Legislation and regulations

Legislation on the protection of volunteers participating in drug research

The Dutch Medical Research Involving Human Subjects Act (WMO)/a> aims to “provide protection to volunteers who participate in medical-scientific research”.

Furthermore, all over the world, drug research must be conducted in accordance with, among other standards, the Declaration of Helsinki (Universal Human Rights) and the internationally recognised guidelines of “Good Clinical Practice”. The ethical and quality standards with which drug research must comply are described in these documents.

Compliance with the law and all international guidelines with which drug research must comply

The Medical Ethics Review Committee/a> also assesses the protocol of the research on the basis of all relevant guidelines. Compliance with the guidelines can then be monitored by QPS staff who are specially trained for the purpose, the Medical Ethics Review Committee, the client or by Dutch or foreign authorities. If necessary for such inspections, the data from the drug study will be made available.

Personal data

We store your personal data and any medical data in an electronic file. We require your consent to store these data. You can indicate your consent on the registration form.

The file in which your data are recorded complies with the Personal Data Protection Act and is therefore protected against use by third parties. You can therefore rest assured that we will only use your personal and medical data to enable you to participate in research studies at QPS.

Research data collected

The data collected from you during the drug study will be entered into the drug study database together with the data from the other volunteers. The data will be made anonymous. This means that your name and other personal data will not be entered into the database. After all data have been entered, the data are described in a report. This report provides an answer to the research question as stated in the protocol. In this way, the report constitutes a building block that contributes to the development of new medicines.