Esther K Chung MD MPH Professor of Pediatrics IRB Chair Children as a Vulnerable Population Subject to coercion and undue influence Potential population of convenience Minimizing risk and distress ID: 1042985
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1. Children as Subjects – Important Ethical and Logistical ConsiderationsEsther K. Chung, MD, MPHProfessor of PediatricsIRB Chair
2. Children as a Vulnerable PopulationSubject to coercion and undue influencePotential population of convenienceMinimizing risk and distressUnderstanding developmental stagesUnderstanding pediatric ethical, clinical and psychosocial issues
3. DefinitionsPreterm newborn infantsTerm newborn infants (0 to 27 days)Infants and toddlers (28 days to 23 months)Children (2 to 11 years)Adolescents (12 to 16-18 years (dependent on region)) – Dr. Chambers talk
4. Psychosocial and cognitive development
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6. Inclusion of ChildrenEquitable selection of subjects to ensure equitable distribution of research benefits, on the one handProtection of vulnerable subjects, on the otherPolicies re: women of childbearing age 1977, 1993In turn, 1998, NIH encouraged the enrollment of children in researchEmphasis on inclusion, understanding that certain studies justifiably exclude children
7. National Commission in the Belmont ReportRespect for persons requires “the opportunity to choose to the extent they are able child assent (ages 7-17) OHR-8CChild assent = affirmative agreement and not passiveresignationParental authority: if research may directly benefit childor if the risks of participation “are equivalent to the normal risks of childhood” (minimal risk)
8. Federal Regulations – Subpart DOHR-26Subpart D—Additional Protections for Children Involved as Subjects in Research. § 46.401-46.409Research not involving greater than minimal risk.Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition.Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
9. Logistical ConsiderationsResearchers – training in pediatrics, including evaluation and management of adverse eventsMinimize number of participants and procedures, consistent with good study designMinimize discomfort and distressAddressing age-appropriate needs: pediatric procedures, play equipment and activities, food appropriate for age, familiar and comfortable environmentBlood sampling – consider maximal number of attempts, 3 ml/kg in a 8-week period OR 0.8 ml (Wayne State U) to 3 ml/kg per blood draw up to 50 ml (OHRP)
10. ReferencesBakert EA and Amdur RJ. Institutional Review Board: Management and Function. Sudbury, MA: Jones and Bartlett Publishers, 2006.The Food and Drug Administration. Guidance for Industry: E11 Clinical Investigation of Medicinal Products in the Pediatric Population, 2000. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073143.pdf Sanders LM, Federico S, Klass P et al. Literacy and Child Health: A Systematic Review. Arch Pediatr Adolesc Med. 2009;163(2):131-140. doi:10.1001/archpediatrics.2008.539Office of Human Research Protections. https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/children-research/index.html World Health Organization. Blood sample volumes in child health research: review of safe limits. http://www.who.int/bulletin/volumes/89/1/BLT-10-080010-table-T2.html