Toward a sociological understanding of service user involvement in health research

1. Toward a sociological understanding of service user involvement in health research John Sitzia Patient and Public Involvement Research Unit Worthing and Southlands Hospitals NHS Trust john.sitzia@wash.nhs.uk

2. Quick chronology of PPI-R • late 1980s / early 1990s – PPI-R in some RCTs, mainly childbirth (e.g. ECMO) and HIV/AIDS (e.g. Concorde) • 1991 – launch of NHS R&D Strategy • 1994 – Consumers for Ethics in Research formed • 1996 April – inaugural meeting of Consumers in NHS Research, now INVOLVE • 1998 – performance indicator for NHS R&D Support Funding • 2001 – consumer involvement a ‘requirement’ under the Research Governance Framework : ‘involvement of consumers, wherever possible’

3. Some current ‘concerns’ • How much is going on? • We have absolutely no idea – lots of anecdotal examples, but poor evidence base • Much ‘structural’ development over past few years: INVOLVE highly active, MRC, NCRI, charities e.g. MS Society, Alzheimers • Condition of some NHS / PRP funding (e.g. London Primary Care Studies Programme) • DH 2002/03 R&D Annual Report feedback: “Slow (if any) progress …” • Who to involve? (representation / experience / skills) • No time! No money! No energy! No interest! • Threat to scientific / NHS research communities • Lack of conceptual work – e.g. on evaluation frameworks

4. Some proposed ‘drivers’ • Political will – the policy of PPI-R • Influential actors • ‘Improving research’ – the concern for Ethics • ‘Improving research’ – Research ‘quality’ • Related fields – disability and mental health

5. Drivers – 1 – Political will • Product of government policy to ‘involve’ service users in every aspect of the NHS, regardless of need, value or cost – as a consumerist right. • True now – but scant mention in 1991 strategy (‘consumer’ charities consulted on priorities) or 1993 revision, which proposed “R&D needed to help develop an effective consumer voice within the NHS” – i.e. R&D into PPI-SDO. • ‘Ad-hoc’ group formed in R&D in Jan 92 (Baroness Jay), to set priorities for “NHS R&D in consumer issues”. Met only once, but 3 reports commissioned and Oct 93 workshop: disseminated Aug 95. • But, in Oct 94, CRDC agreed to establish “a group to monitor and advise on consumer involvement in the NHS R&D Programme”, Ruth Evans (Chair NCC) to chair. • INVOLVE inaugural meeting April 1996 – strong support since

6. Drivers – 2 – Influential actors Prof Sir Michael Peckham – “very keen to bring lay involvement in a real way into the R&D process” (Martin 1997 p12) Prof Sir Iain Chalmers – belief that “the public might be served more effectively by research and researchers if there was greater lay involvement at all stages of the research process” (BMJ 1995 310 p1317)

7. Drivers – 3 – ‘Improving research’ : ethics • Growing disquiet concerning standards of ethics, honesty and general conduct in health research. • Bristol Royal Infirmary: (1984-1995) experimental treatments / innovations conducted with no consent / REC approval (Inquiry 2001) • Alder Hey: From 1948 onwards, children’s body parts were illegal removed and retained, without any parents’ consent, for research (most specimens never used). The catalogue of organs included 2128 hearts, 3575 foetuses, 35 heads, and 188 eyes. (Inquiry 2001)

8. Edward Jenner (1749-1823) (pioneer of medical science / copycat opportunist) tested his theory of vaccination by experimenting upon an eight year old boy, James Phipps, inoculating him first on May 14, 1796, with ‘matter’ taken from a cowpox pustule from the dairymaid Sarah Nelmes and later with smallpox ‘virus’

10. One isolated incident? Research misconduct reported in 2003 • Dr Goran Jamal – falsified data in the trial of a new drug in which he had a financial interest • Prof Simon Shorvon – in a neurological study altered patients’ L-dopa treatment without their consent • ‘Isaacs Report’ – since 1970, 21000 human brains removed at postmortem and, with no family consent, stored for ‘research’, in breach of Human Tissue Act (1961) • Dr Mohammed Naeem Shaukat – falsified mortality data to produce results that showed that British patients ofIndian origin fared significantly worse than other British patientsafter first heart attacks (published in BMJ) • DH investigation into Dr David Jeffreys, senior civil servant, alleged inflation of subject numbers and falsification of data 20 years ago

