Literature DB >> 3365625

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.

G Koren1, J Litwack, D W Biggar.   

Abstract

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.

Entities:  

Keywords:  Biomedical and Behavioral Research; Empirical Approach

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Substances:

Year:  1988        PMID: 3365625      PMCID: PMC1267844     

Source DB:  PubMed          Journal:  CMAJ        ISSN: 0820-3946            Impact factor:   8.262


  7 in total

Review 1.  The current status of chloramphenicol.

Authors:  H C Meissner; A L Smith
Journal:  Pediatrics       Date:  1979-09       Impact factor: 7.124

2.  Clinical biostatistics. XXVI. Medical ethics and the architecture of clinical research.

Authors:  A R Feinstein
Journal:  Clin Pharmacol Ther       Date:  1974-03       Impact factor: 6.875

3.  Therapeutic orphans.

Authors:  H Shirkey
Journal:  J Pediatr       Date:  1968-01       Impact factor: 4.406

4.  Research on infants.

Authors:  H Pratt
Journal:  Lancet       Date:  1977-05-14       Impact factor: 79.321

5.  Research on infants.

Authors:  H Pratt
Journal:  Lancet       Date:  1977-03-26       Impact factor: 79.321

6.  Epidemiologic aspects of drug utilization in a newborn intensive care unit.

Authors:  J V Aranda; J M Collinge; S Clarkson
Journal:  Semin Perinatol       Date:  1982-04       Impact factor: 3.300

7.  Legality of consent to nontherapeutic medical research on infants and young children.

Authors:  G Dworkin
Journal:  Arch Dis Child       Date:  1978-06       Impact factor: 3.791

  7 in total
  1 in total

Review 1.  A practical approach to risk-benefit estimation in pediatric drug research.

Authors:  Gideon Koren
Journal:  Paediatr Drugs       Date:  2015-02       Impact factor: 3.022

  1 in total

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