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The West Midlands MREC should (or ought to) have been concerned about dual or parallel relationships of
the Investigators with the participants, for example if a researcher was currently also employed by the DWP
(who are co‐funders of the trial), or if participants have an insurance policy with an insurance company with
which the researcher has a connection. Such connections could have a significant influence on a
participant’s decision to join a research project, and therefore ought to have been declared.
The Principal Investigators’ “circumstances that might lead to conflicts of interest” include information about
their association, consultation, hospitality and employment with insurance companies and the Department
for Work and Pensions, every one of which might be considered to “affect the independent judgement of the
researcher(s)”, yet initially the Investigators declared no financial or other conflicts of interest (see below).
Was the West Midlands MREC aware that the three Principal Investigators have substantial competing
interests?
Fortunately for the PACE Trial Investigators, particularly for Professor Trudie Chalder, Professor Simon
Wessely was a member of the Institute of Psychiatry/South London and Maudsley NHS Trust Working
Party on Ethical Funding Sources which met on 20 th July 2005 to review existing policy on acceptance of
external research funding (Joint policy and guidance to research staff on the acceptance of external research
funding, updated in March 2006), which provides guidance on the acceptance of funding from, for example,
the DWP:
“The key principles identified by the Working Party were as follows:
“2.1 That research meeting only the highest scientific and ethical standards will be undertaken by staff and
students of IoP and SLaM.
“2.2 That…integrity of the conduct of the research and its results are not compromised.
“2.5 That the nature of the research processes, including study design, data analysis and publication of research
findings are transparent.
“3.3 Questions to consider:
“What are the aims of the funding organisation? Are there any ethical issues that arise e.g. an association
with…organisations that may have harmful consequences for health…?
“Is the nature of the funding organisation clear? Does there appear to be an attempt to conceal the aims…of the
organisation?
“Is the funding organisation seeking to control the design and/or the data analysis? If they are, what are the risks to the
integrity of the research?
“Does the funding organisation have a biased research agenda, for example, supporting projects leading to
‘wanted’ results?
“Is the decision‐making process transparent? Is it clear who makes, and who may influence, funding
decisions?”.
How closely did Professor Chalder follow this guidance?
How “transparent” was the DWP decision‐making process to fund the PACE Trial?
On 31 st July 2007 the DWP was sent an email asking for information, including the following: