Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Glossary Definition

A process used by researchers to communicate with potential and enrolled participants about a clinical study. As part of the informed consent process, researchers:

  • Provide all the important information about the study, so potential participants can decide whether to enroll or, if they are already enrolled, whether to continue to participate
  • Make sure that potential participants understand the risks and potential benefits of participating in the study and the alternatives to the research being conducted
  • Stress that enrolling in, and staying in, a clinical study is completely voluntary. Because giving consent to participate in research is not a contract, participants may leave a study at any time.

The goal of the informed consent process is to protect participants. It begins when a potential participant first asks for information about a study and continues throughout the study until the study ends. The researcher and potential participant have discussions that include answering the participant's questions about the research. All the important information about the study must also be given to the potential participant in a written document that is clear and easy to understand. The informed consent document is reviewed and approved by the human subjects review board before the document is given to potential participants. Generally, a person must sign an informed consent document to enroll in a clinical study.