Informed consent is a fundamental ethical and legal requirement for every clinical trial. It ensures that participants understand what they are agreeing to before joining a study.
What Is Informed Consent?
Informed consent is the process by which a researcher explains all relevant information about a study to a potential participant, and the participant has the opportunity to ask questions and decide freely whether to enroll.
What Must Be Disclosed?
Federal regulations require that the consent form and discussion include:
- The purpose of the study
- The duration and all required procedures
- All foreseeable risks or discomforts
- Any reasonably expected benefits
- What alternatives exist outside the study
- How privacy will be protected
- Compensation available, if any
- Your right to withdraw without penalty
The Consent Form
The consent form is a written document that summarizes all of this information. You will be given a copy to keep. You should take your time reading it, ask questions, and discuss it with your family or physician if you wish.
Signing the Form
Signing the consent form does not lock you in. It means you understood the information at the time of signing and agreed to participate. You still retain the right to withdraw at any time after signing.
Ongoing Consent
If the research team learns new information about risks during the study, they must notify you and give you the opportunity to re-consent or withdraw.
Questions about a specific study? Contact our team at NuLine, we take the time to explain every aspect of consent thoroughly.