Time Required for Review
*Note: The review process may take longer if revisions and additional information are required. Approval is not guaranteed within a definitive timeframe. Submit information well in advance of the anticipated involvement of human participants. Effective 10/24/06, the IRB requires all New Protocol submissions for Full Committee Review to submit:
- 1 complete Original Submission
- 4 copies of complete submission (full protocol, Investigators New Drug, Investigators Brochure)
Number of Copies Required for Review
Items
|
Full Committee Review
|
Exemption and Expedited Review
|
|
Application Checklist
|
1 original, 17 duplicates
|
1 original, 1 duplicate
|
|
New Protocol Submission Form
|
1 original, 17 duplicates
|
1 original, 1 duplicate
|
|
Conflict of Interest/Scientific Misconduct Form
|
1 original, 17 duplicates
|
1 original, 1 duplicate
|
|
Consent/Assent Documentation
|
1 original, 17 duplicates
|
1 original, 1 duplicate
|
|
Protocol
|
1 original, 17 duplicates
|
1 original, 1 duplicate
|
|
If applicable:
|
|
DSMP Addendum
|
1 original, 17 duplicates
|
1 original, 1 duplicate
|
|
Child Risk Assessment Form
|
1 original, 17 duplicates
|
1 original, 1 duplicate
|
|
High Risk Addendum (for Adult and Pediatric studies)
|
1 original, 17 duplicates
|
|
|
Investigational Brochures
|
1 original, 3 OR 4 duplicates
|
|
|
Device (IDE) Addendum
|
1 original, 17 duplicates
|
|
|
Genetics Addendum
|
1 original, 17 duplicates
|
|
|
Investigational New Drug (IND)
|
1 original, 17 duplicates
|
|
|
Waiver of Informed Consent
|
1 original, 17 duplicates
|
1 original, 1 duplicate
|
|
Instruments (e.g. surveys, questionnaires)
|
1 original, 17 duplicates
|
1 original, 1 duplicate
|
|
Advertisements/Recruitment Letters
|
1 original, 17 duplicates
|
1 original, 1 duplicate
|
|
Fee Waiver
|
1 original
|
1 original
|
|
Grant Proposal (when applicable)
|
1 original
|
1 original
|
