Skip to main content
SpringerLink
Log in

Ethical Challenges in Pediatric Oncology Care and Clinical Trials

  • Chapter
  • First Online:
Ethical Challenges in Cancer Diagnosis and Therapy

Part of the book series: Recent Results in Cancer Research ((RECENTCANCER,volume 218))

Abstract

The care of pediatric cancer patients is a vast departure from cancer care of adults. While the available treatment modalities—chemotherapy, radiation, and surgery—are the same, the diseases, care-delivery, and outcomes differ greatly. And just as ‘children are not just little adults,’ pediatric bioethics occupies a distinct place within the broader field of bioethics. In this chapter, we will begin with an introduction to fundamental principles and frameworks for understanding ethical issues in pediatrics, highlighting the triadic nature of medical decision-making between a physician, the child-patient, and the child’s parent as the surrogate decision-maker. We will then delve into further details of how these principles and frameworks shape the care of children with cancer, examining specific ethical challenges commonly encountered by pediatric oncologists. We will traverse this landscape by examining issues involving (a) informed consent; (b) research involving children; (c) end of life; (d) genetic and genomic testing; and (e) professionalism. We also examine ethical challenges in clinical research, in children and more broadly. While not an exhaustive exploration of the myriad ethical issues one might encounter in pediatric cancer medicine and clinical trials, this chapter provides readers with a foundation for further reading.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
eBook
USD 16.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 16.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 139.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Similar content being viewed by others

References

  • Abigail Alliance For Better Access v Von Eschenbach (2007) Abigail alliance for better access v. Von Eschenbach. F. 3d, vol 495, pp 695. Court of Appeals, Dist. of Columbia Circuit

    Google Scholar 

  • Administration, U. F. a. D (2002) Best pharmaceuticals for children act. Public Law: 107–109

    Google Scholar 

  • American Academy of Pediatrics (2000) American academy of pediatrics. committee on bioethics and committee on hospital care. Palliative care for children. Pediatrics 106(2 Pt 1):351–357

    Google Scholar 

  • Appelbaum PS (2007) Clinical practice. Assessment of patients’ competence to consent to treatment. N Engl J Med 357(18):1834–1840

    Article  CAS  PubMed  Google Scholar 

  • Beauchamp TL, Childress JF (2013) Principles of biomedical ethics. Oxford University Press, New York

    Google Scholar 

  • Blake V, Joffe S, Kodish E (2011) Harmonization of ethics policies in pediatric research. J Law Med Ethics 39(1):70–78

    Article  PubMed  Google Scholar 

  • Bosslet GT, Pope TM, Rubenfeld GD, Lo B, Truog RD, Rushton CH, Curtis JR, Ford DW, Osborne M, Misak C, Au DH, Azoulay E, Brody B, Fahy BG, Hall JB, Kesecioglu J, Kon AA, Lindell KO, White DB (2015) An Official ATS/AACN/ACCP/ESICM/SCCM policy statement: responding to requests for potentially inappropriate treatments in intensive care units. Am J Respir Crit Care Med 191(11):1318

    Article  PubMed  Google Scholar 

  • Buchanan AE, Brock DW (1989) Deciding for others: the ethics of surrogate decision making. Cambridge University Press, Cambridge England; New York

    Google Scholar 

  • Burke W, Antommaria AH, Bennett R, Botkin J, Clayton EW, Henderson GE, Holm IA, Jarvik GP, Khoury MJ, Knoppers BM, Press NA, Ross LF, Rothstein MA, Saal H, Uhlmann WR, Wilfond B, Wolf SM, Zimmern R (2013) Recommendations for returning genomic incidental findings? We need to talk! Genet Med 15(11):854–859

    Article  CAS  PubMed  Google Scholar 

  • Burns JP, Truog RD (2007) Futility: a concept in evolution. Chest 132(6):1987–1993

    Article  PubMed  Google Scholar 

  • Caruso Brown AE, Slutzky AR (2017) Refusal of treatment of childhood cancer: a systematic review. Pediatrics 140(6)

