Obstacles to conducting epidemiological research in the UK general population
BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7460.277 (Published 29 July 2004) Cite this as: BMJ 2004;329:277All rapid responses
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The series of articles on the role of Ethics and Research Governance
is a welcome stimulus to the new challenges facing researchers. As a
researcher who can fully empathise with the authors, nevertheless the two
articles by Ward (1) and Jones (2) relating their experiences with their
respective Research Ethics Committees (REC), I do not believe are a fair
challenge to the current ethics process. Ward et al blame poor response in
their control population because of their REC’s refusal to directly
approach patients. An alternative assessment might have been that their
pre-prepared letters were insufficient in detail to recruit patients to a
highly sensitive research question - a topic that has often been portrayed
alarmingly in the media. Our local experience suggests that good
recruitment levels are very possible in the general practice population
(3). Furthermore, resorting to an ‘op-out’ clause that some commercial
companies operate might not engender public trust, judging by the junk
mailing culture we have to endure despite opting-out. Jones and Bamford
relate their ‘minor’ problem that they believe was met with a heavy-handed
approach. However their ‘simple’ qualitative project in patients with
eating disorder would have involved a semi-structured interview covering
quality of life areas such as social contacts, relationships, family and
employment. This approach might have created critical issues in a
vulnerable group of subjects and is the very kind of topic that RECs were
meant to address. Where I would wholeheartedly concur with all the authors
in this debate, is that we require transparency and clarity in all
communications, and efficient procedures that not only protect patients
but also promotes good research. These obligations apply in equal measure
to both researchers and Governance bodies.
1. 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. BMJ 2004; 329:277-279.
2. Jones AM, Bamford B. The other face of research governance. BMJ
2004; 329:280-281.
3. Dunn KM, Jordan K, Lacey RJ, Shapley M, Jinks C. Patterns of
consent in epidemiologic research: evidence from over 25,000 responders.
Am J Epidemiol 2004; 159:1087-94.
Competing interests:
None declared
Competing interests: No competing interests
Editor - Ward et al clearly put in perspective the challenges of
conducting medical research in a system inundated with ethical checks and
balances on research activities. They note that against a background of a
fuzzy definition of confidentiality and an inherently cumbersome procedure
for obtaining ethical approval, case- control studies are fraught with a
considerable chance of selection bias and low response rates.
The veracity of this statement is easily borne out by the fact that
diverse factors ranging from domestic circumstances and socio-econonmic
status to communication habits could influence on who responds to a letter
and who does not.
The author also suggest that depending on a letter , rather than early
direct interaction with potential participants, was a reason for the low
response rate. May I at this point suggest that we also consider that
there may be more to high response rates than potential participants'
enthusiasm.
Taken at surface value, direct interaction may seem to have the virtue of
producing good response rates, but we may well consider how it probably
achieves this. Informed consent is a well defined end, but the means of
achieving it is less well-defined and subject to "innocuous" manipulation.
Quite apart from the possibilty that a non-response to an invitation may
be an individual's way of declining the invitation, calling non-responders
on phone places them at the mercy of the researcher's power of conviction
. This power of conviction is conferred on the researcher by the fact that
a potential participant will not respond to a doctor seen to be on the
course of "public health" in same way as to a salesman on the course of
"personal gain". Sadly for the researcher, there is an attrition of this
privilege and power in a written medium.
This inherent subtle element of coercion is present in all informed
consent achieved by verbal direct interaction and is accentuated by the
ever-present doctor-patient power gradient. It makes one wonder if
obtaining informed consent by direct interaction is ethical in the first
place.
Competing interests:
None declared
Competing interests: No competing interests
Editor,
With regard to the article "Obstacles to conducting epidemiological
research in the UK general population" BMJ 2004; 329: 277-279, we are
currently undertaking a case-control study of patients with lymphoedema
and wish to endorse the experiences documented therein.
Ours is a smaller study involving 113 patients with lymphoedema and
controls originally matched for age, gender and GP. LREC approval was
gained after ensuring that the recruitment of controls complied with
Caldicott guidelines regarding patient confidentiality [1]. We wrote to 78
GP practices and, over a six month period during which reminders were sent
out, we received 17 positive responses and 3 negative responses. 58 GPs
did not respond at all. This protracted exercise provided a total of 23
controls willing to be interviewed.
In view of this poor response rate we reluctantly changed our
methodology and controlled for age and gender only. Our rationale was to
recruit a small number of GPs who are willing to participate and use their
patient data systems to identify controls. Each GP writes to the
identified patient and encloses an information sheet in the normal way
and, in addition, a reply slip is included which the patient sends
directly to the researchers in a postage paid envelope. The reply slip
provides space for the patient to give a contact telephone number so that
arrangements for the interview can be made directly between the researcher
and the patient over the telephone. This change of approach is now having
a positive effect on the recruitment of controls.
