Abstract
The ethics of research in children is complex. We aim in this section to provide information to allow pediatricians and trainees to understand general trends in research ethics, and common pitfalls. Each country has ready access to national standards of ethics review in children. We base much of the content on the Canadian standards, with which are familiar and which are likely to be similar to those of other countries.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Allen V (2017) Children are denied cancer drugs due to EU loophole: Charities slam law that means youngsters can be excluded from trials for new treatments. Daily Mail December 22, 2017 6:14AM. http://www.dailymail.co.uk/health/article-5204283/Children-denied-cancer-drugs-EU-loophole.html. Accessed 4 Sep 2018.
Altman DG (1994) The scandal of poor medical research. BMJ 308(6924):283–284
Arbour L, Field L, Ross P, Erikson A, Yoshida E (2004) The mystery of primary biliary cirrhosis in British Columbia’s first nations people. Int J Circumpolar Health 63(Suppl 2):185–188
Batalden PB, Davidoff F (2007) What is “quality improvement” and how can it transform health care? Qual Saf Health Care 16(1):2–3. https://doi.org/10.1136/qshc.2006.022046
Beecher HK (1966) Ethics and clinical research. N Engl J Med 274:1354–1360. https://doi.org/10.1056/NEJM196606162742405
Bill and Melinda Gates Foundation. https://www.gatesfoundation.org. Accessed 23 April 2019
British Medical Research Council (2019) Annual report and accounts 2017/18. https://mrc.ukri.org/publications/browse/annual-report-and-accounts-2017-18. Accessed 23 Apr 2019
Caldwell PH, Murphy SB, Butow PN, Craig JC (2004) Clinical trials in children. Lancet 364(9436):803–811. https://doi.org/10.1016/S0140-6736(04)16942-0
Calfas J (2017) Bill Gates just made his biggest donation in 17 years. Money August 15, 2017. http://money.com/money/4901017/bill-gates-donation-4-6-billion. Accessed 23 Apr 2019
Canada Institutes of Health Research (2014) Tri-Council Policy Statement: Ethical conduct for research involving humans. http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default. Accessed 4 Sep 2018
Canadian Institutes of Health Research (2019) Funding overview. http://www.cihr-irsc.gc.ca/e/37788.html. Accessed 23 Apr 2019
Casarett D, Karlawish JHT, Sugarman J (2000) Determining when quality improvement initiatives should be considered research: proposed criteria and potential implications. JAMA 283(17):2275–2280
Chalmers I (1995) What do I want from health research and researchers when I am a patient? BMJ 310(6990):1315–1318
Chalmers I, Bracken MB, Djulbegovic B, Garattini S, Grant J, Gülmezoglu AM, Howells DW, Ioannidis JP, Oliver S (2014) How to increase value and reduce waste when research priorities are set. Lancet 383(9912):156–165. https://doi.org/10.1016/S0140-6736(13)62229-1
Comroe JH Jr (1976) What makes the sky blue? Am Rev Respir Dis 113(2):219–222
Confict of interest (2018) In www.OxfordDictionaries.com. https://en.oxforddictionaries.com/definition/conflict_of_interest Accessed 12 Sep 2018.
Cooke M, Mitrou F, Lawrence D, Guimond E, Beavon D (2007) Indigenous well-being in four countries: an application of the UNDP’S human development index to indigenous peoples in Australia, Canada, New Zealand, and the United States. BioMed Cent Int Health Hum Rights 7:9. https://doi.org/10.1186/1472-698X-7-9
Corrigan O, Tutton R (2006) What’s in a name? Subjects, volunteers, participants and activists in clinical research. Clin Ethics 1(2):101–104
Eikelboom JI, Ten Cate OT, Jaarsma D, Raat JA, Schuwirth L, van Delden JJ (2012) A framework for the ethics review of education research. Medical EducationMed Educ 46(8):731–733. https://doi.org/10.1111/j.1365-2923.2012.04293.x
El-Hai J (2017) Henry Knowles Beecher: brief life of a late-blooming ethicist: 1904–1976. Harvard Magazine March–April 2017. https://harvardmagazine.com/2017/03/henry-knowles-beecher. Accessed 21 Sep 2018
Elliott C (2017) The anatomy of research scandals. Hast Cent Rep 47(3):48. https://doi.org/10.1002/hast.704
Ethical Research Involving Children (2018). https://childethics.com. .
Freimuth VS, Quinn SC, Thomas SB, Cole G, Zook E, Duncan T (2001) African Americans’ views on research and the Tuskegee syphilis study. Soc Sci Med 52(5):797–808. https://doi.org/10.1016/S0277-9536(00)00178-7
Friedman Ross L (2006) Children in medical research: access versus protection. Oxford Scholarship Online. https://doi.org/10.1093/0199273286.001.0001.