    Google Scholar 

  • Chang W, Brohl AS, Patidar R, Sindiri S, Shern JF, Wei JS, Song YK, Yohe ME, Gryder B, Zhang S, Calzone KA, Shivaprasad N, Wen X, Badgett TC, Miettinen M, Hartman KR, League-Pascual JC, Trahair TN, Widemann BC, Merchant MS, Kaplan RN, Lin JC, Khan J (2016) Multi dimensional clinomics for precision therapy of children and adolescent young adults with relapsed and refractory cancer: a report from the Center for Cancer Research. Clin Cancer Res 22(15):3810–3820

    Article  PubMed  PubMed Central  Google Scholar 

  • Cohen B, Roth M, Marron JM, Gray SW, Geller DS, Hoang B, Gorlick R, Janeway KA, Gill J (2016) Pediatric oncology provider views on performing a biopsy of solid tumors in children with relapsed or refractory disease for the purpose of genomic profiling. Ann Surg Oncol 23(Suppl 5):990–997

    Article  PubMed  PubMed Central  Google Scholar 

  • Coleman DL, Rosoff PM (2013) The legal authority of mature minors to consent to general medical treatment. Pediatrics 131(4):786–793

    Article  PubMed  Google Scholar 

  • Committee On B (2016) Informed consent in decision-making in pediatric practice. Pediatrics 138(2)

    Google Scholar 

  • Committee on Bioethics, American Academy of Pediatrics. (2010) Children as hematopoietic stem cell donors. Pediatrics 125(2):392–404

    Article  Google Scholar 

  • Congress U (2003) Pediatric research equity act of 2003. Public Law 108(155):117

    Google Scholar 

  • Cousino, M., R. Hazen, A. Yamokoski, V. Miller, S. Zyzanski, D. Drotar, E. Kodish and T. Multi-site Intervention Study to Improve Consent Research, 2011. Cousino M, Hazen R, Yamokoski A, Miller V, Zyzanski S, Drotar D, Kodish E (2011) Multi-site intervention study to improve consent research. Parent participation and physician-parent communication during informed consent in child leukemia. Pediatrics 128(6):e1544–1551

    Google Scholar 

  • Cousino MK, Zyzanski SJ, Yamokoski AD, Hazen RA, Baker JN, Noll RB, Rheingold SR, Geyer JR, Alexander SC, Drotar D, Kodish ED (2012) Communicating and understanding the purpose of pediatric phase I cancer trials. J Clin Oncol 30(35):4367–4372

    Article  PubMed  PubMed Central  Google Scholar 

  • Covolo L, Rubinelli S, Ceretti E, Gelatti U (2015) Internet-based direct-to-consumer genetic testing: a systematic review. J Med Internet Res 17(12):e279

    Article  PubMed  PubMed Central  Google Scholar 

  • Crites J, Kodish E (2013) Unrealistic optimism and the ethics of phase I cancer research. J Med Ethics 39(6):403–406

    Article  PubMed  Google Scholar 

  • Daugherty CK, Banik DM, Janish L, Ratain MJ (2000) Quantitative analysis of ethical issues in phase I trials: a survey interview of 144 advanced cancer patients. IRB 22(3):6–14

    Article  CAS  PubMed  Google Scholar 

  • Daugherty CK, Hlubocky FJ (2008) What are terminally ill cancer patients told about their expected deaths? A study of cancer physicians’ self-reports of prognosis disclosure. J Clin Oncol 26(36):5988–5993

    Article  PubMed  PubMed Central  Google Scholar 

  • Decamp, M., S. Joffe, C. V. Fernandez, R. R. Faden, Y. Unguru and O. Working Group on Chemotherapy Drug Shortages in Pediatric, 2014. Decamp M, Joffe S, Fernandez CV, Faden RR, Unguru Y, Working Group on Chemotherapy Drug Shortages in Pediatric (2014) Chemotherapy drug shortages in pediatric oncology: a consensus statement. Pediatrics 133(3):e716–724

