What are the main ethical principles in developmental psychology?

1. Neill SJ. Research with children: A critical review of the guidelines. J Child Health Care. 2005;9:46–58. [PubMed] [Google Scholar]

2. Diekema DS. Conducting ethical research in pediatrics: A brief historical overview and review of pediatric regulations. J Pediatr. 2006;149(Suppl):S3–11. [PubMed] [Google Scholar]

3. Caldwell PH, Murphy SB, Butow PN, Craig JC. Clinical trials in children. Lancet. 2004;364:803–11. [PubMed] [Google Scholar]

4. Gericke CA, Riesberg A, Busse R. Ethical issues in funding orphan drug research and development. J Med Ethics. 2005;31:164–8. [PMC free article] [PubMed] [Google Scholar]

5. Gitterman DP, Greenwood RS, Kocis KC, Mayes BR, Mckethan AN. Did a rising tide lift all boats? The NIH budget and pediatric research portfolio. Health Aff (Millwood) 2004;23:113–24. [PubMed] [Google Scholar]

6. van Weely S, Leufkens HGM.Orphan diseases. Priority medicines for Europe and the world project. “A public health approach to innovation”. World Health Organization, Department of Essential Drugs and Medicines Policy. <http://mednet3.who.int/prioritymeds/report/background/rare_diseases.doc> (Version current at September 18, 2008).

7. Benjamin DK, Jr, Smith PB, Murphy MD, et al. Peer-reviewed publication of clinical trials completed for pediatric exclusivity. JAMA. 2006;296:1266–73. [PMC free article] [PubMed] [Google Scholar]

8. Interagency Advisory Panel on Research Ethics (PRE). Tri-Council Policy Statement: Ethical conduct for research involving humans. <http://www.pre.ethics.gc.ca/english/policystatement/policystatement.cfm> (Version current at September 18, 2008).

9. World Medical Association Declaration of Helsinki Ethical principles for medical research involving human subjects. JAMA. 2000;284:3043–5. [PubMed] [Google Scholar]

10. Council for International Organizations of Medical Sciences (CIOMS), World Health Organization (WHO). International ethical guidelines for biomedical research involving human subjects. <http://www.cioms.ch/frame_guidelines_nov_2002.htm> (Version current at September 18, 2008).

11. Government of Quebec. Civil Code of Quebec. Éditeur officiel du Québec. <http://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=;2&file=/CCQ/CCQ_A.html> (Version current at September 18, 2008).

12. Department of Health and Human Services, National Institutes of Health, Office of Human Subjects Research. Title 45. Code of Federal Regulations. Part 46. Protection of human subjects. Additional protections for children involved as subjects in research (Subpart D). <http://ohsr.od.nih.gov/guidelines/45cfr46.html> (Version current at September 18, 2008).

13. Weijer C. The ethical analysis of risk. J Law Med Ethics. 2000;28:344–61. [PubMed] [Google Scholar]

14. American Society of Clinical Oncology policy statement Oversight of clinical research. J Clin Oncol. 2003;21:2377–86. [PubMed] [Google Scholar]

15. Shah S, Whittle A, Wilfond B, Gensler G, Wendler D. How do institutional review boards apply the federal risk and benefit standards for pediatric research? JAMA. 2004;291:476–82. [PubMed] [Google Scholar]

16. Emanuel EJ, Wood A, Fleischman A, et al. Oversight of human participants research: Identifying problems to evaluate reform proposals. Ann Intern Med. 2004;141:282–91. [PubMed] [Google Scholar]

17. National Institutes of Health, Office of Human Subjects Research. The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. <http://ohsr.od.nih.gov/guidelines/belmont.html> (Version current at September 18, 2008).

