Informed consent is a person’s voluntary agreement, based on an understanding of the relevant information, to participate in research or a clinical trial, or to undergo a particular medical intervention.
Before any research may be carried out, participants must be informed about all aspects of the study and/or intervention, including the aims, methods, anticipated benefits, and potential risks.
Participants must also be made aware that they can withdraw from the research at any stage without any negative consequences to their ongoing care or treatment. This information must be given in an accessible and understandable way (for instance via a participant information sheet), and individuals should be given the opportunity to ask questions about the research.
Informed consent is usually documented in writing with a signed and dated consent form. However, informed consent should be an ongoing process throughout a study, and researchers should ensure that participants are made aware of any new information which might influence their decision about whether to take part or not.In rare circumstances (for example, when an individual may not be able to give informed consent), the usual practices for informed consent may not be possible. Researchers may obtain delayed consent (for instance, for research into emergency situations) or consent by proxy (when the ability to consent is delegated to someone else). In some cases, informed consent may be implied by a person’s actions or inaction or silence.
EUPATI-Accademia del Paziente esperto (AdPEE) Toolbox Glossary
See also
- Consent
- Consent form
- e-Consent
- Informed consent form
More resources
The Multiregional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard. Clinical research Glossary
NCI Thesaurus, CDISC Controlled Terminology
NIH National Cancer Institute, Dictionary of Cancer terms
To go in depth
Clinical trials: what patients need to know
A comprehensive page on the FDA’s patient site that explains in plain language what informed consent is, what information a patient should receive before being enrolled in a clinical trial, and what the appropriate language should be.
Food and drug administration (FDA) – Informed consent for clinical trials
Risks and benefits of informed consent
From the bookshelf of the NIH National Library of Medicine, an interesting article about informed consent, the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention.
Shah P et al. Informed Consent Last Update: June 5, 2023.
Videos
What is informed Consent?
This video animation realized by the NIH-National Institute of Mental Health shows in details what “informed consent” means when participating in a clinical trial.
Source: NIH National Institute of Mental Health
All you need to know about Informed Consent and e-Consent
This video realized by the Center for Information and Study on Clinical Research Participation’s (CISCRP) provides a clear overview on Informed Consent and e-Consent.
Source: What is Informed Consent. Center for Information and Study on Clinical Research Participation’s (CISCRP)
Informed Consent for Research: What to Expect
This video realized by the Office for Human Research Protection (OHRP) of the US Department of Health and Human Services (HHS) provides basic information about informed consent and what to information you’ll get to help you decide whether to volunteer for a research study.
