1. ETHICS OF NEONATAL RESEARCH John L. Sever, MD, PhD. Children’s National Medical Center George Washington University Medical Center Washington, DC

2. 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.

3. REFERENCES Code of Federal Regulations Title 45, Part 46, Subpart D

4. ETHICAL PRINCIPLES - BELMONT REPORT 1. Respect for Persons Participants voluntarily consent to participate in research Obtain informed consent Privacy and confidentiality

5. 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

6. 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.

7. NEONATAL HIV RESEARCH 1. Respect for Persons Voluntary Consent Must be parent or guardian Understanding? Ability to Cope? Motive?

8. NEONATAL HIV RESEARCH Direct benefit Phase I -- Unlikely Benefit to others Better care Assistance -- Money Social Support/aid Food, formula, diapers

9. NEONATAL HIV RESEARCH Inconvenience Visits/time Travel Medications Side effects Costs

10. NEONATAL HIV RESEARCH 2. Beneficence Background 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

11. NEONATAL HIV RESEARCH Benefits Better suppression of infection Lower risk of transmission Less side effects Easier to administer Better medical care Social support for family Benefit to other children

12. NEONATAL HIV RESEARCH 3. Justice Vulnerable subjects Newborns (Should not be targeted for convenience) General availability - Location of center Recruitment procedures

13. 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