate that their communication data (e.g. e-mail address) can be used for this purpose. The fourth principle, fair distribution of benefits from the data infrastructure, should not only be seen as the fair distribution of the resulting clinical progress, but also as the fair distribution of knowledge gained from the use of data. Sharing general research results adds to this knowledge sharing. Based on these four principles, a recommendation to provide feedback of general research results to data subjects is set up. Other considerations are taken into account when determining how to provide this feedback. In the 1+MG federated infrastructure, the responsibility to engage with data subjects lies with the signatories. It is therefore presumed that feedback is organised by the national nodes. Practical issues, such as restricted time and expertise available to develop information that is clear to data subjects, are taken into account. Below we summarise the recommendations and provide a short list of best practices.