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What is the authorisation procedure for conducting clinical trials in your jurisdiction?
Article 25 of the Hospital Act of 28 August 1998 states that no trial, study or experimentation can be done on a human being with the aim of furthering knowledge in the fields of biological and medical sciences if the project has not first been submitted to the approval of a research ethics committee.
Chapter 5 (Articles 76-79) of the Medical Deontology Code, approved by the Ministerial Decree of 1 March 2013, relates to human experimentation and in particular states that any protocol, whether it is done in a hospital context or not, must have authorisation. The trial can start only after the delivery of a positive opinion from the research ethics committee and after the implicit or explicit approval of the Health Ministry, in agreement with the legal and regulatory requirements that are to be applied in the matter.
Approximately 113 clinical studies are being or have been conducted in Luxembourg. The country of the clinical trial is determined by the location where the clinical research is being studied. Most studies are held in multiple locations and countries.
How robust are the standard good clinical practices followed in your jurisdiction?
The EU standard good clinical practices apply in Luxembourg.
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
The documentation relating to a clinical trial that constitutes the permanent record of the trial includes the essential documents that make it possible to evaluate the completion of the clinical trial and the quality of the data provided.
The investigator immediately notifies the sponsor of all serious adverse events. These notifications are followed by detailed written reports.
More information is provided in the Grand Ducal Regulation of 30 May 2005 on the application of good clinical practice in conducting clinical trials of medicinal products for human use (Modified RGD 30 May 2005).
What are the informed consent obligations with respect to clinical trial subjects?
Informed consent implies a decision, which must be written, dated and signed, to take part in a clinical trial, taken freely after being duly informed of the nature, significance, implications and risks and appropriately documented, by any person capable of giving consent or, where the person is incapable of giving consent, by their legal representative; if the person concerned is unable to write, oral consent in the presence of at least one witness may be given in exceptional cases, as provided for in national legislation.
Templates for informed consent forms (available in French, German and English) are provided on the National Research Ethics Committee website under “Procedures > Submission of a new study”.
Further requirements on granting consent, particularly regarding vulnerable populations, are specified in Articles 3 to 5 of the Grand Ducal Regulation of 30 May 2005 on the application of good clinical practice in conducting clinical trials of medicinal products for human use (Modified RGD 30 May 2005).
What are the insurance requirements for clinical trials?
Provisions for insurance or indemnity to cover the liability of the investigator and sponsor are mandatory.
According to Article 25 of Hospital Act of 28 August 1998, the sponsor and investor must subscribe an insurance covering their responsibility, as well as the responsibility of all the persons involved.
Study insurance covers the risks to patients during their participation in the trial. In case of malpractice and non-conformity to the protocol, the insurance might of course turn against the physician. Physicians in Luxembourg are responsible for having liability insurance and checking whether it covers malpractice.
Essential documents are kept by the investor and sponsor for at least five years after the end of the study. The documents are kept longer if required by applicable requirements or agreement between investigator and sponsor.
What data protection issues should be considered when conducting clinical trials?
Notification to the data protection authority or ombudsmann is mandatory.
Generally, research projects involving human subjects also must be notified to or authorised by the National Data Protection Commission (CNPD).
Notification forms (in French and German) are available on the CNPD website.
Obligations to prior authorisation and related requirements are now specified in Act of 1 August 2018 on the organisation of the National Commission for Data Protection and implementing the EU General Data Protection Regulation (2016/679).
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