UK ME/CFS Biobank: The importance of patient involvement | 06 November 2017

November 6, 2017


Published in the Journal Fatigue: Biomedicine, Health & Behaviour, October 30, 2017.

This editorial, written by key members of the ME/CFS Biobank team, is open access and provides an overview of the methodology behind this vital UK initiative.

It explains the extent to which patients were involved in helping create and then oversee the Biobank, and how important it is to involve patients to better ensure not only acceptance by the community, but also because patients are a valuable resource in their own right.

And it examines the importance of having a UK Biobank in terms of a real way forward in the battle for improved understanding and the development of effective treatments for what remains a largely unexplained but devastating disease.


Using a participatory approach to develop and implement the UK ME/CFS Biobank

Click to read the full editorial

“The lack of validation and legitimisation of ME/CFS has resulted in part from an inadequate understanding of its aetiology and pathophysiology as well as the absence of sensitive and specific tests to confirm diagnosis.

“This in turn has hampered investigation into, and development of, effective treatments. Despite the growing number of published biomedical research studies on ME/CFS, advances in understanding disease mechanisms and the translation of research findings into clinical practice have been limited.

“The lack of coordination in ME/CFS research, of consensus on case definitions, and of attention to methodological rigour have worked together to threaten the interpretation of evidence and the comparability and generalisability of study outcomes.

“Such poor understanding of the causality and disease mechanisms of ME/CFS has led to disagreements about its nature and management among professionals, patients, and the general population.

“These differences have further impeded research progress and affected the healthcare provided to people with ME/CFS (PWME), who often need to overcome significant barriers related to the recognition of their illness and its effect on their lives, as well as to access to care and effective treatment.

“Particularly problematic have been conflicts between patients, doctors and researchers related to distinct perceptions of the nature of the condition and its management. In the clinical context, PWME often have defined ideas about what their issues are and how they might be analysed and managed, which sometimes conflict with those held by medical professionals.

“Disagreements are no less relevant in ME/CFS research, in which research priorities and conducts have been challenged, and patients have been expressing great dissatisfaction with study conclusions, the lack of transparency, and the methodological rigour of some studies, as exemplified by the controversies and disagreements generated by the PACE-trial.

Participation as a way forward

“With sluggish progress in ME/CFS research frustrating many patients and researchers, we sought solutions that were not only robust from technical and logistical viewpoints, but would also find acceptance among researchers, clinicians, patients and the wider ME/CFS community.

“We believe that tissue banks, and biobanks in particular, are essential infrastructure resources that will enable the acceleration of ME/CFS research by ensuring high-quality, standardised procedures for the collection, storage, and management of data and samples, while observing ethical, legal and social issues.

“The sharing of such a resource with both academics and the commercial sector represents a cost-effective way of accelerating science in this area of research.

“In planning the proposed tissue bank, we considered a participatory approach to be best practice. Such an approach recognises both the complementary expertise of patients and researchers and that the ultimate beneficiaries of research are the patients themselves.

“To develop a resource for the study of ME/CFS with no explicit support from the community of beneficiaries would represent a significant risk of being unsuccessful or lacking purpose, and could also risk further deterioration of the relationship between patients and healthcare professionals.

“Using a participatory approach, we investigated the acceptability and feasibility of developing a disease-specific biobank for the study of ME/CFS that would be cost-effective in both its implementation and operation.

“The biobank would aim to be technically robust and responsive to the needs of both patients and scientists. The model would be fully compliant with relevant ethical and legal frameworks and would attract the participation of both PWME and others without ME/CFS as members of control groups.


The ME/CFS Biobank needs your support

The ME Association is the only ME/CFS charity that continues to fund the UK ME/CFS Biobank. Recently, the National Institutes of Health in America made another significant grant in order that a current study – examining the longitudinal effects of ME/CFS – might be extended, but this funding was not for day-to-day operational expenses and neither will it enable continued research using Biobank samples to be developed.

If you would like to help the ME/CFS Biobank and ensure its continued success, you can donate to them direct by clicking the link below and following the on-screen instructions:


Project outline and outcomes

“The consultation phase consisted of discussions with the project's Steering Committee (comprising researchers, clinicians, representatives of ME/CFS charities, and PWME and their carers, and chaired by a representative from an ME/CFS charity), focus group discussions with PWME, and a workshop with a group of experts, i.e. professionals with expertise in biobanking, ethics, clinical, epidemiology and lab-based research. This was followed by the development of the biobank proposal and its subsequent implementation.

“During the consultation, focus group participants clearly expressed their desire for the establishment of an ME/CFS biobank focused on blood sample collection and believed it would be both feasible and cost-effective.

“Their recommendation was to create a disease-specific biobank of blood samples from both PWME and healthy controls, including people severely affected by the disease. The various stakeholders were aligned in highlighting the importance of using appropriate case definitions and inclusion/exclusion criteria for PWME and controls together with careful data collection methods and rigorous protocols for the collection, transport, and storage of samples. Discussions also emphasised the importance of ethical and legal issues.

“The concerns of focus groups participants and their detailed recommendations, together with those given by professionals, were fully taken into account in designing a biobank protocol that was acceptable both to potential participants and the scientific community and responsive to the pressing need for high-quality ME/CFS biomedical research.

“The UK ME/CFS Biobank has, as of May 2017, recruited over 500 participants, including people with a confirmed clinical diagnosis of ME/CFS and others in comparison groups of people with multiple sclerosis and ‘healthy controls’.

Lessons learned

“The positive impacts on the research team, such as, PWME bringing their personal knowledge and perspectives on ME/CFS, and their enthusiastic response for ‘taking part’ and ‘being listened to’, were similar to those described by researchers involved in other participatory research projects.

“The researchers were humbled to share and learn from PWME's narratives and experiences. The challenges identified to the establishment of the disease-specific biobank and ongoing ME/CFS research included the potential constraints of those with symptoms so severe they might be unable to take part, the fear of symptom relapse because of the required blood donations, and the potential misuse of samples by researchers.

“We responded to those challenges with careful planning, including: (i) organising home visits for consenting participants with severe symptoms, (ii) monitoring potential symptoms post-blood donation, and (iii) developing robust research governance mechanisms, including ongoing participation of PWME and carers in decision-making around sample sharing.


“The implementation of the UK ME/CFS Biobank and the successful recruitment of participants is evidence that the participatory approach has been effective.

“The development of the protocol that underpinned the launch of the UK ME/CFS Biobank was informed by the participation of a variety of relevant stakeholders.”


The ME/CFS Biobank needs your support

If you would like to help the ME/CFS Biobank and ensure its continued success, you can donate to them direct by clicking the link below and following the on-screen instructions:


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