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. 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