Research ethics and assent in paediatric research

Overview & Definition

Picture a clinician walking towards a family with a clipboard, not a prescription. The clipboard holds a research protocol. The question on it is never "what is best for this child?" alone — it is "what can we learn, and is it fair to ask this child to help us learn it?" That second question is the whole subject of paediatric research ethics. [8]

Research is systematic investigation designed to develop or contribute to generalisable knowledge. The thing that makes research different from treatment is the aim. Treatment serves the person in front of you. Research serves future patients, and the child in front of you helps by taking part. When the aims diverge, the rules change, because a child should not carry risk for someone else's benefit without careful justification. [8] [3]

Children occupy a special place here because they cannot fully protect their own interests. They cannot give legal consent, their capacity to understand grows with age, and they are susceptible to the authority of adults who may be both their doctors and the investigators. The historical record makes plain what happens without protection — from the deliberate exposure of children to hepatitis at Willowbrook to dosing errors from untested medicines. Those abuses are the reason every modern framework layers safeguards on top of ordinary adult research ethics. [8] [1]

The job of the clinician-investigator is therefore to make the protections visible at the bedside. Identify that this is research. Take it to an ethics committee. Get the parent's informed permission and the child's assent. Sort the study by how much risk it carries and whether the child can benefit. Then keep checking that the family still understands and still agrees. [3] [1]

References15Show ledgerHide ledger

1. [1]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.PMID 14747505
2. [2]Whittle A, Shah S, Wilfond B, Gensler G, Wendler D Institutional review board practices regarding assent in pediatric research Pediatrics, 2004.PMID 15173501
3. [3]Wendler DS Assent in paediatric research: theoretical and practical considerations J Med Ethics, 2006.PMID 16574878
4. [4]Grady C, Wiener L, Abdoler E, et al. Assent in research: the voices of adolescents J Adolesc Health, 2014.PMID 24630932
5. [5]Wiener L, Viola A, Wilfond BS, et al. Contrasting views of risk perception and influence of financial compensation between adolescent research participants and their parents J Empir Res Hum Res Ethics, 2015.PMID 25742666
6. [6]Kopelman LM Using the minimal risk threshold for all no-benefit pediatric studies Am J Bioeth, 2014.PMID 25127267
7. [7]Kopelman LM Minimal risk as an international ethical standard in research J Med Philos, 2004.PMID 15512977
8. [8]Kopelman LM Children as research subjects: a dilemma J Med Philos, 2000.PMID 11262635
9. [9]Tait AR, Voepel-Lewis T, Levine R Using digital multimedia to improve parents' and children's understanding of clinical trials Arch Dis Child, 2015.PMID 25829422
10. [10]Tait AR, Voepel-Lewis T, Malviya S, Philipson SJ Improving the readability and processability of a pediatric informed consent document: effects on parents' understanding Arch Pediatr Adolesc Med, 2005.PMID 15809387
11. [11]Unguru Y Ethical Challenges in Early-Phase Pediatric Research for Life-Limiting Illness Semin Pediatr Neurol, 2015.PMID 26358428
12. [12]Grady C, Wiener L, Wendler D Adolescent Research Participants' Descriptions of Medical Research AJOB Empir Bioeth, 2016.PMID 27004235
13. [13]Lantos JD, Wendler D, Septimus E, et al. Considerations in the evaluation and determination of minimal risk in pragmatic clinical trials Clin Trials, 2015.PMID 26374686
14. [14]Moler FW, Silverstein FS, Holubkov R, et al Rationale, timeline, study design, and protocol overview of the therapeutic hypothermia after pediatric cardiac arrest trials Pediatr Crit Care Med, 2013.PMID 23842585
15. [15]Marron JM, Cronin AM, DuBois SG, et al. 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, 2019.PMID 31240271