Using PHARMO data
The use of the PHARMO data is controlled by the independent Compliance Committee STIZON / PHARMO Institute. The Compliance Committee STIZON / PHARMO Institute consists of representatives of the participating data suppliers and a privacy expert (chairman of this committee). Each study requires permission from this Committee. Prior permission is required dependent on the detail of use of data. For each study, the research question, the data used for the study, the methods used to analyze the data, and the people/organizations who commissioned the study have to be described.
All decisions of the Compliance Committee STIZON / PHARMO Institute are based on the applicable legislation in the Netherlands, e.g. the Personal Data Protection Act and the Medical Treatment Contract Act. Within this legal framework, the Code of Conduct “Use of Data in Health Research” is an important document for the interpretation of the use of this kind of data for scientific research in the Netherlands, and is approved by the Dutch Data Protection Authority (www.dutchdpa.nl).
As soon as any form of intervention or change in routine care is involved in a study, informed consent must be obtained. In addition, explicit ethical approval of a certified Ethical Committee must be obtained. If, for example, patients are to be enrolled in studies, or if additional tests need to be performed in the context of a study, Dutch law mandates informed consent. That is, there is a clear distinction between the analysis of routinely collected data, and conducting a study that requires additional tests or procedures.
Any study that involves additional tests or procedures is submitted to a certified Ethical Review Board in the Netherlands.