The Institutional Review Board (IRB) Questions

1. Is everything clearly in understandable lay language? 2. Is the preclinical data base sufficiently comprehensive? 3. Are subjects appropriately screened? 4. Are risks accurately and fully described? 5. Are benefits realistically estimated? 6. Does the pregnancy clause receive sufficient emphasis? 7. Are subjects assured of privacy and confidentiality? 8. Are the recompense and liability conditions clearly and expressly stated? 9. Is the subject’s freedom to withdraw or refuse expressly preserved? 10. Are the rights of minors or incompetents protected by signatures of parents or guardians? 11. Does each subject receive a copy of the consent form with the name and telephone number of someone on the investigational team? 12. How much is research vs. routine clinical? 13. Someone to call re research subjects rights.