Informed Consent
The process by which a potential participant learns the key facts about a clinical trial, including risks, benefits, and alternatives, before deciding whether to enroll.
In Detail
Informed consent is both a legal requirement and an ethical cornerstone of clinical research. Before enrolling in any clinical trial, potential participants must receive a thorough explanation of the study, including its purpose, procedures, potential risks and benefits, alternative treatments available, how their privacy will be protected, and their right to withdraw at any time without penalty. This information is provided in an informed consent document, which participants must sign before any study procedures begin. However, informed consent is not just a form, it is an ongoing process that continues throughout the trial. Researchers are required to inform participants of any new information that might affect their willingness to continue, such as newly discovered side effects. The informed consent process must use language that is understandable to the participant and may not include exculpatory language that waives the participant's legal rights. For participants who cannot consent for themselves, such as children or individuals with cognitive impairment, a legally authorized representative may provide consent on their behalf, often with the participant's assent. The Institutional Review Board (IRB) reviews all informed consent documents to ensure they are complete, accurate, and understandable. Federal regulations (45 CFR 46 and 21 CFR 50) specify the required elements of informed consent. Patients considering a clinical trial should read the consent document carefully, ask questions, take it home to review, and discuss it with their doctor and family before signing.
Frequently Asked Questions
What does "Informed Consent" mean in clinical trials?
The process by which a potential participant learns the key facts about a clinical trial, including risks, benefits, and alternatives, before deciding whether to enroll.
Why is "informed consent" important for patients?
Understanding informed consent helps patients and caregivers navigate clinical trial participation with confidence. It is part of the broader clinical research process that ensures treatments are safe and effective before reaching patients.
Related Terms
Institutional Review Board (IRB)
An independent ethics committee that reviews and approves clinical research involving human subjects to ensure participants' rights, safety, and welfare are protected.
Inclusion Criteria
The specific characteristics that a person must have to be eligible for a clinical trial, such as age range, diagnosis, or stage of disease.
Exclusion Criteria
The characteristics that disqualify a person from participating in a clinical trial, such as certain medical conditions, medications, or pregnancy.
Clinical Trial
A research study that tests a medical treatment, drug, device, or intervention in human volunteers to determine whether it is safe and effective.
this entity is one of the U.S. clinical trials and research registries concepts that recurs across this site. The definition above is the technical answer; the paragraphs below add the practical context for how the concept connects to the the NIH ClinicalTrials.gov registry data behind every per-entity page on the site.
In the the NIH ClinicalTrials.gov registry data, this concept shapes one or more of the fields that drive the per-entity grades and rankings on this site. The methodology page describes which fields feed into which output; this glossary entry documents the underlying term.
Source: ClinicalTrials.gov, 2026.