Current approaches for informed consent in pediatrics

Abstract

Today in medical practis; codes of ethic are becoming important. New aprroaches has emerged that about to participate with patient\'s consent and child absent understand the own situation should be taken for treatment or process on child. Means of child informing is to given simple information about understandable language. Physicians should support to be shared with the patient\'s medical decision according to the child\'s age and understanding capacity. Informed consent in pediatric patients makes contribution to develepmont of future individuals; therefore that is an important ethic assignment for doctors. J Clin Exp Invest 2014; 5 (3): 496-503

Keywords

• Children, ethic, informed consent

Çocuklarda aydınlatılmış onamda güncel yaklaşımlar

Öz

Günümüz tıp uygulamalarında etik kurallar oldukça önem kazanmıştır. Çocuklarla ilgili tanı, tedavi ve deneysel araştırmalarda hasta ve hasta yakınının tıbbi karara ortak olması ile ilgili yeni yaklaşımlar gündeme gelmiştir. Etik ve yasal açıdan çocuğa uygulanacak işlemler için ailenin onamı ve bunun yanında durumu anlayabilecek çocuğun onayının alınması gerekmektedir. Çocuğun aydınlatılması demek, yapılacak müdahale ile ilgili çocuğa anlaşılır bir dille basit ve kısa bilgiler verilmesidir. Çocuğun yaşına ve anlayış kapasitesine göre çocuğun tıbbi karar katılımı hekimlerce desteklenmelidir. Çocuk hastadan onam alınması; geleceğin bireylerinin özerkliğinin gelişmesine katkı sağlar; bu nedenle hekimler açısından önemli bir etik ödevdir.

Anahtar Kelimeler

• Çocuklar, etik, aydınlatılmış onam

References

1. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. New York. Oxford University Press 2009;99- 148.
2. American Academy of Pediatrics Committee on Bioeth- ics. Informed consent, parental permission and as- sent in pediatric practice. Pediatrics 1995;95;314-317.
3. Appelbaum PS, Lidz CW, Meisel A. Informed consent: Legal theory legal practice. New York: Oxford Press; 1987.
4. Türkiye Biyoetik Derneği, Aydınlatılmış onam almak üzerine öneriler. Murat Civaner. M. Volkan Kavas. Ocak 2007,s2.
5. Malhotra S, Subodh BN. Informed consent and ethical issues in pediatric psychoparmacology. Indian J Med Res 129, January 2009;19-32.
6. Mishkin B. Determining the capacity for making health care decisions. In: Bilig N, Robins PV, editors. Issues in geriatric psychiatry (Advances in Psychosomatic Medicine, Vol 19] Switzerland: Krager S; 1989.151- 166.
7. Roberts IS. The law and psychiatry. In: Robert EH, Staurt GY, editors. Text Book of Clinical Psychiatry. 4th ed. Washington: American Psychiatric Publishing; 2003. p.1585-1628.
8. Laura WR, Ethical and mental illness research. Psych Clin North Am 2002;25;525-545.

