11.1 What is informed consent?
One definition of informed consent is ‘an ongoing agreement by a person to receive treatment, undergo procedures or participate in research, after risks, benefits and alternatives have been adequately explained to them’ (Royal College of Nursing 2005).
There are three requirements that must be satisfied before a potential research participant can be said to have given informed consent:
The consent should be given by someone with the mental ability to do so.
Sufficient information should be given to and understood by the participant.
The consent must be freely given.It is also legally established that personal information should not be used for research without the explicit consent of the individual. This means they must have been asked specifically for their permission to disclose the information, been given an explanation of how the information will be used, and have given their permission in writing for the information to be used (Data Protection Act 1998).
Clearly it is important to ensure that those who take part in research understand exactly what is involved, and informed consent helps to ensure that people are not deceived or coerced into participating in research, and that the researcher has permission to collect and use the person’s personal information.
11.2 Taking informed consent
You are not going to deliberately coerce or deceive people into taking part in your research project; nevertheless, subtle pressures may compromise the voluntary nature of consent. If a person does not have, or does not think they have, many viable options to choose from, this may place a pressure on them to participate. People may feel obliged to participate because:
they do not know that participation is optional
they think that participation is clinically recommended
they think that if they don’t participate, the care they receive will suffer
they feel that they have a duty to help the researcher (possibly someone with whom they have an existing relationship) by participating
they are not given enough time to consider their options (particularly if approached at a time of stress)
they feel that unless they can provide a good reason, they may appear foolish if they refuse to participate
once they have given their consent, and the study is underway, they do not realise that they are free to withdraw from the study at any timeTherefore, it is important to address these issues in the process of obtaining consent. A suggested procedure is outlined here:
Talk through and explain the study in detail to the volunteer verbally, then provide the approved patient information sheet. You may also wish to go through the sheet with the patient or even read it out for visually impaired people.
Take time to stress that participation is voluntary, their care will not be affected by their decision and that they do not have to provide a reason for not taking part.
Be clear about the risks or inconveniences involved in taking part as well as the potential benefits for the volunteer.
Make sure the volunteer has had time to consider the information fully and time to decide whether they want to take part; 24 hours is usually regarded as the minimum time. You must be satisfied that the volunteer has had sufficient time to consider his/her participation and ask any questions they may have.
Look out for clues that a person may feel uncomfortable or are reluctant to take part; some people find it hard just to refuse. You must give them an easy way to say no, for example by suggesting they appear unsure and asking if they would rather not take part. An unwilling research participant is not going to help you complete a good study; it will simply result in more people dropping out or increased non-compliance.
Before asking the volunteer to complete the consent form ask if they have any questions or concerns they want to discuss. Ask if they require any more time to think about it, or to consult their next of kin or another person. Again you must feel confident that the person fully understands the project, and particularly what will be asked of them during the study. It is in your best interest to take care over this stage, not only to protect the volunteer, but also to ensure your carefully recruited and assessed participants don–t drop out further down the line when their expectations are not met.
Ask the volunteers to complete the consent form themselves. The ‘gold standard’ is for each question or statement to be initialled; ask volunteers not to just tick the box. The form should be signed and dated by both the patient and the researcher.
The volunteer must be given a copy of the form. Either ask the volunteer to fill out two forms so they have a copy and you keep a copy, or photocopy the form for them.Recruiting participants can often be difficult and as a researcher you are under pressure to recruit, but you must feel comfortable that all your participants have freely given their consent because you are responsible for the research and your participants’ wellbeing. You need to achieve a balance between encouraging people to take part without coercion, and putting people off unnecessarily by focusing entirely on the risks and difficulties.
The problems of getting consent vary according to the type of study you are carrying out and the participants involved. Healthy volunteers may be influenced by financial reward to take part, whereas elderly participants may take longer to comprehend the details or be more vulnerable to coercion because they feel they have a duty to help. People with English as their second language or with low education or literacy may also need more time and simplified strategies to ensure understanding is complete (Sugarman, McCrory & Hubal 1998). Box 11.1 provides ideas to maximise your ability to get informed consent. You will have to think through these issues and highlight how you intend to ensure the consent process is robust in your ethics application.
A statement about how you intend to approach patients also needs to be included in the ethics application. Ideally potential volunteers should be approached in person, but this is not always possible. If you intend to write to patients or healthy volunteers to ask them to participate in your research, a copy of the proposed letter should be included in the ethics application form for approval.
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