Writing an Informed Consent Form
Informed consent means that participants understand what your study involves and agree to take part freely. The consent form, together with a participant information sheet, is how you record that agreement. In this blog, we'll look at what these documents should cover and how to write them clearly. Always use your university's template if one is provided.
The Participant Information Sheet:
- This explains the study in plain language before the participant decides whether to take part.
- It usually covers: the purpose of the study, who is running it, why the person has been invited, and what taking part involves, including time commitment.
- It should also explain possible risks and benefits, how data will be used and stored, and who to contact with questions or complaints.
What the Consent Form Should Include:
- The study title and the researcher's name and contact details.
- A set of clear statements for participants to confirm, such as:
- "I have read and understood the information sheet and had the chance to ask questions."
- "I understand that taking part is voluntary and that I can withdraw without giving a reason."
- "I agree to the interview being audio recorded."
- "I understand how my data will be stored, anonymised and used."
- Space for the participant's name, signature and date, and for the researcher's signature if required.
Explain Withdrawal Clearly:
- State how participants can withdraw and whether there is a point after which their data cannot be removed, for example once it has been anonymised and analysed.
- Make sure this matches what your ethics application says.
Write in Plain Language:
- Use short sentences and everyday words. Avoid jargon and technical terms.
- Translate the documents if participants are more comfortable in another language, and check the translation carefully.
- Use a readable font size and a clear layout.
Online Surveys and Special Cases:
- For online surveys, consent is often recorded through a tick box at the start, after the information has been shown.
- Studies involving children or people who may lack capacity to consent usually need additional safeguards, such as consent from a parent or guardian. Follow your ethics committee's guidance closely.
Storing Consent Records:
- Keep signed forms securely and separately from the research data, so that names cannot easily be linked to responses.
- Retain them for the period required by your institution.
A good consent process is clear, honest and respectful of participants' choices. Explain your study in plain language, give participants real control over their involvement, and record their consent carefully. Your ethics committee and your participants will both thank you for it.