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Permission given voluntarily after a person has understood what a study involves, including its possible risks and benefits.

Participants should normally give informed consent, understand any possible discomfort or risk and be free to withdraw. Researchers should minimise physical harm and psychological distress.

Agreement given freely after a person has received and understood relevant information about a treatment's possible benefits, risks and alternatives.

Do not write only that an investigation is “unethical”. Identify the issue, such as inability to give informed consent, possible distress or risk of harm.

Keep safety and ethics distinct: physical harm is a safety concern, whereas whether valid informed consent can be obtained is an ethical concern.

Permission given freely by someone who understands the purpose, procedures, possible risks and implications of the research.

Brain damage can affect understanding, communication or decision-making, so a patient may not be able to give valid informed consent. Researchers must not assume that the scientific usefulness of a patient removes that person's rights or welfare needs.

Informed consent

Definition

How each exam board covers it

OCR GCSE Biology A · J247

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OCR GCSE Biology B · J257