Our experience supports the premise that current regulations
developed to protect patient confidentiality produce a number of
additional barriers when attempting to identify and interview suitable
controls. First, researchers are dependent on already overburdened GPs
playing their part in a process they do not always see as their primary
purpose. Second, patients have to make decisions about whether to take
part in a study without the benefit of speaking directly with a researcher
and, finally the process of control identification has become over complex
and expensive in both time and resources.
1. The Caldicott Committee. Report on the review of patient
identifiable information. Department of Health, 1997.
Competing interests:
None declared
Competing interests: No competing interests
The BMJ does well to focus on the many incongruities associated with
obtaining ethical approval for research in the United Kingdom.
Ward et al highlight the fact that people on public databases are
routinely contacted by market researchers and salespersons who have no
need to obtain ethical approval and wonder why the situation is different
for health researchers.
Perhaps the answer lies in the varying perceptions of professional
power by the individuals concerned. People may feel more at ease saying no
to marketers than they would to health professionals.
Competing interests:
IA has recently had to modify an MSc project proposal because of potential difficulties in obtaining ethical approval
Competing interests: No competing interests
Ward et al state that, “Ethics committees should weigh the benefits
to society against costs to the individual when considering studies” (1).
This is a utilitarian argument rejected at the Nuremberg trials and out of
tune with one of the first principles of the Declaration of Helsinki: “In
medical research on human subjects, considerations related to the well-
being of the human subject should take precedence over the interests of
science and society” (2). As such, where the well-being of individual
research participants is threatened for the sake of others, ethics
committees are always likely to take the line of defending the former.
However, Ward et al might reasonably argue that most people would not find
the small violation in confidentiality inherent in their proposal to be a
threat to their well-being. The question then becomes one of whether the
Data Protection Act is unreasonably protective of confidentiality. If so,
this is a fault of law, not of research governance. The authors, and your
journal, are shooting at the wrong target.
1. BMJ 2004;329:277-279
2. WMA. Declaration of Helsinki, 5th Amendment. URL
http://www.wma.net/e/policy/b3.htm
Competing interests:
MREC member
Competing interests: No competing interests
A solution is urgently needed to streamline NHS research governance approval in the context of large-scale epidemiological studies
Editor, we read with much interest the article by Ward et al.
relating to obstacles encountered by epidemiologists in conducting
research in the UK.1 As stated, local research ethical approval for
studies with ‘no local investigator’ has not been required since 2000. We
are currently conducting a case-control study that falls into this
category – the Drug Induced Arrhythmia Risk Evaluation study (funded by
the British Heart Foundation).2 However, despite MREC approval and ‘no
local investigator’ status, we are trying to cope with applying for NHS
R&D approval at Trusts throughout England.
We have estimated that only 100 cases per year will be recruited, and
therefore have no option but to seek approval from as many Trusts as
possible. As we are planning to recruit control patients from primary
care, the number of Trusts involved will run into hundreds. The R&D
approval processes at specific Trusts are, as Dingwall et al. describe,
enormously inconsistent.3 As a result, our study has been subject to
significant delays, we anticipate it will take years to complete all of
the necessary R&D registration forms; and meanwhile there is ongoing
expenditure of charitable funds to satisfy NHS bureaucracy.
It is surely time for the NHS to develop a central R&D approval
process equivalent to MREC in matters ethical. We feel strongly that the
survival of large-scale epidemiological research in the UK will depend on
streamlining existing NHS approval procedures for this kind of research.
As Sir Richard Doll recently pointed out, some types of research may
become impossible.4 Such an outcome would clearly not be in the interest
of society, whilst being diametrically opposed to the ethos of guidance
intended to provoke creativity and innovation in research.5
1. Ward HJT, Cousens SN and Smith-Bathgate B et al. Obstacles to
conducting epidemiological research in the UK general population. BMJ,
2004;329:277-279.
2. Davies M, Behr E, Carter N, Jeffery S, Camm AJ, Shakir SAW. Methodology
of the Drug-Induced Arrhythmia Risk Evaluation Study (abstract).
Pharmacoepidemiology and Drug Safety, 2003;12:S1-S189.
3. Dingwall R and Rowley E. Re: Bureaucracy of ethics applications
(letter). http://bmj.com Rapid Responses for Wald, 329(7460) 282-284,
accessed 04.08.04.
4. Highfield R. Rules threaten medical research (comments from Sir Richard
Doll).http://www.telegraph.co.uk, filed 26/02/04, accessed 02/06/04.
5. Lord Hunt of Kings Heath, Department of Health. Research Governance
Framework for Health and Social Care. Department of Health, March 2001.
Competing interests:
None declared
Competing interests: No competing interests