nach oben

Pediatric Drugs

Erschienen in:

01.01.2001 | Review Article

The Ethics of Drug Research in Children

verfasst von: Dr Terrence F. Ackerman

Erschienen in: Pediatric Drugs | Ausgabe 1/2001

Einloggen, um Zugang zu erhalten

Abstract

The obligation of society to improve the welfare of its members requires the conduct of paediatric drug trials. Nevertheless, research activities must satisfy obligations to individual participants.

The obligation to protect the welfare of children requires that nontherapeutic research procedures generally involve no more than minimal risk. It also requires that randomisation occurs only when the relative merits of therapeutic procedures remain unsettled among the relevant community of experts.

The duty to respect the developing autonomy of children requires that they be included in decision-making about research participation in a manner consistent with the level of their decision-making capacity. However, when children lack mature decision-making capacities, the duty of parents to protect their welfare may properly constrain their choices.

Justice requires that the benefits and burdens of research be distributed in a manner that assures equal opportunity for all children. Vulnerable children should receive special protection against the burdens of nontherapeutic research procedures. The benefits of participating in clinical trials should be available to all children with serious illnesses for which current treatment is unsatisfactory. Justice also requires that initiatives be undertaken to rectify current shortcomings in the scope of paediatric drug research.

Striking an appropriate balance between obligations to conduct research and to protect the interests of participants is essential to the moral integrity of paediatric drug research.

Committee on Drugs, American Academy of Pediatrics. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 1995; 95: 286–94

British Medical Research Council. The ethical conduct of research in children (1991). In: Brody BA. The ethics of biomedical research: an international perspective. New York: Oxford University Press, 1998: 320–1

Jonas H. Philosophical reflections on experimenting with human subjects. In: Freund PA, editor. Experimentation with human subjects. New York: George Braziller, 1969: 1–31

Ackerman TF. Medical research, society and health care ethics. In: Gillon R, editor. Principles of health care ethics. London: Wiley, 1994: 873–84

Feinberg J. Harm to others. New York: Oxford University Press, 1984

United States Food and Drug Administration. Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients. Fed Reg 1998; 63(231): 66631–72

Offices of Drug Evaluation Statistical Report, Center for Drug Evaluation and Research, United States Food and Drug Administration. Publication no. 89-233530. Rockville (MD): US Department of Health and Human Services, 1989

Pina LM. Drugs widely used of flabel in pediatrics, report of the pediatric use survey working group of the pediatric subcommittee. News Along the Pike, 1997 Jan

Levine RJ. Ethics and regulation of clinical research. 2nd ed. Baltimore (MD): Urban and Schwarzenberg, 1986

10.

Freedman B, Fuks A, Weijer C. Demarcating research and treatment: a systematic approach for the analysis of the ethics of clinical research. Clin Res 1992; 40: 653–60PubMed

11.

Ramsey P. The patient as a person. New Haven (CT): Yale University Press, 1970

12.

Brody BA. The ethics of biomedical research: an international perspective. New York: Oxford University Press, 1998

13.

United States Department of Health and Human Services. Code of Federal Regulations, Title 45, Part 46.102(i)

14.

Freedman B, Fuks A, Weijer C. In loco parentis: minimal risk as an ethical threshold for research upon children. Hastings CentRep 1993; 23(2): 13–9CrossRef

15.

Janofsky J, Starfield B. Assessment of risk in research on children. J Pediatr 1981; 98(5): 842–6PubMedCrossRef

16.

Council of the Australian College of Paediatrics. Report on the ethics of research in children. Aust Paediatr J 1981; 17: 162

17.

Humphrey GB, Boon CM, van Linden van den Heuvell GF, et al. The occurrence of high levels of acute behavioral distress in children and adolescents undergoing routine venipunctures. Pediatrics 1992; 90(1): 87–91PubMed

18.

Smith M. Taking blood from children causes no more than minimal harm. J Med Ethics 1985; 11: 127–31PubMedCrossRef

19.

Bartholome WG. Ethical issues in pediatric research. In: Vanderpool HY, editor. The ethics of research involving human subjects. Frederick (MD): University Publishing Group, 1996: 339–70

20.

Royal College of Paediatrics and Child Health: Ethics Advisory Committee: guidelines for the ethical conduct of medical research involving children. Arch Dis Child 2000; 82: 177–82

21.

United States Department of Health and Human Services. Code of Federal Regulations, Title 45, Part 46.406

22.

Council for International Organizations of Medical Sciences/World Health Organization. International ethical guidelines for biomedical research involving human subjects. Geneva: Council for International Organizations of Medical Sciences, 1993: 20–1

23.

Levine RJ. Children as research subjects. In: Kopelman LM, Moskop JC, editors. Children and health care: moral and social issues. Dordrecht: Kluwer, 1989: 73–87CrossRef

24.

Hellman S, Hellman DS. Of mice but not men: problems of the randomized clinical trial. N Engl J Med 1991; 324: 1585–9PubMedCrossRef

25.

Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987; 317: 141–5PubMedCrossRef

26.

