Prior L - Queen's University Belfast

Qualitative Research Design and Ethical
Governance: some problems of ‘fit’
Lindsay Prior, Professor of Sociology, Queen’s University Belfast
Address for Correspondence: School of Sociology, Social Policy and Social Work,
Queen’s University Belfast, Room 2.01, 1 College Park East, Belfast BT7 1NN.
Email: l.prior@qub.ac.uk
In this paper I seek to do three things. First to consider the extent to
which some of the common procedures used by qualitative researchers
‘fit’ the demands of medical research ethics committees. Second, to
highlight some ways in which some key principles of qualitative research
have to be altered so as to facilitate any such fit. Third, to highlight the
range of issues that can (and do) arise out of an actual qualitative
research project. J NI Ethics Forum 2007, 4: 53-64
Just by way of preface to the ensuing discussion it would be as well for
me to draw attention to a number of issues. The first of these is that
qualitative researchers have been sensitive to, and have discussed
problems of research ethics for many decades, and many such
researchers believe themselves to be well attuned to both the
philosophical basis of ethical codes and the practical implications of such
codes for research design and procedure. Thus Miles and Huberman
(1994), for example, outline seven styles of ethical framework that can
inform qualitative research practice and indicate the implications of such
styles for research activity. It is also fair to say that the British
Sociological Association’s statement of Ethical Practice (2002) has not
only provided guidance on ethical problems connected to qualitative
research work for many decades, but also touches upon issues that are
rarely considered by members of contemporary research ethics
committees (such as power and gender imbalances in research
relationships). Similar concerns are covered in the codes of ethical
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practice of other national bodies – such as that of the American
Sociological Association. Finally, there is empirical evidence (Richardson
and McMullan, 2007) that many qualitative researchers hold somewhat
negative opinions of the ways in which REC’s assess their research
design and believe that REC’s actually inhibit, rather than facilitate good
research. In what follows I hope to throw some light on why such
assessments might arise. My strategy is to elaborate on the kinds of
ethical issues that arose out of a specific ESRC research project for
which I was a principal investigator. For a formal report on the project –
outlining the aims, design and some of the findings – see Prior, 2005.
Somewhat inevitably, the discussion of that project herein is selective.
An ESRC Case Study:
The project to which I refer formed one component of the ESRC funded
Innovative Health Technologies Research Programme (Project
L218252046). The research work was undertaken between 2001—04.
The key aims can be summed up in three questions. Exactly how do
clinical professionals in a regional cancer genetics service assemble
cancer genetic risk assessments? What are the consequences of the
risk assessment for patients/clients? How do patients/clients understand
the risk assessment and its implications? The research work was further
linked into a parallel Wellcome funded study on the ways in which
genetic risks might be calculated and used for insurance purposes.
Research ethics approval was sought from, and granted by an MREC
and 4 LREC’s (whose approval was necessary at that stage). Each
required separate applications, and attendance at a committee meeting.
The Wellcome funded project was dealt with under an additional MREC
application.
It is worth emphasising that the research ethics approval process was
time consuming (and therefore expensive) in itself. We began the
process of seeking approval 3 months before the project start date (when
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we were not yet funded), and the process cut into first 3 months of the
funded project. There was also intermittent approval required following
research design modifications.
The kinds of issues that were attended to in the MREC application
involved the processes surrounding informed consent, confidentiality,
anonymity, and the possibility of causing anxiety and distress to lay
respondents (Richards & Shwartz, 2002). Some issues we did not raise
because REC’s are so rarely concerned with them. The latter include
issues relating to the exploitation of the research participants, dangers
and risks that may be faced by the researchers, and the fact that in
health research ‘patients’ often disclose details about their health that
they have deliberately concealed from their doctors. As researchers we
need strategies for handling such circumstances, but for my own part I
prefer not to draw attention to such matters for fear of complications
arising out of the approval process.