    Google Scholar 

  • DeMartino ES, Dudzinski DM, Doyle CK, Sperry BP, Gregory SE, Siegler M, Sulmasy DP, Mueller PS, Kramer DB (2017) Who Decides when a patient can’t? Statutes on alternate decision makers. N Engl J Med 376(15):1478–1482

    Article  PubMed  PubMed Central  Google Scholar 

  • Diekema DS (2004) Parental refusals of medical treatment: the harm principle as threshold for state intervention. Theoret Med 25:243–264

    Google Scholar 

  • Diekema DS (2006) Conducting ethical research in pediatrics: a brief historical overview and review of pediatric regulations. J Pediat 149(1 Suppl):S3-11

    Article  PubMed  Google Scholar 

  • Diekema DS, Botkin JR (2009) Clinical report–Forgoing medically provided nutrition and hydration in children. Pediatrics 124(2):813–822

    Article  PubMed  Google Scholar 

  • Directors, A. B. o. (2015)ACMG policy statement: updated recommendations regarding analysis and reporting of secondary findings in clinical genome-scale sequencing. Genet Med 17(1):68–69

    Google Scholar 

  • Donadieu J, Larabi IA, Tardieu M, Visser J, Hutter C, Sieni E, Kabbara N, Barkaoui M, Miron J, Chalard F, Milne P, Haroche J, Cohen F, Helias-Rodzewicz Z, Simon N, Jehanne M, Kolenova A, Pagnier A, Aladjidi N, Schneider P, Plat G, Lutun A, Sonntagbauer A, Lehrnbecher T, Ferster A, Efremova V, Ahlmann M, Blanc L, Nicholson J, Lambilliote A, Boudiaf H, Lissat A, Svojgr K, Bernard F, Elitzur S, Golan M, Evseev D, Maschan M, Idbaih A, Slater O, Minkov M, Taly V, Collin M, Alvarez JC, Emile JF, Heritier S (2019) Vemurafenib for refractory multisystem langerhans cell histiocytosis in children: an international observational study. J Clin Oncol 37(31):2857–2865

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Drabiak-Syed K (2010) Lessons from Havasupai tribe v. Arizona state university board of regents: recognizing group, cultural, and dignity harms as legitimate risks warranting integration into research practice. J. Health Biomed L. 6:175

    Google Scholar 

  • Drilon A, Laetsch TW, Kummar S, DuBois SG, Lassen UN, Demetri GD, Nathenson M, Doebele RC, Farago AF, Pappo AS, Turpin B, Dowlati A, Brose MS, Mascarenhas L, Federman N, Berlin J, El-Deiry WS, Baik C, Deeken J, Boni V, Nagasubramanian R, Taylor M, Rudzinski ER, Meric-Bernstam F, Sohal DPS, Ma PC, Raez LE, Hechtman JF, Benayed R, Ladanyi M, Tuch BB, Ebata K, Cruickshank S, Ku NC, Cox MC, Hawkins DS, Hong DS, Hyman DM (2018) Efficacy of Larotrectinib in TRK fusion-positive cancers in adults and children. N Engl J Med 378(8):731–739

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Eder ML, Yamokoski AD, Wittmann PW, Kodish ED (2007) Improving informed consent: suggestions from parents of children with leukemia. Pediatrics 119(4):e849-859

    Article  PubMed  Google Scholar 

  • Feinberg J (1980) The child’s right to an open future. In: Aiken W, Lafollette H (eds) Whose child? Children’s rights, parental authority, and state power. Littlefield Adams, pp 124–153

    Google Scholar 

  • Fleischman AR (2016) Pediatric ethics: protecting the interests of children. Oxford University Press, New YorK, NY

    Book  Google Scholar 

  • Flory J, Emanuel E (2004) Interventions to improve research participants’ understanding in informed consent for research: a systematic review. JAMA 292(13):1593–1601

    Article  CAS  PubMed  Google Scholar 

  • Force DST (2019) Drug shortages: root causes and potential solutions. United States Food and Drug Administration

