SFDA: 9 rights for participants in clinical trials…and these are their duties
SFDA: 9 rights for participants in clinical trials…and these are their duties
The Food and Drug Authority has defined the rights and duties of participants in clinical trials, including knowing the details of the clinical study, and the nature and characteristics of the research drug.
The authority stated that the rights of the participants in these experiments include knowledge of medical care and alternative treatment methods, ensuring the confidentiality of personal information, participating in the study without financial compensation and being sponsored by the supporting party, and obtaining compensation for problems or risks.
She pointed out that the participant has the right to refuse to participate or withdraw from the clinical study at any time, while obtaining all information and means of communication related to the research, the research team and the Ethics Committee, as well as contacting the Clinical Trials Department in the Authority for more information.
She indicated that the duties of the participants in the clinical trials include viewing and signing the “informed consent” participation form, commitment and truthfulness in the information, in addition to following the instructions of the research team and informing it of any developments, indicating that “informed consent” represents the process in which the volunteer confirms his desire to participate. In a particular experience after telling him all its elements.