Consent and Participant Information Guidance

There are many ethical and legal issues to consider when involving children and young people in research.

Please refer to our 'Style' guidance for information on designing Participant Information Sheets and Consent forms for research involving children and young people.

Links to further guidance are available in 'Examples & Templates' and from our 'Resources' page.

Legal frameworks and national requirements.

The requirements for consent, where participants are children and/or young people, depend on:

• The type of study; and
• Where in the UK it is taking place.

The 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.
• If your study is not a CTIMP:
  The law regulating how children and young people can be included in your research will vary, depending on where in the UK your research takes place.

The concepts of consent and assent.

Consent is a legally defined decision given by someone who is competent, who has been adequately informed (and has adequate understanding), and who is free from undue influence enabling them to make a voluntary decision. The person can provide consent themselves (provided they are competent). Otherwise someone else who is empowered by law can provide it (e.g. a parent in the case of children). A child who is not capable of giving consent alone can still be involved in the decision-making process with others who are able in law, to provide consent.

Assent is difficult to define and is used in diverse ways, e.g. compliance by a child as young as three, through to the active agreement of a young teenager etc. Assent is agreement given by a child / young person, or others who are not legally empowered to give consent. It is important to provide children / young people with information that matches their capacity when seeking assent.

Select the relevant UK nation on the map.