Toward liberal guidelines for clinical research with children

Our clinical research practices with children and our ethics are in conflict and this has to be faced. Our ethical guidelines for research with children assume paradoxical ethical considerations. Classical individualism deepens the conflict between our clinical research practices and our ethics and merely patches it up. The paradoxes of individualistic ethics are modified and transcended by Solomon Maimon. The dichotomy between therapeutic and nontherapeutic research is false. It is possible to avoid both Ramsey-type neglect and the McCormick-type conscription: the participation of children 12 years of age and above in clinical research should be justifiable by their own consent. For those between 7 and 12 years, parents' assent should be obtained in addition. Below the age of 7, parental consent is lawfully needed and whenever possible should be coupled with the childrens' own assent. Boards of professionals, consumers, and trustees should form open institutions and collaborate in the educational as well as the decision-making processes of clinical research.