APPENDIX II: Sample Protocol

PREPARATION CHECKLIST

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