UNIT 5: Ethics, Informed Consent, and Subject Protection
This unit explains the ethical principles and frameworks that govern clinical research involving human subjects, ensuring protection of rights, safety, and well-being. It details ethical guidelines, informed consent requirements, and the roles of ethics committees throughout the lifecycle of a clinical trial.
Ethical principles form the foundation of all clinical research involving human subjects and are designed to protect individuals from harm, exploitation, and unethical experimentation. These principles ensure that research is scientifically justified, socially valuable, and conducted with respect for human dignity.
| Ethical Principle | Core Meaning | Application in Trials |
|---|---|---|
| Respect for persons | Recognition of autonomy | Voluntary informed consent |
| Beneficence | Maximize benefit, minimize harm | Risk–benefit assessment |
| Justice | Fair subject selection | Equitable recruitment |
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