Background
It is important to provide clear information about your research project to all potential participants involved in your study.
Information materials should give people the necessary understanding of the study’s purpose and procedures to enable them to provide informed consent. This information is often provided in the form of a Participant Information Sheet.
You should develop suitable materials for your specific research context and population under study, there is no ‘one size fits all’. In some cases, it may be more appropriate to provide participant information in a different format, such as an audio or video clip, or a visual/easy-read document etc. Regardless of the format chosen for the research project all materials must be submitted for consideration by the appropriate research ethics committee and as such need to be included as part of your application for ethics review.
Key points to remember when designing participant information materials:
Tone and Language
Information should be presented in a way that is clear and easy to understand by the target population (for example, it should be age, ability, culture and context appropriate). The information should be concise and presented in a length and format which encourages participants to absorb it in full. Try not to use technical language and acronyms unless this is essential. If you do use such terminology, try to give simple and clear explanations of what they mean. Be open and friendly in your tone and avoid being overly persuasive as participants should not feel pressured into participating in your study.
Anonymity and Confidentiality
It is important to provide participants with relevant assurances about how their data will be used and what options there are for their name and other personal details being held securely within the project and not being made public. There are distinct differences between confidentiality and anonymity. For non-researchers the implications of this are not always clear and so it is important to be clear on the meaning of each before providing information to participants about this.
Anonymity
When data is collected and held anonymously, there are no identifiers that can link the information collected to the participant; not even the researcher could identify a specific participant. For further information about anonymity, please see our guidance on Anonymisation and Pseudonymisation.
Confidentiality
When data is collected and held confidentially, the researcher can identify the participants. Research participants have a right to expect that any information they provide will be treated confidentially and that they will not be identifiable in any published work. You should assure research participants that their involvement will be confidential (where at all possible).
There may be situations where it is necessary for researchers to breach confidentiality, for example if the research reveals significant risks to the participant or other people. In these cases, the participant should be informed (where possible) about the action being taken by the researcher, unless this could increase the risk to those concerned. Your information materials should advise participants of any potential limits to confidentiality.
It is also important to remember that sometimes participants want their contribution to be acknowledged in the outputs of the research and therefore do not wish to be subject to assurances of anonymity or confidentiality.
The right to withdraw participant and data from the study
Information materials should assure participants that they have the right to withdraw their participation from the study at any time, without needing to give a reason and without penalty.
Participants should also be informed about when and how they can withdraw their data. This is different from withdrawal of participation. This is because there may be additional limits that apply to the withdrawal of data. These may be practical in nature, for example if data is anonymous then it is not possible to identify data to withdraw it. These limits may also be related to the research design. For example, it is ordinary practice to inform participants that data cannot be withdrawn after a specified point when analysis has started, to protect the ongoing viability of the project. Any limits to the withdrawal should be transparently communicated. For example, if you intend to anonymise participant data, you must make it clear that withdrawal of any data collected can only occur within a certain time frame (e.g., two weeks after data collection).
Financial incentives
It is important to recognise the contribution that research participants make. If your study involves financial incentives or opportunities for financial reimbursements to participants (e.g., gift tokens to thank them for their time, entry into prize draws, or reimbursement of expenses), then information about this should be provided in the participant information materials.
There is guidance on incentive payments to research volunteers available on the University’s Finance & Procurement website. Aside from financial payments, you can recognise participants’ contributions by thanking them, keeping them updated on the progress of the research and informing them about project outcomes.
When using financial incentives researchers should consider the need to treat participants with respect and dignity and remember that certain incentives may influence potential participants to take part in research. For example, will participants from financially disadvantaged groups feel more inclined to participate more often and/or on more ‘risky’ research? As such, it is expected that compensation should be proportionate to the burden of research on the participant and the duration of the participation in the study. There should be no coercion or undue influence on research participants to take part in the research and any use of these incentives will need to be justified in the ethics review form. Finally, consideration should be given to how and when recompense is discussed/advertised. It is best practice not to mention recompense on recruitment materials, but if it is required, information about recompense should not be included at the expense of providing information about the study, what is required from the participants etc.
Guidance and templates
Written participant information sheets should be presented on headed paper with the name of the University and the department where the principal investigator is based. Contact details for the researchers should be clearly provided.
For complex studies where the participant information sheet is long, it is advisable to provide a summary of the important information at the beginning of the information sheet.
You may find University of Bath templates useful in designing information participation sheets. These can be accessed via Ethics@Bath. Note that templates should be considered as framework documents and will require adaption to ensure that they clearly convey the nature of your research.
Participant information materials may cover the following points:
What is the purpose of the project?
Why have I been selected? Or who can be a participant?
Do I have to take part?
What will I be asked to do?
What are the exclusion criteria? Are there any reasons why I should not take part?
What are the possible benefits of taking part?
What are the possible disadvantages or risks of taking part?
Will my participation involve any discomfort or embarrassment?
Who will access to the information I provide?
What will happen to the data collected and the results of the project?
Who has reviewed the project? (Details of ethical consideration)
How and when can I withdraw from the project?
The University of Bath privacy notice
- What happens if there is a problem?
If I require further information, who should I contact and how?
For further information on designing participant information sheets, please see the Health Research Authority guidance