Exploitation of Research Participants, Disability Discrimination and Stigma against M.E.

and CFS patients

CONTENTS

Abbreviations................................................................................................................2 Introduction...................................................................................................................2 Introduction to the evidence..........................................................................................3 Prejudice and stigma.....................................................................................................3 Children and young people...........................................................................................5 Problems with state benefits..........................................................................................7 Disadvantages and discrimination in education............................................................9 Poor healthcare and estrangement from healthcare providers....................................10 Inhibition of research into biological causes of CFS/ME...........................................13 Examples of recent NHS Research Ethics Committee approved research.................14 Research Titles............................................................................................................19 Excerpts from Research Governance Framework for Health and Social Care...................................21 Excerpts from Governance arrangements for NHS Research Ethics Committees.............................23 Declaration of Helsinki...............................................................................................24 REFERENCES............................................................................................................29

Abbreviations
CBT CFS CFS/ME CMO COREC DLA DRA DRC DSPS DWP ME ME/CFS NHS NICE REC MRC Cognitive Behavioural Therapy Chronic Fatigue Syndrome Combined term for CFS and ME. Sometimes ME/CFS Chief Medical Officer (Working group report into ME/CFS 2002) Central Office of Research Ethics Committees Disability Living Allowance Disability Rights Act Disability Rights Commission delayed sleep phase syndrome Department of Work and Pensions Myalgic Encephalomyelitis Combined term for ME and CFS. Sometimes CFS/ME National Health Service National Institute for Health and Clinical Excellence Research Ethics Committee Medical Research Council

Introduction
Some research conducted into psychological theories of CFS/ME is unethical. Such research unduly influences medical professionals attitudes and those of other professions, society and the media, creating prejudice and directly impacting on the well-being of people with these illnesses. People with CFS/ME suffer due to psychological theories and perceptions about their illness. This suffering is experienced in diverse ways which include overt and micro discrimination in the provision of healthcare, education, state benefits and employment rights; loss of status and stigma. This prejudicial treatment which causes actual physical harm, deprivation and mental suffering is in part generated and perpetuated by research into psychosocial, psychological and psychiatric theories about the illness. The exacerbation and perpetuation of such harm is a foreseeable outcome of psychological research into the illness. As such, it is a clearly identifiable risk factor for participants in research who have the illness. For these and other participant groups it is also a risk factor as exacerbating or perpetuating such harm to others may contradict the individuals moral values. Research participants who have not been made aware of this obviously foreseeable risk, cannot be deemed to have given informed consent. Such research would therefore be in breach of NHS and MRC guidelines as well as provisos of the Declaration of Helsinki. It would seem unethical for researchers to conduct research of the kind that fosters prejudice about CFS/ME causing real and foreseeable harm. 2

A substantial amount of research into psychological theories about CFS/ME has not contributed knowledge of any significant value to participants, other patients or society. Such research has not helped to improve diagnosis, treatment or research into the illness and often appears repetitive and gratuitous. Research is expected to contribute to knowledge. If instead, research confounds the advancement of knowledge then perhaps it is ethically unjustifiable. This appears to be the case with some research into CFS/ME which in the UK, seems to have influenced medical, scientific and political opinion away from research to identify the biological causes of the illness. People with CFS/ME are often very disabled. The ethical correctness of inviting expenditure of limited energy resources on research that is unlikely to be of any significant benefit to participants is highly questionable. People suffering with CFS/ME are often too ill to make their grievances known or seek redress. They must therefore depend upon the ethical principals that govern research. That dependence is failing them. COREC could reasonably consider people with CFS/ME are a vulnerable group in need of special protection [Declaration of Helsinki proviso 8]. They could ensure that research proposals are critically examined for their potential harm to participants and others in view of the extraordinary stigma associated with these illnesses. They could also ensure that researchers are aware of the potential for causing harm [i.e. are familiar with related literature examples of which are quoted below] and have provided sufficient information for participants to give properly informed consent. After so many years and repetitive psychological investigations into CFS/ME with inconclusive or findings of little value it is surely time to consider some of this research gratuitous and unethical and not in the best interests of participants, science or society.

Introduction to the evidence

The references provided here are mostly without explanation or context but are generally self explanatory. Complete reference to the sources is included in the text or can be found in the references section and many include hyperlinks to locations where the original can be seen or downloaded. This evidence has been compiled to illustrate how people with CFS/ME suffer discrimination due to their disability. Comments represent my personal opinions and interpretations. Peter Kemp. December 28th, 2006.

Prejudice and stigma

The following evidence shows that prejudice and stigma are widely experienced by people with CFS/ME because of their diagnosis. This prejudice often appears to be based on psychological theories about CFS/ME.

Participants were stigmatised prior to and following diagnosis, and the stigma of CFS was compounded with other stigmatising sources, such as chronic illness and psychiatric illness. Participants experienced both felt and enacted stigma. Additionally, threats of invalidation were derived from interpersonal sources, and included disbelief, turning the 3

abnormal into the normal, commandeering of symptoms, the attribution of negative qualities and responsibility, and dismissal. Threats of invalidation were particularly distressing to participants because they jeopardised well-being, trivialised the pain and suffering that were part of everyday life, questioned the reality and perceptions of the participants, and relegated participants to an inferior status. (p.162) [Travers] Participants were aware that there was something about CFS that provoked strong responses and opinions in others that was not the case for most other illnesses.... They considered this "something" to be stigma and it was familiar to all the participants. (p.163) [Travers] Accounts by people with CFS commonly include descriptions of lost friendships, disrupted familial relationships, and disbelief, criticism and lack of understanding from others (p.33) [Travers 2006] Often CFS sufferers are stigmatised, or fear such labelling, as a 'malingerer', or are treated as having other psychological and somatic properties attributed to their 'undefined' illness (p.128) [Millen, Peterson & Woodward 1998] While the attribution of the label of CFS can bring some relief to the patient in that they have some recognisable illness, the obverse is that the uncertainty of the prognosis and the stigma associated with the illness usually lead to social and/or professional interpretations that they are malingers or merely lazy (p.3) [Holloway & Pinikahana] It appears that those suffering from undiagnosed CFS are simply lazy or lacking in moral fibre often relegated to a marginal status once they are no longer able to live a 'normal' life even close family members may scold or leave them (p.313). [Sachs] The blaming of sufferers for not getting well over time, the emergence of 'mental illness' explanations of ME/CFS and stigma caused by on going denial by professional groups of the illness experience of ME/CFS sufferers' (pp.63-64) [Millen, N. 2002] The lack of easy confirmation of the organic nature of the illness by a readily available investigation lends itself to occasional invasion by those who are not genuine sufferers. The existence of such patients and the inability of some in the medical profession to separate them from genuine patients with CFS/ME enhances the view that all patients with CFS/ME are neurotic and/or not genuinely ill. [Gibson Inquiry 2006] The pattern in the interview responses indicates that, above all, two aspects were stigmatizing: The women experienced their moral characters called into question in interaction with others. They also experienced distress from being psychologized by others, doctors in particular. (p.5) [sbring & Nrvnen. 2002] A consistent pattern was that the women perceived themselves to be challenged by others regarding the veracity of their experience of being ill. This was experienced as deeply violating by the women and was described as a discrepancy between how one defines oneself and how one is defined by others. This questioning constitutes a threat to the identity and may be experienced as a heavier burden than the illness itself: (p.5) [sbring & Nrvnen. 2002] 4