Gaw A (2012) Exposing unethical human research: the transatlantic correspondence of Beecher and Pappworth. Ann Intern Med 156(2):150–155. https://doi.org/10.7326/0003-4819-156-2-201201170-00012
Graham A, Powell M, Taylor N, Anderson D, Fitzgerald R (2013) Ethical research involving children. UNICEF Office of Research Innocenti, Florence
Grodin MA, Glantz LH (eds) (1994) Children as research subjects: science, ethics, and law. Oxford University Press, New York
Gupta A (2013) Fraud and misconduct in clinical research: a concern. Perspect Clin Res 4(2):144–147. https://doi.org/10.4103/2229-3485.111800
Hempelmann LH (1949) Potential dangers in the uncontrolled use of shoe-fitting fluoroscopes. N Eng J Med 241(9):335–336. https://doi.org/10.1056/NEJM194909012410904
Hoppu K, Anabwani G, Garcia-Bournissen F, Gazarian M, Kearns GL, Nakamura H, Peterson RG, Ranganathan SS, de Wildt SN (2012) The status of paediatric medicines initiatives around the world – what has happened and what has not? Eur J Clin Pharmacol 68(1):1–10. https://doi.org/10.1007/s00228-011-1089-1
Horrobin DF (1990) The philosophical basis of peer review and the suppression of innovation. JAMA 263(10):1438–1441
Integrity (2018) In www.OxfordDictionaries.com. https://en.oxforddictionaries.com/definition/integrity Accessed 12 Sep 2018
International Committee of Medical Journal Editors (2018) Defining the role of authors and contributors. http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html. Accessed 21 Sep 2018
Johnson MH, Franklin SB, Cottingham M, Hopwood N (2010) Why the Medical Research Council refused Robert Edwards and Patrick Steptoe support for research on human conception in 1971. Hum Reprod. 25(9):2157–2174. https://doi.org/10.1093/humrep/deq155
Jong-wook L (2005) Public health is a social issue. Lancet 365(9464):1005–1006. https://doi.org/10.1016/S0140-6736(05)71115-6
Joseph PD, Craig JC, Caldwell PH (2015) Clinical trials in children. Br J Clin Pharmacol 79(3):357–369. https://doi.org/10.1111/bcp.12305
Kaiser J (2018) NIH gets $2 billion boost in final 2019 spending bill. https://www.sciencemag.org/news/2018/09/nih-gets-2-billion-boost-final-2019-spending-bill. Accessed 23 Apr 2019
Kauffman RE, Banner W, Berlin CM, Blumer JL et al (1995) Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 95(2):286–294
Kowal E, Pearson G, Peacock CS, Jamieson SE, Blackwell JM (2012) Genetic research and aboriginal and Torres strait islander Australians. J Bioeth Inq 9(4):419–432. https://doi.org/10.1007/s11673-012-9391-x
McCoy AW (2007) Science in Dachau’s shadow: Hebb, Beecher, and the development of CIA psychological torture and modern medical ethics. J Hist Behav Sci 43(4):401–417. https://doi.org/10.1002/jhbs.20271
Nuremburg Military Tribunals (1949) Trials of war criminals before the Nuremberg military tribunals under control council law no. 10, vol. 2. U.S. Government Printing Office, Washington, DC, pp 181–182
Pappworth MH (1967) Human Guinea pigs. Routledge and Kegan Paul, London
Parker L, Williams J, Bero L (2018) Ethical drug marketing criteria for the 21st century. BMJ 361:k1809. https://doi.org/10.1136/bmj.k1809
Pearce N, Foliaki S, Sporle A, Cunningham C (2004) Genetics, race, ethnicity, and health. BMJ 328(7477):1070–1072. https://doi.org/10.1136/bmj.328.7447.1070
Royal College of Paediatrics and Child Health (RCPCH), Child Health: Ethics Advisory Committee (2000) Guidelines for the ethical conduct of medical research involving children. Arch Dis Child 82(2):177–182. https://doi.org/10.1136/adc.82.2.177
Schnarch B (2004) Ownership, control, access, and possession (OCAP) or self-determination applied to research: a critical analysis of contemporary First Nations research and some options for First Nations communications. J Aborig Health 2004:80–95. https://www.researchgate.net/profile/Brian_Schnarch/publication/235413334_Ownership_Control_Access_and_Possession_OCAP_or_Self-Determination_Applied_to_Research_A_Critical_Analysis_of_Contemporary_First_Nations_Research_and_Some_Options_for_First_Nations_Communities/links/567abe2708ae1975838110bf.pdf
Sheehan JG (2007) Fraud, conflict of interest, and other enforcement issues in clinical research. Cleve Clin J Med 74(Suppl 2):S63–S69
Shirkey H (1968) Editorial comment: Therapeutic orphans. J Pediatr 72(1):119–120
Standing Advisory Group Consumer Involvement in the NHS Research and Development Programme (1998) Aims and values. Leeds: NHS Executive. comment: therapeutic orphans. J Pediatr 72:119–120
Titus SL, Wells JA, Rhoades LJ (2008) Repairing research integrity. Nature 453(7198):980–982. https://doi.org/10.1038/453980a
U.S. Department of Health & Human Services (1979) The Belmont report: ethical principles and guidelines for the protection of human subjects of research. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html. Accessed 12 Sep2018
Vogel L (2015) The new ethics of aboriginal health research. CMAJ 187(5):316–317. https://doi.org/10.1503/cmaj.109-4998
Watkins RS, Kimberly J Jr (2004) What residents don’t know about physician–pharmaceutical industry interactions. Acad Med 79(5):432–437
Weißkircher J, Koch C, Dreimüller N, Lieb K (2017) Conflicts of interest in medicine. A systematic review of published and scientifically evaluated curricula. GMS J Med Educ 34(3):Doc37. https://doi.org/10.3205/zma001114
World Medical Association (2013) Declaration of Helsinki: Ethical principles for medical research involving human subjects. https://www.wma.net/wp-content/uploads/2016/11/DoH-Oct2013-JAMA.pdf. Accessed 13 April 2018
Author information
Authors and Affiliations
Rights and permissions
Copyright information
© 2019 Springer Nature Switzerland AG
About this chapter
Cite this chapter
Mitchell, I., Guichon, J.R. (2019). Questions About Research Involving Children. In: Ethics in Pediatrics. Springer, Cham. https://doi.org/10.1007/978-3-030-22617-6_13
Download citation
DOI: https://doi.org/10.1007/978-3-030-22617-6_13
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-030-22616-9
Online ISBN: 978-3-030-22617-6
eBook Packages: Religion and PhilosophyPhilosophy and Religion (R0)