Consent and Participant Information Sheet
Preparation Guidance

Principles of consent: Adults who are not able to consent for themselves

Adults who are not able to consent for themselves should be included in research, provided that you do this in line with relevant legal frameworks and ethical principles.

You should always ensure that what capacity an adult has is optimised and used as far as possible to enable that individual to make decisions for themselves.

Guidance is provided elsewhere on how to assess capacity and when research can be conducted involving adults not able to consent for themselves. For further guidance please refer to our 'Links' page.

In this circumstance, an adult is anyone aged 16 or over.

Legal frameworks and national requirements.

The consent requirements for adults who are not able to consent for themselves, depends on the type of study and where in the UK the research is taking place. Guidance in this section is organised according to UK nation and may be explored by selecting the relevant UK nation on the map. If your study involves recruitment from more than one UK nation, you can return to this map to explore other jurisdictions later.

Key points to consider are:

  • Is my study a Clinical Trial of an Investigational Medicinal Product (CTIMP)?
    To find out, you should visit CTIMP in our Glossary and use the MHRA algorithm.
    For CTIMPs the law is the same across the UK; however the details of who can give consent may vary between nations.
  • If your study is not a CTIMP:
    The law regulating how and when adults lacking capacity can be included in your research will vary, depending on where in the UK your research takes place.
UK Map Link to Scottish info Link to English info Link to Welsh info Link to Northern Ireland info

Select the relevant UK nation on the map.