Assessing ethics of trials in systematic reviews.

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. We propose that systematic reviews of experimental clinical research on humans should also include information on the ethical standards of the trials.