Regulating doctors, ensuring good medical practice

Consent to research: Recording consent

  1. 11. You should record the key elements of your discussion with people about their decision to take part in research. If practical, you should ask them, or someone with valid authority, to give written consent. It is a legal requirement to get written consent from participants in clinical trials of investigational medicinal products.5

Footnote

5 In clinical trials of investigational medicinal products, consent is only valid if it is recorded in writing. If the person is unable to give written consent, for example, if they have a disability which means that they cannot write, they can give consent orally in the presence of at least one witness and this must be recorded in writing. 

 

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Research definitions

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