Guiding good research Project REsource

advertisement
Project REsource
Guiding good research
Key findings from a review of biomedical research ethics
RAND EUROPE RESEARCH AREAS
CHOICE MODELLING &
VALUATION
COMMUNITIES, SAFETY &
JUSTICE
DEFENCE & SECURITY
EMPLOYMENT, EDUCATION & SOCIAL
POLICY RESEARCH
EVALUATION & PERFORMANCE
MANAGEMENT
FUTURES THINKING
HEALTH & HEALTHCARE
INNOVATION & TECHNOLOGY POLICY
INTERNATIONAL DEVELOPMENT
POPULATION & MIGRATION
This product is part of the
RAND Europe research brief
series. A Project REsource
note presents a policy-oriented
summary of completed project
work.
RAND Europe
Westbrook Centre
Milton Road
Cambridge CB4 1YG
United Kingdom
TEL +44 (0)1223 353 329
FAX +44 (0)1223 358 845
Rue de la Loi 82
1040 Brussels
Belgium
TEL +32 (0) 2 669 2400
Steven Wooding
[email protected]
© RAND 2012
www.randeurope.org
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.
RAND Europe is an independent not-for-profit research
institute whose mission is to help improve policy and decisionmaking through research and analysis.
www.randeurope.org
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
Department. R® is a registered trademark.
RAND Offices
Santa Monica, CA • Washington, DC • Pittsburgh, PA • New Orleans, LA/Jackson, MS • Boston, MA • Doha, QA • Abu Dhabi, AE • Cambridge, UK • Brussels, BE
RB-9683-DH (2012)
CHILDREN AND FAMILIES
EDUCATION AND THE ARTS
The RAND Corporation is a nonprofit institution that helps improve policy and
decisionmaking through research and analysis.
ENERGY AND ENVIRONMENT
HEALTH AND HEALTH CARE
INFRASTRUCTURE AND
TRANSPORTATION
This electronic document was made available from www.rand.org as a public
service of the RAND Corporation.
INTERNATIONAL AFFAIRS
LAW AND BUSINESS
NATIONAL SECURITY
POPULATION AND AGING
PUBLIC SAFETY
SCIENCE AND TECHNOLOGY
TERRORISM AND
HOMELAND SECURITY
Support RAND
Browse Reports & Bookstore
Make a charitable contribution
For More Information
Visit RAND at www.rand.org
Explore RAND Europe
View document details
Research Brief
This product is part of the RAND Corporation research brief series. RAND research briefs present policy-oriented summaries of individual published, peer-reviewed documents or of a body of
published work.
Limited Electronic Distribution Rights
This document and trademark(s) contained herein are protected by law as indicated in a notice
appearing later in this work. This electronic representation of RAND intellectual property is
provided for non-commercial use only. Unauthorized posting of RAND electronic documents to
a non-RAND Web site is prohibited. RAND electronic documents are protected under copyright
law. Permission is required from RAND to reproduce, or reuse in another form, any of our research
documents for commercial use. For information on reprint and linking permissions, please see
RAND Permissions.
Download