Volunteers
sharing the details to help you decide
Informed Consent
Have you ever signed a consent document before receiving medical care, such as surgery, signifying your agreement for the doctor to treat you?
Volunteers in clinical research studies sign similar documents, in a process called informed consent.
Informed consent is a two-way process.
- First, the research team explains the details about the study and shares relevant written material.
- Then, prospective volunteers have the opportunity to ask questions and review the material so they can decide whether or not to participate in the study. It’s one-on-one in a private setting.
Volunteers are asked to sign an informed consent document that shows:
- the study has been explained to them
- they understand the study
- they agree to take part in the study
The informed consent covers:
- Rights of the study participants
- Purpose of the study
- How long the study will last
- Required visits with the research team
- Any tests or procedures that are necessary
- The drug or medical device being tested
- Disclosure of appropriate alternative procedures or treatment
- How confidentiality will be maintained
- Risks and benefits of participating in the study
- Key people on the research team and how to contract them
- How volunteers may withdraw at any point during the study
This informed consent process doesn’t end when a volunteer signs the informed consent document. Throughout the study the research team continues to share information with the volunteers and confirms that they wish to remain in the study.
Remember: Informed consent is not a contract. Volunteers can withdraw from a study at any time.