Informed Consent

Definition

Ensuring participants are fully aware of the study and voluntarily agree to participate.

Example

Informed consent is a way to make sure that research participants are fully aware of the nature of the research before they consent to participate. An informed consent typically contains the following elements:

• The title of the research project and an explanation of the research
• An explanation of what will be happening during the study
• An indication of the time commitment that will be required to participate in the study
• A description of risks or discomforts that can be reasonably expected
• A statement indicating how confidential data will be maintained and protected
• A statement indicating that participation is voluntary, and consent to participate can be withdrawn at any time
• Contact information in case there are questions or complaints

Why It Matters

Informed consent protects the rights and dignity of the people who participate in research. It makes sure they know what they’re agreeing to and that they’re free to say no or change their mind at any time. Without informed consent, research can easily cross ethical lines — even with good intentions.

Related Terms

• Institutional Review Board (IRB)