Consent and Participant Information Sheet
Preparation Guidance

Principles

This section of the guidance focuses on the principles of consent (both ethical and legal) and how they relate to your Participant Information Sheet (PIS).

We also highlight what to consider when your research involves:

  • Vulnerable groups (e.g. children / young people or adults not able to consent for themselves);
  • Recruitment of participants from across the UK (i.e. explore the legal differences and requirements in England & Wales, Scotland and Northern Ireland).

info icon Select the headings below to find out more:

We provide links to various reference texts, including the World Medical Association (WMA) Declaration of Helsinki and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Guideline for Good Clinical Practice (ICH GCP), in our 'Links' page.