#17 Practical RWE – Insurance


The necessity for insurance in research studies, including non-interventional studies and clinical trials, hinges on the potential risks and liabilities involved. Here’s a breakdown of why insurance may or may not be required for these different types of studies:

[1] Non-Interventional Studies = Non-interventional studies (observational studies) do not involve assigning specific treatments or healthcare interventions to participants. Instead, researchers observe participants in their normal setting or review existing records to gather data. Generally, non-interventional studies pose no more risk to participants than routine clinical practice (normal life) because the researchers do not influence the care or treatment the participants receive. As a result, insurance is not usually required for non-interventional studies (exceptions include Belgium). However, always check what the local insurance requirements are for your study type.  Ignorance is never an excuse.

[2] Clinical Trials = In the context of medicinal products, clinical trials involve administering new drugs or off-label approved drugs to research participants. The risk of harm to the research participants is higher than would be encountered during normal (routine) clinical practice.  As noted in the Declaration of Helsinki (§22) and ICH GCP (§5.8), the trial sponsor should “should address the costs of treatment of trial subjects in the event of trial-related injuries in accordance with the applicable regulatory requirement(s)”.  Because of this, most (all?) countries require clinical trials to have insurance coverage as part of their regulatory approvals. This is to ensure that participants are protected and compensated for any trial-related injuries.

The key difference in the need for insurance between non-interventional studies and clinical trials lies in the level of risk and the potential for direct harm to the research participants. Clinical trials, especially those that test new medicinal products, carry inherent risks due to the unknown effects (in humans) of the treatments being tested. These risks necessitate a higher level of protection for both participants and researchers. On the other hand, non-interventional studies, which typically involve less direct interaction with participants and no alteration of their standard care, present lower risks, thereby reducing (negating) the need for insurance.


However, the specific requirements for insurance can vary widely depending on the country, the nature of the study, the type of data collected, and the potential risks involved. Researchers should always consult relevant regulations, guidelines, and regulatory bodies to ensure compliance with local laws regarding insurance coverage for their studies.

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