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is one of the most complex and maligned disabilities in the community (p.157) [Mungovan & England 1998] Because there are no definitive diagnostic tests at this stage and with disagreement among the medical fraternity on symptomatology and treatment, the ill-informed and the sceptics often trivialise and ridicule ME/CFS. Even the term "Chronic Fatigue Syndrome" is difficult for those with the condition, disallowing the more diverse and disabling symptoms, and inviting negative responses. (p.157) [Mungovan & England 1998] CFS is associated with ambiguity and negative perceptions, subject to ongoing debates, and with few points of agreement. These degrees of debate and personal criticism are not found with most illnesses and as a consequence, participants experience CFS in a climate different to the social world inhabited by the majority of people with chronic illnesses. (p.141) [Travers 2006] The causal debates found within the medical community and between patients and medical practitioners were interpreted by participants as direct indictments on the character or moral worth of affected individuals and as an affront to their credibility and worthiness. (p.139) [Travers 2006] Wessely is ceaseless in his efforts to discredit ME and its hapless sufferers: in early 2002, at his instigation the British Medical Journal ran a ballot asking doctors to vote on which diseases they considered to be "non-diseases" which are best left medically untreated: Wessely proposed ME. Along with ear-wax accumulation, nail-chewing and freckles, ME was voted a non-disease, and in April 2002 both broadsheet and tabloid newspapers ran banner headlines proclaiming "Obesity and ME are not diseases, say doctors". (p.24) [Hooper et al. 2003] The Media: The UK national newspapers frequently run headlines such as "ME's mainly in the mind---Study reveals yuppie flu can be cured by positive thinking" (Daily Express, 5th January 1996, about one of Mike Sharpe's studies) and "ME is just a myth, sufferers told" (Sunday Telegraph, 20th November 1994, about the conclusions of 150 British psychiatrists attending a pharmaceutical conference in Jersey). On 5th May 1996 the Daily Express carried an article by Jonathan Miller from America, which ran with the headline "Chronic Bandwagon Disease" in which he referred to CFS as "Completely Fictitious Syndrome". (p.26) [Hooper et al. 2003]

Children and young people

Ignorance and lack of understanding of the condition are perceived to exist among healthcare professionals as in society, with a widespread perception that "children don't get CFS/ME". (p.15) [Hutchinson. CMO Report 2002] Younger people do not always understand their friend's illness, and some may share the widespread disbelief surrounding CFS/ME. These problems are compounded by absence from school, which inevitably restricts contact, leading to feelings of isolation. (p.15) [Hutchinson. CMO Report 2002] Strong polarised views which professionals may hold can deny young people access to appropriate supportive services, or result in inappropriate referrals. Professional 5

controversy can contribute to creating "a difficult time at home", with the child or young person conscious of the burden placed on other family members. Disruptions to family functioning have led some professionals to assume that the cause of the illness is "overprotective" parents, with further adverse impact on the child and family. (p.16) [Hutchinson. CMO Report 2002] When their condition is less well known, or when the young person meets disbelief or perceives professional hostility or criticism of his or her parents/carers, the impact of the illness is compounded. (p.58) [Hutchinson. CMO Report 2002] We were concerned to receive written submissions from parents of children with CFS/ME who reported they were disbelieved by social services and community practitioners with the result that their children were put on the at risk register or even made wards of court and removed from the family home. (p.11) [Gibson Inquiry 2006] In the UK, patients with myalgic encephalomyelitis (ME, also known as Chronic Fatigue Syndrome or CFS), particularly children, have suffered gross and barbaric abuse and persistent denigration as a consequence of the beliefs of certain psychiatrists who are attempting to control the national agenda for this complex and severe neuroimmunological disorder (p.3) [Hooper et al. 2003] We constantly work with doctors, teachers and other professionals whose work is exemplary and whose attitude of compassion and dedication we applaud. Unfortunately, they still appear to be in the minority. Tymes Trust has evidence that the very systems set up by the government to help sick children and young people are being interpreted in ways that either ignore children with ME, or threaten, bully and intimidate them. (p.4) [Tymestrust 2006] The Tymestrust (2005, p.5), state: It has been very disturbing and distressing for us to read, over a period of years, the many sad letters and emails we receive from children and young people with ME and their families whose needs are not being met. The great majority report feeling disempowered and ignored. They report decisions that will profoundly affect their lives being taken out of their hands, with little understanding or consultation. They report ending up even more ill, with no suitable education or medical support. Our Advice Line Team hears the same distressing story. All too often, families and children contacting the Advice Line report not being given choices about how they are cared for, or about the treatment they are offered. They report that their education is rarely organised in consultation with them, so as to help them in the best possible way for their own needs. Instead, they are presented with "done deals" that they have to either accept or fight against, thus being labelled as troublesome families with difficult children. This leads to serious misunderstandings when doctors, teachers or social workers feel that there must be some psychologically unhealthy motivation driving families 6

that do not accept what has been arranged for them, but who instead request something different. Young patients and their families are clear about their views and expectations, and about what they do not want to see - they do not want their condition being officially "psychologised" just because there is no medical therapy that can cure the condition. (p.6) [Tymestrust 2005] "I was diagnosed by an Essex consultant paediatrician who was lovely, but GPs at three surgeries didn't believe him. I was accused of school phobia, and my parents of Munchausen's Syndrome by Proxy. I was bruised when made to sit up in hospital, treated appallingly and without regard to human rights. I saw an Essex neurologist privately and waited six months for an inpatient place but was then told I was too ill for this. My mother has filled in this form with input from me as I am unable to hold a pen." (p.12) [Tymestrust 2005] Many families thought that the personal attitude and knowledge of a medical professional was of greater significance than their specialty. They also thought that "incorrect illness beliefs" are a significant and widespread problem among medical professionals, rather than among patients as suggested by the medical literature. From their experience: 10% trusted the medical establishment to care appropriately for children with ME 88% did not trust the medical establishment to care appropriately for children with ME 2% were unsure 18% said personal experience of doctors caring for children with ME had been positive 79% said personal experience of doctors caring for children with ME had been negative 3% said their experiences had been mixed (pp.34-35) [Tymestrust 2005]

Problems with state benefits

The 25% Group charity surveyed members who receive Disability Living Allowance. 59% of those who responded had initially been refused the benefit. 86% of these appealed the decision. 85% who appealed were successful.

Until medical opinion is better informed as to the nature of this illness, ME sufferers will have to live with the double burden of fighting for their health and their benefits. [Gibson Inquiry 2006] In fact, shortly before she chose to die, her ME was much better. She was able to get to the toilet unaided and even move around the flat for no reason other than for the joy of being able to move and do what, we able bodied people, take for granted. She was considerably better but in no way well enough to return to work. She had in the past experienced major problems with the Benefits Agency and had been treated in such a horrendous manner she had said that she would never be able to apply for benefits again. Applying for benefits for an invisible illness, with no diagnostic test is hell. The result largely depends on the beliefs 7

of the doctor sent to examine you. [Investinme 2006] Available at: http://www.investinme.org/mestory0005.htm Accessed Nov 29th 2006. People with ME/CFS, like others, often experience great difficulty in obtaining state sickness and disability benefits and this is reflected in the very high proportion who only succeed by going through the stressful and bureaucratic appeals procedures. At present ME/CFS is defined as a psychosocial illness by the Department for Work and Pensions (DWP) and medical insurance companies. Therefore claimants are not entitled to the higher level of benefit payments. We recognise that if ME/CFS remains as one illness and/or both remain defined as psychosocial then it would be in the financial interest of both the DWP and the medical insurance companies. The Groups feels that patients with CFS/ ME, which is often an extremely long term condition, should be entitled to the higher rate DLA. The sooner there is a biomedical model of assessment for this illness the better. If a virus causes the CFS then the patients should be entitled to the higher rate DLA. (p.30) [Gibson Inquiry 2006] Evidence suggests that benefits agency staff often err on the side of caution. A survey conducted by the 25% ME Group in March 2004 found evidence that 59% of ME patients who applied for DLA were unsuccessful on their first attempt. Of those 86% appealed and of those 85% were successful in their appeal. (pp 30-31) [Gibson Inquiry 2006] There have been numerous cases where advisors to the DWP have also had consultancy roles in medical insurance companies. Particularly the Company UNUM Provident. Given the vested interest private medical insurance companies have in ensuring CFS/ME remain classified as a psychosocial illness there is blatant conflict of interest here. The Group find this to be an area for serious concern and recommends a full investigation of this possibility by the appropriate standards body. It may even be that assessment by a medical 'expert' in a field of high controversy requires a different methodology of benefit assessment. (p.31) [Gibson Inquiry 2006] The categorization of an illness as being psychosomatic also means a further categorisation of an individual as 'deviant' rather than 'ill', so that they are denied sympathy, support, and even benefits they are entitled to. Categorised as 'deviant', the ill then suffer increasing social exclusion and material inequalities. [Hooper et al. 2003] There are particular problems being allocated benefits - particularly Disabled Living Allowance and Incapacity Benefit, especially given the unpredictable nature of this illness. Applying for benefits is often a traumatic experience for ME sufferers as many, like myself, have been met with disbelieving visiting doctors. The doctors who have visited me either didn't believe in the illness, and told me that, or were trying to rediagnose me as they didn't believe that ME could create such severity and debilitation, nor consist of so many severe neurological symptoms. [NICE 2006] Respondents were asked whether they had ever been refused or had difficulties in getting state benefits with the label ME/CFS. 55% (162) answered that they had and 42% (124) said that they had not. The remaining 2% or 6 said that this was not applicable and another 50 did not tick this at all so it is reasonable to assume that 56 had not needed to apply. 25% said that they had difficulties with or been refused private benefits. 65% said that they had not. (p.22) [Cooper 2000] 8

Disadvantages and discrimination in education

People pursuing an education while suffering with CFS/ME appear to have to work harder while contending with disabling symptoms yet gain achievements more slowly. Their diagnosis does not always bring accomodation for their disability, but sometimes leads to prejudicial treatment.

