Patient views on research use of clinical data without consent: Legal, but also acceptable?

Richter G, Borzikowsky C, Lieb W, Schreiber S, Krawczak M, Buyx A (2019)

Publication Type: Journal article

Publication year: 2019

Journal

European Journal of Human Genetics Nature Publishing Group: Open Access Hybrid Model Option B

Book Volume: 27

Pages Range: 841-847

Journal Issue: 6

DOI: 10.1038/s41431-019-0340-6

Abstract

The research exemption implemented in the new EU General Data Protection Regulation (EU-GDPR) gives member states leeway in determining whether patient consent is required for secondary data use in medical research. However, even though broad consent has become common in data-rich medical research in many EU countries, giving up consent altogether is likely to be controversial. The aim of this study was to examine whether abolishing consent for secondary data use would be acceptable to patients. A questionnaire study was conducted among 700 outpatients of a northern German university hospital to assess their attitude towards use of clinical data for scientific research without consent. There was both strong willingness to give broad consent for secondary data use (468 of 503 responders, 93.0%) and strong approval of abolishing patient consent (n = 381, 75.7%) among study participants. The willingness to give consent was moderately associated with approval of the respective stipulations by the EU-GDPR. In research settings where broad consent is widely accepted (e.g. university hospitals), abolishing consent for secondary research use of clinical data will likely be acceptable to a large majority of patients.

Involved external institutions

Christian-Albrechts-Universität zu Kiel DE Germany (DE) Universitätsklinikum Schleswig-Holstein (UKSH) DE Germany (DE) Technische Universität München (TUM) DE Germany (DE)

How to cite

APA:

Richter, G., Borzikowsky, C., Lieb, W., Schreiber, S., Krawczak, M., & Buyx, A. (2019). Patient views on research use of clinical data without consent: Legal, but also acceptable? European Journal of Human Genetics, 27(6), 841-847. https://doi.org/10.1038/s41431-019-0340-6

MLA:

Richter, Gesine, et al. "Patient views on research use of clinical data without consent: Legal, but also acceptable?" European Journal of Human Genetics 27.6 (2019): 841-847.

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