You have just received ethics approval for your primary research study. Your supervisor tells you ethical research involves conducting yourself with integrity, while having due respect for your participants. They remind you of the importance of informed consent. So, you seek guidance on how to ask for informed consent from your participants.
Our advice is to consider the ‘4P’s’ – principle, procedure, process and practice.
Principle of informed consent
Upholding the principle of informed consent is sacrosanct. It requires that your participants be fully conversant with the nature and intention of your research before deciding to take part. Consequently, you must demonstrate that your participants:
- Agree to involvement in your research of their own free will; and
- Make the decision without undue influence or pressure; and
- Receive appropriate information about what they are partaking in; and
- Provide an evidentiary record of their consent (in writing, or from an audio or audio-visual recording).
In the case of children or vulnerable adults, consent should be sought from the participants’ parents or legal guardians.
Procedure for informed consent
When quantitative researchers accumulate their data, they tend not be directly involved with seeking consent (except for face-to-face questionnaires). In contrast, qualitative researchers are nearly always present and immersed when consent is being secured (except for self-completed diary studies).
Whether you are a quantitative, qualitative or mixed methods researcher, you should ensure your participants are aware that:
- Before data collection commences, they have the right to say no, decline or refuse permission to engage in your research.
- During data collection, they still have the right to turn down participation in your research and not proceed with the study, and to reject the use of audio, audio-visual or any other sort of recording device.
- After data collection, they continue to have the right to withdraw from your study, and to amend, revise, omit or delete data relating to them.
The type of informed consent you seek depends on your research time horizons. Typically:
- With a cross-sectional snapshot, asking for consent is a once-off event.
- With a longitudinal study, asking for consent is ongoing. It is then subject to recurring approval or renegotiation during data collection.
- When research is undertaken without participants’ knowledge, such as studies requiring covert observation, asking for consent does not happen. However, this is only acceptable if the absolute success of your investigation depends on participants not being advised of your hidden role.
Process of informed consent
The process of obtaining informed consent entails pre-preparing relevant, user-friendly information. In advance of gathering personal data, you should furnish each participant with details specifying:
- Who is conducting your research.
- Why your research is being carried out.
- What your research is about.
- What are the withdrawal mechanisms.
- Who is financing the research (if applicable).
- What the participant is agreeing to.
- What role the participant plays in your research.
- What are the data (raw, analysed and interpreted) amendment and deletion protocols.
- What happens participant data (including recordings) during collection.
- What happens participant data (raw, analysed and interpreted) after collection.
- How confidentiality is to be preserved.
- How anonymity is to be preserved.
- How are participant data (digital and physical) to be stored.
- How long is participant data (digital and physical) retained for.
- How are participant data (digital and physical) to be disposed of.
- When are participant data (digital and physical) to be disposed.
- Who can access participant data (digital and physical).
- How results and findings are to be disseminated.
- When results and findings are to be disseminated.
- Where results and findings are to be disseminated.
Practice of informed consent
The information supplied should be appropriate for the needs of your participants. It will most likely be in text format, written in a suitable language with accessible wording. Depending on circumstances, it may have to be presented via audio recordings, audio-visual recordings and/or signed language. You should give the information to your participants personally. It should be done in a courteous manner and at an opportune time (that is, before data collection). This enables your participants to grant their informed consent (or not) before engaging in your research.
Remember, when your participants (or their parents’ or legal guardians) offer their informed consent, they trust that their data will be treated in an honourable way. They willingly supply their data to you on a voluntary basis and in confidence. This is the hallmark of ethical research practice.