Users' guide to detecting misleading claims in clinical research reportsBMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7474.1093 (Published 04 November 2004) Cite this as: BMJ 2004;329:1093
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Members of NHS research ethics committees reviewing proposed studies
are sometimes uncertain whether they ought to take study design into
consideration in forming their opinion. This very useful article shows
that aspects of study design may indeed raise issues of ethics.
Some of the reporting biases discussed in the article are not
detectable when the study is presented for ethics review, but design
features which may make biased or unjustified conclusions possible may be
evident at the outset, and ought to be questioned.
Arguments presented to dissuade ethics reviewers from considering
design issues include:
(a) that scientific merit is not an ethical issue, and reviewers should
limit themselves to considerations of risk of harm to patients;
(b) that the design has been approved by a funding body; and
(c) that the design feature is necessary to enable the study to be used
for the purposes intended by the investigator or sponsor (the classic
example is "we must use placebo as the comparator, or we won't get FDA
approval to market the drug in the USA").
The first of these arguments is invalid and the other two, though
politically persuasive, are ethically irrelevant. The ways in which
results may be reported are a valid concern in ethics review, as is
assurance that the results will be published whether not they are
favourable to the intervention under investigation or to the commercial or
other interests of the investigator or sponsor.
Ethics committee members, both medical and lay, require appropriate
training in design and reporting issues. Ethics committees are right to be
suspicious of governance arrangements which put them under pressure to
limit the scope of their review, or expedite approval at the price of
TLJ is a member of a Multicentre Research Ethics Committee
Competing interests: No competing interests