No person may be included in a study without having given his or her consent. Luxemburgish law, based on European directives, is very strict on this subject and protects the rights of participants in research.
Before suggesting that you take part in a study, the promoter of the research must obtain the agreement of the National Ethics Committee for Research (CNER), and must either notify, or request authorisation from the National Data protection Commission (CNPD) depending on the type of study.
Before giving your consent, you must have received an information document explaining the aims of the research, as well as the various stages in the study, examinations or treatments you will have to undergo. The doctor suggesting that you take part in the study will also explain this information to you.
This document must include the name of the investigating doctor and of the contact person you can go to for further information.
You can give your consent to take part in the study and decide to discontinue participation at any time during the study without prejudice. You just have to inform either the doctor or any other member of the research team. You are not obliged to give any reasons for withdrawal of the trial.
Source: www.crp-sante.lu
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Individuals interested in clinical research and potential volunteers will find useful information about the conduct of clinical trials.
