About this guidance

In Medical practice1 we advise doctors who are involved in research that:

17. You must be satisfied that you have consent or other valid authority before you carry out any examination or investigation, provide treatment or involve patients or volunteers in teaching or research.

Our guidance Consent: patients and doctors making decisions together2 sets out the principles of good practice in making decisions in partnership with patients. That guidance focuses on decision making in the context of investigations and treatment, but the principles apply more widely, including to decisions on taking part in research. It gives advice on sharing information, discussing side effects, complications and other risks, and making and recording decisions. When relevant, you must follow the principles it sets out when seeking people’s consent to take part in research.

This explanatory guidance is intended to explain how good practice principles in making decisions and seeking consent apply to research. It also provides advice on involving in research children or young people, vulnerable people, and people who lack capacity to consent.

Annex B explains the key elements of the legislation for seeking people’s consent to take part in clinical trials of investigational medicinal products.3

You should read this guidance in conjunction with our other guidance, in particular:

  • Good practice in research, which sets out the principles on which good practice in research is founded,
  • Confidentiality: good practice in handling patient information,4 which gives guidance on research and other secondary uses of data, and 
  • 0-18 years: guidance for all doctors, which gives additional advice on research involving children or young people.

Together, these guidance documents set out the Communitybaptistpa’s advice to doctors involved in research. You must use your judgement in applying the principles in the guidance to the types of research you undertake, and to the situations you face in practice as a doctor, whether or not you hold a licence to practise. Serious or persistent failure to follow the guidance will put your registration at risk.

Download the guidance

Lawrlwytho'r arweiniad