About Health Science Trials and Research

What do health science trials typically involve and how are they approved? You can read more about this here.

In order to gain new knowledge about diseases and become better at treating them, it is important to conduct research on humans. Only through research can we become better at preventing, diagnosing and, most importantly, treating diseases.

Types of Trials

A trial may involve testing a drug, a medical device or perhaps a new treatment method, such as a trial of a different surgical procedure. When a drug is tested on humans, it is often to investigate the efficacy and safety of the drug and to detect any side effects. Medical device trials are often concerned with the safety and performance of the device. Medical devices are devices used to investigate, treat or alleviate disease (e.g. syringes, surgical devices, patches, pacemakers or hip replacements). Testing of medicines and medical devices requires approval from both the Danish Medicines Agency and a scientific ethics committee. Trials that do not involve medicines must be approved exclusively by the scientific ethics committee system.

Requirements for Researchers

There are educational requirements for the person responsible for the trial, depending on the content of the trial. The person responsible must have the right to conduct research - this can be through employment as a researcher, for example, and they must also have experience treating patients from a hospital ward, for example. In the case of trials involving medicines or medical devices, the person responsible must be a trained doctor or (where applicable) dentist. If serious adverse reactions or serious adverse events occur during the trial, the investigator must immediately notify the scientific ethics committee. If the trial involves medicinal products, the Danish Medicines Agency must also be notified.

The Ethics Committees Approve the Trials

The ethics committees consist of both professionals (health science graduates) and lay people - with a majority of lay people. The committees must safeguard the interests of the trial subjects. While it is important to bring new knowledge to the healthcare system, the interests of the trial subjects always come first. The committees must therefore approve all health science trials in Denmark. Before a trial can be approved, the scientific ethics committee assesses both the risk to the trial subjects and the benefits of the trial. If a trial is in any way unsafe to conduct, it will not be approved. The committee can also reject a trial if it feels that the information provided to you is not good enough. The scientific ethics committee also ensures that there is a compensation or reimbursement scheme if a subject should suffer harm as a result of the trial

Last updated 01-02-2024

Please note that the text on this page has been translated with the help of AI. If you find any errors in the text or something is unclear, please contact us for clarification.

Before You Decide

If you are considering becoming a research subject, it is recommended that you read the brochure "Before You Decide "before you make a final decision. It describes the general aspects of a research project that you should be aware of.

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