Regulating trust in pediatric clinical trials

Medicine, Health Care and Philosophy

Volumn 11, Issue 4, 2008, Pages 439-444

  Pinxten, Wim ^a   Nys, Herman ^a   Dierickx, Kris ^a  

^a UNIVERSITY OF LEUVEN   (Belgium)

Author keywords

Clinical trials; Informed consent; Medical ethics; Medical law; Minors; Trust

Indexed keywords

ARTICLE; CLINICAL TRIAL; ETHICS; HUMAN; JUVENILE; LEGAL ASPECT; METHODOLOGY; PARENTAL CONSENT; PATIENT SELECTION; RESEARCH SUBJECT; TRUST;

CLINICAL TRIALS AS TOPIC; HUMANS; MINORS; PARENTAL CONSENT; PATIENT SELECTION; RESEARCH SUBJECTS; TRUST;

EID: 57949096572     PISSN: 13867423     EISSN: 15728633     Source Type: Journal    
DOI: 10.1007/s11019-008-9157-8     Document Type: Article

References (26)

1. 45CFR 46 Subpart D. Additional DHHS Protections for Children Involved as Subjects in Research. www.llnl.gov/HumanSubjects/appendices/ Appendix03.pdf. Accessed July 31, 2007.
2. André, N., J. Gaudart, J.L. Bernard, and B. Chabrol. 2005. Quelle place pour l'enfant danl la prise de désicion en pédiatrie? Archives de pédiatrie 12: 1068-1074.
3. Beecher, H.K. 1966. Ethics and clinical research. New England Journal of Medicine 274: 1354-1360.
4. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine; Oviedo, 4.IV.1997.
5. Deatric, J.A., D.B. Angst, and C. Moore. 2002. Parents' views of their children's participation in phase I oncology clinical trials. Journal of Pediatric Oncology Nursing 19: 114-121.
6. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European Communities, L 121-34-L 121/44.
7. Food and Drug Administration Modernization Act of 1997. http://www.fda.gov/cder/guidance/s830enr.txt. Accessed July 31, 2007.
8. Gill, D. 2004. Ethical Principles and operational guidelines for good clinical practice in paediatric research. Recommendations of the ethics working group of the Confederation of European Specialists in Paediatrics (CESP). European Journal of Pediatrics 163: 53-57.
9. Hazen, R.A., D. Drotar, and E. Kodish. 2007. The role of the consent document in informed consent for pediatric leukemia trials. Contemporary Clinical Trials 28: 401-408.
10. Hoppu, K. 1999. Patient recruitment - European perspective. Pediatrics 104: 623-626.
11. ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice E6(R1), http://www.ich.org/LOB/media/MEDIA482.pdf. Accessed July 31, 2007.
12. Knox, C.A., and P.V. Burkhart. 2007. Issues related to children participating in clinical research. Journal of Pediatric Nursing 22: 310-318.
13. Mainous III, A.G., D.W. Smith, M.E. Geesey, and B.C. Tilley. 2006. Development of a measure to assess patient trust in medical researchers. Annals of Family Medicine 4: 247-252.
14. Olechnowicz, J.Q., M. Eder, C. Simon, S. Zyzanski, and E. Kodish. 2002. Assent observed: Children's involvement in leukemia treatment and research discussions. Pediatrics 109: 806-814.
15. O'Neill, O. 2004. Accountability, trust and informed consent in medical practice and research. Clinical Medicine 4: 269-276.
16. Pandolfini, C., and M. Bonati. 2005. A literature review on off-label drug use in children. European Journal of Pediatrics 164: 552-558.
17. Pappworth, M.H. 1967. Human guinea pigs experimentation on man. Boston: Beacon Press.
18. Rodriguez, W.J., R. Roberts, and D. Murphy. 2003. Current regulatory policies regarding pediatric indications and exclusivity. Journal of Pediatric Gastroenterology and Nutrition 37(Suppl 1): S40-S45.
19. Ross, L.F. 1998. Children, families and health care decision making. Oxford: Oxford University Press.
20. Ross, L.F. 2006. Children in medical research. Access versus Protection. Oxford: Oxford University Press.
21. Salazar, J.C. 2003. Pediatric clinical trial experience: Government, child, parent and physician's perspective. Pediatric Infectious Disease Journal 22: 1124-1127.
22. Shirkey, H. 1968. Therapeutic orphans. Journal of Pediatrics 72: 119-120.
23. Shirkey, H. 1999. Therapeutic orphans. Pediatrics 104: 583-584.
24. Simon, C., M. Eder, E. Kodish, and L. Siminoff. 2006. Altruistic discourse in the informed consent process for childhood cancer clinical trials. The American Journal of Bioethics 6: 40-47.
25. Snethen, J.A., M.E. Broome, K. Knafl, J.A. Deatrick, and D.B. Angst. 2006. Family patterns of decision-making in pediatric clinical trials. Research in Nursing and Health 29: 223-232.
26. Sztompka, P. 2007. Trust in science. Robert K. Merton's inspirations. Journal of Classical Sociology 7: 211-217.