Psychology research · Reference
What is informed consent in research?
In research ethics, informed consent is the voluntary, informed, and competent agreement of a person to take part in a study, given after they understand its purpose, procedures, risks, and their right to withdraw.
Definition
Informed consent in research is both an ethical principle and a practical process. It rests on respect for autonomy — the right of individuals to decide whether to participate in research that affects them. To be valid, consent must be voluntary (free from pressure or undue inducement), informed (based on clear, accurate information), and given by someone competent to make the decision. This page concerns research ethics specifically and is not guidance on medical or legal consent, which are governed by separate frameworks.
Key elements
Valid informed consent typically requires that participants are told the study's purpose, what participation involves, how long it will take, and any foreseeable risks or benefits. They should also be informed about how their data will be used, stored, and kept confidential, and who to contact with questions.
Crucially, participants must be told that taking part is voluntary and that they may withdraw at any time without penalty. Consent is usually documented, but it is an ongoing process rather than a single signature: participants can reconsider as a study proceeds, and any material change should be communicated.
Ethics committees and oversight
Research involving human participants is typically reviewed in advance by an ethics committee — known as an Institutional Review Board (IRB) in some countries or a Research Ethics Committee (REC) elsewhere. These bodies assess whether the consent process and information provided are adequate and whether risks are justified. The requirement for informed consent and independent review grew out of historical abuses and is now codified in frameworks such as the Declaration of Helsinki and national research-ethics codes, including those issued by professional bodies.
Significance for research integrity
Informed consent is a central pillar of research integrity and the responsible conduct of research. It protects participants' rights and welfare and helps sustain public trust in research. Special provisions apply where participants cannot consent for themselves — such as children or those lacking capacity — requiring proxy consent and additional safeguards. Properly obtained and documented consent is also part of producing ethically credible, publishable evidence.
Key facts
At a glance
- Scope: research ethics (not medical or legal consent)
- Three requirements: voluntary, informed, competent
- Based on: respect for participant autonomy
- Key information: purpose, procedures, risks, data use, withdrawal
- Oversight: ethics committees (IRB or REC)
- Codified in: the Declaration of Helsinki and ethics codes
Common questions
FAQ
What are the key elements of informed consent in research?+
Participants must be told the study's purpose, what taking part involves, foreseeable risks and benefits, how their data will be handled, and that participation is voluntary with the right to withdraw at any time. The decision must be made by someone competent and free from coercion.
Who reviews informed consent in research?+
Research ethics committees — called Institutional Review Boards (IRBs) or Research Ethics Committees (RECs) — review proposed studies before they begin, checking that the consent process and participant information are adequate and that risks are justified.
What happens when a participant cannot give consent themselves?+
For people who cannot consent, such as young children or those lacking decision-making capacity, ethical frameworks require consent from an appropriate proxy along with additional safeguards, and, where possible, the participant's own assent or agreement.
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