Informed Consent
Informed consent is a process of communication designed to help people make a voluntary, well-informed decision about participating in research.
Understanding the Informed Consent Process
What informed consent is: A conversation between researchers and a potential participant (or their legal representative) where key details about a research study — including its purpose, procedures, risks, and benefits — are clearly explained. The goal is to make sure decisions are knowledgeable and voluntary, not rushed or coerced.
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The consent form: A written summary of the study that participants sign if they agree to join, but the form itself is only one part of the overall process.
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Role of review boards: Institutional Review Boards (IRBs) are groups that review and monitor research to protect the rights and welfare of participants. In some cases of low-risk studies, IRBs can waive the need for a signed form.
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Special cases: When a participant can’t give consent — such as children or adults without decision-making capacity — a legally authorized representative (like a parent) can consent on their behalf, and children should be involved appropriately through a process called “assent.”
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Accessibility and comprehension: Researchers should use clear, understandable language and educational tools to ensure people really understand what they’re agreeing to, allowing enough time for questions and thoughtful decision-making.
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Overall, informed consent is about respect, clarity, and choice — making sure people understand what participation means before they agree to participate in the research protocol.