Ethical principles: Confidentiality

The Declaration of Helsinki states that ‘Every precaution should be taken to respect the privacy of the subject and the confidentiality of the patient’s information’ (WMA 2000). Confidentiality is a key issue in research practice. For example, information gained from research must not be disclosed in other settings, such as through informal conversation.

In the OKIS interview study, we will audio-record interviews with patients and then the recording will be typed up or ‘transcribed’. The written accounts of interviews (transcriptions) do not contain any patient identifiers – names of people and places are removed when the audiotape is being transcribed. Each transcription is given a patient identifier, a code number, which means it cannot be linked to a person. Only the main study researchers have the ‘key’ to link the name of individual patients with the identification (ID) code. This helps protect confidentiality of patient data. Information from interviews is stored on the University of York’s password protected computer server and/or in locked filing cabinets in a locked room, in an area accessible only to university members of staff.

Confidentiality also relates to published accounts of the research, in which the identity of the research sites (where the research takes place) and individuals involved should be protected where possible. Names and other identifiers can be changed to protect the privacy of participants. For example, in a published paper, the researchers may refer to ‘‘hospital A’ and ‘hospital B’, situated in a large urban area in the North of England’.

Blogger: Dorothy McCaughan

Is everyone able to give informed consent to take part in a research study?

This is an interesting question which raises a number of issues. For consent to be considered both legal and ethical, it must be: given by a person with capacity; voluntarily given, with no undue influence; given by someone who has been adequately informed; and a fair choice.

What is capacity?

Capacity refers to the everyday ability that individuals possess to make decisions or to take actions that affect them, from simple decisions such as what to have for breakfast to far-reaching decisions about serious medical treatment or financial affairs. A person lacks capacity if he or she is unable to make or communicate a decision about a particular matter because of an impairment of, or a disturbance in, the mind or the brain. This may be the result of a variety of conditions, including dementia, mental illness, learning disability, brain damage, intoxication or any other condition causing confusion, drowsiness or loss of consciousness (e.g. concussion, stroke, heart attack, epileptic fit, serious accident, delirium).

Vulnerable groups

Some groups of people are regarded as ‘vulnerable’ in terms of giving informed consent to take part in research studies. Children (under 16 years of age), people with learning and difficulties and others who may lack capacity to give informed consent (such as people with dementia or enduring and severe mental health problems, or those who are unconscious) fall into this category. The interests of these groups of people are protected in a variety of ways, including by acts of legislation, an important one being The Mental Capacity Act (2005).

Lack of capacity to give consent

The Mental Capacity Act (2005) provides a comprehensive framework for decision making on behalf of adults aged 16 and over who are unable to make decisions for themselves, i.e. they lack capacity. The Act applies to all decisions taken on behalf of people who permanently or temporarily lack capacity to make such decisions themselves, including decisions to include such people in research. All researchers working with research participants who lack, or may lack, capacity need to be aware of its underlying principles and the provisions relating to research. The Act is accompanied by a statutory Code of Practice providing guidance on how it should be used. Researchers and others making decisions involving people lacking capacity have a legal duty to have regard to the guidance in the Code of Practice. The Act applies in England and Wales only.

Children and young people

There are many ethical and legal issues to consider when involving children and young people in research, depending on the type of study being carried out (for example, whether or not it is a clinical trial of a medicinal product (CTIMP), and whereabouts in the UK the study is taking place. In particular, it is important to understand the key concepts of consent and assent.

Consent is a legally defined decision given by someone who is competent, who has been adequately informed (and has adequate understanding), and who is free from undue influence enabling them to make a voluntary decision. The person can provide consent, provided they are competent. Otherwise someone who is empowered by law can provide it (e.g. a parent in the case of children). A child who is not capable of giving consent alone can still be involved in the decision making process with others who are able in law to provide consent. There is no legislative statute in England, Wales or Northern Ireland governing a child’s right to consent to take part in studies other than CTIMPs. Common law presumes that young people aged between 16 and 18 years old are usually competent to give consent to treatment.

Assent is difficult to define and is used in diverse ways e.g. compliance by a child as young as three years old, to active agreement of a young teenager. Assent is agreement given by a child/young person or others who are not legally empowered to give consent. It is important to provide children/young people with information that matches their capacity when seeking assent.

Gillick competence

Case law suggests that if a young person has sufficient understanding and intelligence to fully understand what is proposed, and can use and weigh this information in reaching a decision, they are considered ‘Gillick competent’ and can give consent to treatment. ‘Gillick competence’ is a term originating in medical law to decide whether a child (16 years or younger) is able to consent to his or her own medical treatment, without the need for parental permission or knowledge. The standard is based on a decision of the House of Lords in the case Gillick versus West Norfolk and Wisbech Area Health Authority (1985). The case is binding in England and Wales, and has been approved in Australia, Canada and New Zealand. When a young person is believed to be competent, consent from those with parental responsibility is not legally necessary, although the involvement of parents in decision making is encouraged in most circumstances.

In the absence of law relating specifically to research, it is commonly assumed that the principle of ‘Gillick competence’ can be applied not only to consent for treatment but also to consent for research.

As you can see from the above, researchers hoping to gain consent from individuals to take part in a study must give careful consideration to a range of sometimes complex ethical and legal issues.

Blogger: Dorothy McCaughan

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.

