Abstract

Human beings can be ethically frail under the pressure of situational forces, therefore the constraining force of the law is required. The ethics community need to have the confidence and courage to seek for the best ethical guidelines to become such constraining laws. However laws are themselves only ethical when they informed by a consensus that includes and represents the needs of the parties they are intended to protect, therefore the voice of the volunteer must be heard. Specific examples are adduced to show how the current Clinical Trials Regulations are either insufficient in their scope, or not being fully met. To conclude eight suggestions are given as to how volunteers might be better protected. These include the establishment of an independent funded body to inform and support volunteers, a volunteers charter, greater consultation with volunteers, and a change in ethos involving a more egalitarian partnership between all those involved in the development of new medicines