Informed Consent is the process of voluntary agreement by a fully informed competent person to participate in research. Potential participants must be given sufficient information to allow them to decide whether or not they want to take part in a research study.
Writing a form for informed consent
Where research involves personal contact with the researcher such as face to face interviews, focus groups, direct observation, physiological measurements or other methods of data collection involving personal contact, participants should be given a participant information sheet (or leaflet) and would normally be asked to sign a consent form. In most cases, consent should be actively provided by the participant, but there are instances when implied consent can be used, e.g. an online survey that doesn’t collect any personal or sensitive data and is low risk.
A consent form should be a short document (normally one page but may need to be longer depending on the complexity of the study) containing explicit statements of what taking part in the research project involves and what will become of the data collected.
The consent form should have tick boxes to allow the participant to consent to each of the statements and, when appropriate, allow the participant not to take part in certain aspects of the study by either agreeing or disagreeing to a statement, e.g. not consenting to their data being used in future research. Both the participant and the researcher obtaining consent should sign the form. Two forms should be signed so that the participant can be provided with a signed copy to keep for their records.
Clear evidence must be obtained that the participant has given informed consent to take part in the study. This will normally be in the form of a signed consent form although other evidence may be acceptable (for example by audio recording consent). It is recognised that there are some rare instances when it will not be possible or appropriate to ask for written consent (e.g. where there are cultural or political concerns with signing contract-like documents).
Opt-in consent is City’s preferred approach, as Opt-out does not reflect a conscious decision by those invited to accept or decline an invitation to participate in research. Requests for opt-out consent will only be considered in exceptional cases and a full explanation should be provided.
Please bear in mind that the template does not cover all eventualities but suggests some potential scenarios.
The consent form should include the following statements:
- I confirm that I have had the project explained to me, and have read the participant information sheet, which I may keep for my records. I have been given the opportunity to ask questions and have had them answered to my satisfaction.
- If applicable, a statement asking the participant to consent to audio and or video recording.
- I understand taking part in the study will involve… (e.g. being interviewed, taking part in a focus group, having physiological measures taken)
- I understand that my participation is voluntary, that I can choose not to participate in part or all of the project, and that I can withdraw at any stage of the project without being penalized or disadvantaged in any way.
- I agree to take part in this study.
- A statement that asks the participant to agree to City, University of London recording and processing this information about them and that they understand that the information collected in the study will be used only for the purpose(s) set out in the consent form.
- A statement that asks the participant to confirm that they understand how their data will be handled (e.g. stored, destroyed, sharing, what it will be used for).
In addition to the above it would be expected that explicit consent for the following is obtained where applicable:
- Reuse of data and an explanation what the data will be used for, as well as reassurance that the data will only be reused in studies which have been given ethics approval.
- The use of direct quotes.
- Sharing data outside the research team (e.g. with collaborators).
- If using anonymous online/paper surveys, a statement that asks the participant to confirm that they understand that their data cannot be withdrawn and/or when it is no longer possible to withdraw their data, e.g. once the data has been anonymised.
- A statement that asks the participant to confirm that they understand that their anonymous data will be made open access, e.g. to underpin journal publication or to meet funding requirements.
Writing a participant information sheet
The Guidance for producing a participant information sheet has some standard text which you cannot change but also some text which you can amend and this text is in italics. This guidance helps you complete the sheet by offering further explanation of parts of the information sheet and things to ensure you have included.
The participant information sheet should be designed so that potential participants of your research project can give informed consent to participate in the project.
A participant information sheet should:
- provide sufficient and appropriate information on which they can base an informed decision, including the risks and benefits
- be written in language that potential participants could reasonably be expected to understand
- be free from coercive language and promises that cannot be kept or unjustified claims of benefits
- be provided for each data collection tool separately so if the research involves both interviews and focus groups, there must be a PIS for each activity
- be provided for each group of participants so for example students one information sheet and staff a different one
The advantage of a written Information Sheet is that you and your participants have a record of all the relevant information about the study. In most cases this is supplementary to, rather than replacing, a discussion between the researcher and the potential participant.
For some participants such as very young children, a written information sheet is not appropriate (although for children, their guardian should receive written information about the study). For other participants the information may be presented in a letter or email rather than as an 'Information Sheet'.