[Children as medical research subjects].

This article presents and evaluates 105 project proposals submitted for review by a regional committee for medical research ethics in Norway from 1987 to 1997 and presents the committee's reasons for allowing research on children and discusses some pertinent problems in research ethics.

Abstract

This article presents and evaluates 105 project proposals submitted for review by a regional committee for medical research ethics in Norway from 1987 to 1997. The committee's review practice is presented in a historical and international perspective. Until recently, no serious objections seem to have been raised to the suitability of children as research subjects. Abuse of children in research has been uncovered; as a result, strict criteria for including children in research have been developed. Our regional research ethics committee has reviewed project proposals on this background. Over a ten-year period the regional committee reviewed 105 project proposals with children as subjects, advising against implementation in only nine cases. Most projects were approved with changes. 16 approved projects were invasive and non-therapeutic. We present the committee's reasons for allowing research on children and discuss some pertinent problems in research ethics. Recently it has been shown that protective caution excludes children from research. As a result, medical services for children are not of the same quality as those for adults. There is a need for a change of practice towards including children in research unless there are scientific or ethical reasons to exclude them. The new guidelines of the National Institutes of Health attest to this change.