In clinical trials, patient safety and patient rights are essential, so all tests should be performed in accordance with Good Clinical Practice Guidelines (GCP for short), ie Good Clinical Practice (GCP).
The most important rights of a participant in clinical trials:
- Participation in a clinical trial is completely voluntary.
- The patient has the right to refuse to participate in a clinical trial without any consequences. In case of refusal to participate in the study, the patient does not lose his rights to treatment, which is considered standard and appropriate in his case.
- The patient must have sufficient time to carefully read the written information of the study and the informed consent form to participate in the study.
- The decision to participate in a clinical trial must be fully informed. If the data contained in the information about the patient is not clear to him, he has the opportunity to ask questions to the doctor with a proposal to participate in the study. Patient information is evaluated by independent ethics committees in terms of, among other things, its ability to be understood by the average patient.
- The patient has the right to receive a copy of the written information about the study and the informed consent to participate in the study, signed by him and the doctor.
- The patient can interrupt the study at any time if he considers it in his best interest. However, he must inform the doctor of his resignation. He must also come in time for a follow-up visit, the purpose of which is to assess his health after completing his participation in the study.
- Refusal to participate in a study while it is ongoing has no consequences. It is the physician’s duty to provide additional treatment in accordance with the generally accepted principles of medical practice.
- The patient has the right to receive information from the doctor about his state of health at each stage of the clinical trial and to have access to his documentation.
- The patient has the right to be informed of any new data that could influence his decision to continue participating in the study. For example, he may receive new information about the risks of taking a test drug.
- The patient is entitled to compensation if he has suffered an irreversible health problem directly related to the medicine or medical procedure used, according to the requirements of the examination protocol, in accordance with the principles established in the Ordinance of the Minister of Finance. on compulsory liability insurance for investigators and sponsors …
- The patient is entitled to reimbursement of additional documented costs incurred in connection with participation in a clinical trial.
- The cost of treating side effects is covered by the study sponsor, usually a pharmaceutical company.
- Participation in a clinical trial is free for the patient. The research sponsor is responsible for the costs of investigational medicines, specialist examinations and medical care.
- Patients have the right to complete anonymity and the protection of their personal data.
Both during and after the examination, the patient has the right to inform the attending physician of any observed changes in well-being.
- Patient participation in a clinical trial is free. All treatment costs (costs of investigational drugs, specialty tests, and medical care) are borne by the study sponsor.