    Google Scholar 

  • Gill J, Obley AJ, Prasad V (2018) Direct-to-Consumer genetic testing: the implications of the US FDA’s first marketing authorization for BRCA mutation testing. JAMA 319(23):2377–2378

    Article  PubMed  Google Scholar 

  • Gillam L (2016) The zone of parental discretion: an ethical tool for dealing with disagreement between parents and doctors about medical treatment for a child. Clin Ethics 11(1):1–8

    Article  Google Scholar 

  • Goldschmidt D (2015) Teen’s forced chemo may continue. Connecticut court rules

    Google Scholar 

  • Gollust SE, Gordon ES, Zayac C, Griffin G, Christman MF, Pyeritz RE, Wawak L, Bernhardt BA (2012) Motivations and perceptions of early adopters of personalized genomics: perspectives from research participants. Public Health Genom 15(1):22–30

    Article  CAS  Google Scholar 

  • Gray SW, Hicks-Courant K, Lathan CS, Garraway L, Park ER, Weeks JC (2012) Attitudes of patients with cancer about personalized medicine and somatic genetic testing. J Oncol Pract 8(6):329–335, 322 p following 335

    Google Scholar 

  • Green RC, Berg JS, Grody WW, Kalia SS, Korf BR, Martin CL, McGuire AL, Nussbaum RL, O'Daniel JM, Ormond KE, Rehm HL, Watson MS, Williams MS, Biesecker LG, American College of Medical and Genomics G (2013) ACMG recommendations for reporting of incidental findings in clinical exome and genome sequencing. Genet Med 15(7):565–574

    Google Scholar 

  • Grodin MA, Glantz LH (1994) Children as research subjects: science, ethics, and law. Oxford University Press, New York

    Google Scholar 

  • Hall MA, Rich SS (2000) Laws restricting health insurers’ use of genetic information: impact on genetic discrimination. Am J Hum Genet 66(1):293–307

    Article  CAS  PubMed  Google Scholar 

  • Harris MH, DuBois SG, Glade Bender JL, Kim A, Crompton BD, Parker E, Dumont IP, Hong AL, Guo D, Church A, Stegmaier K, Roberts CWM, Shusterman S, London WB, MacConaill LE, Lindeman NI, Diller L, Rodriguez-Galindo C, Janeway KA (2016) Multicenter feasibility study of tumor molecular profiling to inform therapeutic decisions in advanced pediatric solid tumors: the individualized cancer therapy (iCat) study. JAMA Oncol 2(5):608–615

    Article  PubMed  Google Scholar 

  • Harttrampf AC, Lacroix L, Deloger M, Deschamps F, Puget S, Auger N, Vielh P, Varlet P, Balogh Z, Abbou S, Allorant A, Valteau-Couanet D, Sarnacki S, Gamiche-Rolland L, Meurice G, Minard-Colin V, Grill J, Brugieres L, Dufour C, Gaspar N, Michiels S, Vassal G, Soria JC, Geoerger B (2017) Molecular screening for cancer treatment optimization (MOSCATO-01) in pediatric patients: a single-institutional prospective molecular stratification trial. Clin Cancer Res 23(20):6101–6112

    Article  CAS  PubMed  Google Scholar 

  • Health, C. o. S. a. P. (2018) Drug shortages: update. American Medical Association

    Google Scholar 

  • Henderson GE, Churchill LR, Davis AM, Easter MM, Grady C, Joffe S, Kass N, King NM, Lidz CW, Miller FG, Nelson DK, Peppercorn J, Rothschild BB, Sankar P, Wilfond BS, Zimmer CR (2007) Clinical trials and medical care: defining the therapeutic misconception. PLoS Med 4(11):e324

    Article  PubMed  PubMed Central  Google Scholar 

  • Horng S, Grady C (2003) Misunderstanding in clinical research: distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism. Irb 25(1):11–16

    Article  PubMed  Google Scholar 

  • In re Cassandra (2015) In re Cassandra C. A. 3d, vol 112, pp 158. Supreme Court, Conn

