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
Vulnerable Adults
Children and Young People

(Please use the tabs on the left to explore these topics further).

To take part in a study, research participants must give their full, informed consent. 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 become 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. If a participant is unable to sign a document, (i.e. young child or vulnerable adult) they should give their consent verbally in the presence of an appropriate witness, who can sign on their behalf.

What is Consent?

Consent is the central act in research ethics, as set out in the 1947 Nuremberg Code. The 1964 Helsinki Declaration stipulated 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 a 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.

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:

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 questionnaires, where in most cases, the principle of implied consent may be invoked (i.e. where consent is apparent by the return of a completed document).
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 there is to be no interaction between researchers and the public). Where research is to be undertaken in public places, those carrying out 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.

These situations do not remove the necessity for ethical approval.

Vulnerable Adults and Consent

For a research participant who lacks capacity to give valid consent, the researcher must act in accordance with the provisions of the Mental Capacity Act 2005 (MCA). The Act applies to all decisions taken on behalf of people who permanently or temporarily lack capacity to make decisions for themselves, including decisions to involve such individuals in research. All researchers working with participants who lack, or may lack, capacity need to be aware of its underlying principles and the statutory provisions relating to research.

Researchers should note that for research proposals intending to involve individuals coming within the definition of mental incapacity within the terms of the Act, research ethics approval will need to be obtained from a Health Research Authority authorised committee. There are special statutory safeguards required in relation to the conduct of research intended to involve such individuals; see sections 30-33 of the Mental Capacity Act 2005 and appropriate guidance.

Research involving individuals from whom it is not possible to obtain consent, including proxy or advance consent, should be done only if the physical or mental condition that prevents obtaining informed consent is a necessary characteristic of the research population. The scientific reasons for involving research participants with a condition that renders them unable to give informed consent must be stated for consideration and approval by the appropriate Research Ethics Committee. The research must also meet one of two requirements:

The research must have some chance of benefiting the person who lacks capacity. The benefit must be in proportion to any burden caused by taking part; or
The aim of the research must be to provide knowledge about the cause of, or treatment or care of people with, the same impairing condition, or a similar condition.

If undertaking work which engages the MCA, please refer to the Mental Capacity Act Code of Practice before preparing your proposal.

Briefly, the responsibilities of the researcher in studies where participants lack capacity to consent are:

Researchers should assume that a person has capacity to make a decision unless it can be established that they lack capacity; a person's capacity must be assessed specifically in terms of their capacity to make a particular decision at the time it needs to be made (see chapter 4 of the Code of Practice).
The potential participant must receive support to help them make their own decision (see chapter 3 of the Code of Practice).
Researchers must obtain approval from the appropriate body (usually the Health Research Authority).
The views of any carers or other relevant people must be sought before involving a person who lacks capacity in research. This means acting in accordance with section 32 of the MCA to determine whether the person should be included.
The wishes, objections and feelings of the person must be respected.
More importance should be placed on the person's interests than on those of science and society.
Even when a consultee agrees that a person can take part in research, the researcher must still consider the person's wishes and feelings.
Researchers must not do anything the person who lacks capacity objects to. They must not do anything to go against any advanced decision to refuse treatment or other statement the person has previously made expressing preferences about their care or treatment. Researchers must assume that the person's interests in this matter are more important than those of science and society.

A researcher must withdraw someone from a project if:

They indicate in any way that they want to be withdrawn (e.g. if they become upset or distressed), or
If any of the Act's requirements are no longer met.

For further advice on the process of obtaining approval for research under the MCA please contact the UREC.

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, investigators should also adopt approaches that are not coercive and that provide full disclosure of all study procedures when recruiting participants.

Human Resources (HR)