Blogger: Dorothy McCaughan

A complex problem

In an earlier post I described what makes a review 'systematic'. In considering all the relevant research, we have to use transparent and replicable methods. Ideally, a reader of our review should be able to reproduce the review and get the same results. An important part of our methods is to clearly specify the nature of the research to be included in the review, our ‘inclusion criteria’.

Inclusion criteria are set out using an acronym called PICOS which stands for Participants, Interventions, Comparators, Outcomes and Study designs. In a review looking at a new drug to improve survival in breast cancer, for example, the participants are those with breast cancer, the intervention is the new drug, the comparator the currently prescribed drug, the outcome survival and usually the study design will be randomised controlled trials (often abbreviated to RCTs) as these are the most rigorous form of medical research.

Rarely, however are systematic reviews so straightforward.  The OKIS review is particularly complex as our inclusion criteria are very broad.  The participants are people with neuromuscular disorders of which there are many types. Neuromuscular disorders can involve the structure of the muscle cells in conditions such as Muscular Dystrophy the neuromuscular junction where the nerves and muscles meet such as Myasthenia Gravis and the motor nerves in the arms, legs, neck and face as in Charcot-Marie Tooth Disease to give just a few examples. This review also includes neuromuscular disorders arising from central nervous system causes such as Stroke, Multiple Sclerosis and Post-Polio Syndrome. The common element in all these disorders for this review is knee instability.

Another complexity in this review is that there is more than one type of orthotic intervention that may be used to help with knee instability. Some orthoses are fixed below the knee supporting the ankle and foot. Others are longer and cover the knee, ankle and foot. For severe weakness they can also include a hip band. Each one has its own acronym! The range of possible comparators is equally diverse. And, you’ve guessed it, the range of outcomes is wide and varies according to the conditions investigated. Pain, walking ability, usage of the orthotic and patient satisfaction are just some of the outcomes of interest. Furthermore, this topic area is at an early stage of research so we cannot restrict our study design inclusion criteria to RCTs as these have not been conducted in great numbers. We will, therefore, consider a range of study designs.

The complexity of this topic will be challenging at every stage but we now know the terms we need to use as we start to search for all the relevant research...but that will have to be the subject of another blog post!

Blogger: Debra Fayter

What is qualitative research?

In addition to seeing what research evidence already exists about the use of knee orthotics by people with neuromuscular diseases, we are undertaking a qualitative study.

Qualitative research is used when we are interested in understanding how people make sense of their world and the experiences they have. Most qualitative research studies are small scale, focusing on a relatively small number of cases. However they provide depth and detail in the context of the chosen setting; this is sometimes referred to as ‘rich description’. Qualitative studies tend to focus on words rather than numbers. Qualitative research includes a range of methods, such as interviews, focus groups, direct observation, and analysis of texts and documents, or of audio/video recorded speech or behaviour.

For this project we will be undertaking interviews with people who have a neuromuscular disease and an orthotic device for knee instability. We are especially interested in finding out what people think are the most important measures of the success of an orthotic device – what is important to them as individuals. We also plan to run some focus groups with a small number of people who have the same neuromuscular condition. This will provide additional detail on outcomes and factors of interest across a number of common neuromuscular diseases.

Blogger: Dorothy McCaughan

Seeking patient representatives in Yorkshire region

Can you help us in our research?

We are a group of researchers at the University of York carrying out research into the use of orthotic devices to help adults with neuromuscular conditions who have an unstable knee.

We are seeking two people who can bring the perspective of patients to our Project Advisory Group.

The role of the Project Advisory Group is to make sure that the research takes into consideration the views of patients and healthcare professionals and to ensure the research is of a high standard. The project will last 12 months and started on 1^st April 2014. The group will meet three times over the year. We might also contact you occasionally in between meetings. We are seeking two people who

·                Have been offered an orthotic device to help with knee problems related to a neuromuscular condition

·                Are comfortable working as part of a small team

·                Are willing to share their opinions at a meeting and listen to the views of others

·                Are able to attend three Advisory Group meetings at the University of York– so live within easy travelling distance of York

You do not need to have any research experience just an enthusiasm and interest in the project. Information about the research and the team is available in our other blogs and pages.

If you would like to join us, please send an email to Catriona McDaid at kneeorthotics@gmail.com explaining why you would like to join the Project Advisory Group by Friday 25^th April.  You can also email Catriona if you have any queries about this role or would like further information.                       

Thank you for your interest.

Getting the perspective of patients

A priority for the OKIS project is to recruit two people to bring the perspective of patients to our Project Advisory Group. We have prepared an advert and a description of the role to send out to relevant patient organisations.

In summary:

• The role of the Project Advisory Group is to make sure that the research takes into consideration the views of patients and healthcare professionals and to ensure the research is of a high standard.
• The project will last 12 months, starting on 1st April 2014
• The group will meet three times over the year and we might also contact you occasionally in between meetings.
• We were seeking two people who:
• Have been offered an orthotic device to help with knee problems related to a neuromuscular condition
• Are comfortable working as part of a small team
• Communicate effectively and are willing to share their opinions at a meeting and listen to the views of others
• Are able to attend meetings at the University of York– so live within easy travelling distance of York

The people who express an interest in joining the project will take part in a brief telephone interview and the successful applicants appointed. We will be offering an induction session and mentor from the team should they wish some support in their role.