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 volunteers
- 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 the volunteers 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.