Informed consent

What is informed consent?

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). 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:

  • Stage 1 (giving information): the person reflects on the information given; they are under no pressure to respond to the researcher immediately.
     
  • Stage 2 (obtaining consent): the researcher reiterates the terms of the research, often as separate bullet points or clauses; the person agrees to each term (giving explicit consent) before agreeing to take part in the project as a whole. Consent has been obtained.

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.

Written or oral consent – which process suits your project?

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, and not usually allowed by the Medical Sciences IDREC. 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 sample informed consent templates for each process.

Expand All

A written process is used where:

  • Reading and signing forms is not problematic.
  • The research is complex or has multiple stages.
  • First access to the research participants is by providing written information.

Though opinions differ about the legal force of signed consent forms, a signed consent form acts as 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:

  • where literacy is a problem,
  • where there are cultural or political concerns with signing contract-like documents,
  • where either the researcher and/or the participant could be put at risk by existence of a paper record,
  • where time for consent is limited, eg a chance interaction between researcher and participant (although you should not use an oral process merely to correct poor planning of research).

It may also be more appropriate when interviewing elite participants as part of the research.

It is highly unlikely that oral consent processes will be permissible when applying to the Medical Sciences IDREC. If in doubt, please contact the Medical Sciences IDREC for advice.

For all other research, how you arrange your oral process depends on how you will encounter your participants (eg email, phone, an on-the-street-meeting by chance). Between information 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 (eg audio recorder if you are conducting an interview) or, if participants do not agree to audio recording or if using/keeping audio records is unsafe, by using a researcher record of oral consent template.

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.

Written informed consent process (including online surveys)

Any relevant advertising or recruiting material (poster, email text, social media advert)

Written sheet of information, aka participant information sheet, participant invitation letter/email

Participant information sheet for CUREC 3 studies

Written sample consent form

Consent form for CUREC 3 studies

For online surveys only, where there is no face-to-face contact with human participants: please adapt the template given in Annex A of the best practice guidance on internet-based research may be adapted.

 

Oral informed consent process

Any relevant advertising or recruiting material (poster, email text, social media advert) (if applicable)

Oral script
Written information sheet (if using)
Assent template for studies recruiting children
Alongside your script, the use of an oral consent record form is recommended. This is a form only you fill in, and helps you keep track of any specific conditions attached to an oral consent (optional, for researcher's own use)
   

 

Exceptions

Expand All

Researchers should always aim to inform people fully and obtain appropriate consent. However, in some cases the research may be straightforward enough that a separate, deliberate process for obtaining consent is not needed. In these cases participants, by their actions, imply consent. This is seen most often in research:

  • where researchers have no direct contact with participants, eg research survey deployed via an online survey platform such as Qualtrix (however, please see CUREC’s separate guidance on internet-based research (BPG 06), including an informed consent template specifically for online surveys in Appendix A);
  • where no participant personal details are obtained;
  • where the topic of research is very low risk and no sensitive data will be collected; and
  • where participation is confined to one small task, eg completing a survey or simple pencil or computer task.

Please note: consent cannot be inferred from inaction (eg failure to move away from a camera).
 

If your research employs deception, you will not be able to inform participants fully about your project’s true aims. In this case please check if you can fully apply the CUREC approved procedure on research involving the deception of participants. If the deception raises ethical concerns such that the application is not covered by this procedure please prepare a full CUREC 2 application form.

Some research settings evolve very rapidly (eg in conflict studies). Similarly, some research participants may only be revealed in time-poor or emergency settings (eg heart attack patients). This infringes on the standard information-giving stage of research. The vulnerability of participants in those settings may justify an expedited or fully waived consent process. Again it is important to describe the research setting clearly. You may need to complete a full CUREC 2 application to the relevant committee in these cases: please check with your DREC or your IDREC.

List of site pages