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Guiding good research
Key findings from a review of biomedical research ethics
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Abstract
Ethical scrutiny of health research has been
integrated into the research process only recently,
and is characterised by a multitude of bodies and
countries issuing different sets of regulations and
recommendations - on what should be universal
values. Add to this the personal and cultural factors
that guide interpretation of core ethical principles,
and varying operating frameworks of ethics
committees, and the stage is set for inconsistent
outcomes from ethics reviews. The system is viewed
by researchers as burdensome and bureaucratic,
and in response, efforts have been made in several
countries to streamline and standardise processes.
interpretation of universally acknowledged core
principles is guided by other personal and cultural values and contextual parameters, which
can lead to differing outcomes.
Key Finding 3: Most research locations
require ethical review of planned research
but operating frameworks for ethics committees vary significantly. Most biomedical
research is now required to undergo ethical
review, either through national laws or as a
condition of funders, host institutions, research
partners, or publishers. However, the belief
that the ethical dimension of research must be
examined furnishes no obvious guidance as to
who is best placed to judge such issues, and
how. Accordingly, a range of ethics commitKey Finding 1: Systematic ethical scrutiny
tee models has emerged. Also, the scope and
of health research is a relatively recent
impact of committee authority can vary subpractice. Even though consideration of the
ethical aspects of biomedical research is no new stantially as committees cover various areas and
phenomenon, its systematic integration into the can have different responsibilities.
research process has lagged behind the progress
Key Finding 4: Ethics reviews aim to supof medical discovery itself. While governments
port good research but they are often
and professional bodies have taken measures to
seen as burdensome and questionable, as
uphold standards and protect the public, cases
identical applications do not necessarily
of malpractice have made clear the need to
produce consistent review outcomes. Many
formulate basic ground rules to be followed by
researchers have voiced their frustration on
all those involved in research.
the issue of the bureaucracy of ethics reviews,
to the point of suggesting that the system has
Key Finding 2: Ethical guidance is chardegenerated into a self-sustaining ‘machinery’
acterised by a multitude of sources of
with a vested interest in complications. Also,
guidance and differing interpretations of
there is ample, if anecdotal, evidence for variakey ethical principles. By its nature, ethics
tion in ethics committee decisions, both within
guidance seeks universality and authority, yet
countries and internationally, most particularly
regulations, recommendations, statements and
within multicentre studies.
comments are issued by a wide range of bodies
within and across countries. Also, the practical
Key Finding 5: Several measures have
been designed to facilitate ethics reviews.
Depending on local or national context, different steps have been taken to ensure that
proposed research is reviewed more reliably,
and with as little disruption as possible. In less
research-intensive regions, the creation of more
ethics committees has been a fundamental step.
Efforts have also been made in several countries to standardise application documents and
Ethical guidance involves many different inputs before it
processes, despite reservations about a ‘one-sizecan generate a universal output
fits-all’ approach to ethics review.
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PRiSM is a unit that aims to understand the process of biomedical research and is hosted within RAND Europe.
www.science-of-science.org
This Project Resource note summarises the RAND report DB536:
Shergold, M., Evaluating Guiding Good Research: Biomedical Research Ethics and Ethics Review: Observatory on Health Research Systems, RAND Europe
(DB-536-DH), 2008. www.rand.org/pubs/documented_briefings/DB536.html
Find other projects on the PRISM website at:
www.science-of-science.org/projects
This Project Resource note describes work done for the Policy Research Programme in the Department of Health. The views expressed are not necessarily those of the
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