The American Report states on page 8 that "the physician should work with the school to limit class time, if necessary, and to resume school attendance gradually", but the UK Report urges "an immediate return to school" (10.12). The American Report advises "Home tuition may be an alternative" but the UK Report states "School phobia is important as a complication of CFS" (10.8) and "We discourage home tuition" (10.12). (p.35) [Hooper et al. 2003] Many students commented on how teaching staff had difficulty accepting an ME/CFS diagnosis as a genuine illness. The greatest problem faced was the attitudes of teaching staff towards their diagnosis. Many teaching staff caused distress by not believing ME/CFS is a medical condition and by: Demanding an explanation of the disability; Discouraging them from joining classes; Unwilling to deal with the formal paperwork; Unwilling to accept the unpredictable nature of ME/CFSc Ignoring medical documentation and insisting on an able-bodied students level of performance; Accusing the student with ME/CFS of making excuses for poor performance; insisting ME/CFS did not exist; Labelling the student with ME/CFS as either suffering from depression or an attitude problem; Not accepting ME/CFS as a pre-existing medical condition and requesting more reports; Discouraging ME/CFS disclosure to other staff; Not accepting the medical documentation when presented. (p.167) [Mungovan & England 1998] The most disabling symptoms identified by the students are cognitive dysfunctions for which no accommodations are made by the academic institutions. (p.22) [Morris 2003] Numerous problems arose with lecturers, supervisors and peers and whenever accommodations for disability are sought. Many tend to regard students with ME/CFS as lazy, malingerers or as exhibiting attitudinal problems. Participants pointed out the concessions granted were often minimal and made with bad grace (to the extent that some decided to make no further requests). (p.245) [Morris 2003] Additionally many students, who would pursue their rights further, found that the debilitation of ME/CFS had left them too exhausted to make further negotiation. It appeared that most students merely state that they have CFS and accept whatever accommodation is then offered, irrespective of whether it meets their needs (Morris 2002a; 2002b). The term Chronic Fatigue Syndrome emerges from this inquiry as a major problem as it demonstrably prejudices not only lay but even medical understanding of the condition and of sufferers needs by impacting on the credibility of students in their interactions with lecturers, disability liaison officers and peers (Morris 2001a; 2002a). This is the lived experience of tertiary students with ME/CFS. (p.250) [Morris 2003]

Students with ME/CFS are, in practice, constrained by others perceptions of their condition. (p.253) [Morris 2003]

Poor healthcare and estrangement from healthcare providers

A diagnosis of CFS/ME appears to lead to many problems for patients in getting proper healthcare.

Influence of general practitioners beliefs on management The doctors stereotyping of patients with chronic fatigue syndrome meant that the condition ceased to be seen as a discrete disorder and became the defining feature of that patient. This value laden approach may have prevented general practitioners from assessing each patient as objectively as possible. It was not surprising that this attitude, sometimes combined with a breakdown of the relationship between doctor and patient, led to ambivalence towards treatment options. For most of the participants, choosing appropriate treatments for chronic fatigue syndrome was like groping in the darkeither not knowing who to refer to (GP 86) or just feeling hopeless and more hopeless (GP 14). They might therefore consider mental health interventions only as part of a process of trying a range of treatments: You would do anything for these patients (GP 45). So it is not surprising that general practitioners described caring for patients with chronic fatigue syndrome as a burden (GP 18): I would rather treat a whole surgery full of people with irritable bowel syndrome than people with chronic fatigue (GP 84). (p.2) [Raine, Carter, Sensky and Black 2004] Many issues surrounding the management of people with CFS/ME have their origins in knowledge (or lack of) and attitudes. Key issues are: _ Poor recognition of CFS/ME by professionals _ Difficulties that arise over diagnosis _ Lack of professional and public acceptance and acknowledgement (p.9) [Hutchinson. CMO Report 2002] Some were concerned that their illness is not taken seriously, that some GPs show indifference, or that they do not always understand the illness and its possible severity. Some participants suggested that GPs and the wider primary healthcare team need improved knowledge and skills to support people with chronic or incurable illness in general and with CFS/ME specifically. (pp 11-12) [Hutchinson. CMO Report 2002] A particular concern is if a referral to mental health services is made because the illness is being characterised as "all in the mind". There is evidence that some patients "fight" for referrals, and in general GPs are confused over where to refer patients, so diagnosis can be a "hit and miss" affair. This has led patients to pursue their own specialist referrals for diagnosis; though in that situation the expressed experiences suggest that ongoing advice and support are lacking. (p.11) [Hutchinson. CMO Report 2002] Sadly, the overall experience of specialist and hospital services among participants was predominantly negative. [Hutchinson. CMO Report 2002] Views were expressed that when GPs were confronted with a patient whose illness is complex and does not improve with treatment then they can feel helpless, and may effectively "withdraw to the sidelines" leaving the patient to feel totally alone. "Dumped in the community - totally invisible." (p.14) [Hutchinson. CMO Report 2002] 10

A proportion of patients feel alienated from clinical professionals by early responses to their symptoms, illness experience, and disability. Actual or perceived dismissiveness, incomprehension, or even disbelief are encountered, and have profoundly negative impacts. (p.30) [Hutchinson. CMO Report 2002] The Working Group is concerned about several issues. Patients and carers often encounter a lack of understanding from healthcare professionals. This lack seems to be associated with inadequate awareness and understanding of the illness among many health professionals and in the wider public. (p.67) [Hutchinson. CMO Report 2002] Why is this report necessary? CFS/ME is one of the most contentious illnesses in modern medicine. Due to a lack of knowledge of and research into the illness in the UK it exists somewhere between the schools of psychology and neurology. At present the only treatments are symptomatic and psychosocial. For the extremely affected sufferer this is not satisfactory. Nor is the current state of affairs satisfactory to this Group. (p.7) [Gibson Inquiry 2006] The close link with depression in many ME cases may be explained by the nature of the illness. It is likely the inactivity and lethargy caused by the ME combined with psychological aspects such as the sense that professionals do not believe them, social stigma, lack of classification or possibility of a cure, leave the ME sufferer more disillusioned than those with other chronically disabling diseases and thus more prone to depression. (p.26) [Gibson Inquiry 2006] The Group heard a number of extremely disturbing testimonials from patients. These included patients whom had been dismissed by their GPs as 'attention seeking' or indeed malicious in intent. (pp 30-31) [Gibson Inquiry 2006] The material effects of such sloppy 'science' have had two main consequences for ME sufferers: firstly, the medical impairments of the illness have often been ignored and left untreated, and many sufferers therefore become severely disabled, their physical health absolutely devastated and their chances of a restoration to good health uncertain at best. Secondly, children in particular end up victims of institutional abuse (though this can happen to adults too). In the case of children, they may be forcibly removed from their concerned parents and subjected to draconian 'treatments' that could, quite easily, be termed abuse. (p.6) [Hooper et al. 2003] The women described the psychologizing of their health problems as especially stigmatizing. It occurred primarily before a diagnosis was established, although it also occurred afterward, as the illnesses are associated with psychological causal mechanisms in the minds of some caregivers. Some interviewees felt that certain doctors, in advance and without having carried out proper examinations, categorized their problems as fictitious or related to psychological reasons, and this was experienced as deeply violating. (p.6) [sbring & Nrvnen. 2002] The interviewees also described withdrawing from caregivers, doctors in particular. After feeling as though they were called into question or violated in another way by the doctor, the women hesitated to seek care or waited as long as possible before contacting him or her again. (p.8) [sbring & Nrvnen. 2002] 11