18. Barfield RC, Church C. Informed consent in pediatric clinical trials. Curr Opin Pediatr. 2005;17:20–4. [PubMed] [Google Scholar]

19. De Lourdes Levy M, Larcher V, Kurz R. Informed consent/assent in children. Statement of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP) Eur J Pediatr. 2003;162:629–33. [PubMed] [Google Scholar]

20. Miller VA, Drotar D, Kodish E. Children’s competence for assent and consent: A review of empirical findings. Ethics Behav. 2004;14:255–95. [PubMed] [Google Scholar]

21. Fernandez CV. Context in shaping the ability of a child to assent to research. Am J Bioeth. 2003;3:29–30. [PubMed] [Google Scholar]

22. Simon CM, Siminoff LA, Kodish ED, Burant C. Comparison of the informed consent process for randomized clinical trials in pediatric and adult oncology. J Clin Oncol. 2004;22:2708–17. [PubMed] [Google Scholar]

23. Lidz CW. The therapeutic misconception and our models of competency and informed consent. Behav Sci Law. 2006;24:535–46. [PubMed] [Google Scholar]

24. Angiolillo AL, Simon C, Kodish E, et al. Staged informed consent for a randomized clinical trial in childhood leukemia: Impact on the consent process. Pediatr Blood Cancer. 2004;42:433–7. [PubMed] [Google Scholar]

25. Kodish E, Eder M, Noll RB, et al. Communication of randomization in childhood leukemia trials. JAMA. 2004;291:470–5. [PubMed] [Google Scholar]

26. Miller VA, Drotar D, Burant C, Kodish E. Clinician-parent communication during informed consent for pediatric leukemia trials. J Pediatr Psychol. 2005;30:219–29. [PubMed] [Google Scholar]

27. Kuther TL, Posada M. Children and adolescents’ capacity to provide informed consent for participation in research. Adv Psychol Res. 2004;32:163–73. [PubMed] [Google Scholar]

28. Kon AA. Assent in pediatric research. Pediatrics. 2006;117:1806–10. [PubMed] [Google Scholar]

29. Joffe S, Fernandez CV, Pentz RD, et al. Involving children with cancer in decision-making about research participation. J Pediatr. 2006;149:862–868. [PubMed] [Google Scholar]

30. Hurley JC, Underwood MK. Children’s understanding of their research rights before and after debriefing: informed assent, confidentiality, and stopping participation. Child Dev. 2002;73:132–43. [PubMed] [Google Scholar]

31. Tait AR, Voepel-Lewis T, Malviya S. Do they understand? (part II): Assent of children participating in clinical anesthesia and surgery research. Anesthesiology. 2003;98:609–14. [PubMed] [Google Scholar]

32. Wendler DS. Assent in paediatric research: Theoretical and practical considerations. J Med Ethics. 2006;32:229–34. [PMC free article] [PubMed] [Google Scholar]

33. Gill D. 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) Eur J Pediatr. 2004;163:53–7. [PubMed] [Google Scholar]

34. Ethics Working Group of the Confederation of European Specialists in Pediatrics. Gill D, Crawley FP, et al. Guidelines for informed consent in biomedical research involving paediatric populations as research participants. Eur J Pediatr. 2003;162:455–8. [PubMed] [Google Scholar]

35. American Society of Clinical Oncology Revised conflict of interest policy. J Clin Oncol. 2006;24:519–21. [PubMed] [Google Scholar]

36. Johns MM, Barnes M, Florencio PS. Restoring balance to industry-academia relationships in an era of institutional financial conflicts of interest: Promoting research while maintaining trust. JAMA. 2003;289:741–6. [PubMed] [Google Scholar]

37. Lo B, Wolf LE, Berkeley A. Conflict-of-interest policies for investigators in clinical trials. N Engl J Med. 2000;343:1616–20. [PubMed] [Google Scholar]

38. McCrary SV, Anderson CB, Jakovljevic J, et al. A national survey of policies on disclosure of conflicts of interest in biomedical research. N Engl J Med. 2000;343:1621–6. [PubMed] [Google Scholar]

39. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. <www.icmje.org> (Version current at September 18, 2008).

