In this section we will address Consent.

The topics covered will help you to better understand what consent is and the challenges faced by researchers in relation to determining:

whether or not consent is required
the meaning of informed consent
exceptional situations that may require you to plan and think differently

Research participants must give their full, informed consent to take part in a research study. This consent must be given voluntarily and only once the participant understands the nature, significance and implications of the study. It is important that participants do not feel under any pressure to agree to becoming involved. Participants must know their rights and these cannot be waived – even willingly, participants cannot release the researcher or research sponsor (Brunel) from liability and responsibility towards them.

Gaining informed consent is not just about signing a form; it is a process which must be followed carefully. This process begins with giving clear explanation of the research, its purpose, its risks and the procedures or activities the participant will be undertaking. If, after this, a participant wishes to give their consent, it must then be recorded in writing, dated and signed, and a copy kept by both the researcher and the participant. If a participant is unable to sign a document (or in other circumstances in which a formal consent document is not appropriate), they should give their consent verbally in the presence of an appropriate witness, who can sign on their behalf.

If participants give their informed consent at the start of the study, it does not mean they have consented to take part until the end. They are free to withdraw from the research at any time and can also ask for their data to be withdrawn. It is important that this point is made clear before consent is obtained. If it is a longitudinal or long-running study, it is good practice to seek consent from participants more than once, at suitable intervals during the process. Participants must also be re-consented if there are material changes in the conditions or procedures of the research.

What is Consent?

Consent is the central act in research ethics, as set out in the 1947 Nuremberg Code. The 1964 Helsinki Declaration stipulates that valid consent is properly informed and also freely given – without pressures such as coercion, threats or persuasion. The Nuremberg Code and Helsinki Declaration remain at the foundation of principles of consent in research today.

Participants and researchers may define ‘harm’ very differently. The consent process needs to allow time to clarify any differences. Researchers may then gain new insights into risks, and how to reduce them.

Consent is therefore a process – not simply 'yes' or 'no'. It is the process by which potential participants can decide if it is worth taking part in a study despite any risks and costs. This may sound rather extreme for a decision to take part in a small study, but respect for consent sets standards of respect for the whole relationship between the researchers and participants.

What should I think about in relation to Consent?

To take part in a study, research participants must freely give their full, informed consent. The elements of consent can be stated as follows:

Disclosure – the potential participant must be informed as fully as possible of the nature and purpose of the research, the procedures to be used, the expected benefits to the participant and/or society, the potential of reasonably foreseeable risks, stresses and discomforts, and alternatives to participating in the research. There should also be a statement that describes procedures in place to ensure the confidentiality and/or anonymity of the participant. The Participant Information Sheet should make it clear who to contact with questions about the research.

Understanding – the participant must understand what has been explained and must be given the opportunity to ask questions and have them answered by one of the researchers. The Participant Information Sheet must be written in simple language, avoiding any technical jargon.

Voluntariness – the participant’s consent to participate in the research must be voluntary, free of any coercion or promises of benefits unlikely to result from participation. Inducements (such as financial awards) must not be made without robust justification, particularly where such inducements may compromise consent.

Competence – the participant must be competent to give consent – i.e. capable of understanding and retaining the information, and capable of weighing risks and making a choice. If the participant is not competent due to mental status, disease, or emergency, the principles of the Mental Capacity Act 2005 become engaged.

Consent – the potential participant must authorise his/her participation in the research study, preferably in writing, although at times a verbal consent or assent may be appropriate.

Freely given informed consent entails:

giving sufficient and appropriate information about the research, to allow participants to make a meaningful choice about whether or not to take part
ensuring that there is no explicit or implicit coercion, so prospective participants can make an informed and free decision on their possible involvement.

Information for participants should be provided in an accessible and comprehensive format, typically in written form via a Participant Information Sheet (or in a form that participants can access after the end of the research interaction).

Time should be allowed for the participants to consider their choices and to discuss their decision with others if appropriate.

Research should not normally proceed until participants have indicated their consent and this has been recorded. This can typically be done by asking participants to sign a consent form, but in some cases it may be more appropriate (and more ethical) to use alternative approaches to record consent.

Consent, however, is not simply given through the formal signing of a consent document at the start of research. Instead it should, as far as possible, and in an appropriate balance with resources available and researchers' responsibility to truth-telling, be open to revision and withdrawal throughout the research lifecycle of a project.

Informed consent should take into account the long-term use of participant research data, including the potential for further data linkage and preservation of data when obtaining consent. Participants need, as far as possible, to give specific consent if data are to be archived and shared.

When eliciting consent, researchers should make clear the limits to confidentiality, particularly when working with potentially vulnerable individuals or groups, for example children, families and vulnerable populations, or individuals involved in illegal activities. If an interview reveals that a participant or another person identified in the interview is in significant danger, the researcher will be obliged to take action in response to that disclosure to protect the participant or third parties.

Informed Consent - are there any exceptions?

There are a number of exceptions that can apply – most notably, in situations involving mental incapacity, where the provisions of the Mental Capacity Act 2005 (MCA) with regard to personal consultees become engaged (see section on participants unable to consent for themselves); and in relation to surveys or questionnaires, where in most cases, the principle of implied consent may be invoked (i.e. where consent is apparent by the submission of a completed questionnaire).

Individual consent may be unnecessary for some research activities, such as community research which is unintrusive (for example, studies involving observation of human behaviour). Where research is to be undertaken in public places, those engaged in the research must have due regard to religious and cultural sensitivities.

Where the nature of the research is such that informing participants before the work is carried out may render the results invalid, researchers must provide convincing reasons why such research should go ahead despite the absence of informed consent. An appropriate debrief procedure must also be in place.

These situations do not remove the necessity for ethical approval, and researchers must provide a justification for their proposed consent arrangements in all cases.

Deception

As a general rule, people should know beforehand that they are participating in a research study and be asked to give their consent. However, some studies may involve an aspect about which the participant is not made aware (e.g. provision of a placebo treatment) where informing the participant would invalidate the research. In all cases the procedure to be used must be accepted and approved by the relevant Research Ethics Committee upon adequate justification by the researcher.

Right to Withdraw

Gaining informed consent is much more than signing a piece of paper. It should be a continuous process of communication between the researcher and the participants.

During a study, the body of knowledge impacting a study can frequently change and so it should not be expected of participants that their informed consent at the start of the study, means they have consented to take part until the end of a study. Participants have the right to withdraw from the research at any time and can also ask for their data to be withdrawn without giving a reason or without any consequences. They also have the right to refuse to answer any particular question(s) or participate in a particular set of procedures.

It is important that this point is made clear to a participant before consent is obtained. If it is a longitudinal or long-running study, it is good practice to seek consent from participants more than once, at suitable intervals during the process. Participants must also be re-consented if there are material changes in the conditions or procedures of the research.

Based on this, researchers must design their study so that a participant can exercise their rights to withdraw. This may include stating a time period in which participants have to withdraw their data (e.g. once results are published) or by debriefing a participant with their participant number and relevant contact details so that the participant knows how to withdraw their data.

To ensure voluntary participation, researchers should also adopt approaches that are not coercive and that provide full disclosure of all study procedures when recruiting participants.

Multimorbidity: Current challenges and research opportunities