The use of infants in drug research when there is no direct benefit to them: a survey of Canadian health care professionals serving on ethics committees.
Canadian health care professionals and lawyers serving on ethics committees were questioned about their views on pharmacokinetic research in newborn infants who are not likely to benefit directly from the results. Of the 50 respondents 13 felt that blood samples should be taken only for therapeutic reasons; 10 of the 13 argued that additional blood samples should not be taken, because there is no direct benefit to the infant; and 8 felt that proxy consent cannot be given for invasive nontherapeutic research. Four of the five participating lawyers would not permit additional blood samples to be taken. Of the 37 respondents who would permit additional blood samples to be taken, 27 felt that the number of samples taken should depend on the researcher's justification for that number of samples; only 7 of the respondents had a clear idea of what the "upper limit" of the number of blood samples should be.
Koren
G
G
Division of Clinical Pharmacology, Hospital for Sick Children, Toronto, Ont.
Litwack
J
J
Biggar
D W
DW
D000900:Anti-Bacterial Agents / Q000493:pharmacokinetics*; D001291:Attitude of Health Personnel; D002170:Canada; D006805:Human Experimentation; D006801:Humans; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000188:drug therapy*
D000900:Anti-Bacterial Agents