Ethical boundaries of medical research in infants and children in the 80s: analysis of rejected protocols and a new solution for drug studies

Developmental Pharmacology and Therapeutics
G Koren

Abstract

To assess the difficulties in conducting pediatric research, we reviewed the 351 protocols dealing with research in infants and children in our institute between July 1982 and August 1988. Of the 16 rejected protocols (4.5%), 12 were drug studies, 3 dealt with the nature of course of disease states and 1 was in the area of behavioral sciences. Drug studies were significantly more likely to be rejected than all other studies. The most common reason for rejection (n = 10) were major scientific flaws which, according to the committee, would result in inability of the study to answer the questions posed by the researchers. In 9 cases, the committee judged a study to be physically invasive without a direct benefit to the involved infant/child. In 3 cases, the committee rejected a study because patients with serious medical conditions might be randomized to receive placebo and not a drug which, based on current knowledge from adults, would possibly improve their condition. In 3 protocols current antimicrobial therapy covered all pathogens causing the infection and the proposed new therapy could not improve the prognosis further but only be equal or inferior. Researchers who had more than one protocol rejected had submitted significan...Continue Reading

Citations

Jan 1, 1996·International Journal of Technology Assessment in Health Care·J Lumley, H Bastian
Apr 1, 2003·Paediatrics & Child Health·Michael J Rieder

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