Most Common Reasons why Protocols are Not Approved by the IRB
The UVa Program-Protocol Builder is designed to obtain information necessary for compliance with federal regulations, state statutes, and local policy regarding the protection of human subjects in research. The IRB evaluates the protocol and consent document(s), when applicable, to assure that all procedures are adequately described and documented.
- The protocol requires the approval of another UVa Committee prior to IRB review (e.g., Cancer Center Protocol Review).
- Research is to be conducted at a non-UVa site. Additional documentation is required for research conducted at a non-UVa site. (e.g., letter of cooperation, letter of approval from other site's IRB).
- Submission of wrong versions of protocol or consent (e.g., old version of protocol, consent form for a different research study).
- The application is incomplete; requires completion of additional documentation.
- Documentation concerns:
- Significant discrepancies exist between the protocol and consent form (e.g., sample size, duration of research procedures, description of risks).
- The consent form is deficient (e.g. missing required elements of consent, includes exculpatory language and inappropriate compensation for injury language).
- Recruitment and the informed consent process are not adequately explained in the protocol.
- In the protocol, probable risks to the participants are not adequately justified and potential societal benefits are not mentioned.
- Safeguards to protect personal health information and research data from an erroneous breach of confidentiality are inadequate (e.g., investigator stores personal information and research data on portable device).
- Research team members have not completed the required CITI modules