Balancing the interests of patient data protection and medication safety monitoring in a public-private partnership.
Author(s)
Type
Journal Article
Abstract
Obtaining data without the intervention of a health care provider represents an opportunity to expand understanding of the safety of medications used in difficult-to-study situations, like the first trimester of pregnancy when women may not present for medical care. While it is widely agreed that personal data, and in particular medical data, needs to be protected from unauthorized use, data protection requirements for population-based studies vary substantially by country. For public-private partnerships, the complexities are enhanced. The objective of this viewpoint paper is to illustrate the challenges related to data protection based on our experiences when performing relatively straightforward direct-to-patient noninterventional research via the Internet or telephone in four European countries. Pregnant women were invited to participate via the Internet or using an automated telephone response system in Denmark, the Netherlands, Poland, and the United Kingdom. Information was sought on medications, other factors that may cause birth defects, and pregnancy outcome. Issues relating to legal controllership of data were most problematic; assuring compliance with data protection requirements took about two years. There were also inconsistencies in the willingness to accept nonwritten informed consent. Nonetheless, enrollment and data collection have been completed, and analysis is in progress. Using direct reporting from consumers to study the safety of medicinal products allows researchers to address a myriad of research questions relating to everyday clinical practice, including treatment heterogeneity in population subgroups not traditionally included in clinical trials, like pregnant women, children, and the elderly. Nonetheless, there are a variety of administrative barriers relating to data protection and informed consent, particularly within the structure of a public-private partnership.
Date Issued
2015-04-15
Date Acceptance
2015-03-16
Citation
JMIR Medical Informatics, 2015, 3 (2), pp.e18-e18
ISSN
2291-9694
Publisher
JMIR Publications
Start Page
e18
End Page
e18
Journal / Book Title
JMIR Medical Informatics
Volume
3
Issue
2
Copyright Statement
© Nancy A Dreyer, Stella Blackburn, Valerie Hliva, Shahrul Mt-Isa, Jonathan Richardson, Anna Jamry-Dziurla, Alison Bourke,
Rebecca Johnson. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 15.04.2015. This is an open-access
article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/),
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR
Medical Informatics, is properly cited. The complete bibliographic information, a link to the original publication on
http://medinform.jmir.org/, as well as this copyright and license information must be included.
Rebecca Johnson. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 15.04.2015. This is an open-access
article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/),
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR
Medical Informatics, is properly cited. The complete bibliographic information, a link to the original publication on
http://medinform.jmir.org/, as well as this copyright and license information must be included.
License URL
Identifier
PII: v3i2e18
Subjects
Internet
data protection
ethics
pharmacovgilance
pregnancy
public-private partnerships
Publication Status
Published
Article Number
e18