“Ethical and Legal Implications of Research Microbiome Samples” – BBMRI.at partner presentation at WHO/IARC & BBMRI ELSI meeting in France

The Symposium was co-organised by BBMRI-ERIC, IARC/WHO and UNIMIB as an activity of the BBMRI Academy and showcased 10 years of insight and outlook on ethical, legal, and societal implications (ELSI) pertinent to biobanks and biomedical research. This meeting celebrated the multifaceted diversity of ELSI expertise across countries, coming from both interdisciplinary service delivery and research. Esteemed speakers from across the globe shared their expertise. The sessions covered a spectrum of topics, including artificial intelligence, genetics and genomics, gender, governance, and regulatory compliance of datafication, to name just a few examples.

An essential aspect of the discussions addressed on the relevance of ‘Ethical and Legal Implications of Research Microbiome Samples’. BBMRI.at representatives from the University of Vienna illuminated this topic in session 2, on June 4 and discussed open questions like the legal status of microbiome samples and issues of privacy and informed consent.

The presentation focused on the European Union Substances of Human Origin Regulation Proposal in particular with regard to its applicability to human microbiome samples intended for human application. Ethical and legal issues pertaining to research with such samples were also briefly covered by means of an abridged literature review, with emphasis placed on those issues which may concern biobanks (and ‘stool banks’, in particular). Ethical and legal issues that derive from the use of such samples include – but are not limited to – the privacy of data subjects, collection of informed consent, governance of the opportunities for the development of personalised medicine and use as forensic tools, implementation of measures to resolve issues of compelled disclosure, “ownership” of samples and their commercial value, product liability and security/safety of medicinal products manufactured from microbiome samples, among others.

The intersection of biobanking and microbiome research will be exemplified by the EU project MICROBE, where BBMRI.at representatives from Med Uni Graz, are partners. MICROBE (standing for ‘Microbiome Biobanking (RI) Enabler’) aims to develop methods and technologies for biobanking of microbiome samples and to work out an operational framework for microbiome biobanking considering relevant data infrastructure, pre-analytical sample quality and quality control as well as the necessary legal and ethical framework.