Different strategies are developed to handle the encounters with these patients. The results also illuminate the physician's interpretations of patients in moralising terms. Conditions given the status of illness were regarded, for example, as less serious by the physicians than those with disease status. Scepticism was expressed regarding especially CFS, but also fibromyalgia. Moreover, it is shown how the patients are characterised by the physicians as ambitious, active, illness focused, demanding and medicalising. The patient groups in question do not always gain full access to the sick-role, in part as a consequence of the conditions not being defined as diseases. [sbring & Nrvnen. 2003] In this study of 68 CFS patients referred to a hospital fatigue clinic, nearly half had previously recieved a psychiatiric dignosis from a GP or hospital doctor. Two-thirds of them had been incorrectly diagnosed, with most showing no evidence of past or current disorder. In contrast, one-third of those who had never been given a psychiatric diagnosis actually had a treatable psychiatric disorder in addition to CFS. [Deale and Wessley 2000] Some patients with CFS/ME have reported that exercise programmes have, at times, been applied inflexibly without consideration of individual circumstances and goals, sometimes with significant adverse responses. (p.139) [NICE 2006] Scepticism on the part of GPs in recognising that CFS actually exists remains a problem to this day. Only 56% of the GP responders believe that CFS is a recognised condition despite findings from reports by the joint Royal Colleges and the National Task Force being in the public domain. Of the 44% who did believe that the illness exists, none reported using the CDC or Oxford criteria for CFS definition. This is surprising as both case definitions are readily available to medical and research staff and patient groups alike. [Thomas and Smith 2005] When questioned, only 57% of the GPs surveyed were aware that a CFS specialist was consulting within their local health authority region. The majority of those who were not aware of this referred patients to general medical outpatient clinics. This has been problematical in the past. Unless the patient is fortunate enough to be referred to a physician who, if not knowledgeable on the subject, is aware of specialist help, this will invariably result in the patient being told that there is 'nothing physically wrong with them'. The patient then returns to a GP who has two courses of action open to them: refer the patient to another outpatient department or try to manage the patient's condition themselves. This is bound to result in frustration on the part of the physician, who has the patient's best welfare at heart, as much as the patient. [Thomas and Smith 2005] It is important during the process of diagnosing CFS, that other illnesses presenting fatigue-like symptoms are ruled out. However, only two-thirds of the GP respondents reported conducting further investigations to exclude these conditions. [Thomas and Smith 2005] When respondents were asked to tick 'other concerns' the kind of concern was not solicited, but they were asked to specify what these were. The majority of respondents that did, referred to the negative attitudes towards the illness and particularly the disbelief and hostility encountered from the medical profession. A typical comment was ' the ignorance of the medical profession and the attitude of the media and the public'. Another stated 'finding doctors sympathetic to ME' (p.9)[Cooper 2000] 12

Inhibition of research into biological causes of CFS/ME

A search on PubMed (National Library of Medicine and the National Institute of Health) on Dec 1st 2006, returned 3308 titles for Chronic Fatigue Syndrome dating from May, 1997 to the present. Covering the same period a search for Multiple Sclerosis returned 22990 matches.

No representative who appeared at the Oral Hearings proposed CFS/ME was entirely psychosocial, so why has this model taken such a prominent role in the UK? [Gibson Inquiry 2006] The Group believes that the MRC should be more open-minded in their evaluation of proposals for biomedical research into CFS/ME and that, in order to overcome the perception of bias in their decisions, they should assign at least an equivalent amount of funding (11 million) to biomedical research as they have done to psychosocial research. [Gibson Inquiry 2006] However, there is clearly a need for research into causation, the spectrum of the illness over time, therapeutic interventions and models of care. It is indeed surprising that, given the talent and interest that there is, huge frustration remains in providing funding for research and the different approaches to research. The NICE guidelines must surely recognise the inadequacy of our knowledge in all these areas and indeed we may inhibit discovery and make profound mistakes in the absence of a national, all round research policy. (p.28) [Gibson Inquiry 2006] The underlying theme in all or our hearings was the paucity of research into causes. (p.28) [Gibson Inquiry 2006] By contrast, since April 2003 the MRC has funded five applications relating to CFS/ME, mostly in the psychiatric/psychosocial domain (Professor Francis Creed, Professor K Bhui, Professor Peter White's PACE trial, Alison Wearden's FINE trial and Richard Morriss' study of "medically unexplained symptoms"). (p.29) [Gibson Inquiry 2006] Biomedical applications in respect of ME/CFS known to have been rejected include those by Professor Jill Belch (herself a Principal Fellow of the MRC) and Dr Vance Spence of Dundee, as well as Dr Jonathan Kerr of St Georges, London. (p.29) [Gibson Inquiry 2006] ME and CFS have been defined as neurological illnesses by the World Health Organisation. Various clinical and epidemiological research studies in countries around the world have suggested CFS/ME to have a biomedical cause. The UK has not been a major player in the global progress of biomedical research into CFS/ME. Although some interesting biomedical research has been done in the UK precedence has been given to psychological research and definitions. (p.33) [Gibson Inquiry 2006] There is a great deal of frustration amongst the CFS/ME community that the progress made in the late 1980s and early 1990s toward regarding CFS/ME as a physical illness has been marginalised by the psychological school of thought. It is clear the CFS/ME community is extremely hostile to the psychiatrists involved. (p.33) [Gibson Inquiry 2006] We recommend that this condition be recognised as one which requires an approach as important as heart disease or cancer. There is no compelling evidence it is a purely 13

psychosocial. Where the disease or diseases fit in the spectrum of psycho or biomedical disturbances in any individual requires much further research. However, this will depend on well-funded research that must be made a priority in our health research programme. (p.34) [Gibson Inquiry 2006] Despite the findings of the CMO's Report some three years ago. There has been no massive investment in funding of research into ME. Instead, we have seen a review of treatment by NICE based on existing evidence and existing symptomatic techniques. We must research to find alternatives. (p.34) [Gibson Inquiry 2006] The Immediate Future This group believes that the MRC should be more open-minded in their evaluation of proposals for biomedical research into CFS/ME and that, in order to overcome the perception of bias in their decisions, they should assign at least an equivalent amount of funding (11 million) to biomedical research as they have done to psychosocial research. It can no longer be left in a state of flux and these patients or potential patients should expect a resolution of the problems with only an intense research programme can help resolve. It is an illness whose time has certainly come. (p.35) [Gibson Inquiry 2006] Influenced by these psychiatrists, Government bodies such as the Medical Research Council have continued to propagate the same falsehoods with the result that patients are left without any hope of understanding or of health service provision or delivery. As a consequence, Government funding into the biomedical aspects of the disorder is nonexistent (p.4) [Hooper et al. 2003] In relation to ME/CFS at least, flawed, unsubstantiated theories have been uncritically adopted and treated as 'fact', even against the already substantial (and substantiated) body of bio-medical evidence which continues to grow. [Hooper et al. 2003] Despite the findings from the US that CBT is ineffective, in the UK Wessely School psychiatrists have just been granted a further 11.1 million (2.6 million from the MRC plus 8.5 million from Government) in order to "strengthen" their own very weak evidence that such mind-altering management regimes are effective and are the best "evidence-based" management option; this sum is in addition to previous funding of over 4 million. (p.46) [Hooper et al. 2003] Whilst many appeared willing to consider management therapy research, almost all people with ME with whom we come in contact are very concerned that without significant investment in biomedical research (eg tissue testing), the underlying causes of the illness will not be identified, hampering diagnosis and the development of treatment. (p.28) [Tymestrust 2005]

Examples of recent NHS Research Ethics Committee approved research

[National Research Register 2006]
Introduction Much of the research conducted in the UK into psychological and psychosocial theories of CFS/ME is not only approved by, but also receives funding from the NHS and MRC.

