Abstract
Limitation of the number of blood samples obtained from infants is a major problem In clinical research, especially when repeated samples have to be obtained and when the specific patient does not have a direct benefit from these studies. Ethical committees often have to approve or disapprove such studies. In the present study we investigated the views of Canadian health professionals and lawyers participating in ethical committees and the principles that govern their decisions. Fifty individuals from 11 centers in Canada answered a questionnaire addressing this issue. There were 25 physicians, 5 PhD scientists, 5 lawyers and 15 others (nurses, clergy ect.). There were 20 women and the mean age was 42 years. The majority (75%) felt that blood sampling should be permitted whereas 25% indicated that blood pricking should not be allowed because no proxy (including parents) can approve it, or because of lack of direct benefit (20%) or because other ways of research can be found (10%). Of those permitting blood sampling, the majority (86%) stated that the total number of permitted samples depends upon the evidence presented by the researcher at the committee. However, the majority of participants did not have a clear idea on the actual number of samples that should be permitted for meaningful pharmacokinetic interpretation and felt that an ad hoc committee should decide on this issue. No correlation could be found between age, sex, number of children of participants and their views. There was, however, a clear tendency of the lawyers (4/5) not to permit extra blood sampling for research, when compared to health professionals (10/45).
This study indicates that there does not exist a consensus of ethicists on this important issue. Most participants indicated the need for a knowledgable decision on how many samples should be allowed, based on scientific evidence.
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Koren, G., Litwack, J. ETHICS OF DRUG STUDIES IN NEONATES: HOW MANY SAMPLES SHOULD BE PERMUTED FOR PHARMACO-KINETIC ANALYSIS. Pediatr Res 21 (Suppl 4), 284 (1987). https://doi.org/10.1203/00006450-198704010-00701
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DOI: https://doi.org/10.1203/00006450-198704010-00701