Consent to research
About this guidance
Our guidance Consent: patients and doctors making decisions together1 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 supplementary 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.2
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,3 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 GMC’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.
Using Consent to research on-line
- To read the guidance as it appears in the print version, you can use the navigation arrows at the bottom of the page. Begin reading.
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For an overview of Consent to research you can use the contents page.
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You can use the links in the boxes on the right to access further GMC guidance and external web links. Where a link refers to a specific paragraph or bullet point, this is indicated using square brackets (for example [4d] Consent guidance).
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You can search all our current ethical guidance, including Consent to research, using our A-Z of Ethical Guidance.
Footnotes
1 Consent: patients and doctors making decisions together
2 Under the Medicines for Human Use (Clinical Trials) Regulations 2004 a clinical trial means ‘any investigation in human subjects, other than a non-interventional trial, intended –
- (a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products,
- (b) to identify any adverse reactions to one or more such products, or
- (c) to study absorption, distribution, metabolism and excretion of one or more such products,
with the object of ascertaining the safety or efficacy of those products’.
An investigational medicinal product ‘means a pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a reference in a clinical trial, and includes a medicinal product which has a marketing authorization but is, for the purposes of the trial -
- (a) used or assembled (formulated or packaged) in a way different from the form of the product authorised under the authorization,
- (b) used for an indication not included in the summary of product characteristics under the authorization for that product, or
- (c) used to gain further information about the form of that product as authorised under the authorization’.
3 Confidentiality