Lantos JD, Frader J. Extracorporeal membrane oxygenation and the ethics of clinical research in pediatrics. N Engl J Med 1990; 323: 409–13PubMedCrossRef

27.

Freedman B, Glass KC, Weijer C. Placebo orthodoxy in clinical research I: empirical and methodological myths. J Law Med Ethics 1996; 24: 243–51PubMedCrossRef

28.

Freedman B, Glass KC, Weijer C. Placebo orthodoxy in clinical research II: ethical, legal and regulatory myths. J Law Med Ethics 1996; 24: 252–9PubMedCrossRef

29.

Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. Tri-council policy statement: ethical conduct for research involving humans. Ottawa, Canada: Public Works and Government Services, 1998: 7.4–7.5

30.

Clark PI, Leaverton PE. Scientific and ethical issues in the use of placebo controls in clinical trials. Annu Rev Public Health 1994; 15: 19–38PubMedCrossRef

31.

Schiller LR, Fordtran JS. Ulcer complications during short-term therapy of duodenal ulcer with active agents and placebo. Gastroenterology 1986; 90: 478–81PubMed

32.

Buchanan AE, Brock DW. Deciding for others: the ethics of surrogate decision making. New York: Cambridge University Press, 1989

33.

Baylis F, Downie J, Kenny N. Children and decisionmaking in health research. IRB: Rev Human Subj Res 1999; 21(4): 5–10

34.

Weithorn LA, Campbell SB. The competency of children and adolescents to make informed treatment decisions. Child Develop 1982; 53: 1589–98PubMedCrossRef

35.

Scherer DG. The capacities of minors to exercise voluntariness in medical treatment decisions. Law Human Behav 1991; 15(4): 431–49CrossRef

36.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Research involving children: report and recommendations. Washington (DC): DHEW publication no. (OS) 77-0004, 1977

37.

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: DHEW publication no. (OS) 78-0012, 1978

38.

Weijer C. Research involving the vulnerable sick. Accountability in Research 1999; 7: 21–36PubMedCrossRef

39.

Lebacqz K. Justice and human research. In: Shelp E, editor. Justice and health care. Boston (MA): Reidel, 1981: 179–91CrossRef

40.

Nelson RM. Children as research subjects. In: Kahn JP, Mastrioanni AC, Sugerman J, editors. Beyond consent: seeking justice in research. New York: Oxford University Press, 1998: 47–66

41.

Kopelman LM. When is the risk minimal enough for children to be research subjects? In: Kopelman LM, Moskop JC, editors. Children and health care: moral and social issues. Dordrecht: Kluwer, 1989: 89–99CrossRef

42.

Levine C. Changing views of justice after Belmont: AIDS and the inclusion of ‘vulnerable’ subjects. In: Vanderpool HY, editor. The ethics of research involving human subjects. Frederick (MD): University Publishing Group, 1996: 105–26

43.

Murphy SB. The national impact of clinical cooperative group trials for pediatric cancer. Med Pediatr Oncol 1995; 24: 279–80PubMedCrossRef

44.

Bleyer WA, Tejeda H, Murphy SB, et al. National cancer clinical trials: children have equal access; adolescents do not. J Adolesc Health 1997; 21: 366–73PubMedCrossRef

45.

Ackerman TF. Protectionism and the new research imperative in pediatric AIDS. IRB: Rev Human Subj Res 1990; 12(5): 1–5

46.

National Institutes of Health. NIH policy and guidelines on the inclusion of children as participants in research involving human subjects. The Ethics of Drug Research in Children. Bethesda (MD): NIH, 1998 Mar 6

Titel: The Ethics of Drug Research in Children
verfasst von: Dr Terrence F. Ackerman
Publikationsdatum: 01.01.2001
Verlag: Springer International Publishing
Erschienen in: Pediatric Drugs / Ausgabe 1/2001
Print ISSN: 1174-5878
Elektronische ISSN: 1179-2019
DOI: https://doi.org/10.2165/00128072-200103010-00003

Update Pädiatrie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.

Newsletter bestellen

Springer Medizin

The Ethics of Drug Research in Children

Abstract

Neu im Fachgebiet Pädiatrie

Neuer Typ-1-Diabetes bei Kindern am Wochenende eher übersehen

Neue Studienergebnisse zur Myopiekontrolle mit Atropin

Spinale Muskelatrophie: Neugeborenen-Screening lohnt sich

Fünf Dinge, die im Kindernotfall besser zu unterlassen sind

Update Pädiatrie

Springer Medizin

Abstract

Bitte loggen Sie sich ein, um Zugang zu diesem Inhalt zu erhalten

Weitere Artikel der Ausgabe 1/2001

Caffeine Citrate

Vitamin K in Neonates

Management of Sepsis and Septic Shock in Infants and Children

Immunosuppressive Drugs in Paediatric Liver Transplantation

Neu im Fachgebiet Pädiatrie

Neuer Typ-1-Diabetes bei Kindern am Wochenende eher übersehen

Neue Studienergebnisse zur Myopiekontrolle mit Atropin

Spinale Muskelatrophie: Neugeborenen-Screening lohnt sich

Fünf Dinge, die im Kindernotfall besser zu unterlassen sind

Update Pädiatrie