ethics of neonatal research john l. sever, md, phd. children’s national medical center george...
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ETHICS OF NEONATAL RESEARCH
John L. Sever, MD, PhD.
Children’s National Medical CenterGeorge Washington University Medical
CenterWashington, DC
REFERENCES
• American Academy of Pediatrics
Policy Statement
Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations. Pediatrics, Vol. 95, Number 2, February 1995, pages 286-294.
REFERENCES
• Code of Federal Regulations
Title 45, Part 46, Subpart D
ETHICAL PRINCIPLES - BELMONT REPORT
1. Respect for Persons
• Participants voluntarily consent to participate in research
• Obtain informed consent
• Privacy and confidentiality
ETHICAL PRINCIPLES - BELMONT REPORT
2. Beneficence
• The risks of research are justified by potential benefits to the individual or society
• The study is designed so risks are minimized
• Conflicts of interest are managed adequately
ETHICAL PRINCIPLES - BELMONT REPORT
3. Justice
• Vulnerable subjects are not targeted for convenience
• People who are likely to benefit from research participation are not systematically
excluded.
NEONATAL HIV RESEARCH
1. Respect for Persons
Voluntary Consent Must be parent or guardian
Understanding?Ability to Cope?Motive?
NEONATAL HIV RESEARCH
Direct benefitPhase I -- Unlikely
Benefit to othersBetter careAssistance --
MoneySocial Support/aidFood, formula, diapers
NEONATAL HIV RESEARCH
InconvenienceVisits/timeTravelMedicationsSide effectsCosts
NEONATAL HIV RESEARCH
2. BeneficenceBackground Information
Laboratory, Animals, Adults
Risks:May not be infected (98%)Toxicities in neonates Different metabolism Long-term effects -
Growth/Development/Mental Effect of maternal treatment - Resistance
NEONATAL HIV RESEARCH
Benefits
Better suppression of infectionLower risk of transmissionLess side effectsEasier to administer
Better medical careSocial support for familyBenefit to other children
NEONATAL HIV RESEARCH
3. Justice
Vulnerable subjects Newborns (Should not be targeted for convenience)
General availability - Location of centerRecruitment procedures
IRB: RISK/PEDIATRICS
1. Not More Than Minimal Risk
Direct Benefit/No Direct Benefit OK
2. Minor Increase Over Minimal Risk Direct Benefit/No Direct Benefit OK
3. More Than Minimal Risk Direct Benefit OK
No Direct Benefit To HHS Panel
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