Ethical Governance and conducting social science research in health service settings

1. Ethical Governance and conducting social science research in health service settings Anne Rogers (Division of Primary Care, University of Manchester)

2. Decisions and rules of Health Service ethics committees have had a significant impact on what is researched and the way it is conducted. • This poses dilemmas and challenges for carrying out field work and applying for and carrying out research.

3. Social Science Guidelines assumptions • The Nature of Research Governance in health settings- legacy and contemporary history • ethical committees and lack of understanding of social science research: • Informed consent • Participant observation

4. Social science research • "All of us consider ourselves ethical; not perfect perhaps, but more ethical than most of humanity.“ • Babbie, E. (1983) The Practice of Social Research, Third edn, Wadsworth Publishing Company.(c) Wadsworth Publishing Company, 1983. Permission requested

5. Components of the Ethical Research Relationship Acknowledgement of Bias Rigor Rapport Respect for autonomy Avoidance of exploitation Confidentiality

6. Personal Conduct of sociologist in health settings- common ethical issues • The researcher-researched relationship • Anonymity and confidentiality • Privacy • Exploitation

7. Principles of BSA Guidelines 2002 • Ethical codes are inherently ambiguous and indeterminate inevitable difficulties in interpretation of ethical dilemmas • Exceptions, Contingencies Situationally Contextually bound • Not a rule –governed approach to research ethics • Difficult choices on the bases of principles values and conflicting interests

8. Organisational Constraints Whatever passes as ‘good’ or ‘bad’, explained Friedrich Nietzsche, has something to do with hierarchy, superiority and inferiority, domination and rule. There is no ‘natural’, intrinsic relationship between certain conduct and goodness; the link needs to be decreed first to be seen. And those who have the power to decree and make the decree hold - do. {Cited in Bauman (1995) Life in Fragments: taken from Nietzsche,F (1956) The Genealogy of Morals,}

9. The Policing of the self misses the new context we are operating in • The NHS research ethics application process is increasingly bureaucratic, time consuming and restrictive. • The remit of NHS Local Research Ethics Committees has expanded over the past decade • It includes not only research conducted on NHS patients,but NHS staff and research NHS premises. • The spread… mounting pressure on researchers from the UK funding councils, (e.g. ESRC, MRC) the larger non-governmental and academic journals to acquire some kind of ethical permission.

10. Not only ethics approval • CRB Checks • Research Governance of individual authority – Primary Care Trust • Research Passport • A medical…….etc

11. What is the Research Passport? • The Research Passport is designed to be completed by researchers who wish to carry out research in NHS organisations, on NHS premises or with NHS patients, their organs, tissue or data. The completion of the passport will enable them to be issued with an honorary research contract. The introduction of a Research Passport ensures that researchers gain the correct checks to satisfy NHS organisations prior to their application for an honorary research contract (HRC). An HRC will not be issued without the completion of the Research Passport. Once the passport is complete the researcher can present the information and attachments to the Research and Development or Human Resources department dealing with the application and an HRC can be issued. If the researcher wants to then apply to more NHS organisations to carry out the same or a different study, the Research Passport can be presented and along with existing HRC and a letter can be issued from that organisation(s) which constitutes an HRC. (Otherwise separate applications….)

12. Recent ethical concerns extension of concern with Clinical Governance • Medicine -governed or regulated via methods of management and systems of regulations • standardization of practices gathered speed with the emerging discourse of ‘Evidence-Based Medicine’ 1990’s • the development and operationalisation of practice and clinical guidelines, which assemble evidence from scientific research into particular recommendations for health practitioners.

13. Specific Governance Policies • Quality National Service Frameworks • Patient Safety Agency • Accreditation –appraisal • National Institute of Clinical Excellence

14. A Modern Epidemic • Harold Shipman – serial killer and mass murderer • Bristol Childrens’Hospital –patient safety • Alder Hey-organ scandal

15. Northwick Park • Six taken ill after drug trials • “Experts investigating the drug trial which almost killed six young volunteers have made 22 recommendations on how to avoid such mistakes again”.

16. Health Services Research not Bio-medical Research • The Hazards are not the same- potential for minor, transient emotional distress not risk of death, serious disabling and permenant injury • Accountability to the management of the NHS and not the individual user

17. no case for regulation in the social sciences vs biomedical sciences? The risks to human subjects are not comparable and the power relationship between researcher and researched is so different as to render prior scrutiny irrelevant and inappropriate. The rise of ethical regulation in social science is driven by a demand for ceremonial conformity, which, in turn, is a vehicle for professional dominance and, increasingly, for the interests of the office-holders and bureaucracies generated to service this demand. This ‘regulatory creep’ is colonizing new groups, practices and institutions jurisdiction • (Haggerty 2004) Dingwall 2006).

