Research Ethics - Consent

Consent to participate is the fundamental component in research ethics and should, in all circumstances, be valid, voluntary and informed. In addition, there should be absolute certainty on the part of the researcher that the participant is competent to decide whether or not to participate in the research.

The principle of consent is enshrined at the core of both the Nuremberg Code (1947) and Helsinki Declaration (1964), which continue to form the foundation of principles of consent in research to this day.

What is valid consent?

For consent to be valid, the participant must be provided with sufficient information on the proposed research so as to be able to make a fully informed decision. The agreement to participate in the proposed research must be free from coercion or inducement and the participant must have sufficient capacity to understand the purpose of the research and what participation entails.

In Good practice in research and Consent to research (2010), the General Medical Council state that consent from a participant is "...legally valid and professionally acceptable only if they have the capacity to decide whether to take part in the research, have been properly informed, and have agreed to participate without pressure or coercion".

What is informed consent?

Informed consent (otherwise also known as valid consent) ensures that the participant is given suitable and sufficient information on the purpose of the proposed study and that no form of coercion to participate has taken place. This will ensure that the participant is able to make a free and informed decision as to whether or not they wish to participate.

The process of obtaining valid consent will involve providing sufficient time for participants to review the information provided on the proposed research prior to providing signed consent to confirm a willingness to participate. In the event that the participant is not legally responsible (e.g. children, those with diminished mental capacity), written consent must be obtained from their legal representatives, parents, guardians or 'gatekeepers'.

The participant information sheet should include:

an outline of the proposed research and what is involved;
the purpose of the research;
who will be conducting the research;
details on funding source and sponsoring institution;
what will happen to the data and what parties will have access to it;
how long the data will be stored or archived for;
the requirements of participation;
the length of the research;
the participant's rights to confidentiality and anonymity;
procedures for confidentiality and anonymity (e.g. use of pseudonyms, anonymisation of data, removal of direct and indirect identifiers, coding).
the participant's right to withdraw from the research at any without consequence;
protocol for support if participant experiences psychological or physical distress;
procedure for filing a complaint.

The participant information sheet should be written in lay terms and should be free from jargon or technical language. Those responsible for the proposed research must ensure separate terms of consent are offered for interviews, focus groups, video or audio recording and any other forms of data collection inherent to the research.

With regard to participant withdrawal, some consideration should be given to measures for retroactive withdrawal. Should a participant seek to withdraw from the research completely, thus requesting the removal of any pre-existing data, the situation can be problematic. Where the proposed research involves a small group of participants, the removal of a significant amount of data can be potentially very damaging. The UK Data Archive put forward the following guidance for researchers dealing with a request for retroactive withdrawal:

If a participant requests retroactive withdrawal (of all their contribution), you should request a meeting to explain to the participant the costs to the project. If appropriate, the participant should be asked to reconsider their decision.
Although the option of being able to withdraw as a project proceeds should be explained in information and consent forms, the option of retroactive withdrawal need not be made explicit as an option. It can be dealt with on a case-by-case basis, only if it arises.
Projects should be clear in their own planning what they will do in the event of a participant continuing to insist on full withdrawal. In most cases, the ethical duty to the participant and the risk to a project for loss of goodwill are more than sufficient to offset any possible gain by retaining the data, and the project will accede to the participant's request in the final instance.
If all fails and they do wish to withdraw retroactively, participants could be asked to consider whether some of the data could be used, for example, that which could be completely anonymised.

The process of consent is active and continuous, with consent being specific to the proposed arrangements put forward to the participant. Should the arrangement of the research design be altered in such a way that ethical considerations change, the original written consent of the participant may no longer be valid. In such cases, participants must be informed of the proposed change to the research and consent under the new arrangement obtained.