3. Informed Consent
You can decide whether or not to participate in a clinical trial of your own volition
A clinical trial cannot be initiated without the patient's free and voluntary written consent.
The physician will give the patient an "explanation document" that describes the purpose of the clinical trial, the methods, the treatment if the patient does not participate in the clinical trial, and the characteristics of the "drug candidate" and explain its contents in detail. Patients can ask any questions they have, including those they do not understand and those they wish to confirm, until they are satisfied with the information.
Then, they can decide whether or not to participate in the clinical trial of their own volition, without being forced to do so by anyone. You may not decide on the spot after receiving the explanation, but may take the explanation document home and consult with your family before deciding.
Once the patient agrees to participate, the patient and the physician in charge of the clinical trial will sign the "Consent Document" in their own handwriting. A copy of the consent document and the explanation document will be given to the patient. This "explanation and consent" is called informed consent.
What is written in the explanation document
- The purpose of the clinical trial, how the investigational drug will be used, the details of the tests, and the participating institutions
- Expected effects and anticipated side effects
- That participation in the clinical trial can be terminated at any time, and that no disadvantages will be incurred in the event of non-participation.
- If a side effect occurs and you suffer damage, you can claim compensation.
- Medical records such as medical records and test results will be reviewed by the pharmaceutical company that requested the clinical trial, the Ministry of Health, Labor and Welfare, and the Clinical Trial Review Committee.
- Name and contact information of the physician in charge
- Contact information for questions and consultation regarding the clinical trial
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As of December 2023The contents that should be included in the explanatory document are specified in GCP.