Every person who participates in a clinical trial is protected by a robust set of rights established under federal law and international research ethics standards. Here is what you need to know.
The Right to Informed Consent
Before you agree to participate, the research team must explain the study in plain language, including its purpose, what will happen during the study, known risks and benefits, and any alternatives to participation. You must have time to ask questions and discuss the decision with your family or doctor.
The Right to Withdraw at Any Time
You may leave any clinical trial at any time, for any reason. Withdrawing from a study has no effect on your ability to receive standard medical care elsewhere, and there is no penalty of any kind.
The Right to Privacy
All personal health information collected during a clinical trial is protected by HIPAA and additional federal privacy regulations. Your identity is never disclosed in published research.
The Right to Know the Results
You have the right to learn the overall results of the study once it is completed.
The Right to Safety Monitoring
Every FDA-regulated clinical trial includes an independent Data Safety Monitoring Board (DSMB) that reviews safety data throughout the study. If the treatment is found to be harmful, the trial will be stopped.
The Right to IRB Protection
An Institutional Review Board (IRB), an independent committee of scientists, physicians, and community members, must approve every clinical trial before it begins. The IRB’s job is to protect your rights and welfare.
Questions to Ask Before You Enroll
- Who is sponsoring this trial?
- What are the known risks?
- Will I receive a placebo?
- What happens if I am injured?
- Who can I contact if I have concerns?
At NuLine, our team welcomes every question. Contact us or call 754-331-5331.