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