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 Regulation of Clinical Trials on Human Subjects

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 Regulation of Clinical Trials on Human Subjects
 Regulation of Clinical Trials on Human Subjects

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.