What is Informed Consent?
Every participant must provide informed consent to be enrolled in a clinical trial. This involves documentation that summarizes the research and the participant's rights. In addition, the informed consent process includes communication with the researchers and review of any necessary additional supporting documents for the study.
Other aspects of informed consent include:
- Providing adequate information to allow for an informed decision about participation in the trial.
- Facilitating the potential participant's understanding of the information.
- Providing an appropriate amount of time to ask questions and to discuss the research protocol with others before deciding to participate.
- Obtaining the potential participant's voluntary agreement to participate.
- Continuing to provide information as the clinical investigation progresses or as needed.
The informed consent process is designed to protect enrollees. The process may involve brochures, verbal instructions, Q&A sessions, and confirmation of the participant's understanding of the trial. The informed consent documentation is NOT a contract. Volunteers may withdraw from a study at any time.
Each trial that is conducted or supported by the federal government, and each study of a drug, product, or medical device regulated by FDA must be reviewed, approved, and monitored by an institutional review board (IRB). These boards are made up of doctors, researchers, and others in the community.
The IRB's role is to ensure the study is ethical and to protect the rights and welfare of the participants.