Ethical considerations in research involving children

Abstract

Ethical concerns and medical advances unique to children and adolescents make pediatric research an evolving endeavor. The child's changing physiology from infancy to maturity requires understanding of the benefits and risks of medical therapies currently available, but often not tested in children, as well as the risks and benefits of inclusion of children in clinical research. Recent mandates from the US Food and Drug Administration (FDA) require that drugs be tested for safety and efficacy in children. Growing concern for the prevalence of chronic disorders and increasing understanding of distinct phenotypes of these disorders points to a likely need for unique interventions matched to specific phenotypes. All contribute to the increasing complexity of ethical considerations in pediatric research.

Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews

“…Pediatric research should be limited to studies addressing only essential scientific questions that produce useful information [ 78 , 118 , 132 ]. It is not ethical to conduct research in children if comparable results can be obtained by using other methods, such as valid extrapolations from adult data or from existing data on off-label use [ 66 , 96 , 99 ]. Ensuring that research does not expose participants to greater than minimal risk is an ethical requirement of pediatric research and trials must take measures to reduce risks for participants.…”

The paucity of ethical analysis in allergology

“…For example, and as mentioned above, a significant proportion of ethical scrutiny has focused on asthma research. Several publications identify particular ethical issues related to human subjects specifically [40,43,50,52,59,76], where many ethical analyses identify particular risks, benefits, and concerns of asthma investigations involving adolescent and other paediatric populations [45,46,48,53,55,56,58,64,65,69]. Additionally, allergy professionals have questioned whether it is appropriate to uphold the status quo in clinical trials for novel asthma medications.…”

“…Since food allergy and associated risks of anaphylaxis disproportionately afflicts children [95,96], ought trials focus on establishing appropriate dosing schemes for this population? While children will stand to benefit most from clinical developments from these trials, including this vulnerable population in research is typically discouraged and often encounters significant ethical challenges (e.g., informed consent with young children is often impossible) [55,97]. The allergy research community will need to debate these ethical issues.…”

Clinical trials in children

“…There is a dilemma in finding a balance between the obligation to conduct trials to protect children from the risk of using untested medicines and to protect children against unknown risks and harms which may occur with trial participation [27,39,108,109]. The ethical principles of respect for persons, beneficence, non-maleficence and justice in trials involving children are the same as for adults.…”