The research design contained many features, but at base it was
intended to be an ‘ethnography’ of a clinical service. The key site for
research was an institute of medical genetics, and the service covered
an entire UK region. I have no wish to elaborate on the theory and
practice of ethnography here, so suffice it to say that ethnography truly
involves immersion into the culture of the selected study group. An
important feature of ethnographic practice is its capacity to capture
aspects of behaviour, human interaction, events, happenings and so
forth ‘on the wing’; as they emerge and unfold in the hurly burly of daily
life - that’s what it’s all about. And once a study begins then everything
and everyone is ‘in’ the research frame. To quote from one of the
greatest exponents of the method (the anthropologist Bronislaw
Malinowski);
“There is a series of phenomena of great importance which cannot
possibly be recorded by questioning or computing documents, but have
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to be observed in their full actuality. Let us call them the imponderabilia
of actual life …” (Malinowski, 1922:18)
One implication of this for the ethnographer is that the process of
informed consent as conceptualized by REC’s can be somewhat
stultifying and inimical to good research. That, not least because consent
(in an ethnographic setting) has to be viewed as an ongoing, negotiable,
and continuous process, rather than something that can be wrapped up
in a single (signed) document - but more of consent in a moment.
Essentially, all that I wish to emphasize at this stage is that it is the
emergent, unfolding nature of the research trajectory that tends to affect
the balance between the demands of the RECs and the practices of
qualitative researchers.
Types of data collected:
In the case study to which I refer, various kinds of data were collected.
These included: observations of professionals at work in the clinic and
the associated laboratory; discussions between nurse-counsellors and
clinical geneticists about risk assessment of patients (which I call
‘naturally-occurring’ data, rather than interview data); consultations
between clinical professionals and patient/clients about risk assessment
and its implications; interviews between social scientists and patients
about their understandings of their risk assessment; interviews with lab
scientists and some clinical staff; medical records (such as pedigrees)
and documents of various kinds including GP referral letters. An example
of the kind of data collected is provided in Box1. The discussion begins
with a nurse reading out a GP referral letter and flows into a discussion
between a consultant geneticist and two nurses about the case under
referral.
Now, gaining informed consent from the nurse-counsellors and the
consultant is not a problem – we know in advance who they are, and
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what they will be doing. However, we do not know on any one (Monday)
morning who is to be referred to the clinic – this is the task at hand for
the clinic professionals. To capture discussion about a referral therefore
requires ‘being there’ on the day, and it would simply not be possible to
get consent from either the GP or the patient under discussion about the
presence of a researcher for we have no idea who is being referred in
advance of the referral. This kind of problem arises in quite a few medical
settings - such as studies of emergency psychiatric admissions, for
example, where seeking consent from an angry and confused person
who is about to be ‘sectioned’ is simply not feasible. Clearly, if ‘informed
consent’ were to be held to as a sine qua non of all research activity,
then large numbers of very important procedures would lay beyond the
boundaries of investigation (Sin, 2005).
A related problem arises in consideration of medical pedigrees – an
example of which is provided in figure 1. This figure is of a family tree or
pedigree of a client of a genetics service. Females are represented by
means of circles and males by squares. People affected by cancers are
indicated by solid black symbols and deaths by diagonal lines; the arrow
(lower left) points to the proband or client of the service. The pedigree
was drawn by a computerised decision-aid named ‘Cyrillic’, which also
calculates a life-time risk of inheriting a known mutation. In this case (for
breast cancer) the capacity to calculate the risk of inheriting a cancer
related mutation for family members is not particularly easy. For some
conditions, however, (such as, say, Polycystic Kidney Disease (PKD) or
Huntingdon’s disease), knowledge about one member of family can
provide easy-to-calculate, important and critical information about many
other members of the same family. So it is more than possible to obtain
key medical data on relatives of an individual without the relatives either
knowing or consenting. Unfortunately, there is no easy way of getting
such consent – often relatives are out of touch with the proband, or the
proband does not want relatives contacted, perhaps addresses are
unknown, and whether relatives are living or dead can only be guessed
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at. There are of course strategies for dealing with such problems, but
none of them involve getting informed consent from each an every
individual in the frame.
Sampling: Another problem area
Selecting samples in qualitative research designs also tends to cause
problems for RECs. This is because qualitative researchers are rarely
interested in getting hold of random samples from large populations. Talk
of power calculations and confidence intervals is simply not appropriate.
Indeed, it is usually the case that the qualitative researcher is seeking
specific cases of events, happenings and people rather than general
samples. Often they seek out what might be termed outliers rather than
cases that might be categorised as average. On occasion the sampling
strategy makes sense to all – thus a study of adverse events necessarily
focuses on instances when things have ‘gone wrong’ and where a study
of representative cases would be inappropriate. In other instances the
qualitative researcher might invoke the techniques of grounded theory to
justify their research sampling strategy.
