Hi Adrian
Only a couple (well, three actually): 

a) check whether you really do require ethics approval for what you want to
do
b) if you do, think through the particular risks for each of the stakeholder
groups and ensure that your processes minimise risk and, maximise safety and
protection against those specific risks
c) keep a close eye on the potential for conflict of interest and work out
how to manage it if/where it exists.

Cheers
Gill 

-----Original Message-----
From: Adrian Rohrbasser [mailto:[log in to unmask]] 
Sent: Monday, 3 March 2014 7:16 AM
To: 'Realist and Meta-narrative Evidence Synthesis: Evolving Standards';
'Gill Westhorp'
Subject: AW: ethical approval

Hi Gill,
After your input, I realized I may need to describe who the stakeholders of
this project are: they represent different levels of interest: health
professionals who participate in Quality Circles, facilitators, tutors,
training staff and representatives from professional networks like Swiss
Association of Family Medicine and Colleges, and representatives from
networks providing primary health care. Some of these networks collaborate
closely with health insurance companies.
Any more hints?
Best wishes
Adrian


-----Ursprüngliche Nachricht-----
Von: Realist and Meta-narrative Evidence Synthesis: Evolving Standards
[mailto:[log in to unmask]] Im Auftrag von Gill Westhorp
Gesendet: Sonntag, 2. März 2014 20:42
An: [log in to unmask]
Betreff: Re: ethical approval

Hi Adrian
And to add a final twist - it depends what country you're in and what you
mean by 'stakeholder'.  In Australia, one wouldn't necessarily need research
ethics approval to involve end users, but we would to involve clients.

Cheers
Gill 

-----Original Message-----
From: Realist and Meta-narrative Evidence Synthesis: Evolving Standards
[mailto:[log in to unmask]] On Behalf Of Soo Downe
Sent: Sunday, 2 March 2014 11:48 PM
To: [log in to unmask]
Subject: Re: ethical approval

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
Email   [log in to unmask]

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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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