40. Ramsey BW. Appropriate compensation of pediatric research participants: Thoughts from an Institute of Medicine committee report. J Pediatr. 2006;149(1 Suppl):S15–9. [PubMed] [Google Scholar]

41. Fernandez CV, Kodish E, Weijer C. Informing study participants of research results: An ethical imperative. IRB. 2003;25:12–9. [PubMed] [Google Scholar]

42. Markman M. Providing research participants with findings from completed cancer-related clinical trials: Not quite as simple as it sounds. Cancer. 2006;106:1421–4. [PubMed] [Google Scholar]

43. Dixon-Woods M, Jackson C, Windridge KC, Kenyon S. Receiving a summary of the results of a trial: Qualitative study of participants’ views. BMJ. 2006;332:206–10. [PMC free article] [PubMed] [Google Scholar]

44. Partridge AH, Winer EP. Informing clinical trial participants about study results. JAMA. 2002;288:363–5. [PubMed] [Google Scholar]

45. Bookman EB, Langehorne AA, Eckfeldt JH, et al. Reporting genetic results in research studies: Summary and recommendations of an NHLBI working group. Am J Med Genet A. 2006;140:1033–40. [PMC free article] [PubMed] [Google Scholar]

46. Ravitsky V, Wilfond BS. Disclosing individual genetic results to research participants. Am J Bioeth. 2006;6:8–17. [PubMed] [Google Scholar]

47. Agrawal M, Emanuel EJ. Ethics of phase 1 oncology studies: Reexamining the arguments and data. JAMA. 2003;290:1075–82. [PubMed] [Google Scholar]

48. Geller G, Tambor ES, Bernhardt BA, Fraser G, Wissow LS. Informed consent for enrolling minors in genetic susceptibility research: A qualitative study of at-risk children’s and parents’ views about children’s role in decision-making. J Adolesc Health. 2003;32:260–71. [PubMed] [Google Scholar]

49. Kodish E, Stocking C, Ratain MJ, Kohrman A, Siegler M. Ethical issues in phase I oncology research: A comparison of investigators and institutional review board chairpersons. J Clin Oncol. 1992;10:1810–6. [PubMed] [Google Scholar]

50. Nwomeh BC, Waller AL, Caniano DA, Kelleher KJ. Informed consent for emergency surgery in infants and children. J Pediatr Surg. 2005;40:1320–5. [PubMed] [Google Scholar]

51. Weijer C, Goldsand G, Emanuel EJ. Protecting communities in research: Current guidelines and limits of extrapolation. Nat Genet. 1999;23:275–80. [PubMed] [Google Scholar]

52. Arar NH, Hazuda H, Steinbach R, Arar MY, Abboud HE. Ethical issues associated with conducting genetic family studies of complex disease. Ann Epidemiol. 2005;15:712–9. [PubMed] [Google Scholar]

53. Burke W, Diekema DS. Ethical issues arising from the participation of children in genetic research. J Pediatr. 2006;149(Suppl):S34–8. [PubMed] [Google Scholar]

54. Knoppers BM, Joly Y, Simard J, Durocher F. The emergence of an ethical duty to disclose genetic research results: International perspectives. Eur J Hum Genet. 2006;14:1170–8. [PubMed] [Google Scholar]

55. Anderson BD, Adamson PC, Weiner SL, McCabe MS, Smith MA. Tissue collection for correlative studies in childhood cancer clinical trials: Ethical considerations and special imperatives. J Clin Oncol. 2004;22:4846–50. [PubMed] [Google Scholar]

56. Estlin EJ, Cotterill S, Pratt CB, Pearson AD, Bernstein M. Phase I trials in pediatric oncology: Perceptions of pediatricians from the United Kingdom Children’s Cancer Study Group and the Pediatric Oncology Group. J Clin Oncol. 2000;18:1900–5. [PubMed] [Google Scholar]

57. Kodish E. Pediatric ethics and early-phase childhood cancer research: Conflicted goals and the prospect of benefit. Account Res. 2003;10:17–25. [PubMed] [Google Scholar]

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Ethical principles impacting research in children