Participant information sheets & informed consent forms

Potential participants need information on which to base their choice to take part in clinical research. It is important that information given to participants before obtaining their written informed consent is clear and concise and fully explains all aspects of the research. 

The HRA (Health Research Authority) provides detailed guidelines to help avoid delay at sponsor and ethics review. Make sure that you use the latest version.

Please also refer to: 

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Providing an information sheet is just one part of seeking the consent of participants. The REC will consider the whole process.

  • The level of detail should be appropriate to the complexity of the study.
  • Write in simple, non-technical terms that a lay person will understand.

Discussion is the most effective way to ensure consent is 'informed'. It is important that the person seeking consent spends time going through written information and does not simply give it to the participant to read on their own. This should be outlined at the top of the information sheet, perhaps suggesting how long it may take.

Depending on your research goal, you may need to consider a number of information sheets as follows:

  • 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)

Information sheets for minors

Where the Clinical Trial Regulations apply (ie for CTIMPs), a minor is defined as someone under the age of 16. Where common law applies (all research not covered by the regulations), the law states that the age of majority is 18.

Be clear in all documentation about whether you are seeking consent or assent (seeking the child’s agreement) and, if in doubt, contact CTRG.

Consent requires a full explanation of the study. Assent requires a clear explanation (comprehensible rather than comprehensive) as consent will be sought from the parent.

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.

Ideally such material should be shorter than that designed for adults, whilst retaining all relevant information.
 

The consent form is to be designed so that the participant is consenting to everything described in the text of the information sheet. The purpose of the form is to record the participant’s decision to take part.

For some studies, specific text may be needed to cover important issues, especially if additional elements are optional for the participant. These may include:

  • additional invasive tests or samples required for study purposes only (ie additional to normal care)
  • consent to use of audio/video-taping, with possible use of verbatim quotation or use of photographs
  • transfer of data/samples to countries with less data protection
  • agreement to receive individual feedback from testing
  • requirement to contact their GP

For University-sponsored studies where samples are collected, specific wording is required. The first statement is essential; others may be used (and adapted) where required for a particular study.

  • I consider these samples a gift to the University of Oxford and I understand I will not gain any direct personal benefit from this.
  • I understand that data obtained from my samples may be used for commercial purposes and that I will not gain any financial compensation should this occur.
  • I give permission for genetic testing to be carried out on these samples.

You should consider whether leftover samples taken for research could be a valuable resource to other researchers in the future. If so, then retention should be covered in the protocol and information sheet, and the following statement included on the consent form:

  • I give consent for samples to be retained and used in future research studies.

 Depending on your research goal, you may need to consider a number of forms as follows:

  • consent form for adults
  • consent form for parents/guardians (if involving young people)
  • assent form (for young people who are agreeing to take part)
  • consultee declaration form (for adults lacking capacity to consent)
     
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