New medicines and vaccines market me aane se pehle clinical trials se guzarne padte hain. Human subjects pe testing ethically sensitive hai, isliye strong legal framework mandatory hai.
Main pillars:
- Ethics committee approval – independent body scientific and moral aspects review karti hai,
- Informed consent – participants ko risks, benefits, procedures, compensation sab bataya jata hai, written consent li jati hai,
- Risk–benefit balance – expected benefit, existing alternatives, and potential harm weigh kiye jate hain,
- Safety monitoring – adverse events reporting, immediate medical care, stopping rules.
Special protection vulnerable groups ke liye – children, pregnant women, prisoners, economically weak – taaki unka exploitation na ho. Compensation rules bhi hote hain for trial-related injury or death.
Sponsors and investigators ko detailed record keeping, protocol compliance, and regulator reporting follow karna hota hai. Fabricated data, suppressed side-effects, ya protocol violations heavy penalties attract kar sakte hain.
Public trust science pe tabhi banega jab log dekhenge ki trials transparent, well-regulated, aur genuinely participant-respecting hain.