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Research investigating psychosocial and psychological theories about CFS/ME has been conducted for many years and has contributed nothing of value to participants, other patients, science or medicine. Continuing such research appears to be entirely gratuitous. This type of research does, however, discredit people diagnosed with CFS/ME as it suggests that patients symptoms are simulated or imagined or exaggerated. Furthermore, it fosters a climate of discrimination against people diagnosed with CFS/ME who must contend not only with disabling illness but also harassment and discrimination. People with CFS/ME who enrol as participants in this type of research will be inadvertently contributing to derogatory theories about their illness. They are being asked to participate in research that might contribute to them being treated with discrimination in the delivery of healthcare, education, state benefits and employment rights. Have participants been warned of these readily foreseeable adverse effects of their participation? Are potential participants given complete information regarding the research objectives prior to giving Informed Consent? Not only are participants in such research likely to contribute to additional suffering for themselves and others, but as many will previously and currently be payers of tax and national insurance, and as much of this is publicly funded and approved research, they have inadvertently helped to pay for the privilege.

TI:Core beliefs and affective information processing in chronic fatigue syndrome: Comparison with rheumatoid arthritis patients and healthy controls.
PI:N0281168748 PR:Wolverhampton City Primary Care Trust RE:West Midlands Regional Office MR:To determine the types of core beliefs (beliefs about the self, others and the world) that individuals with chronic fatigue syndrome hold and to assess whether these beliefs are different to individuals with another chronic illness (rheumatoid arthritis) or no illness at all. Specifically, it is predicted that individuals with chronic fatigue syndrome will hold beliefs concerning emotion inhibition ( the tendency to suppress emotions rather than express them). MT:Questionnaire design. SA:90 participants will be recruited (30 per group) OU:1. Scores on self-report measures 2. Emotional stroop task (reaction times and accuracy) 3. Face processing (accuracy,distinctiveness/intensity ratings) MC:This record refers to a multi-centre study led by another centre LC:University of Birmingham EC:05/MREC07/43 SD:1/6/2005 ED:30/6/2006 ST:Complete AU:Dr Kirsty/KL Gillings AD:University of Birmingham, Department of Clinical Psychologuy, Edgbaston, Birmingham, B15 2TT, UK PH:07950551610 EM:klg724@bbham.ac.uk PN:5MV PT:NP F1:University of Birmingham F3:250 PK:MeSH terms not yet assigned

TI:Living with chronic fatigue syndrome (CFS), attributions, perceptions, health beliefs and coping with illness and treatment
PI:N0263148868

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PR:University College London Hospitals NHS Foundation Trust RE:London Regional Office MR:To evaluate the affect of a battery of treatments received & to find out whether there were significant differences in treatment outcome between patients who attributed the cause of their illness MT:Database Analysis SA:60 patients from Complementary Medicine OU:To measure the effectiveness of a range of treatments received by CFS patients. To measure the possible influence of health beliefs and attribution on the treatment outcome MC:This record refers to a multi-centre study led by another centre SD:1/8/2004 ED:1/12/2006 ST:Ongoing AU:Dr M Jenkins AD:Complementary Medicine, Royal London Homoeopathic Hospital, Greenwell Street, London, W1W 5BP, UK PH:020 7391 8895 FA:020 7391 8812 EM:michael.jenkins@uclh.nhs.uk PN:RRV PT:Reducing inequalities: social psychological and biological pathways to inequalities in health; the development of tools to quantify health problems; examination of differing care arrangements F4:NHS R&D Support Funding F5:2006/07 F6:4716.8644 PK:MeSH terms not yet assigned

TI:A cross-sectional comparison of chronic fatigue and chronic fatigue syndrome between Brazil and the United Kingdom.
PI:N0116140770 PR:Kings College Hospital NHS Trust R&D Consortium RE:London Regional Office MR:Primary Objectives: 1. To quantitatively compare the perpetuating factors of fatigue amoung patients with chronic (CF) between Brazil and the UK: somatic attribution of cause, fear of exercise, aviodance and focusing on bodily symptoms. 2. To qualitatively compare the illness model of patients meeting the case definition of chronic fatigue syndrome (CFS) between Brazil and the UK. MC:This record refers to a single-centre study SD:29/3/2004 ED:30/9/2005 ST:Complete AU:Professor S Wessely AD:Academic Dept of Psychological Medicine, GKT School Medical School, 103 Denmark Hill, London, SE5 8AZ, England PH:0207 848 0796 FA:0207 346 3363 EM:s.wessely@iop.kcl.ac.uk PN:RJ2 PT:Healthcare from the patient's perspective F1:Institute of Social Psychiatry F2:207514 F4:NHS R&D support funding F5:2005/2006 F6:27794 PK:MeSH terms not yet assigned

Comment: This research demeans people diagnosed with CFS/ME in the UK. No wonder so many people with these diagnoses have difficulty getting proper healthcare when professionals who read medical journals find items of research referring to, somatic

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attribution of cause, fear of exercise, aviodance and focusing on bodily symptoms. This is another piece of research that is funded by the NHS (69,882). Following is the Brazilian connection of this research project described at the 2nd Annual International Mental Health (IMH) at the IOP (IMH 2005)

A cross-cultural comparison of chronic fatigue and chronic fatigue syndrome between Brazil and the United Kindgom Dr Hyong Jin Cho IOP Chronic fatigue syndrome (CFS) as a severe illness with physical causes seems to be a unique phenomenon in the West. Several cognitive-behavioural factors are believed to perpetuate CFS: somatic attribution of cause, fear of exercise, avoidance as coping strategy and focusing on bodily symptoms. These perpetuating factors seem to be influenced by several sociocultural factors uniquely observed in the West-e.g. awareness of CFS among the population, media coverage, litigation and overemphasis on a biomedical model of health care. Brazil is a country where CFS is practically unknown and the above-mentioned scoiocultural factors are far scarcer than in the UK. The hypothesis are: 1) The perpetuating factors of fatigue are less prevalent among Brazilian patients with chronic fatigue (CF: a subsyndromal counterpart to CFS) than their British counterparts. 2) Brazilian patients with CF are less disabled. A cross-sectional survey at primary care level is being conducted in So Paulo and London. Consecutive attendees to general practices, aged 18-45 years, are being screened with the Chalder Fatigue Questionnaire and GHQ-12. All patients with CF will answer the questionnaires on the perpetuating factors and disability. They will also undergo application of the CFS case definitions and a psychiatric interview. We screened 3930 attendees and interviewed 580 CF patients in Brazil. The survey in the UK is in progress and we anticipate that we will have preliminary results of this cross-cultural comparison by the occasion of the present conference, August 2005. TI:An investigation of the role of fatigue related fear on disability for individuals diagnosed with Chronic Fatigue Syndrome and Fibromyalgia Syndrome
PI:N0207138691 PR:Royal Liverpool and Broadgreen University Hospitals Trust RE:North West Regional Office MR:An investigation of the role of fatigue related fear on disability in Chronic Fatigue Syndrome and Fibromyalgia Syndrome. MT:A cohort design study consisting of a group of individuals diagnosed with either CFS or FMS. The study will include both cross sectional and longitudinal data collection. SA:120 participants - approx 10 per month. The age group will be from 17 years upwards. OU:1. Test a simplified model from chronic pain studies that high fatigue-related fear leads to increased disability for individuals with chronic fatigue. 2. To determine whether fatigue related fear is more disabling than fatigue itself and other variables known to maintain disability. 3. To examine whether the duration of symptoms of chronic fatigue is associated with fatigue related fear. MC:This record refers to a multi-centre study led by another centre LC:cco SD:1/2/2004 ED:1/9/2005 ST:Complete AU:Mrs Laura Harwood AD:Department of Clinical Psychology, University of Liverpool, Whelan Building, Quadrangle, Brownlow Hill, Liverpool, L69 3GB PH:01244 7945530

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FA:0151 794 5537 EM:Laurah@liv.ac.uk PN:RQ6 PT:Delivering effective health services F1:No External Funding F4:NHS R&D Support Funding F5:2005/06 F6:2726.7538 PK:MeSH terms not yet assigned

