Most Common Reasons why protocols are not approved by the IRB

1. Research is to be conducted at a non-UVA site. Additional documentation required for research conducted at a non-UVA site has not been submitted. (e.g., letter of cooperation from school).
2. The application is incomplete; requires completion of additional documentation such as approvals from other UVA Compliance Committees.
3. Research team members have not completed the required CITI modules 
4.  Documentation concerns: 

• Significant discrepancies exist between the protocol and consent form (e.g., sample size, duration of research procedures, description of risks).
• Recruitment and the informed consent process are not adequately explained in the protocol.
• Risks to the participants are not adequately justified or explained.
• Safeguards to protect health information and research data from an erroneous breach of confidentiality are inadequate.