Dear Adrian
Edwin is right in his comments below. In terms of the issue of what kind of ethics approval should be sought for stakeholders - this is a grey area in the UK in fact. There an increasing imperative for service user engagement in research in general (all research, not realist research specifically) in the uk in terms of deciding on the topic for research, and helping to shape the research design/instruments/data collection/data analysis/interpretation/dissemination. To date, this has not been seen as a research activity and so discussion groups/meetings held for PPI purposes (Patient and Public Involvement) are NOT subject to any ethics proceedures. The stakeholder component in realist research is, therefore, a grey area, as I say. It could be seen as an extension of PPI, and therefore not subject to ethics. Or is could be seen as intrinsic to the research method, and therefore subject to approval. I think this is a very interesting area for debate.
In the case of our NIHR (UK govt) funded realist research study, we put all aspects of the study through our university ethics system (including the stakeholder groups, which include media people, educators, and a pre-existing group of young people). There was no problem in getting ethics approval. However, I am still not completely convinced that we really needed to go through ethics (as opposed to governance) proceedures.
All the best
Soo
-----Original Message-----
From: Realist and Meta-narrative Evidence Synthesis: Evolving Standards [mailto:[log in to unmask]] On Behalf Of Edwin van Teijlingen
Sent: 27 February 2014 18:57
To: [log in to unmask]
Subject: Re: ethical approval
Dear Adrian,
you put forward some interesting questions around research ethics which I think are not unique to realist reviews. There exist more stringent bureaucratic procedures, governing the conduct of health services and health promotion research in the UK than some other countries like Switzerland or the Netherlands. Over the past quarter of a century many scholars have commented on/criticized this situation in the UK [1-12].
I think the ethical approval you seek for a realist project is similar to the kind of ethical approval you see for most qualitative research. Take for example focus group research. When a researcher runs a focus group he or she does not know what will be in the discussion as the discussion is open between different participants whose comments can trigger ideas and reactions and comments from other focus group participants. You want ask for consent prior to the focus group to ensure people are happy for the group to be recorded, for their quotes to be used in publications (usually anonymously, but not always), you would what is referred to as 'informed consent'. The ethical approval is from the university, the informed consent (to apply with your ethical approval and to ensure you do your research ethically is from the participants).
Does that help at all?
Best wishes
Edwin
1 Wald D: Bureaucracy of ethics applications, British Medical Journal 2004, 329: 282-284.
2 Jamrozik K: Research ethics paperwork: what is the plot we seem to have lost?, British Medical Journal 2004, 329: 286-287.
3 Warlow C: Clinical Research Under the Cosh Again, British Medical Journal 2004, 329: 241-242
4 Gilbert C, Fulford KWM, Parker C: Diversity in the practice of district ethics committees. British Medical Journal, 1989, 299:1437-9.
5.Meade TW. The trouble with ethics committees. Journal of the Royal College of Physicians London 1994; 28(2): 102-4.
6 While A: Ethics committees: impediments to research or guardians of ethical standards?, British Medical Journal, 1995, 311: 611.
7 Ah-See K W , Mackenzie J, Thakker NS, Maran AGD: (1998) Local research ethics committee approval for a national study in Scotland, Journal of the Royal College of Surgery, Edinburgh,1998, 43: 303-305
8 Hannigan B, Allen D: A tale of two studies: research governance issues arising from two ethnographic investigations into the organisation of health and social care, International Journal of Nursing Studies, 2003, 4: 685-695.
9 Ward HJT, Cousens SN, Smith-Bathgate B, Leitch M, Everington D, Will RG, Smith PG: Obstacles to conducting epidemiological research in the UK general population, British Medical Journal 2004, 329: 277-279.
10 Howarth L, Kneafsey R: The impact of research governance in health care and higher education organization, Journal of Advanced Nursing 2005, 49(6) : 675-683.
11 Angell EL, Jackson CJ, Ashcroft RE, Bryman A, Windridge K, Dixon-Woods M: Is "inconsistency" in Research Ethics Committee decision-making really a problem? An empirical investigation and reflection, Clinical Ethics 2007, 2: 92-99
12 van Teijlingen, E, Douglas, F, Torrance, N: Clinical governance & research ethics as barriers to UK low-risk population-based health research? BMC Public Health 2008, 8(396)
Prof. Edwin van Teijlingen
Centre for Midwifery, Maternal & Perinatal Health Bournemouth University
Tel. +44 (0)1202-961564
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From: Realist and Meta-narrative Evidence Synthesis: Evolving Standards [[log in to unmask]] On Behalf Of Adrian Rohrbasser [[log in to unmask]]
Sent: 27 February 2014 18:21
To: [log in to unmask]
Subject: ethical approval
Hello everybody,
So far I have never participated in these discussions but maybe you will be able to help me with a question about ethics concerning stakeholder involvement I realist reviews:
I'm working on a realist review: Exploring why Quality Circles work in Primary Health Care. QCs are small groups of health care professionals who meet at regular intervals to improve their practice. Stakeholders have contributed to the development of the question, focussing the research questions and will stay involved during the project to participate in data analysis, weighing results and dissemination of findings. It started as a national project in Switzerland. The Swiss committee of ethics told me that I would not have to bother about ethical approval since there are no patients involved (concerning Swiss stakeholders). Since the project expanded to a European level and since I carried this project to my DPhil in Oxford, I face another sort of ethical approval that has to go through university.
What I wonder now is what sort of ethics approval you have to get from your universities when applying for a realist project. Do you have some tips on how to address ethical applications when I think that asking for signatures is not appropriate like before / after informal and formal discussions, group processes and other opportunities when information from stakeholders about programme theory is gathered?
Looking forward to reading your thoughts and ideas!
Adrian
Dr. med. Adrian Rohrbasser
General Practitioner
SAFM Delegate for Quality in Family Medicine MSc in Evidence Based Health Care DPhil student University of Oxford, Department of Primary Care Health Sciences Santémed Gesundheitszentrum Friedtalweg 18
9500 Wil
Switzerland
+41 71 913 54 00
+41 79 603 65 31
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