The ethical boundaries of drug research in pediatrics

Pediatric Clinics of North America

Volumn 44, Issue 1, 1997, Pages 27-40

  Rowell, M ^a   Zlotkin, S ^a  

^a HOSPITAL FOR SICK CHILDREN   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL PROTOCOL; CLINICAL RESEARCH; DRUG COST; DRUG EFFICACY; DRUG RESEARCH; DRUG SAFETY; HUMAN; MEDICAL ETHICS; PATIENT SELECTION; PEDIATRICS; REVIEW; RISK BENEFIT ANALYSIS;

EID: 0031054534     PISSN: 00313955     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0031-3955(05)70461-2     Document Type: Article

References (47)

1. T. Ackerman The ethics of phase 1. Pediatric oncology trials IRB: A Review of Human Subjects Research 17 1995 1 5
2. T. Ackerman Fooling ourselves with child autonomy and assent in non-therapeutic clinical research Clinical Research 27 1979 345 348
3. T. Ackerman Protectionism and the new research imperative pediatric AIDS IRB: A Review of Human Subjects Research 12 1990 2
4. American Academy of Pediatrics, Committee on Drugs Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations Pediatrics 95 1995 287
5. M. Aviram A. Tal Z. Benzvi Monitoring theophylline therapy using citric acid-stimulated saliva in infants and children with asthma Pediatrics 80 1987 894 897
6. T. Beauchamp J. Childress Principles of Biomedical Ethics ed 3. 1989 Oxford University Press Oxford 307 365
7. L. Burns J. Hodgman A. Cass Fatal circulatory collapse in premature infants receiving chloramphenicol N Engl J Med 261 1959 1318 1321
8. M. Kopelman Children W. Reich Encyclopedia of Bioethics vol. 1 1995 MacMillan Library References, USA, Simon & Schuster and Prentice Hall International New York 357 368
9. B. Coller The newly dead as research subjects Clinical Research 37 1989 487 494
10. Council for International Organizations of Medical Sciences (CIOMS): International Ethical Guidelines for Biomedical Research Involving Human Subjects. 1993.
11. Delcaration of Helskinki [Adopted by the World Medical Assembly, Helsinki 1964. Revised 1975 (Tokyo), 1983 (Vienna), 1989 (Hong Kong)] W. Reich Encyclopedia of Bioethics, rev Ed vol 5 1995 MacMillan Library References, USA Simon Schuster and Prentice Hall New York 2765 2767
12. J. Gilman P. Gal Pharmacokinetic and parmacodynamic data collection in children and neonates Clin Pharmacokinet 23 1992 1 9
13. K. Graham G. Koren J. Klein Detecting gestational exposure to cocaine by hair analysis JAMA 262 1989 3328 3330
14. D. Grant B. Tang W. Kalow Variability in caffeine metabolism Clin Pharmacol Ther 33 1983 591 602
15. M. Grodin J. Alpert Children as participants in medical research Pediatr Clin North Am 35 1988 1391
16. D. Halperin G. Koren E. Pellegrini Topical skin anesthesia for venous, subcutaneous drug reservoir and lumbar puncture in children Pediatrics 84 1989 281 284
17. S. Harth Y. Thong Parental perceptions and attitudes about informed consent in clinical research involving children Soc Sci Med 40 1995 1573 1577
18. E. Huth Irresponsible authorship and wasteful publication R. Bulgar E. Heitman S. Reiser The Ethical Dimensions of the Biological Sciences 1993 Cambridge University Press Cambridge 136
19. Katz J. Experimentation with Human Beings. New York, Russell Sage Foundation. 633 1972, pp 9–65 1010 1007.
20. G. Koren Ethics of drug research in pregnancy, infancy and childhood G. Koren Textbook of Ethics in Pediatric Research 1993 Krieger Publishing Company Malabar, Florida 174
21. G. Koren The eutectic mixture of local anesthetics: Changing the risk-benefit ratio in pediatrics research IRB: A Review of Human Subjects Research 14 1992 4 6
22. G. Koren A. Pastusak Medical research in infants and children in the eighties: Analysis of rejected protocols Pediatr Res 27 1990 423 435
