IRB Forms Revised

October 23, 2006

To more accurately capture the information needed for IRB review, the new application for full review and continuation review report have been revised.

Revisions to the new application for full review include:

• New feature: if a section does not apply to your study, you can skip the questions
• New section: adverse events
• Expanded sections: non-English-speaking subjects, multicenter studies, use of data, HIPAA, confidentiality, radiation, IBC
• New appendices: Repository, Registry, or Databank Form; Cancer Surveillance System (CSS) Case Subject Recruitment Method Form; Coordinating Center Operations Form
• Biostatistician's signature is no longer needed
• Questions about conflict of interest have been moved to the Protocol Disposition Form

Revisions to the continuation review report include:

• New feature: you can skip some questions (depending on type of study)
• New sections: vulnerable populations, repository/registry/databank, radiation, gene therapy, summary of progress
• Expanded or updated sections: funding, gender/ethnicity, multicenter studies, FDA, conflict of interest, adverse events

Although the new forms are preferred, the IRB will continue to accept the old forms until January 1, 2007. After that, IRB staff will return the application and request resubmission using the revised forms.