Informed consent is one of the founding principles of research ethics. Its intent is that human participants can enter research freely (voluntarily) with full information about what it means for them to take part, and that they give consent before they enter the research.
Consent should be obtained before the participant enters the research (prospectively), and there must be no undue influence on participants to consent. The minimum requirements for consent to be informed are that the participant understands what the research is and what they are consenting to.
There are two distinct stages to a standard consent process for competent adults:
Researchers should ensure that they comply with the General Data Protection Regulation (GDPR) during and after the consent process, especially if they will be collecting 'special category' (ie sensitive) data or personal data in the course of their research (also refer to the advice on consent in research involving children). See also the guidance on data protection and research and the data protection checklist for use when preparing an application for ethical review.
Where your research includes filming or photography, you should refer to specific guidance in the Photography and GDPR toolkit.
Which process to use depends on the research project (its context, design and participants), though an oral process is usually only appropriate where a written process is not feasible. Any consent process must be understandable to the participants concerned. Please see the sections below to find out about different processes which may be used depending on the context, as well as informed consent templates for each process.
A written process is used where:
Though opinions differ about the legal force of signed consent forms, they provide extra proof that the terms of consent have been understood. This can be especially important when seeking consent for copyright over data, or for future uses of data. Also, future funders or regulators may want written proof of the terms of original consent.
For literate participants who are not put off by written information, a written process is often a straightforward way of communicating the 'research contract'.
Between the provision of information and obtaining consent, the participant should be given a reasonable amount of time to consider whether to consent and to ask questions, though the time given depends on the project design, the context of the research and the participants.
The written consent templates below can be adapted to suit your study.
An oral consent process is where researcher and participant have a conversation to give information and obtain consent. There is no paper form to sign. It is normally used:
It may also be more appropriate when interviewing elite participants as part of the research.
For all other research, how you arrange the oral process depends on how you will encounter your participants (for example email, phone, an on-the-street-meeting by chance). Between the information-giving and consent stage the participant should be given a reasonable amount of time to consider whether to consent, though this depends on the project design, the type of participants and the context of the research.
When obtaining oral consent, please ensure you are recording the consent process either using a recording device (for example audio recorder if you are conducting an interview that needs to be recorded) or, if participants do not agree to audio recording or if using or keeping audio records is unsafe, by using a researcher record of oral consent template or completing a written consent form on their behalf.
The oral consent templates below can be adapted to suit your study, but careful consideration is required to ensure that these are appropriate for the research and the participants.