ABSTRACT
As genomic research becomes commonplace across the world, there is an increased need to coordinate practices among researchers, especially with regard to data sharing. One such way is an international code of conduct. In September 2020, an expert panel consisting of representatives from various fields convened to discuss a draft proposal formed via a synthesis of existing professional codes and other recommendations. This article presents an overview and analysis of the main issues related to international genomic research that were discussed by the expert panel, and the results of the discussion and follow up responses by the experts. As a result, the article presents as an annex a proposal for an international code of conduct for data sharing in genomics that is meant to establish best practices.
Subject(s)
Genomics , Information Dissemination , Humans , Research PersonnelABSTRACT
This paper explores the legal and ethical concept of human subject research in order to determine whether genetic research with already available biosamples and data falls within this concept. Although the ethical concept seems to have evolved to recognize research based on data as human research, from a supranational legal perspective this form of research is not considered human subject research. Thus human subject research regulations do not apply and therefore do not invoke the requirement of obtaining consent prior to using an individual's biosample or genetic data in research. Furthermore, it remains ambiguous in both the legal and ethical realm whether the use of biosamples or genetic data without additional links to the individual would invoke the same safeguards as research involving additional or specific identifiers. Seeing that research based on already available biosamples and genetic data is not governed by rules concerning human subject research, the second part of the paper analyses whether any consent requirements apply for the further use of already available bio-samples or genetic data in research. Whereas further use of biosamples is subject to considerably lax consent requirements under Article 22 of the Oviedo Convention, under the General Data Protection Regulation further use of genetic data might not be subject to a prior consent requirement at all, unless it is stipulated in national laws. When it comes to clinical trials, however, sponsors will have the possibility under Article 28(2) of Regulation 536/2014 to obtain open consent for further use of data in any kind of future research.
Subject(s)
Data Collection/ethics , Genetic Research/ethics , Guidelines as Topic , Human Experimentation/ethics , Informed Consent/ethics , International Cooperation , Computer Security , Confidentiality , Data Collection/legislation & jurisprudence , Ethics, Research , Genetic Research/legislation & jurisprudence , Human Experimentation/legislation & jurisprudence , Humans , Privacy , Research SubjectsABSTRACT
EU law does not regulate genetic research per se, but the latter is governed to a certain extent by data protection law. Regardless of the harmonizing efforts of the General Data Protection Regulation (GDPR), research regulations remain fragmented in the data protection framework. This is mainly due to the vast discretion granted to Member States in this regard in the GDPR. Albeit the GDPR enabling data flows for research cooperation in the EU, it creates a hurdle for cross-border research by ignoring the intra-EU conflict of laws that inevitably arises in a fragmented regulatory framework. Imagining ways to solve the dilemma of applicable national law under the GDPR generally is not that difficult, but becomes trickier in a research context. Whether the national data protection law of one or the other Member State is to be applied, either the interests of data subjects or those of researchers might end up compromised.
