Patient and Participant Information and Informed Consent

It is vital that participants are involved in the development of the information sheets and informed consent forms.  For each trial, specific consent documentation consisting of a participant information sheet and consent form must be developed and approved by the ethics committee. The HRA and MRC have a toolkit that can be used to help develop the consent documentation.

It is essential that you carefully consider the target audience for your research. This may mean you need to consider a number of information sheets, such as:

  • participant information sheet for adults
  • information sheet for parents/guardians (if involving children/young people)
  • information sheet(s) for children/young people
  • consultee information sheet (for consultees of adults lacking capacity to consent)

Consent Documentation for Children

Information sheets should be designed for each appropriate age range to reflect comprehension and development, for example:

  • children or young people 11–15 years
  • children 6–10 years
  • children 5 years and under: predominantly pictorial, with very simple sentences to be shown/read to the child. Parents need to provide consent since assent is not sought from children under 5.

Online Research

For online surveys/questionnaires that pose a minimal risk to participants it is possible to obtain “Implied Consent”. For certain types of low risk research the completion and submission of the survey/questionnaire implies that consent for the use of the questionnaire data has been given. Participants should still be given the same type of information (e.g. why they have been asked to participate, voluntary participation, risks of being involved, confidentiality/anonymity, right to withdraw etc). Importantly, the questionnaire must be preceded by written information about the project and its aims (including how the research may be written up and published, eg, in a student thesis or peer-reviewed journal).

It is also good practice to include a small number of check boxes or radio buttons such as “I am over 18” and “I agree to take part in the research by completing this questionnaire” alongside a “Submit” button leading to the questionnaire itself.

Researchers should also make clear whether the additional metadata obtained (data which a lay user may not be aware of, but which may provide researchers with more information than participants would intend to provide e.g. time stamps on tweets or posts) are intended for analysis, or whether cross-referencing of data sources is planned. Both the use of metadata and cross-referencing carry a greater risk of privacy breaches for individuals and could affect their autonomy over their online information.

Additional guidance is available.