Isoniazid Preventive Therapy in HIV Infected Children in Kenya

The investigator was planning a clinical trial of administering INH to HIV+ children in Kenya; controls were to be historical controls.

Suggestions from Ethics consultant

1. Frame issues in terms of Subpart D, the federal regulations for research involving children. Her study offers the prospect of direct benefit and is more than a minor increase over minimal risk.
2. Assent from children is not required (one parent or guardian may enroll the child even if he or she objects). So need to decide if they will enroll children who do not assent, or whether they will treat teenagers differently than younger children (may be difficult for parents to make them take the medicine).
3. Will children who are orphans but have no legal guardian be eligible for the study, for example if they have an adult relative who is caring for them but not the legal guardian? There may be a discrepancy between Kenyan and U.S. standards regarding formal guardianship.
4. Investigators need to consider the possibility that family members may share the INH pills.
5. Some suggestions to wording of consent document.
6. Advised the investigator to ask senior staff person at CHR to review the submission before submitting protocol.
7. Advised the investigator to clarify responsibility and authorship with Kenyan collaborators before the study begins.