Advice on Formulating Participant Information Sheets
Participant Information Sheets must be designed to assist participants to make informed choices. Potential recruits must be given sufficient information to allow them to decide whether or not they want to take part. The process of obtaining consent and the accompanying documentation must be approved by a research ethics committee and, where only verbal consent to research is contemplated, include consideration of an appropriate process for witnessing the consent.
Researchers must take the steps necessary to ensure that all participants in the research understand the process in which they are to be engaged, including why their participation is necessary, how it will be used and how and to whom it will be reported, so that the prospective participant can make an informed decision about whether (s)he really does want to take part.
It is highly recommended that the information provided is presented on headed paper and is accurate, clear and simple so that someone with a reading age of 8 would understand the contents (use short words, sentences and paragraphs). The information should be specific to the proposed research and appropriate for the social and cultural context in which is it being given. It is important to avoid technical terms, jargon and abbreviations, bias, coercion or any inappropriate inducements.
What should the information sheet include?
- A friendly invitation to participate.
- A brief and simple explanation of the purposes of the research and a statement explaining how the participant was chosen and how many other participants will be involved in the study.
- A statement that participation is voluntary; refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled; and the participant may discontinue participation at any time without penalty or loss of benefits.
- A thorough explanation of the expected duration of participation in the research and the procedures to be followed.
- A description of any reasonably foreseeable risks or discomforts and any benefits to the participant.
- For research involving more than minimal risk, an explanation as to whether any compensation or any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
- A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained. The information sheet should include a statement that the data will be collected and stored in accordance with the Data Protection Act 1998, how long it will be retained, to whom it many be made available and that the data will be disposed of in a secure manner.
- It is considered good practice for researchers to debrief participants at the conclusion of the research and to provide them with copies of any reports or other publications arising from their participation.
- If appropriate, a statement indicating that the data might be used for additional or subsequent research.
- An explanation of who to contact for answers to pertinent questions about the research and the rights of the participant and who to contact in the event of a research-related injury to the participant.
- If applicable, a statement declaring that each researcher who may have access to children (aged under 18) or vulnerable adults has undergone a satisfactory criminal records check.
- Remember to thank your participant for considering taking part in the study and include a statement indicating that the research study has been approved by the UCL Research Ethics Committee.
Language and Layout
It is highly recommended that the information provided is presented on headed paper and is accurate, clear and simple.The information should be specific to the proposed research and appropriate for the social and cultural context in which is it being given. It is important to avoid technical terms, jargon and abbreviations, bias, coercion or any inappropriate inducements.
The following points should be considered when writing an information sheet:
- Use clear, non-technical language.We recommend that you refer to the Plain English Campaign: http://www.plainenglish.co.uk
- Use appropriate language for the target audience.For example, consider the different ways needed to communicate to primary school children as opposed to their teachers, or people with expertise in the area of study as opposed to people with no such knowledge.
- Divide the text into paragraphs for ease of reading.
- Consider using sub-headings for clarity (such as questions and answers).
- Make sure the font and font size are legible.
Ask someone else to review your information sheet before it is circulated.