An ethics committee to aid in implementing a randomized clinical trial

Individuals who care for children are sometimes reluctant to participate in experimental research because of concern about withholding a potentially helpful intervention from some of their patients and their impressions about the effects of the treatment being studied. These concerns may conflict with investigators' interests in obtaining subjects for protocols. This report describes the use of an external review committee to assess the appropriateness of enrolling patients in a randomized clinical trial. The committee served as a mechanism for assessing the validity of physicians' concerns about randomization of a given patient and for reconciling clinicians' differences about enrollment. It appears to have helped implement randomization by affording a procedure to ensure patients' rights and quality of care. It is offered as a technique for resolving the practical dilemmas of those conducting clinical research while at the same time respecting the rights of patients.