Zusammenfassung

Reexamination of legal and ethical principles in the United States and England yields suggestions concerning standards for the use of children in clinical investigation.Where the research is therapeutic, a minor may be included if informed consent is obtained from the parents or guardian. Where the research is not therapeutic, minors may be included if 14 years of age or older and if intelligent and mature enough to give informed consent. Parental consent is also required with discernible risks or hazards. For tissue and organ donation, the donor should be 14 years old or older and intelligent and mature enough to give informed consent and have parental or guardian consent also. Donations should be restricted to relatives or close friends. Also children under 14 may participate in clinical investigation which is not for their direct benefit where the studies are sound, promise important new knowledge for mankind, and there is no discernible risk.