18. Like Topsy, it just grew’The Research Governance Framework additions : • The Health and Social Care (Community Health and Standards) Act 2003 • The Human Tissue Act 2004 • The Mental Capacity Act 2005 • The Medicines for Human Use (clinical Trials Regulations 2004 Clinical Trials Directive

19. "Ethical advice from NHS REC required • a. patients and users of the NHS. research participants recruited by virtue of the patient or user's past or present treatment by, or use of, the NHS. NHS patients treated under contracts with private sector institutions • b. Relatives/ carers of users of the NHS, • c. access to data, organs bodily material • d. fetal material and IVF involving NHS patients • e. the recently dead in NHS premises • f. the use of, or access to, NHS premises • g. NHS staff - recruited by virtue of their professional role."

20. Distinctive roles • Funders: ensure quality and value for money, arrangements for independent expert review • Sponsor ensuring expert scientific ethics review, arrangements to be alerted to significant developments, arrangements for compensation • Chief investigator accountable for design management reporting, each investigator aware of legal duties for trials involving medicine • Organisation ensure the sponsor assumes responsibility etc • Misconduct NHS Counter Fraud etc etc zzzzzzz

21. Ethical Review • Ethical review must happen before study starts • Protocol must not change without ethics/MHRA approval • For Clinical trials on medicines the ethics committee must be recognised by the United Kingdom Ethic Committee Authority (UKECA) • Researchers must keep ethics comittees informed of progress • Central office for research ethics comittees (COREC) has transferred to the National Patient Safety Agency

22. Review of Research- Problems for iterative research design! • Independent expert review of protocols is required • All data must be available to inspection and auditing bodies • Protocol must not change without formal agreement from those who gave it permission

23. The Sociologists Dilema • First formal ethical hurdles attaining ethical approval • Great store is put on this anticipation and addressing of ethical issues • Problem of dominance of the context of bio-medical research • Lack of knowledge about social sciences or methods

24. Experience of gaining Ethics in Health Context • had to attend an ethics committee for the prison service funded project asking young offenders about physical and mental health problems and needs in relation to services.  The committee was mostly made up of doctors and I think that many of them would have been happier if I had been sticking needles into these young people but the thought that I was TALKING to them seemed to cause them a lot of concern.  Despite the fact that we had carefully produced information sheets which had been adapted from a previous study, had protocols for dealing with distress if it arose with the young people or the researchers, had devised a method of recruiting young people which tried to ensure that their participation was voluntary, and that we all had experience of working both with young people generally, and specifically in this setting, I had to defend the study for about forty minutes.  I felt that there was a lack of understanding amongst most of the committee about qualitative research and the questions and queries came mostly from the medics.  I was successful in getting approval but it was a gruelling (and in my opinion unnecessarily so) experience.   

25. Experience led to wanting to do research on this topic • I just remembered that I wrote a PhD proposal on this subject in mid-late 90s.  It was for an R&D studentship and got to interview, but then didn’t in the end get funded.  I think the nature of the research idea at that stage might have ruffled a lot of feathers and questions led me to believe the committee thought it a bit ‘controversial’ – surprise surprise!  Anyway, my ideas for that subject came from my experiences of applying for ethics approval for a qualitative study and facing questions from a committee as a very junior researcher.  They just had no clue about qualitative research and kept asking me what my outcomes were!  The subject was ‘community versus hospital follow-up for childhood asthma’ – we wanted to interview parents and consultants, but I think the ethics committee thought it wasn’t scientifically rigorous because we were not measuring peak-flow rates, doing x-rays etc!

26. Clinical norms predominate in practice despite applied • Committee felt that I had not explained adequately the psychiatric measures included in my study. They had a specialist psychiatrist to help out on the committee, yet I felt he was making me include difficult psychiatric jargon (when it was irrelevant)…..similar projects to mine had been passed for ethical approval where the researchers had no working experience of mental health patients and where researchers with no clinical supervision yet during my process, I was advised well I felt forced to find a clinical supervisor in a short period of time…despite the fact I was a trained RMHN and CPN in the community and had working experience and knowledge. I do feel the committees failed to be consistent and this has implications for researchers and their planning of the project.

27. Applying for ethics in a self care study at the moment….. • difficulties are with obtaining consent - first contact has to be through the health professional and participants have to opt in rather than opt out. I'm still not quite sure how that works - but it makes the process of obtaining informed consent very long and possibly an unecessary burden on patients and health professionals? I am also unsure about the need for consent for observational fieldwork and if it is needed, how to go about getting it from patients prior to their attendance at clinics - haven't yet actually dealt ethics committees concerning this issue - but it is tying me in knots thinking about how to phrase it in the ethics application

28. Informed Consent • Informed consent seen as central to ethical research. • obtaining informed consent including a choice not to take part requires steps to be taken to protect an individual’s right to make choices.  Ensuring that the individual receives full disclosure of relevant information • Ensuring that the individual is competent to decide • Ensuring that the individual acts voluntarily in the consent process.

