Abstract
In 2017 the Swiss federal government established the Swiss Personalized Health Network (SPHN), a nationally coordinated data infrastructure for genetic research. The SPHN advisory group on Ethical, Legal, and Social Implications (ELSI) was tasked with the creation of a recommendation to ensure ethically responsible reporting of genetic research findings to research participants in SPHN-funded studies. Following consultations with expert stakeholders, including geneticists, pediatricians, sociologists, university hospitals directors, patient representatives, consumer protection associations, and insurers, the ELSI advisory group issued its recommendation on “Reporting actionable genetic findings to research participants” in May 2020. In this paper we outline the development of this recommendation and the provisions it contains. In particular, we discuss some of its key features, namely: (1) that participation in SPHN-funded studies as a research subject is conditional to accepting that medically relevant genetic research findings will be reported; (2) that a Multidisciplinary Expert Panel (MEP) should be created to support researchers’ decision-making processes about reporting individual genetic research findings; (3) that such Multidisciplinary Expert Panel will make case-by-case decisions about whether to allow reporting of genetic findings, instead of relying on a pre-defined list of medically relevant variants; (4) that research participants shall be informed of the need to disclose genetic mutations when applying for private insurance, which may influence individual decisions about participation in research. By providing an account of the procedural background and considerations leading to the SPHN recommendation on “Reporting actionable genetic findings to research participants,” we seek to promote a better understanding of the proposed guidance, as well as to contribute to the global dialog on the reporting of genetic research findings.
Highlights
The Swiss Personalized Health Network (SPHN) is a Swiss federal government initiative aimed at promoting innovation in personalized medicine by making genetic and other health related data more interoperable and broadly accessible for research
The SPHN’s ELSI advisory group has issued recommendations on how to report findings generated in the context of genetic research
The method of consultation with expert stakeholders is beneficial, as it provides the opportunity for cross-disciplinary learning with potential to enrich ethical deliberation in tangible ways. Similar examples of such an open approach to framing ethical recommendations are public hearings and workshops held by The German Ethics Council or the Nuffield Council of Bioethics, which stress inclusion of the voices of various stakeholders, including the public
Summary
The Swiss Personalized Health Network (SPHN) is a Swiss federal government initiative aimed at promoting innovation in personalized medicine by making genetic and other health related data more interoperable and broadly accessible for research. A Reporting Individual Genetic Research Findings coordinated nationwide infrastructure was established to efficiently manage, exchange, and process consented health data. Data sources may include clinical information systems (basic and specific data, such as imaging and lab results), clinical data registries and research data, patient and citizen self-reported user-data including data collected via mobile and wearable devices, and molecular and -omics data generated in hospitals or research facilities. Reference data sets such as environmental, geographical, and statistical data may be used as well
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