Revisions to IRB Forms: Frequently Asked Questions
Which forms have been revised?
We have revised the new application for full review and the continuation review report.
What's new in the revised forms?
Our goal was to more accurately capture the information needed for IRB review. Here are some of the major changes (note: this is not an exhaustive list).
In the new application for full review:
- 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
In the continuation review report:
- New feature: 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
When do I have to start using the revised forms?
You may start using them now, but we will still accept the old forms until January 1, 2007. If you use the old forms after that, we will return your application and ask you to re-submit using the revised forms.
Why can't I submit forms electronically?
Electronic submission of forms (eSubmission) isn't ready yet, but we're working on it! Our goal is to make eSubmission available in late 2007.
How can I make sure I'm using the right form?
We recommend you not save the forms on your hard drive (we make minor corrections often, so it's easy to go out of date). Instead, bookmark the forms page and visit whenever you need a form.
Questions? Contact the IRO