    Google Scholar 

  • In re EG (1989) In re EG. NE 2d, vol 549, pp 322. Supreme Court, Ill

    Google Scholar 

  • Johnson LM, Leek AC, Drotar D, Noll RB, Rheingold SR, Kodish ED, Baker JN (2015) Practical communication guidance to improve phase 1 informed consent conversations and decision-making in pediatric oncology. Cancer 121(14):2439–2448

    Article  PubMed  PubMed Central  Google Scholar 

  • Katz AL, Webb SA, Committee On B (2016) Informed consent in decision-making in pediatric practice. Pediatrics 138(2)

    Google Scholar 

  • Kearns L, Bateman-House A (2017) Who stands to benefit? Right to try law provisions and implications. Therap Innov Regul Sci 51(2):170–176

    Article  Google Scholar 

  • Kesselheim JC, Lehmann LE, Styron NF, Joffe S (2009) Is blood thicker than water? Ethics of hematopoietic stem cell donation by biological siblings of adopted children. Arch Pediatr Adolesc Med 163(5):413–416

    Article  PubMed  Google Scholar 

  • Kimmelman J (2017) Is participation in cancer phase I trials really therapeutic? J Clin Oncol 35(2):135–138

    Article  PubMed  Google Scholar 

  • Kodish E (2003) Pediatric ethics and early-phase childhood cancer research: conflicted goals and the prospect of benefit. Account Res 10(1):17–25

    Article  PubMed  Google Scholar 

  • Kodish E, Eder M, Noll RB, Ruccione K, Lange B, Angiolillo A, Pentz R, Zyzanski S, Siminoff LA, Drotar D (2004) Communication of randomization in childhood leukemia trials. JAMA 291(4):470–475

    Article  CAS  PubMed  Google Scholar 

  • Kodish E, Stocking C, Ratain MJ, Kohrman A, Siegler M (1992) Ethical issues in phase I oncology research: a comparison of investigators and institutional review board chairpersons. J Clin Oncol 10(11):1810–1816

    Article  CAS  PubMed  Google Scholar 

  • Kopelman LM (1997) The best-interests standard as threshold, ideal, and standard of reasonableness. J Med Philos 22(3):271–289

    Article  CAS  PubMed  Google Scholar 

  • Laetsch TW, DuBois SG, Mascarenhas L, Turpin B, Federman N, Albert CM, Nagasubramanian R, Davis JL, Rudzinski E, Feraco AM, Tuch BB, Ebata KT, Reynolds M, Smith S, Cruickshank S, Cox MC, Pappo AS, Hawkins DS (2018) Larotrectinib for paediatric solid tumours harbouring NTRK gene fusions: phase 1 results from a multicentre, open-label, phase 1/2 study. Lancet Oncol 19(5):705–714

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Lin B, Gutman T, Hanson CS, Ju A, Manera K, Butow P, Cohn RJ, Dalla-Pozza L, Greenzang KA, Mack J, Wakefield CE, Craig JC, Tong A (2019) Communication during childhood cancer: systematic review of patient perspectives. Cancer

    Google Scholar 

  • Mack JW, Fasciano KM, Block SD (2018) Communication about prognosis with adolescent and young adult patients with cancer: information needs, prognostic awareness, and outcomes of disclosure. J Clin Oncol 36(18):1861–1867

    Article  PubMed  Google Scholar 

  • Mack JW, Grier HE (2004) The day one talk. J Clin Oncol 22(3):563–566

    Article  PubMed  Google Scholar 

  • Marron JM (2018) Not all disagreements are treatment refusals: the need for new paradigms for considering parental treatment requests. Am J Bioeth 18(8):56–58

    Article  PubMed  Google Scholar 

  • Marron JM, Cronin AM, DuBois SG, Glade-Bender J, Kim A, Crompton BD, Meyer SC, Janeway KA, Mack JW (2019) Duality of purpose: participant and parent understanding of the purpose of genomic tumor profiling research among children and young adults with solid tumors. JCO Precis Oncol 3