29. Informed consent (continued). • Researchers must also attend to the quality of a patient’s understanding as part of this process.  This includes an understanding of: • The purpose & nature of the trial • What they have to do • Possible benefits • Possible risks (If there are any risks, the risks must be in proportion to the potential benefit).

30. Theories of Consent Alderson and Goodey 1998 • Assumptions of positivism – that there is real consent in the ‘factual’ exchange of medico-legal information • Social constructionism – consent a complex and ambiguous process not a single event – shows how people initially thought to be incompetent • Functionalist Consent’ a polite ceremony’- consent treated as a simple or tedious formality • Critical Theory opposite a necessary protection against useless harmful interventions • Alderson P and Goodey C (1998) Theories of Consent BMJ 317:1313-5

31. Positivist Concepts of Consent • Medicine,psychology Law • Appropriate information : percentage risks • Assessed by testing patient recall and recount of standard details • Judged by measure of information given • Problems in consent attributed to patient and doctors limited knowledge and communication skills • Addressed by efforts to improve knowledge and skills • Social pressures are assumed to inhibit patients’ ability to make independent rational choices (so should be avoided or reduced)

32. Guidance for completion of information sheets • follow guidance the standard statements are there for legal reasons which you should adhere to. • Use simple lay language. • Get a lay person to read it and see if they fully understand it. • “Remember your duty to get informed consent”

33. Respect for Informed consent added Benefits • Encourages professionals to be accountable and to know and explain what they plan to do and why • Basic information standards are agreed and achieved through research audit and professional education and thus improves health care • Respect for patients consent/refusal expresses ideals of respect for physical and mental integrity • Defends in part from unwanted interventions and from deception coercion during treatment and research

34. Limitations • Set high standards-many people excluded on bases of ignorance, dependency, too emotional to be competent • Real consent is unrealistic for many ordinary people clinicians and researchers are cynical and despondent about obtaining it • People don’t know what they are consenting to in advance • No consensus about what Informed consensus means amongst researchers • No applicability across vulnerable groups

35. Powerful Ethnographies • Being Sane in Insane Places Rosenthal • Hospitals in Trouble J.P.Martin • Asylums –Goffman • Danger of interview only studies • The death of capturing the reality and complexity of people’s thoughts, beliefs and actions by studying them as they actually occur within their full social context?

36. Implementation of Contemporary Rules Impossible for Social Research? Observation in a Hospice • senior medical staff members would inform patients on their admission to the hospice • option of opting out of any observations. • Pragmatics = patients admitted more than one at a time, emergency ‘The hospice was not a bounded community, but by its very nature, a place that patients continiously passed through…’Lawton 2001QHR

37. Clash with Sociologist assumptions • Covert methods violate the principles of informed consent and may invade the privacy of those being studied • There are serious ethical and legal issues in the use of covert research but the use of covert methods may be justified in certain circumstances… Researchers may also face problems when access to spheres of social life is closed to social scientists by powerful of secretive interests

38. Halo effect distortion…Undermines method • ‘if ethnographers operate in a highly obvious fashion, continuously informing all participants about every detail of the research, then there is the very real danger that these disclosures will influence the behaviour of the people with whom they work. The practice can fundementally change the dynamics of what the researcher is studying, thereby undermining and invalidating the findings of the research…..Although few ethnographers would be willing to admit that they have intentionally decieved their informants (by conducting covert research) most would agree that some of the most rich and interesting data are gained on those occassions where informants have seemingly forgotten that the research is taking place ( Gaining and Maintaining Consent Lawton 2001 Qualitative Health Research

39. What can researchers do? • Researchers have a responsibility to the data they collect in a sensitve,ethical and reflexive manner…every effort should be made to quote patients and to use specific case studies in a highly selective fashion. The experience of many patients were only drawn upon in abstract ways, for example in developing the generalised themes and trends that were highlighted and analysed in the study

40. Informed consent • Study participants less in favour of regulating the way research is conducted • More in favour of guidelines that assist researchers balance conflicting pressures of research (Wiles, Crow, Charles et al 2007)

41. A positive side to the process of applying for research ethics permission • , whilst there “is considerable work in preparing an ethics committee application and this can at times seem onerous, however, it should be remembered that quality of the research proposal will be improved by early consideration of these details” (Van Teijlingen & Cheyne 2004: 210).

42. Be Prepared… • For Ceremonial conformity • To articulate and be assertive about the theories and approach you are taking and its roots • To discuss ‘sample size’ and explain the foundations of theoretical or purposeful sampling • To gain access via other means…..