Ethical principles: Informed consent

This is the first in a short series of blog posts that briefly looks at each of the key ethical principles it has been important to consider for the OKIS interview study.

Informed consent is the principle that individuals should not be coerced or persuaded, or induced, into research ‘against their will’, but that their participation should be voluntary, and based on a full understanding of the implications of participation. This is especially important if the research involves certain groups of people regarded as ‘vulnerable’ in this respect, such as children, or people with learning difficulties.

Informed consent means that patients should be given sufficient information about a study, and time to consider and decide whether or not they wish to take part.  Information about the study may be given to patients verbally as well as in writing.  In many cases, patients are initially informed about research studies by the health care professionals looking after them.

In the OKIS study, patients aged 16 years and over, who have been fitted with an orthotic device (such as a brace or calliper), will be told about the research by their healthcare professional, who will also give them the written participant information sheet.  If someone is interested in hearing more about the study, the healthcare professional will ask for their permission to pass on their telephone number to me as the researcher and I will contact them in a few days’ time to answer any questions. If the patient decides that they would like to take part in the study, a mutually convenient time and place will be arranged for an interview to take place.  If the participant wishes, a family member or carer may be present during the interview.     

Before the start of the interview, I will ask the participant to sign a written consent form which has been prepared specifically for this study. By signing the consent form, the participant is agreeing to take part in an interview and for it to be recorded.  They are also agreeing that quotations from their interview may be used in reporting the study findings. However, everything said during an interview will be made anonymous, so that individual participants cannot be identified. The consent form makes it clear that the participant can leave the study at any time, and that this will not affect their medical management in any way.

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