Regulations for Good Clinical Practice Article 4

Clinical trials should be conducted in accordance with the ethical principles of the Declaration of Helsinki.Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks and inconveniences.The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.The Ethics Committee should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid to trials that may include vulnerable subjects.