TI:Experimental evidence to show whether people witn Chronic Fatigue Syndrome (CFS) demonstrate an attentional or memory bias towards symptom-related stimuli. Protocol Version 1 dated 7.10.03.
PI:N0176135496 PR:Oxford Radcliffe Hospitals NHS Trust RE:South East Regional Office MR:1. Compared to people with Multiple Sclerosis (MS) and healthy people, do people with Chronic Fatigue Syndrome (CFS) pay more attention to symptom-relevant information (I.e. symptoms chaacteristic of CFS) than neutral information? 2. Compared to people with MS and healthy people, do people with CFS remember more symptom-relevant information than neutral information? 3. In people with CFS are any differences in attention and memory for symptom-relevant information (compared to neutral information) related to symptoms/levels of activity/mood? MT:Questionnaire, cross-sectional study SA:30 healthy people, 30 pateints, 30 control patients OU:Completed MMSE and NART, completed self-report measures, data collected from computer dot probe task and free recall memory task. Statistical analysis will then be used to examine significant differences between conditions and groups, based on hypotheses and research questions. MC:This record refers to a single-centre study SD:5/1/2004 ED:30/9/2004 ST:Complete AU:Ms Amy Silver AD:The Ethox Centre, Institute of Health Sciences, Old Road Campus, Headington, Oxford, OX3 7LF, UK PH:01865 226431 FA:01865 226364 EM:amy.silver@hmc.ox.ac.uk PN:RNU PT:Oxford Mental Health Collaborative Research Grouping (CRG) R&D Programme PK:FATIGUE SYNDROME CHRONIC [psychology]; FATIGUE SYNDROME CHRONIC [complications]; MEMORY DISORDERS [psychology]; MEMORY DISORDERS [etiology]; MULTIPLE SCLEROSIS [psychology]; MULTIPLE SCLEROSIS [complications] SK:HUMAN; CROSS-SECTIONAL STUDIES

TI:How do the beliefs and responses of significant others' of patients with chronic fatigue syndrome (CFS) impact on the patient's symptoms, adaptation and functioning?
PI:N0207125755 PR:Royal Liverpool and Broadgreen University Hospitals Trust RE:North West Regional Office MR:How do the beliefs and responses of significant others' of patients with chronic fatigue syndrome (CFS) impact on the patient's symptoms, adaptation and functioning? MT:This is a cross-sectional study of patients and their nominated closest adult family member (their 'significant other') SA:176: 88 patients and 88 significant others. Participants will be aged 16 and over, with no upper age limit. OU:The data obtained from the study will be used to obtain a detailed understanding of significant others' beliefs and compared to the measures taken of patient functioning to produce quantitative measures which might predict patient functioning. MC:This record refers to a single-centre study SD:1/5/2003 ED:1/9/2005

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ST:Complete AU:Dr Frederick J Nye AD:Tropical and Infectious Diseases Unit, RLUH, Liverpool, L7 8XP, England PH:0151 706 3836 FA:0151 706 5944 EM:Frederick.Nye@rlbuht.nhs.uk PN:RQ6 PT:Delivering effective health services F1:Economic and Social Research Council F3:10000 F4:NHS R&D Support Funding F5:2005/06 F6:2726.7538 PK:ADAPTATION PSYCHOLOGICAL; FATIGUE SYNDROME CHRONIC [psychology] SK:HUMAN; CROSS-OVER STUDIES; ADOLESCENT; ADULT

Research Titles
With parallel studies removed, the titles of completed Single Centre research approved by NHS Research Ethics Committees show (as well as I can split them) 98 biological research and 66 psychological research. That is 40% psychological research in the UK into Chronic Fatigue Syndrome. This is following many years and numerous projects of such research that has failed to help people with these diagnoses. This list of recent research titles approved by NHS RECs, many of which are/were funded by the NHS and MRC shows the kind of prejudicial and often strange ideas that some researchers have about CFS/ME. This research influences health professionals and others opinions and impacts on patients lives.

TI:A cohort study of chronic fatigue in Brazil: Prognosis and perpetuating factors TI:Aerobic exercise and Fluoxetine in the treatment of chronic fatigue syndrome TI:Aerobic exercise in chronic fatigue syndrome TI:Ambulatory study of the Psychophysiological Responses to Activity in Patients with Chronic Fatigue Syndrome and Sedentary Controls TI:An investigation into the role of psychological factors in the symptomatology of chronic fatigue syndrome (CFS); information processing of self-referent emotional material TI:A pilot study for a community randomised controlled trial of self help versus no treatment in the prevention of chronic fatigue and chronic fatigue syndrome (CFS) following glandular fever. TI:A pilot study of a new instrument to measure family responses to chronic fatigue syndrome TI:A pilot study of guided self-help for adolescents with chronic fatigue syndrome. TI:A placebo, double blind, cross -over study on Immuvit (Ginseng extract) on Chronic Fatigue Syndrome. TI:A qualatitive study of mindfulness base cognitive therapy (MBCT) group for people with chronic fatigue syndrome (CFS). TI:A randomised controlled trial of cognitive behaviour therapy for chronic fatigue syndrome TI:Are thoughts about activity related to the levels of physical activity seen in chronic fatigue Syndrome (CFS) patients?

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TI:A study of the quality of life and clinical characteristics of patients with chronic fatigue syndrome attending a psychiatric fatigue clinic and an immunology fatigue clinic TI:A study to investigate health beliefs of people with non-epileptic seizures (NES) and people with chronic fatigue syndrome (CFS) TI:Attention training in Chronic Fatigue Syndrome: a case series evaluation. TI:Causal attributions for somatic sensations in patients with Chronic Fatigue Syndrome and their relatives. TI:Childhood experiences and parenting in adults with chronic fatigue syndrome, adults with multiple sclerosis and a nromal control group: a pilot study (097/99) TI:Childhood experiences of illness and parenting in adults with chronic fatigue syndrome and adults with diabetes mellitus: A pilot study. TI:Cognitive behaviour therapy (CBT) in Chronic Fatigue Syndrome (CFS): a randomised controlled trial of a group programme for the primary care population. TI:Cognitive Behaviour Therapy vs Relaxation for Chronic Fatigue Syndrome: Outcome at five year follow-up. TI:Does a group occupational therapy programme for clients with chronic fatigue syndrome improve functioning scores as measured by the functional limitations profile? TI:Effectiveness of Counselling within the treatment of CFS TI:Evaluation of a rehabilitation programme for patients with chronic fatigue syndrome TI:Evaluation of the Wellness Enhancement Learning programme for patients with Chronic Fatigue Syndrome/ME TI:Experiences and expectations of Chronic Fatigue Syndrome (CFS) patients who have undergone treatment through a CFS group based on CBT TI:Experimental evidence to show whether people witn Chronic Fatigue Syndrome (CFS) demonstrate an attentional or memory bias towards symptom-related stimuli. Protocol Version 1 dated 7.10.03. TI:Exploration of Perceived Changes in Occupational Function in Chronic Fatigue Syndrome TI:Family focussed Cognitive Behavioural Therapy for Adolescents with Chronic Fatigue Syndrome TI:Family history study of chronic fatigue syndrome. TI:Frequency of attendance in general practice before development of chronic fatigue syndrome: a case control study TI:Group therapy for chronic fatigue syndrome. TI:How do the beliefs and responses of significant others' of patients with chronic fatigue syndrome (CFS) impact on the patient's symptoms, adaptation and functioning? TI:Identity and Illness in Context: The Case of Chronic Fatigue Syndrome TI:Information-processing biases in patients with the Chronic Fatigue Syndrome (CFS) and comparison groups. TI:Neurobiological changes and predictors of outcome after CBT for chronic fatigue syndrome TI:People with chronic fatigue syndrome and their perspective of 'self' TI:Personality dimensions and family functioning in chronic fatigue syndrome: A comparison with depression 20

TI:Personality traits in Chronic Fatigue Syndrome TI:Pilot study for a narrative analysis of patient accounts of Chronic Fatigue Syndrome TI:Psychological intervention in patients with chronic fatigue syndrome. TI:Quality of Life and Performance Perception in Patients with Chronic Fatigue Syndrome TI:Randomised controlled trial of cognitive behaviour therapy versus graded exercise in the chronic fatigue syndrome TI:Randomized controlled trial of cognitive behaviour psychotherapy in chronic fatigue syndrome. TI:Self esteem, attribution an coping in chronic fatigue syndrome (+1) TI:Short term intervention for people with chronic fatigue syndrome: The Patient's Perspective. TI:Social Identity in Chronic Fatigue Syndrome TI:The effect of Transcutaneous Electrical Nerve stimulation (TENS) on pain perception and functional ability in patients with Chronic Fatigue Syndrome. TI:The effects of Mindfulness-Based Stress Reduction (MBSR) in the treatment of Chronic Fatigue Syndrome (CFS) in a Group Setting TI:The experience of living with chronic fatigue syndrome. TI:The Experience of Living with Chronic Fatigue Syndrome/M.E. TI:The relationship between social support and severity of symptoms in chronic fatigue syndrome TI:University of Sheffield Integrated Health Clinic - A pilot clinic to test the acceptability and effectiveness of an adapted model of brief interpersonal psychotherapy for students presenting with stress-related medical symptoms TI:Using beliefs to predict exercise tolerance in patients with chronic fatigue syndrome

