Guiding Good Research
Biomedical Research Ethics and Ethics Review
Miriam Shergold
RAND Europe's Health Research System Observatory Documented Briefing series, funded by the UK Department of Health
2008
Available online PDF file [45p.] at: http://www.rand.org/pubs/documented_briefings/2008/RAND_DB536.pdf
“…….The purpose of the document is to brief non-specialists on the key aspects of the evolution, and current debate, of biomedical research ethics and the assessment of proposed research by ethics committees or review boards. Ethical approval is now an almost universal requirement in the research process, and various national and international fora have formulated appropriate ground rules.
However, practical interpretation of basic ethical principles, as well as the stringency and design of the review process, vary significantly from one location to the next. On the basis of desk research and expert interviews, this briefing highlights principal areas of consensus and tension, and outlines different approaches to the formal ethical scrutiny of proposed research. Its scope is international, with an emphasis on research intensive nations. It does not aim to deliver an exhaustive discussion of ethical principles, or take position regarding current controversies.
The report is organised in two parts. The first part provides an introduction to the history of research ethics, as well as key documents and current debates.
The second part presents key aspects of the ethics review process, and describes different models currently in use.
Summary: Key Points
• The codification of universal principles for ethics in health research is a 20th century achievement that has not, however, eliminated malpractice or dispute.
• Ethics guidance emanates from a range of different sources, resulting in a ‘normative polyphony’.
• Agreement on basic principles does not guarantee identical or even similar decisions on the ethical acceptability of a specific practical research endeavour.
• There are multiple models for the review process to safeguard ethical research, including choice and authority of the reviewers.
• Reviewing the ethical aspects of a research proposal is a demanding task, which researchers find burdensome and which has led to a range of streamlining efforts…”
Content:
Summary
Introduction
Ethics in Biomedical Research
Ethics Reviews
Outlook
Reference List
Also:
Health and Medical Research in:
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