Koren G, Litwack J, Biggar D W
Division of Clinical Pharmacology, Hospital for Sick Children, Toronto, Ont.
CMAJ. 1988 May 15;138(10):899-902.
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.
加拿大在伦理委员会任职的医疗保健专业人员和律师被问及他们对不太可能直接从研究结果中受益的新生儿进行药代动力学研究的看法。在50名受访者中,13人认为仅应出于治疗原因采集血样;这13人中的10人认为不应采集额外的血样,因为对婴儿没有直接益处;8人认为对于侵入性非治疗性研究不能给予替代同意。五名参与调查的律师中有四人不允许采集额外的血样。在37名允许采集额外血样的受访者中,27人认为采集的样本数量应取决于研究人员对该样本数量的理由说明;只有7名受访者清楚知道血样数量的“上限”应该是多少。