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Education And Debate

Assessing ethics of trials in systematic reviews

BMJ 2004; 328 doi: (Published 22 April 2004) Cite this as: BMJ 2004;328:1013
  1. Michael A Weingarten, professor (,
  2. Mical Paul, registrar2,
  3. Leonard Leibovici, head of department3
  1. 1Department of Family Medicine, Tel-Aviv University, Tel-Aviv, Israel
  2. 2Internal Medicine and Infectious Diseases Unit, Beilinson Hospital, Rabin Medical Centre, Petah Tikva, Israel
  3. 3Beilinson Campus, Rabin Medical Centre
  1. Correspondence to: M A Weingarten
  • Accepted 30 January 2004

Routine assessment may improve ethical standards and overall quality of trials

Our awareness of the requirements for ethical clinical research has increased over the past century. Research ethics committees were set up after the Declaration of Helsinki to review research proposals. Many journals now require a statement that ethical approval has been obtained before they consider a research report for publication. Nevertheless, many published studies do not come up to standard, or at least do not report that they do. For example, 30 out of 37 consecutive studies published in five general paediatric journals did not report whether informed consent was obtained. Twenty four of them did not report whether the committee on research ethics had approved the study.1 We propose that systematic reviews of experimental clinical research on humans should also include information on the ethical standards of the trials.

Why include ethical information?

The main reason for including ethics in the checklist of systematic reviews is to increase awareness in the scientific community about the need for high ethical standards in research on humans. The proposal would also encourage reviewers to identify those occasional studies that were so unethical that there may be doubts about the morality of using the results. Although such trials are rare, history has given us too many real examples to allow us to be complacent.2 3 Opinions differ on whether it is justified to disseminate the results of such studies.4 Either way, a conscious decision should be made and revealed to readers of the review.

Issues around ethical quality overlap importantly with the central issues of the validity, reliability, and generalisability of research findings. They relate to some of the more subtle potential sources of bias in experimental clinical research. It is thus important to include ethical …

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