23. 2 breath tests as monitors of the cytochrome p-4 dependent mixed function monooxygenase system S.M. MacLeod A.B. Ohey S. Spielberg Developmental Pharmacology 1983 Liss New York 119 145
24. C. Levine Children in HIV/AIDS clinical trials: Still vulnerable after all these years Law, Medicine and Health Care 19 1991 3 4
25. Levine R. Appropriate guidelines for the selection of human subjects for participation in biomedical and behavioral research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Washington, DC, US Department of Health, Education and Welfare, 1978, pp 41–44. 103 DHEW publication (OS) 78-0013.
26. R. Levine Ethics and Regulation of Clinical Research ed 2. 1986 Yale University Press New Haven 241
27. D. Long G. Koren A. James Ethics of drug studies in infants: How many samples are required for accurate estimation of pharmacokinetic parameters in neonates J Pediatr 111 1987 918 921
28. Lynch A. Research involving children: Why not? In Lynch A (ed): The Good Pediatrician: An Ethics Curriculum for Use in Canadian Pediatric Residency Programs. Toronto, The Pediatrics Ethics Network, in press
29. A. Lynch The therapeutic/nontherapeutic research distinction: Why/why not? J. Nicholas Moral Priorities in Medical Research: The Second Hannah Conference 1984 The Hannah Institute for the History of Medicine Toronto 163 173
30. R. McCormick Proxy consent in the experimentation situation Perspect Biol Med 18 1974 2 20
31. H. Meissner A. Smith The current status of chloramphenicol Pediatrics 64 1979 348 356
32. E. Meslin Philosophical considerations about risk and risk assessment in medical research G. Koren Textbook Ethics in Pediatrics Research 1993 Krieger Publishing Company Malabra, Florida 41
33. J. Miller Ethical standards for human subject research in developing countries IRB: A Review of Human Subjects Research 14 1992 7 8
34. National Council on Bioethics in Human Research (NCBHR). Reflections on Research Involving Children. 1994, R853 H8M35.
35. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC, Department of Health, Education, and Welfare, 1978, pp 4–9, DHEW Publication (OS) 78-0012.
36. National Institute of Health, Office of Extramural Research, Office for Protection from Research Risks Protecting Human Subjects: Institutional Review Guidebook 1993 National Institutes of Health Washington, DC XXI NIH publication 20402-9328.
37. Nuremberg Code W. Reich rev. ed. Encyclopedia of Bioethics vol 5 1995 MacMillan Library References New York 2763 2764
38. P. Ramsey Children as research subjects: A reply Hastings Cent Rep 7 1977 40 42
39. P. Ramsey The Patient as Person 1970 Yale University Press New Haven 11 58
40. G. Rawlings Ethics and regulation in randomised controlled trials of therapy A. Grubb Challenges in Medical Care 1992 John Wiley & Sons Chichester, England
41. Royal College of Physicians Research on Healthy Volunteers J Royal College of Physicians 20 1986 244 257
42. H. Shirkey Therapeutic orphans J Pediatr 72 1968 119 120
43. G. Sigman G. O'Connor Exploration for physicians of the mature minor doctrine J Pediatr 119 1991 520 525
44. G. Koren A practical approach to risk-benefit estimation in pediatric research G. Koren Textbook of Ethics in Pediatric Research 1993 Kreiger Publishing Malabar, FL 57 62
45. B. Smith Sharing of quantitative risks with patient and families: A difference between prospective and retrospective risk ascertainment? Calyx 5 1995 1 3
46. P. Sprent Taking Risks: The Science of Uncertainty 1988 Penguin Books London
47. United Nations General Assembly 1960 Declaration of the Rights of the Child: Adopted by the General Assembly of the United Nations 1959 United Nations New York