1. Children as Subjects – Important Ethical and Logistical Considerations
Esther K. Chung, MD, MPH
Professor of Pediatrics
IRB Chair

2. Children as a Vulnerable Population
Subject to coercion and undue influence
Potential population of convenience
Minimizing risk and distress
Understanding developmental stages
Understanding pediatric ethical, clinical and psychosocial issues

3. Definitions Preterm newborn infants
Term newborn infants (0 to 27 days)
Infants and toddlers (28 days to 23 months)
Children (2 to 11 years)
Adolescents (12 to years (dependent on region)) – Dr. Chambers talk

4. Psychosocial and
cognitive
development

6. Inclusion of Children
Equitable selection of subjects to ensure equitable distribution of research benefits, on the one hand
Protection of vulnerable subjects, on the other
Policies re: women of childbearing age 1977, 1993
In turn, 1998, NIH encouraged the enrollment of children in research
Emphasis on inclusion, understanding that certain studies justifiably exclude children

7. National Commission in the Belmont Report
Respect for persons requires “the opportunity to choose to the extent they are able  child assent (ages 7-17) OHR-8C
Child assent = affirmative agreement and not passive
resignation
Parental authority: if research may directly benefit child
or if the risks of participation “are equivalent to the normal risks of childhood” (minimal risk)

8. Federal Regulations – Subpart D
OHR-26
Subpart D—Additional Protections for Children Involved as Subjects in Research. §
Research 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 Considerations
Researchers – training in pediatrics, including evaluation and management of adverse events
Minimize number of participants and procedures, consistent with good study design
Minimize discomfort and distress
Addressing age-appropriate needs: pediatric procedures, play equipment and activities, food appropriate for age, familiar and comfortable environment
Blood sampling – consider maximal number of attempts, 3 ml/kg in a 8-week period OR ml (Wayne State U) to 3 ml/kg per blood draw up to 50 ml (OHRP)

10. References
Bakert 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, /ucm pdf
Sanders LM, Federico S, Klass P et al. Literacy and Child Health: A Systematic Review. Arch Pediatr Adolesc Med. 2009;163(2): doi: /archpediatrics
Office of Human Research Protections. policy/guidance/faq/children-research/index.html
World Health Organization. Blood sample volumes in child health research: review of safe limits.