What is informed consent?

Obtaining freely given informed consent is a fundamental ethical principle. The particular process will vary from study to study depending on the research context and the population being recruited. While providing participants with sufficient appropriate information about the research is often an important component (as described here ), obtaining consent should not be reduced to the provision of these materials alone. Indeed, in some disciplines and contexts the provision of written materials may not be appropriate.

Instead, ‘informed consent’ should be understood as a process that must be tailored to each study context with the overall goal being to enable participants to make a meaningful choice about whether to take part. This might include having a conversation with potential participants, or participants being provided with abbreviated information sheets, or collecting detailed written consent forms. Further details are provided below.

It is important that there is no explicit or implied coercion to take part so that participants can make an informed decision where they do not feel pressured. Participants should be given sufficient time to consider their choices. It is also important that provision is made for participants to change their mind and to stop participating or withdraw their data. Informed consent should cover all pertinent aspects of participation including how the information that the participant provides will be stored, shared and used in the future.

Who should provide informed consent?

Individuals who participate in research, by providing their time and/or data (or in other words “participants”), should provide informed consent before doing so. While this definition is straightforward, there are additional nuances to be aware of when establishing who should properly be deemed to be a “participant”.

In some research methodologies it is quite clear. For example, if conducting interviews, researchers should obtain informed consent from the interviewees. If interviewing a vulnerable group, the consent of additional stakeholders will often be required, for example if recruiting children under the age of 16 parental consent should also be obtained.

The question of who to obtain informed consent from is more complicated in certain contexts, for example in ethnographic observations in a public setting where incidental (and unpredictable) involvement of individuals not under direct study is possible. In this research context, the ethical and legal demands on researchers must be balanced against the background of what is practically possible. Generally, consent should be obtained from all those directly under study, and appropriate measures should be taken to ensure legal obligations are met, with regards to those who may incidentally be involved. This may involve privacy or courtesy notices being posted (unobtrusively) in public view. Alternatively, it may involve engaging with appropriate gatekeepers and strictly anonymising incidental data. In summary, it is not a strict ethical requirement to seek written consent from all those who may be incidentally involved, but the ethical and legal challenges of a research context should be explored.

How can people indicate their consent to take part in research?

In some disciplines it is standard practice for informed consent to be recorded in writing by using a consent form.

In some cases, however, it may be more appropriate to record consent in other ways. It may be necessary, for example, to obtain verbal consent and if appropriate, this could be audio-recorded to provide a record of the consent agreement. Justification for alternative approaches can be provided on strong ethical grounds.

In some contexts, for example naturalistic ethnographic research, the method of obtaining informed consent will significantly differ from the use of standardised consenting materials at the outset of a project. In these cases, researchers are encouraged to explain their chosen approach in detail in their applications for ethical review, with reference to best practice and disciplinary codes of ethics where these exist.

What should I include in my consent form?

If using consent forms, these should be clear and concise, formatted on headed paper with the current University logo. The project title should be clearly stated. The consent form should cover the main points from the Participant Information materials, with statements to which participants can agree or disagree. For example, it is common to include statements where participants can confirm whether they:

• have understood the information they have been given and had the opportunity to ask questions
• have understood whether they can withdraw their participation and data (and how to do this)
• consent to data being preserved for sharing, or used for new purposes
• consent to sensitive personal data being used in the research (if appropriate)

This list is not exhaustive and when designing your consent form, you should consider what is appropriate and relevant to your specific study and target population.

There should be space for the person providing consent to sign and print their name and the date.

You may find the University of Bath templates useful in designing consent forms. These can be accessed via the Ethics@Bath . Note that templates should be considered as framework documents and will require adaption to best suit the nature of your research.

Do participants always have to give informed consent?

There are some types of research where it is impractical for participants to consent or where it would undermine the objectives of the research. If you feel that this applies to your project, you should include full details and explanation in the ethics application. One example where this is accepted practice would be studies that involve deception that is methodologically justified and accompanied by appropriate mitigations to protect participants (such as including an appropriate debrief). One source of guidance on deception is provided by the British Psychological Society here.

Useful Resources

• The Library webpages provide guidance on informed consent:

• Further useful information on obtaining informed consent is available from the UK Research and Innovation webpages

• The Health Research Authority provides useful guidance on the principles of consent and design of participant information and consent materials