Your Rights in a Clinical Trial

Most clinical research is federally regulated with built-in safeguards to protect your rights and safety.

  • Each clinical trial follows a carefully controlled protocol (or study plan) that details what researchers will do in the study. As a clinical trial progresses, researchers report the results at scientific meetings, in medical journals, and to government agencies. Your name remains confidential and is not mentioned in these reports.

  • All institutions that conduct human clinical trials must have an Institutional Review Board (IRB) that initially approves and periodically reviews the research. The purpose of the IRB is to make sure clinical research adheres to strict ethical guidelines and poses no unnecessary risks to participants.

  • Anyone participating in US clinical trial has the right to informed consent. This process provides key information about the study in language that is easy to understand and guarantees the participant’s right to receive information throughout the course
    of the trial.

  • You cannot be enrolled in a clinical trial without your knowledge. Informed consent protects you from unauthorized research. Your privacy will be protected. Your name cannot be revealed, and your medical information must remain confidential.

  • You always have the right to say “no,” if you are uncomfortable with what you are being asked to do or if you don't fully understand it. Because participation is voluntary, you can withdraw from a clinical trial at any time.

  • You do NOT have to pay to participate in a clinical trial. Costs of routine tests and procedures that are part of your normal health care will be paid in accordance with the terms of your health insurance plan. This is one of the advantages of taking part in a clinical trial.

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