Secondary research use of personal medical data: patient attitudes towards data donation.
Data donation
Medical research
Patient consent
Precision medicine
Public health
Secondary data use
Journal
BMC medical ethics
ISSN: 1472-6939
Titre abrégé: BMC Med Ethics
Pays: England
ID NLM: 101088680
Informations de publication
Date de publication:
15 12 2021
15 12 2021
Historique:
received:
05
05
2021
accepted:
16
11
2021
entrez:
16
12
2021
pubmed:
17
12
2021
medline:
21
12
2021
Statut:
epublish
Résumé
The SARS-CoV-2 pandemic has highlighted once more the great need for comprehensive access to, and uncomplicated use of, pre-existing patient data for medical research. Enabling secondary research-use of patient-data is a prerequisite for the efficient and sustainable promotion of translation and personalisation in medicine, and for the advancement of public-health. However, balancing the legitimate interests of scientists in broad and unrestricted data-access and the demand for individual autonomy, privacy and social justice is a great challenge for patient-based medical research. We therefore conducted two questionnaire-based surveys among North-German outpatients (n = 650) to determine their attitude towards data-donation for medical research, implemented as an opt-out-process. We observed a high level of acceptance (75.0%), the most powerful predictor of a positive attitude towards data-donation was the conviction that every citizen has a duty to contribute to the improvement of medical research (> 80% of participants approving data-donation). Interestingly, patients distinguished sharply between research inside and outside the EU, despite a general awareness that universities and public research institutions cooperate with commercial companies, willingness to allow use of donated data by the latter was very low (7.1% to 29.1%, depending upon location of company). The most popular measures among interviewees to counteract reservations against commercial data-use were regulation by law (61.4%), stipulating in the process that data are not sold or resold (84.6%). A majority requested control of both the use (46.8%) and the protection (41.5%) of the data by independent bodies. In conclusion, data-donation for medical research, implemented as a combination of legal entitlement and easy-to-exercise-right to opt-out, was found to be widely supported by German patients and therefore warrants further consideration for a transposition into national law.
Sections du résumé
BACKGROUND
The SARS-CoV-2 pandemic has highlighted once more the great need for comprehensive access to, and uncomplicated use of, pre-existing patient data for medical research. Enabling secondary research-use of patient-data is a prerequisite for the efficient and sustainable promotion of translation and personalisation in medicine, and for the advancement of public-health. However, balancing the legitimate interests of scientists in broad and unrestricted data-access and the demand for individual autonomy, privacy and social justice is a great challenge for patient-based medical research.
METHODS
We therefore conducted two questionnaire-based surveys among North-German outpatients (n = 650) to determine their attitude towards data-donation for medical research, implemented as an opt-out-process.
RESULTS
We observed a high level of acceptance (75.0%), the most powerful predictor of a positive attitude towards data-donation was the conviction that every citizen has a duty to contribute to the improvement of medical research (> 80% of participants approving data-donation). Interestingly, patients distinguished sharply between research inside and outside the EU, despite a general awareness that universities and public research institutions cooperate with commercial companies, willingness to allow use of donated data by the latter was very low (7.1% to 29.1%, depending upon location of company). The most popular measures among interviewees to counteract reservations against commercial data-use were regulation by law (61.4%), stipulating in the process that data are not sold or resold (84.6%). A majority requested control of both the use (46.8%) and the protection (41.5%) of the data by independent bodies.
CONCLUSIONS
In conclusion, data-donation for medical research, implemented as a combination of legal entitlement and easy-to-exercise-right to opt-out, was found to be widely supported by German patients and therefore warrants further consideration for a transposition into national law.
Identifiants
pubmed: 34911502
doi: 10.1186/s12910-021-00728-x
pii: 10.1186/s12910-021-00728-x
pmc: PMC8672332
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
164Informations de copyright
© 2021. The Author(s).
Références
PLoS One. 2019 Nov 20;14(11):e0224240
pubmed: 31747408
BMC Med Ethics. 2015 Sep 09;16:60
pubmed: 26354520
Eur J Hum Genet. 2021 Jan;29(1):11-19
pubmed: 32737438
Biopreserv Biobank. 2020 Jun;18(3):204-212
pubmed: 32302503
Eur J Hum Genet. 2021 Mar;29(3):495-502
pubmed: 33005018
Eur J Hum Genet. 2020 Aug;28(8):1000-1009
pubmed: 32238912
Genet Med. 2019 May;21(5):1131-1138
pubmed: 30262927
Eur J Hum Genet. 2019 Jun;27(6):841-847
pubmed: 30683927
EGEMS (Wash DC). 2019 Jul 25;7(1):33
pubmed: 31367650
Hastings Cent Rep. 1987 Apr;17(2):20-4
pubmed: 3294743
J Med Ethics. 2019 Nov 12;:
pubmed: 31719155
Intern Med J. 2018 Jan;48(1):84-87
pubmed: 29314513
JAMA Netw Open. 2019 Aug 2;2(8):e199550
pubmed: 31433479
J Med Internet Res. 2019 Nov 27;21(11):e14537
pubmed: 31774410
Expert Rev Mol Diagn. 2013 Jan;13(1):35-47
pubmed: 23256702
BMC Med Ethics. 2016 Nov 10;17(1):73
pubmed: 27832780
Genet Med. 2018 Jan;20(1):76-82
pubmed: 28640237