Working with the private sector: the need for institutional guidelines
BMJ 2002; 325 doi: https://doi.org/10.1136/bmj.325.7361.432 (Published 24 August 2002) Cite this as: BMJ 2002;325:432
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It is interesting to learn from Singer of the University of Toronto's
efforts to develop guidelines for industry-sponsored clinical research,
and their key principles are mirrored in our own guidelines to staff. We
did not explicitly mention the right for investigators to disclose safety
concerns but do advise staff that contracts should make it clear that
LSHTM will control decisions with regard to publication, dissemination of
results and materials.
We were, like Ong, slightly bemused by the picture that accompanied
our article - of peasants supping with the devil - but were not
responsible for choosing it! We were surprised however, to be perceived
as purveying a tone of 'bewilderment and fear'. This we robustly deny -
our guidelines are motivated by a wish to work productively with the
private (and public) sector - and to anticipate problems before they
occur.
Competing interests: No competing interests
Sir
The article by Walt et al on the need for institutional guidelines in
dealing with the private sector(1), should be applauded. Although the
authors present a balanced argument, the tone reflects a sense of
bewilderment and fear. The accompanying medieval picture of peasants
feasting with the devil is also not particularly helpful.
Funding from government sources and private charity organisations is
decreasing relative to the number of researchers seeking such resources.
In a free market economy, it should come as no surprise that industry is
playing an increasingly important role(2).
As the authors rightly point out, industry is profit orientated.
Hence, the occasional disagreement regarding intellectual property rights
and the filing of patents is inevitable and should not surprise us either.
Partnership with industry does have huge advantages. Apart from
resources, it also allows for the cross-fertilisation of ideas(2) and
prevents stagnation of thinking within academic circles—-a fact that
everybody in academia is aware of, but nobody seems willing to admit,
especially in institutions where inbreeding is prevalent.
Partnership implies the involvement of two or more parties of equal
strength. Industry is formidable. But in the main, so is academic
science. Industry has thrown academia a lifeline. Rather than cower,
academic science should have the courage to reach out. Rather than
demonise, we should forge new alliances.
Stephen Ong
Clinical Research Fellow
Nottingham City Hospital, U.K.
Kah L. Ong
Consultant in Polymer Technologies
Melbourne, Australia
References
1) Walt G, Brugha R, Haines A. Working with the private sector: the need
for institutional guidelines. BMJ. 20002; 325: 432-5. (24 August)
2) Kealey T . The economics of research--why the linear model fails. In:
Kealey T (ed), The economic laws of scientific research, 1st edition.
London: MacMillan Press. 1996: 203-36.
Conflict of interest
K.L. Ong has worked in private industry and academia, and has received
funding from both.
Competing interests: No competing interests
We congratulate Walt et al. for addressing the important topic of
institutional guidelines for working with the private sector.(1) They
describe the experience at London School of Hygiene and Tropical Medicine
in developing such guidelines, and note that "drawing up guidelines is
only part of the process of working towards transparent
public-private concerns. Much will depend on how they are implemented and
monitored."
Two years ago, the University of Toronto embarked on a similar
research governance exercise, involving not only the University but all
fully-affiliated teaching hospitals. We undertook a guideline development
exercise, implemented new standards for industry-sponsored clinical
research, audited early experience with the guidelines, and published
the findings.(2)
The Toronto guidelines were based on 3 key principles: no censorship
or suppression of research results, a cap on the amount of publication
delay to usually less than 6 months with a maximum delay of 12 months, and
retaining the right for investigators to disclose safety concerns. After
implementation, an audit of 152 clinical study agreements at 7 teaching
hospitals showed that, respectively, 100%, 92.8%, and 82.2% of clinical
study agreements met these standards. Subsequent to this audit, additional
barriers to implementation have been addressed to further enhance
compliance, and additional work is underway to refine the
guidelines so as to address a wider range of issues.
The Toronto experience with implementation and audit of these new
standards for industry-sponsored clinical research demonstrate the
feasibility of moving in the direction advocated by Walt et al., as well
as the importance of basing progress on a cycle of implementation,
audit, and improvement. We encourage other institutions to evaluate their
experience with implementation of institutional guidelines for working
with the private sector, and share their results so institutions
can learn from each others’ experience.
1. Walt G, Brugha R, Haines A. Working with the private sector: The
need for institutional guidelines. BMJ 2002; 325: 432-5.
2. Naylor CD, for the Research Committee an Clinical Study Agreements
Working Group of the Toronto Academic Health Sciences Council. CMAJ 2002;
166: 543-6.
Competing interests: No competing interests
We agree with Tremblay and Ford that conflict of interest may occur
when research is funded from government and charitable sources and that
instutional guidelines might be extended to take this into account.
However we believe that conflicts of interest are often most obvious
in the case of private sector funding because of the potential commercial
gain that may arise from the results of such research. Tremblay suggests
that accepting funds from a commercial source whose products have
substantial adverse effects on health, such as the tobacco industry, poses
ethical issues rather than a conflict of interest. We consider that it may
do both, for example where a researcher, anxious to obtain further funds
from the same source, consciously or subconsciously minimises the harm
caused by the product in question when presenting or discussing the
results of the research.