Grounded theory (Glaser & Strauss, 1967) is undoubtedly one of the
most widely cited and successful qualitative research strategies yet
invented. It comes in a variety of forms. In virtually all of its forms
however it advocates the use of conceptual or theoretical sampling rather
than random sampling. The key idea related to theoretical sampling
involves comparison of cases. Crudely put, the research begins with
case 1 and then seeks out an alternative and contrasting case for study,
which leads to the identification of another (third) contrasting case and so
on until the field of possibilities has been ‘saturated’. In the words of
Glaser and Strauss (1967:45);
“Theoretical sampling is the process of sampling … whereby the analyst
jointly collects codes and analyzes his data and [then] decides what data
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to collect next and where to find them in order to develop his theory as it
emerges.”
Needless to say, this strategy is not conducive to the requirements for a
carefully specified research protocol. As a result, strategies and
justifications have to be devised by qualitative researchers somewhat
artificially so as to fit REC queries about ‘numbers’. In my own case I
always structure the sample to throw up contrasts in advance – but this is
in no way a standard procedure. An example of a sample of cases
structured for contrast is illustrated in Table 1 – the contrasts being site
of cancer and level of risk. The cell numbers are determined on the basis
of possibilities (how many ‘other’ genetically determined cancers might
we get?), and experience (one rarely needs more than 10 cases to get a
full sense of what is going on in any specific social environment).
Table 1 .Numbers of patients interviewed by site of cancer and
level of risk in the ESRC study
Cancer site by risk Low Risk Moderate High Risk Total
Risk
Breast 8 11 6 25
Ovarian 8 3 6 11
Colorectal 6 10 4 20
Other cancers 1 0 1 2
Total 17 24 17 58
The interview schedule:
It would be amiss of me to ignore concerns about interview schedules.
Once again, however, there are often antithetical understandings about
the role of the interviewer and the interview in qualitative research. Thus,
for many REC members the ‘instrument’ is the interview schedule – and
therefore ought to be precisely specified. For qualitative researchers, on
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the other hand, the key instrument is the interviewer him or herself. It is
they that constitute the key resource.
For my own part I always try to get a ‘story’ out my respondents. In fact, I
just ask respondents to ‘tell me your story’ – about how they got into a
clinic, what happened next, and after that, the future. From this style of
questioning one gets the data for a series of narratives, and it is in terms
of narratives that such data can be (very profitably) analysed (see, for
example, Frank, 1995). In the ESRC study we presented a somewhat
more complicated interview schedule than was suggested above - but
the ‘tell me your story’ approach would have served just as well. (For
some results of the approach see Scott, Prior, Wood and Gray, 2005).
Miscellaneous considerations:
As I suggested in my opening statement, qualitative researchers are fully
aware of a complex inter-relationship of ethical concerns that arise in the
doing of research, and often pay respect to principles that RECs can be
unduly quiet about. In terms of the case-study referred to here, however,
it might be worth mentioning a few other considerations that arose during
the course of the work. The first of these is quite common. It relates to
the fact that in virtually all instances of research involving patients, some
respondents will invariably seek medical advice from the (social
scientific) interviewer – clear direction to interviewers on how to handle
such eventualities is essential. Secondly, clinicians and others can
sometimes be unhappy about the specific features of a research
procedure and seek to alter the protocol or the findings – for example,
nephrologists might object to PKD being described or characterised to
their patients as a ‘genetic’ condition in the information leaflet. An
advisory committee to which such problems can be referred can be
useful in such instances. Thirdly, there can be ethical problems involved
in archiving data – for whilst the identity of respondents and places can
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e rendered anonymous in written transcripts the same cannot be said
about voice recordings.
Conclusion:
The ‘fit’ between qualitative research and research ethics committees is
not an easy one. The research style and ‘ethos’ implied by the REC
forms (at the outset) is geared to a specific (and very different) style of
research practice and scientific rhetoric. More directly, qualitative
researchers often face difficulties in justifying sample numbers, and
accounting for the emergent shifts in direction that inevitably occur in
qualitative work. In addition, there can be problems justifying open-ended
interviews.
