Your Rights in a Clinical Research Trial

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

• Each clinical research trial follows a carefully controlled protocol (or study plan) that details what researchers will do in the study. As a clinical research 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 research 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.

• Anyone participating in US clinical research trial has the right to "informed consent." This 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 research trial.

As a participant in a clinical research trial, you have certain rights and responsibilities. This section outlines those rights and responsibilities, presents a list of questions for you to ask the study team, and describes informed consent.