The guidelines that were the subject of our article were not designed
to cover all the issues of ethics and governance that may arise during the
course of research. LSHTM, in common with many other academic
institutions, has its own ethical procedures and is about to disseminate
guidance on research governance to its staff.
Competing interests: No competing interests
While sympathetic to Walt et al, I think that the focus on the
private sector in their paper is missing the point. It is research
sponsorship that provokes potential conflicts of interest. In over 30
years as a health economist, I have had more pressure from public bodies
to achieve their preferred outcome than I have ever had from private
sector companies. To overlook this is to give the public sector credit
for ethical standards that it may not always hold dear.
Competing interests: No competing interests
This paper is broadly welcomed. However, it is worth remembering
that conflict of interest is endemic wherever people have interests, and
not just when private sector organisations are involved. The
disinterested pursuit of science is more a fairy tale than reality -- we
all do things for reasons and those reasons give rise to our actions and
motivations.
Being a government or charity does not remove potential conflict and
indeed governments have been known to suppress studies, or massage data to
achieve particular ends. And of course engaging in collaborative work
with a colleague has its own potential conflicts where self-interest, and
personal promotion are known features which even peer review cannot
bypass.
We will of course need to distinguish an ethical dilemma from a
conflict of interest -- accepting funding from a tobacco company raises
ethical issues, I'm not sure what the conflict of interest is though.
Perhaps at least with the private sector the conflict is more clear
and obvious. Though I daresay that the authors' list of pros and cons
from their experience with the private sector may be more a feature of
work itself and not who pays the bills.
I'd like to suggest that we need generalisable guidelines and
expectations regarding conflict of interest. At least that way may avoid
granting some financial sponsors an immunity that may not be warranted.
Competing interests: No competing interests
Institutional guidelines are even more important for the health service than academia
Academic institutions should have transparent guidelines for working
with the private sector as described by Walt et al for the London School
of Hygiene and Tropical Medicine (LSHTM) (1). The importance of
maintaining integrity of public bodies is also an issue for the World
Health Organization (WHO) (2). It is possibly even more important that
public bodies such as the National Health Service, Public Health
Laboratory Service (PHLS) and forthcoming Health Protection Agency (HPA)
develop and follow such guidance than academic centres, since these bodies
are vulnerable to accusations that the private sector has undue influence
on policy and practice.
The PHLS has worked with private sector organisations for many years
in a variety of ways and particularly in the field of vaccination. As in
many other countries, the UK public sector does not manufacture vaccines.
It is necessary for public bodies to work with vaccine manufacturers to
ensure the best possible vaccination programme. The success of the UK
group C meningococcal vaccination programme, the first such national
programme to be implemented in the world, is testimony to how private-
public sector partnership can have clear benefits for public health (3).
Around the same time as LSHTM was developing its policy, the PHLS
Immunisation Division was developing its own guidelines. We borrowed
heavily from draft WHO policy and guidelines developed by the US Centers
for Disease Control and Prevention (4). Our guidelines are now available
on our website:
http://www.phls.org.uk/dir/cdsc/immunisation.htm
The guidelines include the requirement for authors to declare any
potential conflict of interest. Declaring potential conflicts of interest
may reduce the impact of scientific publications, although as more authors
comply this effect may be attenuated (5).
All public bodies should have explicit guidance for working with the
private sector which is accessible to the public. Any policy-making group
also requires guidelines, such as those of the Joint Committee on
Vaccination and Immunisation which usefully distinguishes specific and non
-specific and personal and non-personal interests (6).
Public-private partnership is necessary and in the UK context is
would be naïve to think it could be avoided. Our responsibilities as
publicly funded guardians of health are to make such partnerships explicit
and open to scrutiny, to ensure that policy-making mechanisms are robust,
and that policy is based only on the best available evidence. Policy must
not only be unbiased, it must be seen to be unbiased.
Guidelines on private sector collaboration set standards which need
to be implemented and audited. The commitment and resources for this
should be provided in the frame of clinical governance. Ethics committees
and other project and research review bodies should also ensure that the
bodies they support follow such guidelines from initiation of research all
the way through to its eventual publication.
References
1. Walt G, Brugha R, Haines A. Working with the private sector: the
need for institutional guidelines. BMJ 2002;325:432-5
2. Yamey G. WHO in 2002. Why does the world still need WHO?. BMJ
2002;325:1294-8
3. Miller E, Salisbury D, Ramsay M. Planning, registration, and
implementation of an immunisation campaign against meningococcal serogroup
C disease in the UK: a success story. Vaccine 2001 Oct 15;20 Suppl 1:S58-
67
4. Centers for Disease Control Guidance for collaboration with the private
sector http://www.cdc.gov/od/foia/policies/collabor.htm
5. Chaudhry S, Schroter S, Smith R, Morris J. Does declaration of
competing interests affect readers’ perceptions? A randomised trial. BMJ
2002;325:1391-2
6. Joint Committee on Vaccination and Immunisation Members’ Code of
Practice. http://www.doh.gov.uk/jcvi/code.htm
Competing interests:
None declared
Competing interests: No competing interests