How do I know that negative research stories from the past won’t happen again?
Click on the video below to hear about safety and ethics in clinical trials.
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Today, clinical trials are conducted under strict guidelines, with oversight from the Food and Drug Administration (FDA).Every trial has a person in charge, usually a doctor, who is called the principal investigator. The principal investigator prepares a plan for the study, called a protocol, which explains what the trial will do, how the study will be carried out, and why each part of the study is necessary.
Your rights and safety are further protected by:
- Institutional Review Board (IRB), which ensures researchers follow all ethical guidelines and laws.
- Federal regulations, which requires that clinical trials are done ethically and your rights and safety are protected
- Informed consent in which you learn important information about the clinical trial to help you decide whether to participate; you can leave the study at anytime.
- Ongoing monitoring by research teams and study sponsors for compliance