    Google Scholar 

  • Marron JM, DuBois SG, Glade Bender J, Kim A, Crompton BD, Meyer SC, Janeway KA, Mack JW (2016) Patient/parent perspectives on genomic tumor profiling of pediatric solid tumors: the Individualized Cancer Therapy (iCat) experience. Pediatr Blood Cancer 63(11):1974–1982

    Article  PubMed  PubMed Central  Google Scholar 

  • Martin N (2018) How DNA companies like Ancestry and 23AndMe are using your genetic data. Retrieved December 10, 2019, from https://www.forbes.com/sites/nicolemartin1/2018/12/05/how-dna-companies-like-ancestry-and-23andme-are-using-your-genetic-data/#3806fdca6189

  • McCullough LB (2010) Contributions of ethical theory to pediatric ethics: pediatricians and parents as co-fiduciaries of pediatric patients. In: Miller G (ed) Pediatric bioethics. Cambridge University Press, New York, pp 11–21

    Google Scholar 

  • McIntyre A (2018) Doctrine of double effect. In: Zalta EN (ed) The stanford encyclopedia of philosophy

    Google Scholar 

  • Metzger ML, Billett A, Link MP (2012) The impact of drug shortages on children with cancer–the example of mechlorethamine. N Engl J Med 367(26):2461–2463

    Article  CAS  PubMed  Google Scholar 

  • Miller FG, Joffe S (2011) Equipoise and the dilemma of randomized clinical trials. N Engl J Med 364(5):476–480

    Article  CAS  PubMed  Google Scholar 

  • Mody RJ, Wu YM, Lonigro RJ, Cao X, Roychowdhury S, Vats P, Frank KM, Prensner JR, Asangani I, Palanisamy N, Dillman JR, Rabah RM, Kunju LP, Everett J, Raymond VM, Ning Y, Su F, Wang R, Stoffel EM, Innis JW, Roberts JS, Robertson PL, Yanik G, Chamdin A, Connelly JA, Choi S, Harris AC, Kitko C, Rao RJ, Levine JE, Castle VP, Hutchinson RJ, Talpaz M, Robinson DR, Chinnaiyan AM (2015) Integrative clinical sequencing in the management of refractory or relapsed cancer in youth. JAMA 314(9):913–925

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • National Bioethics Advisory Commission (2001) Ethical and policy issues in international research: clinical trials in developing countries, vol 1. https://bioethics.georgetown.edu/nbac/clinical/Vol1.pdf

  • Neel DV, Shulman DS, DuBois SG (2019) Timing of first-in-child trials of FDA-approved oncology drugs. Eur J Cancer 112:49–56

    Article  PubMed  PubMed Central  Google Scholar 

  • O’Leary M, Krailo M, Anderson JR, Reaman GH (2008) Progress in childhood cancer: 50 years of research collaboration, a report from the Children’s Oncology Group. Semin Oncol 35(5):484–493

    Article  PubMed  PubMed Central  Google Scholar 

  • Office for Protection from Research Risks (1983) Protection of human subjects. Bethesda, Md., National Institutes of Health (U.S.)

    Google Scholar 

  • Oken D (1961) What to tell cancer patients. A study of medical attitudes. JAMA 175:1120–1128

    Article  CAS  PubMed  Google Scholar 

  • Opel DJ, Diekema DS (2006) The case of A.R.: the ethics of sibling donor bone marrow transplantation revisited. J Clin Ethics 17(3):207–219

    Article  PubMed  Google Scholar 

  • Parsons DW, Roy A, Yang Y, Wang T, Scollon S, Bergstrom K, Kerstein RA, Gutierrez S, Petersen AK, Bavle A, Lin FY, Lopez-Terrada DH, Monzon FA, Hicks MJ, Eldin KW, Quintanilla NM, Adesina AM, Mohila CA, Whitehead W, Jea A, Vasudevan SA, Nuchtern JG, Ramamurthy U, McGuire AL, Hilsenbeck SG, Reid JG, Muzny DM, Wheeler DA, Berg SL, Chintagumpala MM, Eng CM, Gibbs RA, Plon SE (2016) Diagnostic yield of clinical tumor and germline whole-exome sequencing for children with solid tumors. JAMA Oncol 2(5):616–624