Excerpts from

Research Governance Framework for Health and Social Care

Second edition, 2005
First published: March 2001 Second edition: April 2005 Crown Copyright 2005 Produced by COI for the Department of Health

1.1 The Government is committed to enhancing the contribution of research to health and social care. Research is essential to the successful promotion and protection of health and well-being, and also to modern, effective e health and social care services. At the same time, research can involve an element of risk, both in terms of return on investment and sometimes for the safety and well-being of the research participants. Proper governance of research is essential to ensure that the public can have confidence in, and benefit from, quality research in health and social care. The public has a right to expect high scientific, ethical and financial standards, transparent decision-making processes, clear allocation of responsibilities and robust monitoring arrangements. [p.6] 2.2 ETHICS 2.2.1 The dignity, rights, safety and well-being of participants must be the primary consideration in any research study. Box A (see page 10) describes a scenario to illustrate good practice in protecting research participants rights within a study. [p.11] 21

2.2.3 Informed consent is at the heart of ethical research. Most studies involving individuals must have appropriate arrangements for obtaining consent, and the ethics review process pays particular attention to those arrangements. [p.11] 2.2.8 Some research may involve an element of risk to those participating in it. If there are any risks to participants, the risks must be in proportion to the potential benefit.7 Risks, pain or discomfort must always be kept to a minimum, and explained clearly both to the relevant research ethics committee8 and to participants. It must always be explained whether there are arrangements for compensation in the unlikely event of non-negligent harm. 2.3 SCIENCE 2.3.1 All existing sources of evidence, especially systematic reviews, must be considered carefully before undertaking research. Research which duplicates other work unnecessarily, or which is not of sufficient quality to contribute something useful to existing knowledge, is unethical. 2.7.2 The key elements of a quality research culture are: respect for participants dignity, rights, safety and well-being; valuing the diversity within society; personal and scientific integrity; leadership; honesty; accountability; openness; clear and supportive management. 3.4.1 Effective and responsive services depend on good research. Through this framework and related provisions, the Government and its partners strive to ensure that research conducted in health and social care in England offers the likelihood of real benefits either to those who participate, or to those who use services subsequently, or both. Anyone using health and social care services should give serious consideration to becoming involved in developing or undertaking research studies. 3.6.3 For research in health or social care, the chief investigator is responsible for ensuring the following. The research team gives priority at all times to the dignity, rights, safety and well-being of participants. 3.7 RESPONSIBILITIES OF RESEARCH FUNDERS 3.7.1 Organisations that fund research have a responsibility to ensure that it is a proper use of the funds they control and provides value for money. 3.7.2 The main research funder plays a critical role in assuring the quality of a study. It will normally take the lead in establishing that the research proposal is worthwhile, of high scientific quality, and represents good value for money.20 3.12.6 Research ethics committees provide an independent opinion. The decision whether or not to give permission for research in a care organisation rests with that organisation. Similarly, Directors of Social Services are responsible for considering permission for social care research conducted within their local authorities. Subject to a favourable 22

ethical opinion, health and social care organisations will not normally withhold permission unless there are local factors that would lead to an unacceptable impact on the quality of health or social care. It is not for research ethics committees or reviewers to give legal advice, nor are they liable for any of their decisions in this respect. It is the researchers and the health or social care organisations32 who have the responsibility not to break the law. If a research ethics committee suspects that a research proposal might contravene the law, it is expected to advise both the chief investigator and the appropriate authority. Then the chief investigator and the organisation will need to seek legal advice. The same applies to those under taking ethics review of social care research.
3.12.7

Nothing in this research governance framework is intended to transfer the legal duties of health and social care organisations to sponsors or to others. Whoever takes on sponsorship, if a study affects a health or social care organisations duties, it remains that organisations responsibility to satisfy itself that there are systems to conduct the study to appropriate scientific and ethical standards.
4.8

5.9 In the case of misconduct, professional groups are subject to disciplinary action by their professional bodies. The Council for the Regulation of Health Care Professionals will promote best practice and cooperation between regulatory bodies. For example, doctors are responsible to the General Medical Council for their professional conduct as researchers as well as clinicians. [p.52] Excerpts from

Governance arrangements for NHS Research Ethics Committees

[Department of Health 2001] 1.3 The Research Governance Framework states that the dignity, rights, safety and wellbeing of participants must be the primary consideration in any research study. The Department of Health requires that all research falling within certain categories (set out in 3.1) is reviewed independently to ensure it meets the required ethical standards. 1.10 The protection of research participants is best served by close co-operation and efficient communication amongst all those who share the responsibility for it. Whilst not sacrificing the independence of their decision on the ethics of a proposal, RECs should, where appropriate, work closely with actual and potential participants, researchers, funders, sponsors, employers, care organisations and professionals - and each other - in order to achieve this goal.
[Comment. I would very much like to see the evidence that people diagnosed with CFS/ME and their patient organizations have been actively involved prior to RECs giving ethical approval of some psychological research into the illness.]

2.2 The purpose of a Research Ethics Committee in reviewing the proposed study is to protect the dignity, rights, safety and well-being of all actual or potential research 23

participants. It shares this role and responsibility with others, as described in the Research Governance Framework for Health and Social Care. 2.3 RECs are responsible for acting primarily in the interest of potential research participants and concerned communities, but they should also take into account the interests, needs and safety of researchers who are trying to undertake research of good quality. However, the goals of research and researchers, while important, should always be secondary to the dignity, rights, safety, and well-being of the research participants. 2.4 RECs also need to take into consideration the principle of justice. This requires that the benefits and burdens of research be distributed fairly among all groups and classes in society, taking into account in particular age, gender, economic status, culture and ethnic considerations. In this context the contribution of previous research participants should also be recalled. 2.5 RECs should provide independent, competent and timely review of the ethics of proposed studies. Although operating within the Governance Framework determined by the Department of Health, in their decision-making RECs need to have independence from political, institutional, profession-related or market influences. They need similarly to demonstrate competence and efficiency in their work, and to avoid unnecessary delay. 2.6 In common with all those involved in research in the NHS and Social Care environments, RECs should have due regard for the requirements of relevant regulatory agencies and of applicable laws. It is not for the REC to provide specific interpretation of regulations or laws, but it may indicate in its advice to the researcher and host institution where it believes further consideration needs to be given to such matters. 7.3 Standard operating procedures shall be compatible with European and UK law, and, where appropriate, to the relevant provisions in Good Clinical Practice. 7.30 Reports to the committee should also be required if there are any other unusual or unexpected results which raise questions about the safety of the research. (See Section B for further details). 7.31 Reports on success (or difficulties) in recruiting participants provide the REC with useful feedback on perceptions of the acceptability of the project among potential research participants. RECs may wish to request such reports where they anticipate potential difficulties.

