Do patients and research subjects have a right to receive their genomic raw data? An ethical and legal analysis.
Background: As Next Generation Sequencing technologies are increasingly implemented in biomedical research and (translational) care, the number of study participants and patients who ask for release of their genomic raw data is set to increase. This raises the question whether research participants...
| Published in: | BMC Medical Ethics Vol. 21; no. 1; pp. 1 - 13 |
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| Main Authors: | , , |
| Format: | research Journal Article |
| Published: |
BioMed Central
1/16/2020
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=141233781&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 141233781 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 14726939 1CHX jtl: BMC Medical Ethics issn: 14726939 maglogo: N pubinfo: dt: 1/16/2020 vid: 21 iid: 1 pid: 24147 pub: BioMed Central artinfo: ui: 141233781 141233781 NLM31948449 141233781 10.1186/s12910-020-0446-y NLM31948449 141233781 ppf: 1 ppct: 12 formats: tig: atl: Do patients and research subjects have a right to receive their genomic raw data? An ethical and legal analysis. aug: au: Schickhardt, Christoph Fleischer, Henrike Winkler, Eva C. affil: National Center for Tumor Diseases (NCT), Department of Medical Oncology, Heidelberg University Hospital, Heidelberg, Germany sug: subj: Research Subjects Genetic Research Ethical Issues Patients Genetic Privacy Legislation and Jurisprudence Genetic Privacy Ethical Issues Genomics Ethical Issues Genetic Research Legislation and Jurisprudence Consent Ethical Issues Privacy and Confidentiality Legislation and Jurisprudence Europe Privacy and Confidentiality Ethical Issues Human Ethics Consent Legislation and Jurisprudence Research Personnel Ethical Issues Validation Studies Comparative Studies Evaluation Research Multicenter Studies Impact of Events Scale Questionnaires ab: Background: As Next Generation Sequencing technologies are increasingly implemented in biomedical research and (translational) care, the number of study participants and patients who ask for release of their genomic raw data is set to increase. This raises the question whether research participants and patients have a legal and moral right to receive their genomic raw data and, if so, how this right should be implemented into practice.Methods: In a first step we clarify some central concepts such as "raw data"; in a second step we sketch the international legal framework. The third step provides an extensive ethical analysis which comprehends two parts: an evaluation of whether there is a prima facie moral right to receive one's raw data, and a contextualization and discussion of the right in light of potentially conflicting interests and rights of the data subject herself and third parties; in a last fourth step we emphasize the main practical consequences of the ethical analyses and propose recommendations for the release of raw data.Results: In several legislations like the new European General Data Protection Regulation, patients do in principle have the right to receive their raw data. However, the procedural implementation of this right and whether it involves genetic counselling is at the discretion of the Member States. Even more questions remain with respect to the research context. The ethical analysis suggests that patients and research subjects have a moral right to receive their genomic raw data and addresses aspects which are also of relevance for the legal discussion such as the costs of release of raw data and its impact on academic freedom.Conclusion: Taking into account the specific nature and implications of genomic raw data and the contexts of research and health care, several concerns and potentially conflicting interests of the data subjects themselves and involved researchers, physicians, biomedical institutions and relatives arise. Instead of using them to argue in favor of restrictions of the data subjects' legal and moral right to genomic raw data, the concerns should be addressed through provision of information and other measures. To this end, we propose relevant recommendations. pubtype: Academic Journal doctype: research Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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