11. A few isolated incidents? • 2001 survey of newly-appointed UK hospital consultants indicated a widespread problem: 56% of the 194 respondents had witnessed some form of research misconduct, 18% stated they might commit misconduct in future, and only 17% had received any training in research ethics. (Geggie et al J Med Ethics 27: 344-346) • 2002, US government pledged to tighten its oversight of the conduct of medical research following an enquiry finding that many commercial trials recruiters are breaching ethical guidelines, especially in respect to informed consent (Gibbs Brown 2000) • 2003 review of financial disclosure in clinical trials found that in 31% of pharmaceutical industry-sponsored trials, the financial relationships between sponsor and investigator was not disclosed, whilst 8% of ‘independent’ investigators either owned stock in the sponsor company or a share in the product licence. (Gross et al BMJ 326: 526-527)

12. But • What about NHS Research Ethics Committees? • Large majority of misconduct cases concern plagiarism, duplicate publication, and invention of participants • Will dishonest researchers working outside the system really be influenced by PPI-R?

13. Drivers – 4 – ‘Improving research’ : quality • March 2000: DH advised that PPI-R is an element – one of only three – in a ‘quality framework’ for NHS R&D (R&D for a First-Class Service) • INVOLVE also promote tenet that PPI-R ‘improves quality’ • 2 obstacles to reasoned debate: • No evidence • Lack of definition of word ‘quality’ • (at least) 2 distinct meanings: • quality of the ‘science’ of the study • quality of the process e.g. • – recruitment & retention strategies • – participant information • – above all, perhaps, ‘relevance’ of topic: Alzheimer’s Society QRD, MS Society, NHS R&D Programmes (consultation?)

14. Drivers – 5 – User-led research in disability and mental health • PPI-R driven by strong tradition in these fields? • Physical Impairment: • ‘A Life Apart’ (1972) – researchers’ “objectivity” • BCODP (1981), Social model of disability (Oliver 1983 Social Work with Disabled People: Macmillan) • Emancipatory Disability Research: 6 core principles • the researchers must be accountable to the disabled community; • the work must adhere to the social model of disability; • the precept that ‘value freedom’ (objectivity) is a misconception; and that all data interpretation is influenced by personal, economic, political and cultural forces; • no inherent preference for any method / research strategies • disabled peoples’ experiences and stories are couched firmly within an environmental and cultural context; • the work should aim for some meaningful practical outcome for disabled people. • More recently, similiar movement in mental health ‘survivor’ research

15. BUT are these values transferable to PPI-R? • Places an emphasis upon civil rights and citizenship – conceived as a broadly political movement – a ‘new’ ‘politics of participation’ • (Does PPI-R follow the democratic or consumerist model of ‘involvement?) • (Passionately) ‘user-led’ – emphasis upon ‘self-organisation’ and ‘self-advocacy’, and user control of resources (Does the PPI-R research establishment really want to share (give up some) power?) • (Passionately) directly linked to positive change for service users (Is this NHS researchers’ priority?) • “Calls into question the legitimacy of traditional research and the problems of bias associated with research and knowledge linked culturally, politically, organisationally and financially with the service and policy system.” (Beresford 2001 Critical Social Policy 4: 494-512.

16. CITIZEN CONTROL DELEGATED POWER Degrees of citizen power PARTNERSHIP PLACATION CONSULTATION Degrees of tokenism INFORMING THERAPY Non participation MANIPULATION What level of participation? Arnstein S. (1969) A ladder of citizen participation. Journal of the American Institute of Planners 35: 216-224.

17. Thoughts • Does it matter how we got here? • Is the political dogma of PPI-SDO relevant to NHS research? • Are the ‘ethical’ and ‘research quality’ arguments persuasive? • Is the influence of EDR / survivor research real or imaginary? • Are the values of user-led research transferable to ‘collaborative’ research? • More research needed!