Declaration of Helsinki
[World Medical Association 2006] Ethical Principles for Medical Research Involving Human Subjects A. INTRODUCTION 1. The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical 24

research involving human subjects includes research on identifiable human material or identifiable data. 2. It is the duty of the physician to promote and safeguard the health of the people. The physician's knowledge and conscience are dedicated to the fulfillment of this duty. 3. The Declaration of Geneva of the World Medical Association binds the physician with the words, "The health of my patient will be my first consideration," and the International Code of Medical Ethics declares that, "A physician shall act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient." 4. Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects. 5. In medical research on human subjects, considerations related to the wellbeing of the human subject should take precedence over the interests of science and society. 6. The primary purpose of medical research involving human subjects is to improve prophylactic, diagnostic and therapeutic procedures and the understanding of the aetiology and pathogenesis of disease. Even the best proven prophylactic, diagnostic, and therapeutic methods must continuously be challenged through research for their effectiveness, efficiency, accessibility and quality. 7. In current medical practice and in medical research, most prophylactic, diagnostic and therapeutic procedures involve risks and burdens. 8. Medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights. Some research populations are vulnerable and need special protection. The particular needs of the economically and medically disadvantaged must be recognized. Special attention is also required for those who cannot give or refuse consent for themselves, for those who may be subject to giving consent under duress, for those who will not benefit personally from the research and for those for whom the research is combined with care. 9. Research Investigators should be aware of the ethical, legal and regulatory requirements for research on human subjects in their own countries as well as applicable international requirements. No national ethical, legal or regulatory requirement should be allowed to reduce or eliminate any of the protections for human subjects set forth in this Declaration. B. BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH 10. It is the duty of the physician in medical research to protect the life, health, privacy, and dignity of the human subject. 25

11. Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and on adequate laboratory and, where appropriate, animal experimentation. 12. Appropriate caution must be exercised in the conduct of research which may affect the environment, and the welfare of animals used for research must be respected. 13. The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol. This protocol should be submitted for consideration, comment, guidance, and where appropriate, approval to a specially appointed ethical review committee, which must be independent of the investigator, the sponsor or any other kind of undue influence. This independent committee should be in conformity with the laws and regulations of the country in which the research experiment is performed. The committee has the right to monitor ongoing trials. The researcher has the obligation to provide monitoring information to the committee, especially any serious adverse events. The researcher should also submit to the committee, for review, information regarding funding, sponsors, institutional affiliations, other potential conflicts of interest and incentives for subjects. 14. The research protocol should always contain a statement of the ethical considerations involved and should indicate that there is compliance with the principles enunciated in this Declaration. 15. Medical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given consent. 16. Every medical research project involving human subjects should be preceded by careful assessment of predictable risks and burdens in comparison with foreseeable benefits to the subject or to others. This does not preclude the participation of healthy volunteers in medical research. The design of all studies should be publicly available. 17. Physicians should abstain from engaging in research projects involving human subjects unless they are confident that the risks involved have been adequately assessed and can be satisfactorily managed. Physicians should cease any investigation if the risks are found to outweigh the potential benefits or if there is conclusive proof of positive and beneficial results. 18. Medical research involving human subjects should only be conducted if the importance of the objective outweighs the inherent risks and burdens to the subject. This is especially important when the human subjects are healthy volunteers.

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19. Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research. 20. The subjects must be volunteers and informed participants in the research project. 21. The right of research subjects to safeguard their integrity must always be respected. Every precaution should be taken to respect the privacy of the subject, the confidentiality of the patient's information and to minimize the impact of the study on the subject's physical and mental integrity and on the personality of the subject. 22. In any research on human beings, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail. The subject should be informed of the right to abstain from participation in the study or to withdraw consent to participate at any time without reprisal. After ensuring that the subject has understood the information, the physician should then obtain the subject's freely-given informed consent, preferably in writing. If the consent cannot be obtained in writing, the nonwritten consent must be formally documented and witnessed. 23. When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in a dependent relationship with the physician or may consent under duress. In that case the informed consent should be obtained by a well-informed physician who is not engaged in the investigation and who is completely independent of this relationship. 24. For a research subject who is legally incompetent, physically or mentally incapable of giving consent or is a legally incompetent minor, the investigator must obtain informed consent from the legally authorized representative in accordance with applicable law. These groups should not be included in research unless the research is necessary to promote the health of the population represented and this research cannot instead be performed on legally competent persons. 25. When a subject deemed legally incompetent, such as a minor child, is able to give assent to decisions about participation in research, the investigator must obtain that assent in addition to the consent of the legally authorized representative. 26. Research on individuals from whom it is not possible to obtain consent, including proxy or advance consent, should be done only if the physical/mental condition that prevents obtaining informed consent is a necessary characteristic of the research population. The specific reasons for involving research subjects with a condition that renders them unable to give informed consent should be stated in the experimental protocol for consideration and approval of the review committee. The protocol should 27

state that consent to remain in the research should be obtained as soon as possible from the individual or a legally authorized surrogate. 27. Both authors and publishers have ethical obligations. In publication of the results of research, the investigators are obliged to preserve the accuracy of the results. Negative as well as positive results should be published or otherwise publicly available. Sources of funding, institutional affiliations and any possible conflicts of interest should be declared in the publication. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication. B. ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE 28. The physician may combine medical research with medical care, only to the extent that the research is justified by its potential prophylactic, diagnostic or therapeutic value. When medical research is combined with medical care, additional standards apply to protect the patients who are research subjects. 29. The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists. See footnote 30. At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study. See footnote 31. The physician should fully inform the patient which aspects of the care are related to the research. The refusal of a patient to participate in a study must never interfere with the patient-physician relationship. 32. In the treatment of a patient, where proven prophylactic, diagnostic and therapeutic methods do not exist or have been ineffective, the physician, with informed consent from the patient, must be free to use unproven or new prophylactic, diagnostic and therapeutic measures, if in the physician's judgement it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, these measures should be made the object of research, designed to evaluate their safety and efficacy. In all cases, new information should be recorded and, where appropriate, published. The other relevant guidelines of this Declaration should be followed.

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Millen, N. 2002. 'A sociological gaze on ME/CFS: a modern malady in need of humane medicine', The Medical Practitioners' Challenge: Proceedings of the Third Sydney International Clinical and Scientific Meeting 2001, Alison Hunter Memorial Foundation, Bowral, NSW. Morris, Dorothy. 2003. Doctorate Thesis for Deakin University. Double disability: Lived experience of Australian Tertiary Students with ME/CFS. http://tux.lib.deakin.edu.au/adt-VDU/public/adtVDU20051110.110308/ Mungovan, A. & England, H. 1998. Bridging the Gap: Understanding the issues and needs of students and staff with Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS) within Tertiary Education: A NSW Regional Disability Liaison Officer Initiative, Sydney, NSW. National Research Register. 2006. [Online]. Available at: http://www.update-software.com/National/ Accessed Dec 18th 2006. Raine, R., Carter, S., Sensky, S., and Black, N. 2004. General practitioners' perceptions of chronic fatigue syndrome and beliefs about its management, compared with irritable bowel syndrome: qualitative study. BMJ, doi:10.1136/bmj.38078.503819.EE. [Online] Available at: www.bmj.com Accessed 3rd Dec 2006. Sachs, L. 2001. 'From a lived body to a medicalized body: diagnostic transformation and chronic fatigue syndrome', Medical Anthropology, vol.19, no.4, pp.299-317. Jason, A., L. Holber, C., Torres-Harding, S., Taylor., R. 2004. Stigma and the Term Chronic Fatigue Syndrome: Results of Surveys on Changing the Name. [Online]. Available at: http://www.questia.com/PM.qst?a=o&d=5006656589&er=deny Accessed Dec 3rd 2006. Thomas, M., Smith, A., 2005. Primary healthcare provision and Chronic Fatigue Syndrome: a survey of patients' and General Practitioners' beliefs. Centre for Occupational and Health Psychology, School of Psychology, Cardiff University, 63 Park Place, Cardiff, UK. [Online]. Available at: http://www.biomedcentral.com/1471-2296/6/49 Travers, Michele Kerry. 2006. University of Sydney. Clinical Nursing. From Violation to Reconstruction. [Online] Available at: http://ses.library.usyd.edu.au/handle/2123/636 [Part 2] Accessed Nov 30th 2006. Tymestrust (The Young M.E. Sufferers Trust). 2001. Registered Charity 1080985. Whispered Words. [Online pdf] Available at: http://www.tymestrust.org/tymespublications.htm Accessed Dec 1st 2006. Tymestrust (The Young M.E. Sufferers Trust). 2003. Registered Charity 1080985. The Forgotten Children. [Online pdf] Available at: http://www.tymestrust.org/tymespublications.htm Accessed Dec 1st 2006. Tymestrust (The Young M.E. Sufferers Trust). 2005. Registered Charity 1080985. Our Needs, Our Lives. Survey [Online pdf] Available at: http://www.tymestrust.org/tymespublications.htm Accessed Dec 1st 2006. World Medical Association. 2006. [Online]. Available at: http://www.wma.net/e/policy/b3.htm Accessed Dec 1st, 2006.

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