9. Malcol JG. Informed consent in the practice of psychia- try. In: Simon RI, editor. American psychiatric press review of clinical psychiatry and the law, vol 3. Wash- ington, American Psychiatric Press; 1992. P.186-198
10. The Nuremberg Code. Trials of War Criminals be- fore the Nuremberg Military Tribunals under Control Council Law No. 10, Washington DC: US Government Printing Office; 1949;2:181-182.
11. World Medical Association: Declaration of Hel- sinki; Recommendations guiding physicians in bio- medical research involving human subjects. JAMA 1997;277:925-926.
12. National Commission for the Protection of Human Subjects. Belmont report: Ethical and guidelines for the protection of human subjects of research. Wash- ington DC: US Government Printing Office, 1978.
13. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Department of Health, The Belmont report; Ethical principles and guidelines for the protection of human subjects of research. Education and Welfare, April 18, 1979;44:23192-23197.
14. American Academy of Pediatrics, Committee on Drugs. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 1977;60:91-101.
15. Protection of human subjects - proposed regula- tions on research involving children. Federal Register 1978;43:786.
16. Additional protections for children involved as sub- jects in research. Federal Register 1983;48:114-117.
17. European Parliament, Directive 2001/20/EC 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 Prac- tice in the Conduct of Clinical Trials on Medicinal Products for Human Use (2001].
18. Department of Health, Therapeutic Products Dırectorate Guidelines: Inclusion of Pediatric Subjects in Clinical Trials, Department of Health, Ottawa, On- tario, 1997.
19. Australian Drug Evaluation Committee, Report of the Working Party on Registration of Drugs in Children, 1997.
20. The European Agency for the Evaluation of Medicinal Products; Committee for Proprietary Medicinal Prod- ucts, Note for Guidance on Clinical İnvestigation of Medicinal Products in Children, 1997.
21. Council for International Organizations of Medical Sciences (CIOMS], International Ethical Guidelines for Biomedical Research Involving Human Subjects: Revised Draft, 2001.
22. Türkiye Cumhuriyeti Anayasası, 2. Kısım, Temel Hak- lar ve Ödevler; 2. Bölüm, Kişinin Hakları ve Ödevle- ri; Madde 17, Kişinin Dokunulmazlığı, Maddi ve Ma- nevi Varlığı. Kanun No: 2709. 2.11.1982. (Değişik: 7.5.2004-517073 md.]
23. Tababet ve Şuabat’ı Sanatlarının Tarz-ı İcrasına Dair Kanun. Kanun No:1219. 14.4.1928. Altıncı Fasıl, Ahkamı Umumiye. Madde 70. (Değişik: 578 s. K.- 8.2.2008-26781.
24. İnsan Hakları ve Biyotıp Sözleşmesi. Kanun No:5013. 3.11.2003-16.3.2004.
25. Sağlık Bakanlığı Hasta Hakları Yönetmeliği. 01.08.1998-RG-23420 (Değişik: 22. Madde, Şerh No. 14428. 5. Madde, Şerh No. 633.]
26. World Medical Association. Declaration of Ottawa on the Right of the child to Healthcare. 50th World Medical Assemly, Canada, 1998.
27. Committee on Medical Liability. Consent by proxy for nonurgent pediatric care. Pediatrics 2003;112:1186- 1195.
28. Saunder C. The vulnerable among us: protection of children in medical research. Research Nurse, March/ April 1996;pp.24-28.
29. Simar MR, Johnson VA. Pediatric Informed Consent, Challenges for Investigators. Applied Clinical Trials, 2002.
30. Philip JG. Children: problems in pediatrics. In: Jocelyn YH, editor. Ethics and child mental health. Jerusalem: Gefen Publishing House:1994.p186-198.
31. Piaget J, Inhelder B. The growth of logical thinking from childhood to adolescence, New York: Basic Books; 1958.
32. Lewis C, Lewis M, Ifekwunigue M. Informed consent by children and participation in an influenza vaccine trial. Am J Public Health 1978;68:1079-1082.
33. Weithorn L, Campbell S. The competency of children and adolescents to make informed decisions. Child Dev 1982;53:1589-1598.
34. Leiken S. Minors assent, consent or descent to medi- cal research. IRB Rev Hum Subj Res 1993;15:1-7.
35. Boris B, David A. Pediatric psychopharmacology. In: Benjamin JS, Virginia AS, editors. Comprehensive text book of psychiatry. 8th ed. Philadelphia: Lippin- cott Williams and Wilkins; 2005.P.3363-3376.
36. Ondrusek N, Abramovitch R, Pencharz P, Koren G. Empirical examination of the ability of children to con- sent to clinical research. J Med Ethics 1998;24:158- 165.
37. Dorn LD, Susman EJ, Fletcher JC. Informed consent ın Children and Adolescents: age, maturation and psy- chological state. J Adolescents Health 1995;16:185- 190.
38. Laor N. Toward liberal guidelines for clinical research with children. Med Law 1987;6:127-137.
39. Abramovitch R, Freedman JL, Henry K, Van Brunschot M. Children’s capacity to agree to psychological re- search: Knowlodge of rısks and benefıts and volun- tariness. Ethics Behavior 1995;5:25-48.
40. Broome ME, Stietglitz KA. The consent process and children. Res Nurs Health 1992;15:147-152.
41. Society for Adolescent Medicine. Guidelines for adolescent health research: a position paper for the society for adolesceny medicine. J Adolesc Health. 1995;17:270-276.
42. Arnold LE, Stoff DM, Cook E Jr, et al. Ethical issues in biological psychiatry research with children and adolescents. J Am Acad Child Adolesc Psychiatry 1995;34:929-939.
43. Dresser R. Mentally disabled research subjects: the enduring policy issues. JAMA 1996;276:67-72.
44. NHS Central Office for Research Ethics Committees. Multicenter research ethics committees guidance notes, 2000. Research on children.
45. Helmut R. Ethical aspect and treatment in child psychiatry. In: Jocelyn YH, editor. Ethics and child mental health. Jerusalem: Gefen Publishing House. 1994;p.150-160.
46. Sağlık Bakanlığı Hasta Hakları Yönetmeliği. 01.08.1998-RG-23420 (Madde 24, Madde 26.]
47. Jonsen AR, Siegler M, Winslade WJ. Clinical ethics. New York, Mc-Graw Hill. Inc.1992;173-174.
48. Gillick v West Norfolk and Wisbech area health au- thority. 1986 AC 112.
49. Sanci LA, Sawyer SM, Weller PJ, Bond LM, Patton GC. Youth health research ethics: time for a mature- minor clause? Med J Aust 2004;180:336-338.
50. Ersoy N, Şenses MÖ, Aydın Er R. Acil Tıp’ta aydınla- tılmış onam. Turk J Trauma Emerg Surg 2010;16:1-8.
51. Jane FK, Margaret AD, Ronald AF, et al. Consent for emergency medical services for children and adoles- cents. Pediatrics 2003;111:703-706.
52. American College of Physicians. Ethics manual 4th ed. Ann Intern Med 1998;128:576-594.
53. Childress JF. Consents. Who should decide ? Pater- nalism in Health Care. New York: Oxford University Press. 1982; p.77-101.
54. Dickens DM, Cook RJ. Adolescents and consent to treatment. Int J Gynaecol Obstet 2005;89:179-184.M.
55. Leikin S. The role of adolescents in decisions con- cerning their cancer therapy. Cancer 1993;71:3342- 3346.
56. Annas GJ. The rights of patient. Tottawa, New Jersey: Humana Press. 1992;110-112.
57. Committee on Bioethics. Ethics and the care of criti- cally ill infants and children. Pediatrics 1996;98:149- 152.
58. Ersoy N. Aydınlatılmış onam. In: Erdemir AD, Oncel O, Aksoy Ş, editors. Çağdaş Tıp Etiği. İstanbul: Nobel Tıp Kitabevleri. 2003;p204-240.