Questions and answers about the biobank

Three charities – Action for ME, the ME Association and ME Research UK – and a private donor have joined forces to fund the UK’s first biobank of human blood samples for research into the causes of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The biobank will be situated at London’s Royal Free Hospital where it will be able to link in with the extensive research facilities at University College London. The principal researchers are Dr Eliana Lacerda and Dr Luis Nacul, of the London School of Hygiene and Tropical Medicine.

What is the biobank?

The aim of the project is to set up a biobank consisting initially of blood samples from clinically well-characterised cases of ME/CFS and healthy controls. With the creation of the fundamental infrastructure required to underpin a disease-specific biobank for ME/CFS in the long term, the research community would have access to a well-characterised cohort of patients with biological, clinical and laboratory data attached. Phase 1 of the biobank project is now complete, and phase 2 is underway and will last until early 2014.

Can I donate blood to the biobank?

Not yet, unfortunately. During both phases of the biobank, participants will be recruited via the ME/CFS Disease Register or specialist ME/CFS service, and a number of GP surgeries in England. This is because consenting patients have to be clinically assessed according to defined study criteria, and have a blood sample taken using a strict protocol, which includes ensuring that  samples arrive at the biobank within a few hours of being drawn. These are intricate and time-consuming processes, which involve much more than, say, accepting a blood sample in the post. The research team are looking at ways of expanding recruitment as the project grows, and we shall keep you updated with information as it becomes available.

In the near future, people who wish to donate to the biobank will be able to enrol in the ME/CFS Disease Register, which is in the process of being tranferred to New Buckinghamshire University. Details of how to contact the Disease Register research team will be provided as soon as the register is enrolling new participants.

How will samples from severely affected patients be collected?

The aim in the medium term is for a research health professional to visit these patients in their homes and immediately dispatch samples via authorised courier or in person to arrive at the biobank within six hours.

Is it safe for ME patients to give blood?

Blood donation in this case means “blood samples of 50 to 60 mL” (which is approximately 10 to 12 teaspoons), including the amount for lab tests and for long term storage.

There is no evidence that giving this amount of blood exacerbates patients’ symptoms, but adverse effects will be monitored by asking all participants to complete a specific form in the days following blood-sample drawing.

What criteria will be used to select donors?

All selected donors must have received a diagnosis of ME/CFS at some time in the past. However, as there are inconsistencies in how the diagnosis is made in primary, secondary or tertiary care, it is essential that all cases are newly assessed by a health professional trained in the diagnosis of ME/CFS. Patients will be assessed on whether they fulfil the CDC-1994 (Fukuda) criteria and the Canadian 2003 criteria.

Since cases meeting the Canadian criteria have been shown in most cases to also meet the Fukuda criteria, this will enable the sub-grouping of cases into those meeting and not meeting the Canadian criteria, throwing light on the appropriateness of the different classifications. In due course, comprehensive phenotyping (categorising patients based on their clinical information) of patients may enable categorisation of individuals according to other clinical criteria.

Patients will be excluded from donating samples if they have:

  • recently used (in the preceding three months) drugs known to alter immune function, e.g. anti-viral medications and vaccinations,
  • acute and chronic infectious diseases such as hepatitis B and C, tuberculosis, HIV (but not herpes virus or other retrovirus infection),
  • other severe illness and mood disorders.

What information will be collected about each donor?

Subjects will be assessed using standard forms that enable the confirmation of an ME/CFS diagnosis according to study criteria. This will be complemented by a number of tests and the completion of study forms (self-completed or completed with the aid of a next of kin, in cases of very severe ME/CFS).

These will enable further characterisation of cases according to clinical data (phenotype), disease severity and, for cases and controls, in relation to a range of demographic (i.e. age, gender etc.), socio-economic and other exposure variables, which were chosen based on our previous experience at the ME/CFS Observatory and the practices at the existing UK Biobank.

The following additional instruments will be used to characterise participants: Medical Outcomes Survey Short Form-36 (SF-36), for assessment of functional capacity and quality of life; the pain analogue scale, for the assessment of pain severity; the fatigue severity scale and energy fatigue scale; the Mini International Neuropsychiatric Interview (MINI); and the Epworth sleepiness score.

In addition to a full history and clinical examination, all donors will undergo a detailed physical assessment and laboratory tests including full blood count, blood chemistry, liver function tests, erythrocyte sedimentation rate, C-reactive protein, rheumatoid factor, thyroid function tests, tissue transglutaminase antibodies, serum vitamin B12, red cell folate and urine analysis.

Confidentiality is a key element of biobanking. Data will be anonymised and confidentiality will be preserved, with identifiers kept securely in separate files at the LSHTM, and used solely for the purpose of linkage of data with samples. None of the funders of the project will have access to patient data.

What sort of research will the biobank be used for?

The biobank is intended to be a key resource for biomedical research and is expected to be particularly useful for studies investigating phenotypes and biomarkers for diagnosis and prognosis.

How will researchers gain access to samples from the biobank?

Applications to use the biobank for research will be subject to a formal approval process before issuing anonymised blood products together with clinical information about the donors. The approval process will include external ethical approval from a duly constituted ethics committee, either within a university or the NHS. An expert panel will be set up to manage the approval process. Details will be announced in due course.

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