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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:
Providing an information sheet is just one part of seeking the consent of participants. The REC will consider the whole process.
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:
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:
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:
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.
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:
Depending on your research goal, you may need to consider a number of forms as follows: