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Appendix I
Discussion Paper1
Health Research as a Public Good
Michael D. Rawlins, Academy of Medical Sciences Working Group on the
Regulation and Governance of Health Research2
The arrangements for the regulation and governance of health
research in the United Kingdom (UK) have evolved, piecemeal, over the
past 30 years, and much is now enshrined in UK and European Union
(EU) legislation. Each individual measure was introduced with the best
of intentions, but the law of unintended consequences has meant that
the regulatory and governance framework for health research is now
dysfunctional, uncoordinated, and no longer “fit for purpose.” The EU
directive regulating clinical trials places unnecessary and unreasonable
burdens on investigators; there are at least a dozen bodies involved in
granting ethical approval for health research; and each National Health
Service (NHS) hospital involved in a study insists on re-examining the
ethical, legal, and financial arrangements that have already been largely
scrutinised by one (and often more) of the relevant ethics committees.
1 The views expressed in this discussion paper are those of the authors and not necessarily
of the authors’ organizations or of the Institute of Medicine. The paper is intended to help
inform and stimulate discussion. It has not been subjected to the review procedures of the
Institute of Medicine and is not a report of the Institute of Medicine or of the National
Research Council.
2 Participant in the activities of the IOM Forum on Drug Discovery, Development, and
Translation. This discussion paper is based on a submission to the Forum’s November 2011
workshop, Envisioning a Transformed Clinical Trials Enterprise in the United States: Estab -
lishing an Agenda for 2020, to inform the workshop discussions surrounding international
case studies in the area of clinical research transformation.
207
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208 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE
BOX 1
Guiding Principles for the Regulation and
Governance of Health Research
1. S
afeguard the well-being of research participants
2. F
acilitate high-quality health research for public benefit
3. B
e proportionate, efficient, and coordinated
4. B
uild and maintain confidence in the conduct and relevance of health research
through transparency, clarity, accountability, and contestability
The goal of health research—encompassing experimental medicine,
clinical trials, and epidemiology—is to improve and sustain the public’s
health. Whether involving healthy volunteers, patients, or the public
more widely, the Academy of Medical Sciences (2011) has enunciated four
fundamental principles (see Box 1) that should underpin the regulatory
environment for health research.
In the United Kingdom, however, none of these principles is fully (and
in many instances even partially) met. Even Principle 1—safeguarding
the well-being of research participants—is undermined by the mindless
controls that are too often imposed and that lead to a false sense of secu-
rity. Principles 2, 3, and 4 are observed in the breach. Yet we know that
the public, in the United Kingdom, has an appetite for research. Most
patients, given the opportunity, want to take part in clinical trials. Half
a million members of the general public have contributed their personal
details (in anonymised form), as well as blood, urine, and saliva, to UK
Biobank. In order to meet the aspirations of patients, the public, and the
health research community (including both the life sciences industries
and academic investigators), the following measures are being taken:
1. In response to the advice of the Academy of Medical Sciences’
report, the government has created (as of December 1, 2011) a
Health Research Agency (HRA). In line with the academy’s pro-
posals, it is intended that this new body fulfill two functions. First,
it will bring together the current disparate arrangements for pro -
viding ethics approvals for health research. The National Research
Ethics Service has already moved into the HRA and other bodies
will do so shortly. Some of the arrangements for ethics review
are enshrined in primary legislation and will take a little time to
unravel, but there is a real determination, on the part of the govern-
ment, to ensure that rapid progress is made. Second, the Academy
of Medical Sciences expects the HRA to coordinate the research
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209
APPENDIX I
governance arrangements in individual NHS hospitals. For multi -
centre studies a “lead” institution could take responsibility for the
global checks, leaving individual hospitals to confirm the avail -
ability of patients and staff time. Consortia of individual NHS
hospitals have already started to do this. Alternatively or addition-
ally, the HRA could itself undertake the global checks. Whatever
arrangements that emerge, individual hospitals—as independent
legal entities—will need to agree, formally, to take part in particu -
lar studies. It will therefore be incumbent on the new agency to
earn and retain the confidence of the NHS hospitals themselves as
well as the wider research community and the public.
2. In its report on the current climate for health research, the acad-
emy was highly critical of both the principles and the operational
details of the EU’s Clinical Trials Directive. This directive is over-
burdensome (including so-called “non-investigational” studies
that have no place in the context of drug regulation), dispropor-
tionate, and applied inconsistently across the European Union. As
a member state of the European Union, the United Kingdom has
no alternative but to subscribe to the provisions of the EU Clinical
Trials Directive. Nevertheless, the UK government is committed
to re-negotiating the provisions of the directive to ensure that, in
revised form, it is less burdensome, appropriately proportionate,
and applied evenly across the European Union. At the same time,
it will seek to ensure that patients’ interests are safeguarded.
3. The National Institute for Health Research (NIHR) is developing
metrics that will allow it to monitor the time taken for regulatory
and governance approvals. The research charity, Cancer Research
UK, estimates that in 2009 the time between its award of a grant to
conduct a trial and the entry of the first patient averaged 631 days.
The NIHR seeks for this to come down to 70 days. NHS hospitals
failing to meet this requirement will face financial penalties.
Britain has a long and proud history of health research. The regula-
tory and governance arrangements instituted over the past 30 years have
seriously eroded its historical position. The measures recently enacted,
as well as those planned for the near future, should allow the United
Kingdom to regain its rightful place in this endeavour (Rawlins, 2011).
REFERENCES
Academy of Medical Sciences. 2011. A new pathway for the regulation and governance of health
research. London: Academy of Medical Sciences.
Rawlins, M. 2011. A new era for UK medical research? Lancet 377:190-193.
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