How Applications Are Evaluated

Here, as an example of how an ethics committee operates, you will find information on how the MREC processes applications for clinical drug trials and clinical trials of medical devices.

Upon receiving an application, the MREC prepares a scientific ethics opinion.

In the scientific ethics evaluation, emphasis is placed on whether:

  • the disadvantages of participating in the trial outweigh the benefits of participation
  • the rights of the trial participants are secured
  • personal data regulations are complied with, including whether Danish health information is sent abroad
  • a plan for handling incidental findings is established
  • which research collaborations have been entered into
  • and an assessment of the project's finances, including compensation for trial participants

Specifically for Clinical Trials of Medical Devices

For Article 62 trials, the Danish Medicines Agency also conducts an evaluation. For more information on the processing of these applications, refer to the Danish Medicines Agency's website.

Significant changes to an already approved clinical trial must be approved by the authorizing authorities. Significant changes are those that can affect the safety, health, or rights of the trial participants or the robustness or reliability of the clinical data generated in the trial.

Last updated 01-02-2024
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