As a result of the different interpretations of what good research design
looks like, tensions can arise. Indeed, some social science researchers
often feel that the procedures of ethical governance are used as forms of
censorship and control – rather than a means of facilitating good
research (Dingwall, 2006). For my own part I can say that only once
have I ever had a real problem with a REC. In any event I shall conclude
with a reference to one of the greatest ethicists of all time, namely
Aristotle (384-321 BCE). In the Nicomachean Ethics, Aristotle argued
that ethics aims at ‘the Good’ and that the good is a form of politics
(I,1,4-ii). In that context he offers an interesting juxtaposition of a
principle (the search for the good) and practice (organizing social affairs
so that different interpretations of ‘the good’ can be facilitated).
Unfortunately, qualitative researchers sometimes feel that interpretations
of good ‘science’ as interpreted by REC members can be strangely onedimensional,
and that their own (qualitative) style of understanding the
world is being forced into a format that suits legalistic principles more
than the requirements of sound research procedures.
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Professor Prior was one of the speakers at the NI Ethics Forum Evening Meeting in
November 2007 focusing on the theme of research governance and qualitative
research.
References
[1] Aristotle Nicomachean Ethics. Trans. H. Rackham. Cambridge: MA.
Loeb Classical Library. Harvard University Press 1926.
[2] BSA (2002) Statement of Ethical Practice for the British Sociological
Association. http://www.sociology.org.uk/as4bsoce.pdf
[3] Dingwall R. Confronting the anti-democrats. The unethical nature of
ethical regulation in social science. Medical Sociology Online. 1. 2006:
51-8.
[4] Frank A.W. The wounded storyteller. Body, Illness and Ethics.
Chicago: University of Chicago Press 1985.
[5] Glaser B.G., Strauss A.L. The discovery of grounded theory.
Strategies for qualitative research. Chicago: Aldine 1967.
[6] Malinowski B. Argonauts of the Western Pacific. London: Routledge &
Kegan Paul 1922.
[7] Miles M.B., Huberman A.M. Qualitative Data Analysis. An expanded
Sourcebook. 2 nd Ed. Thousand Oaks: CA. Sage 1994
[8] Prior L. The construction of risk estimates in a cancer genetics clinic.
Swindon: ESRC 2005.
[9] Richards H.M., Schwartz L. J. Ethics of qualitative research. Are there
special issues for health service research? Family Practice, 2002;
19:135-9.
[10] Richardson S., McMullan M. Research Ethics in the UK. Sociology
2007; 41:1115-32.
[11] Scott S., Prior L., Wood F., Gray J. Repositioning the patient. The
implications of being at-risk. Social Science & Medicine 2005; 60: 1869-
79.
[12] Sin C.H. Seeking informed consent. Reflections on research
practice. Sociology 2005; 39: 277-94.
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BOX1
Nurse-Counsellor1 (NC1): This is JH who is 32. [Reading the referral
letter from the patient’s GP] ‘This lady’s 35 year old sister has just been
diagnosed with breast cancer. She herself is 33 and is naturally
concerned. There are other sufferers of the disease in the family. An
aunt was also diagnosed in her early 30s. She realises that the risks are
going to be higher than average. She has been thinking of the
contraceptive pill although I have asked her to put this on hold until she
has been seen and then presumably I will be able to give her a
progesterone only pill if you feel this is indicated.’ It’s from her GP.
NC2: It’s a really good GP.
Clinical Geneticist (CG): Yes, [examining the pedigree] the thing is if you
really start to tease it apart there are lots of black lines all over the place,
they are all on different parts of the family. Her grandmother’s niece. 40s.
NC1: That’s 3 rd degree.
CG: Well that is 3 rd degree yeah. And her mother’s grandfather’s
sister at 67 so I think we can discount that one. This is the one that is of
more concern. She has a sister at 35 and then somebody else at 38
over here. So there are two young people and I suspect that puts her
into a high – oh! – 24.6% (Looks at risk estimate from Cyrillic). Mm.
NC1: What did you think, because you had some good thoughts about
this one?
CG: This is one that I would put into a high risk group. Can you think
why I have decided to put her into a high risk group?
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Figure 1. Pedigree drawn and risk calculated via CYRILLIC
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