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Informed consent in pediatric practice


Informed consent is a communication process of providing the patient/parents/guardians with relevant information regarding the treatment and the diagnosis, so that they can make informed decisions. The process of informed consent in pediatric patients is not well understood. The amount of information to be disclosed in an informed consent is a matter of debate. There are four basic elements to the content of informed consent form: nature of procedure, risks, benefits and alternatives. The article delineates the essential elements and legal implications of informed consent in pediatric practice.

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  1. Berkowitz KA, Foglia MB, Chanko BL. Informed consent. Chest 2004;125:2367–2368.

    PubMed  Article  Google Scholar 

  2. Kohli S. Medical negligence. Accessed from: Accessed on 31 January, 2010.

  3. Barton A. Consent to medical treatment. In: Paynejames J, Dean P, Wall J, editor. Medico legal Essentials in Healthcare. New York: Churchill livingstone; 1996. p. 37–47.

    Google Scholar 

  4. Mantous CA. Informed consent. Chest 2004;125:2367–2368.

    Article  Google Scholar 

  5. Jesani A. About student research and blanket consent from patients. Ind J Med Ethics 2009; 6(4). Accessed from: Accessed on 05 March, 2010.

  6. DMC/DC/14/2/Comp.504/2009. Order. Accessed from Accessed on 31 January, 2010.

  7. Consent. Accessed from: http// Accessed on 24 January, 2010.

  8. Jacob R, Chowdury AN. Assessment of mental capacity in patients recruited in clinical trials in psychiatry and its relationship to informed consent. Indian J Med Ethics 2009; Jan–Mar; 6. Accessed from Accessed on 5 March, 2010.

  9. Buchanan A. Mental capacity, legal competence and consent to treatment. J R Soc Med 2004;97:415–420.

    PubMed  Article  Google Scholar 

  10. Grisso T, Appelbaum PS. The MacCAT-T: A clinical tool to assess patients’ capacities to make treatment decisions. Psychiatric Services 1997;48:1415–1419.

    CAS  PubMed  Google Scholar 

  11. Yadav M. Age of consent in medical profession: A food for thought. J Indian Academy Forensic Med 2007; 29. Accessed from: Accessed on 5 March, 2010.

  12. Indian Penal Code Section. Accessed from: Accessed on 1 December, 2009.

  13. Sharma RK. Consent. In: Sharma RK, editor. Legal aspects of patient care. New Delhi: Modern publishers; 2000:3–6.

    Google Scholar 

  14. Guardians and Ward Act 1890. Accessed from: Accessed on 1 December, 2009.

  15. Sobti PC, Biswas G, Sobti BS. Medicolegal issues in adolescent health care. In: Bhave SY. Bhave’s Textbook of Adolescent Medicine. Jaypee Brothers. New Delhi 2006. p. 42–59.

    Google Scholar 

  16. Foreman DM. The family rule: a framework for obtaining ethical consent for medical interventions from children. J Med Ethics 1999;25:491–496.

    CAS  PubMed  Article  Google Scholar 

  17. Ondrusek N, Abramovitch R, Pencharz P, Koren G. Empirical examination of the ability of children to consent to clinical research. J Med Ethics 1998;24:158–165.

    CAS  PubMed  Article  Google Scholar 

  18. Committee on Bioethics. Informed Consent, Parental Permission, and Assent in Pediatric Practice. Pediatrics 1995;95:314–317.

    Google Scholar 

  19. Bianco EA, Hirsh HL. Consent to and refusal to medical treatment. In: Sanbar SS, Firestone MH, Fiscina S, Leblang TR, Wecht CH, Zaremski MJ. Eds. Legal Medicine. American College of Legal Medicine Textbook Committee. Philadelphia: Elsevier publications; 2007. P. 274–296.

    Google Scholar 

  20. Singh D. Informed vs valid consent: legislation and responsibilities. Ind J Neurotrauma 2008;2:105–108.

    Google Scholar 

  21. BS Yadwad, H Gouda. Consent — Its medico legal aspects. J Assoc Physcians India 2005;53:891–894.

    CAS  Google Scholar 

  22. Allmark P, Mason S. Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process. J Med Ethics 2006;32:439–443.

    CAS  PubMed  Article  Google Scholar 

  23. Bottrell MM, Alpert H, Fischbach RL, Emanuel LL. Hospital informed consent for procedure forms. Arch Surg 2000;135:26–33.

    CAS  PubMed  Article  Google Scholar 

  24. Sachdeva A. Gupta S, Soni A, Kumar R, Gupta D, Raina A, and Pruthi PK. Evaluation of Informed Consent (IC). Presented at SIOP XXXIV meeting Medical and Pediatric Oncology 2002;39:262.

