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
Purpose of the Study
Background:
Characteristics Of The Subject Population
Target Accrual
Gender of the Subjects
Age Range of Adult Subjects
Age Range of Pediatric Subjects
Race and Ethnic Origin
Inclusion Criteria
Exclusion Criteria
Vulnerable Subjects
Methods and Procedures
Methods and Procedures
Drugs and Devices
Data Storage Confidentiality
Risk/Benefit Assessment
Potential Risks
Protection Against Risks
Potential Benefits to the Subject
Potential Benefits to Society
Therapeutic Alternatives
Risk/Benefit Relationships
Financial Obligations and Compensation
Financial Obligations of the Subject
Study-Specific Research Costs versus Standard Treatment Costs
Financial Compensation for Participation
Subject Identification, Recruitment and Consent/Assent
