What are my rights?

Your Rights as a Clinical Trial Participant

Clinical trials are important for advancing medical science, but your safety and dignity come first. Here are your rights as a participant in any clinical study:

1. The Right to Informed Consent

You must be given clear, complete, and understandable information about:

• The purpose of the trial

• Procedures involved

• Risks and potential benefits

• Alternative treatments

• Their right to decline or withdraw at any time

Informed consent must be obtained in writing before your participation begins, and you can ask questions at any time.

2. The Right to Voluntary Participation

Your participation must be entirely voluntary. You cannot be coerced or misled. You may withdraw from the trial at any time, for any reason, without loss of care.

3. The Right to Privacy and Confidentiality

Your personal and medical information must be kept confidential and handled in compliance with laws like HIPAA in the U.S. Only authorized personnel should access identifying data.

4. The Right to Know About Risks and Benefits

You must be made aware of all known and potential risks, as well as possible benefits. If new risks emerge during the trial, you must be informed immediately.

5. The Right to Receive Medical Care

You are entitled to appropriate medical attention for any adverse effects or complications that occur during the trial. In many cases, the sponsor covers the cost of such care.

6. The Right to Ask Questions and Be Heard

You have the right to ask questions at any time and receive honest, clear answers. You can also voice concerns or complaints without fear of retaliation.

7. The Right to Access Support and Advocacy

You may have access to patient advocates or ethics boards (such as Institutional Review Boards or IRBs) that oversee the trial and ensure it adheres to ethical standards.

8. The Right to Be Informed of Trial Results

You may ask whether you will be informed of the trial’s results and findings, including which treatment you received—though this is often after the study concludes.

9. The Right to Continued Care

If a treatment proves effective during the trial, you may have the right to continued access after the trial ends, especially in compassionate use or expanded access programs.

If you have questions or concerns about your rights, contact your study team or the study’s ethics board (IRB).