    Google Scholar 

  25. Shilling B, Young B. How do parents experience being asked to enter a child in a randomised controlled trial? BMC Medical Ethics 2009, 10:1.

    PubMed  Article  Google Scholar 

  26. Kalantri SP. Informed consent in public hospitals. Ind J Med Ethics 2000; 8: 21–27. Accessed from: Accessed on 5 March, 2010.

    Google Scholar 

  27. Knowledge and attitudes of doctors on medical ethics in a teaching hospital, Manipur. Indian J Med Ethics. 2009; 6. Accessed from: Accessed on 31 January, 2010.

  28. Cassileth BR, Zupkis RV, Sutton-smith K, March V. Informed consent-why are goals imperfectly realized. N Engl J Med 1980;302:896–900.

    CAS  PubMed  Article  Google Scholar 

  29. Patrick JD, Dawes BS. Informed consent: what patients want to know? J Roy Soc Med 1994;87:149.

    Google Scholar 

  30. Sanwal AK, Kumar S, Sahni P, Nundy S. Informed consent in Indian patients. J R Soc Med 1996;89:196–198.

    CAS  PubMed  Google Scholar 

  31. Code of medical ethics, professional conduct, etiquettes, ethics regulation. Medical Council of India Act 1992.

  32. Pandit MS, Pandit S. Medical negligence: criminal prosecution of medical professionals, importance of medical evidence: some guidelines for medical practioners. Indian J Urol 2009;25:379–383.

    CAS  PubMed  Article  Google Scholar 

  33. Bhat R. Regulating the private health sector: the case of the Indian consumer protection act. Health Policy and Planning 1996;11:265–279.

    CAS  PubMed  Article  Google Scholar 

  34. Cooper R, Koch KA. Neonatal and pediatric critical care: ethical decision making. Crit Care Clin 1996;12:149–164.

    CAS  PubMed  Article  Google Scholar 

  35. Sirotnak AP, Krugman RD. Child abuse and neglect. In: Hay WW, Levin MJ, Sondheimer JM, Deterding RR (eds). Current Pediatric Diagnosis and Treatment. 18th edn. Philadelphia: Lange publication; 2003. P. 219–224.

    Google Scholar 

  36. Mehta MN. Child abuse and neglect. In: Parthasarathy A. IAP Textbook of Pediatrics. New Delhi: Jaypee Publication; 2006. p 952–959.

    Google Scholar 

  37. Spinetta JJ, Masera G, Jankovic M, Oppenheim D, Martins AG, Arush MWB, et al. Valid informed consent and participative decision-making in children with cancer and their parents: A report of the SIOP Working Committee on Psychosocial Issues in Pediatric Oncology. Med Pediatr Oncol 2003;40:244–246.

    PubMed  Article  Google Scholar 

  38. Woodsong C, Karim QA. A model designed to enhance informed consent: Experiences from the HIV prevention trials network. Am J Public Health 2005;95:412–419.

    PubMed  Article  Google Scholar 

  39. Ryan R, Prictor M, McLaughlin KJ, Hill S. Audiovisual presentation of information for informed consent for participation in clinical trials. Cochrane Database of Systematic Reviews 2008, Issue 1. Art No: CD003717.DOI:10.1002/14651858. CD003717. pub 2.

  40. Eder ML, Yamokoski AD, Wittmann PW, Kodish ED. Improving informed consent: Suggestions from parents of children with leukemia. Pediatrics 2007;119;e849–e859.

    PubMed  Article  Google Scholar 

  41. Pape T. Legal and ethical considerations of informed consent. AORN J 1997;65:1122–1127.

    CAS  PubMed  Article  Google Scholar 

  42. Bastia BK. Consent to treatment: practice vis-à-vis principle. Indian J Med Ethics 2008; 5. Accessed from: Accessed on 31 January 2010.

  43. Taylor HA. Barriers to informed consent. Semin Oncol Nurs 1999;15:89–95.

    CAS  PubMed  Article  Google Scholar 

  44. Moazam F. Comment on “ Consent to treatment: practice vis-à-vis principle ” by BK Bastia. Indian J Med Ethics 2008; 5. Accessed from: Assessed on 28 January, 2010.

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Correspondence to Jaya Shankar Kaushik.

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Kaushik, J.S., Narang, M. & Agarwal, N. Informed consent in pediatric practice. Indian Pediatr 47, 1039–1046 (2010).

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Key words

  • Assent
  • Child
  • India
  • Informed consent
  • Parents