Clinical trials on human participants are essential for developing new medicines and treatments, but they also raise serious ethical and legal concerns. To protect participants, strict regulations usually apply.
First, every trial must be approved by an ethics committee or institutional review board that checks scientific validity, risk-benefit balance, and participant safeguards. Second, informed consent is non-negotiable. Participants must be told, in understandable language, about the purpose of the study, possible risks and benefits, procedures, and their right to withdraw at any time.
Special protection is required for vulnerable groups — children, mentally impaired individuals, economically disadvantaged people. Compensation mechanisms for trial-related injury or death are typically mandated.
Data privacy is another key area. Personal and medical information collected during trials must be securely handled, with clear rules on who can access it and for what purpose.
When laws are respected, trials can advance medical science while respecting human dignity. When corners are cut, they become exploitation, and regulators and courts are empowered to respond strongly.