Before you submit your human subjects protocol to the Institutional Review Board for review, please print this checklist and use it to ensure that your application packet is complete.
Purpose Of The Study And Background 1. Purpose of the Study 2. Background:
Characteristics Of The Subject Population 3. Target Accrual 4. Gender of the Subjects 5. Age Range of Adult Subjects 6. Age Range of Pediatric Subjects 7. Race and Ethnic Origin 8. Inclusion Criteria 9. Exclusion Criteria 10. Vulnerable Subjects Methods and Procedures 11. Methods and Procedures 12. Drugs and Devices 13. Data Storage Confidentiality
Risk/Benefit Assessment 14. Potential Risks 15. Protection Against Risks 16. Potential Benefits to the Subject 17. Potential Benefits to Society 18. Therapeutic Alternatives 19. Risk/Benefit Relationships Financial Obligations and Compensation 20. Financial Obligations of the Subject 21. Study-Specific Research Costs versus Standard Treatment Costs 22. Financial Compensation for Participation
Subject Identification, Recruitment and Consent/Assent 23. Method of Subject Identification and Recruitment 24. Competing Protocols 25. Subject Competency 26. Process of Informed Consent 27. Subject/Representative Comprehension 28. Information Purposely Withheld 29. Consent/Assent Forms 30. Documentation of Consent/Assent