    Article  PubMed  PubMed Central  Google Scholar 

  • Piel J (2016) Informed consent in right-to-try cases. J Am Acad Psychiatry Law 44(3):290–296

    PubMed  Google Scholar 

  • Pope TM (2011) The best interest standard: both guide and limit to medical decision making on behalf of incapacitated patients. J Clin Ethics 22(2):134–138

    Article  PubMed  Google Scholar 

  • President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1983) Deciding to forego life-sustaining treatment: a report on the ethical, medical, and legal issues in treatment decisions. United States, Government Printing Office, Washington, DC

    Google Scholar 

  • Quill TE, Dresser R, Brock DW (1997) The rule of double effect–a critique of its role in end-of-life decision making. N Engl J Med 337(24):1768–1771

    Article  CAS  PubMed  Google Scholar 

  • Regalado A (2018) Exclusive: Chinese scientists are creating CRISPR babies—a daring effort is under way to create the first children whose DNA has been tailored using gene editing. MIT Technol Rev

    Google Scholar 

  • Rosenberg AR (2015) Poison. J Clin Oncol

    Google Scholar 

  • Rosenberg AR, Starks H, Unguru Y, Feudtner C, Diekema D (2017) Truth telling in the setting of cultural differences and incurable pediatric illness: a review. JAMA Pediatr 171(11):1113–1119

    Article  PubMed  PubMed Central  Google Scholar 

  • Ross L (2006) Phase I research and the meaning of direct benefit. J Pediatr 149(1 Suppl):S20-24

    Article  PubMed  Google Scholar 

  • Ross LF (1998) Children, families, and health care decision making. Clarendon Press, Oxford; New York

    Google Scholar 

  • Ross LF (2009) Against the tide: arguments against respecting a minor's refusal of efficacious life-saving treatment. Camb Q Healthc Ethics 18(3):302–315; discussion 315–322

    Google Scholar 

  • Salazar EG, Bernhardt MB, Li Y, Aplenc R, Adamson PC (2015) The impact of chemotherapy shortages on COG and local clinical trials: a report from the Children’s Oncology Group. Pediatr Blood Cancer 62(6):940–944

    Article  CAS  Google Scholar 

  • Schmidt C (2017) Children with cancer get more access to experimental drugs. Science 357(6351):540

    Article  CAS  PubMed  Google Scholar 

  • Shulman DS, DuBois SG (2019) Winning the RACE: Expanding pediatric cancer drug approvals. Pediatr Blood Cancer 66(8):e27705

    Article  PubMed  PubMed Central  Google Scholar 

  • Sisk BA, Kodish E (2018) Therapeutic misperceptions in early-phase cancer trials: from categorical to continuous. IRB 40(4):13–20

    Article  PubMed  Google Scholar 

  • Texas Health and Safety Code (1999) Texas Advance Directives Act of 1999. Texas Health and Safety Code

    Google Scholar 

  • Truog RD (2009) Counterpoint: the Texas advance directives act is ethically flawed: medical futility disputes must be resolved by a fair process. Chest 136(4):968–971

    Article  PubMed  Google Scholar 

  • Unguru Y (2011) Pediatric decision-making: informed consent, parental permission, and child assent. In: Diekema DS, Mercurio MR, Adam MB (eds) Clinical ethics in pediatrics: a case-based textbook. Cambridge University Press, Cambridge, pp 1–6

    Google Scholar 

  • Unguru Y, Coppes MJ, Kamani N (2008) Rethinking pediatric assent: from requirement to ideal. Pediatr Clin North Am 55(1):211–222, xii

    Google Scholar 

  • United States Congress (2008) Genetic Information Nondiscrimination Act of 2008 (GINA). HR 493. United States of America

    Google Scholar 

  • United States Congress (2018) Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act. United States of America, 115th Congress

    Google Scholar 

  • US Food and Drug Administration (FDA). Expanded access (Compassionate Use). Retrieved 1 Aug 2017, from https://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm

  • Vacco v. Quill (1997) Vacco v. Quill, vol 521, pp 793. Supreme Court, US

    Google Scholar 

  • Waligora M, Bala MM, Koperny M, Wasylewski MT, Strzebonska K, Jaeschke RR, Wozniak A, Piasecki J, Sliwka A, Mitus JW, Polak M, Nowis D, Fergusson D, Kimmelman J (2018) Risk and surrogate benefit for pediatric Phase I trials in oncology: a systematic review with meta-analysis. PLoS Med 15(2):e1002505

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  • Weber JS, Levit LA, Adamson PC, Bruinooge S, Burris HAT, Carducci MA, Dicker AP, Gonen M, Keefe SM, Postow MA, Thompson MA, Waterhouse DM, Weiner SL, Schuchter LM (2015)American society of clinical oncology policy statement update: the critical role of phase I trials in cancer research and treatment. J Clin Oncol 33(3):278–284

    Google Scholar 

  • Weise KL, Okun AL, Carter BS, Christian CW, Committee On B, Section On H, Palliative M, Committee On Child and Neglect A (2017) Guidance on forgoing life-sustaining medical treatment. Pediatrics 140(3)

    Google Scholar 

  • Wolfe J, Grier HE, Klar N, Levin SB, Ellenbogen JM, Salem-Schatz S, Emanuel EJ, Weeks JC (2000) Symptoms and suffering at the end of life in children with cancer. N Engl J Med 342(5):326–333

    Article  CAS  PubMed  Google Scholar 

  • Zhang J, Walsh MF, Wu G, Edmonson MN, Gruber TA, Easton J, Hedges D, Ma X, Zhou X, Yergeau DA, Wilkinson MR, Vadodaria B, Chen X, McGee RB, Hines-Dowell S, Nuccio R, Quinn E, Shurtleff SA, Rusch M, Patel A, Becksfort JB, Wang S, Weaver MS, Ding L, Mardis ER, Wilson RK, Gajjar A, Ellison DW, Pappo AS, Pui CH, Nichols KE, Downing JR (2015) Germline mutations in predisposition genes in pediatric cancer. N Engl J Med 373(24):2336–2346

    Article  CAS  PubMed  PubMed Central  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Division of Hematology-Oncology, Department of Pediatrics, Vanderbilt University Medical Center, 2220 Pierce Avenue 397 PRB, Nashville, TN, 37232-6310, USA

    Daniel J. Benedetti

  2. Division of Pediatric Hematology/Oncology, Harvard Medical School, Center for Bioethics, Dana-Farber/Boston Children’s Cancer and Blood Disorders Center, Boston, MA, 02215, USA

    Jonathan M. Marron

Authors
  1. Daniel J. Benedetti
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Jonathan M. Marron
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Daniel J. Benedetti .

Editor information

Editors and Affiliations

  1. History, Philosophy and Ethics in Medicine, University Medical Centre Mannheim, Mannheim, Baden-Württemberg, Germany

    Axel W. Bauer

  2. Outpatient Department, Interdisciplinary Tumour Centre, University Medical Centre Mannheim, Mannheim, Baden-Württemberg, Germany

    Ralf-Dieter Hofheinz

  3. Skin Cancer Unit, German Cancer Research Center (DKFZ), University Medical Centre Mannheim, Mannheim, Baden-Württemberg, Germany

    Jochen S. Utikal

Rights and permissions

Reprints and permissions

Copyright information

© 2021 Springer Nature Switzerland AG

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Benedetti, D.J., Marron, J.M. (2021). Ethical Challenges in Pediatric Oncology Care and Clinical Trials. In: Bauer, A.W., Hofheinz, RD., Utikal, J.S. (eds) Ethical Challenges in Cancer Diagnosis and Therapy. Recent Results in Cancer Research, vol 218. Springer, Cham. https://doi.org/10.1007/978-3-030-63749-1_11

Download citation

  • DOI: https://doi.org/10.1007/978-3-030-63749-1_11

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-030-63748-4

  • Online ISBN: 978-3-030-63749-1

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics

Search

Navigation