Worksheets/Checklists
These documents are generally for use by the IRBs and OIA staff. They do not need to be completed or submitted by researchers.
Worksheets
301 Review Materials
302 Calculation of Approval Intervals
303 Communication of Review Results
304 IRB Composition
305 Evaluation of Quorum and Expertise
306 Drugs
307 Devices
308 Admin Pre-Review
310 Human Research Determination
313 Eligibility for Review Using the Expedited Procedure
314 Criteria for Approval and Additional Considerations
314B Requirements for Informed Consent
315 Advertisements
316 Payments
317 Short Form of Consent Documentation
318 Additional Federal Criteria
319 Approval Period
320 Scientific or Scholarly Review
321 Review of Reportable Events
322 Emergency Use
323 Criteria and Additional Considerations HUD
335 Minutes Quality Improvement Assessment
Checklists
401 Pre-Review
410 Waiver or Alteration of the Consent Process
411 Waiver of Written Documentation of Consent
414 Neonates of Uncertain Viability
415 Prisoners
416 Children
417 Cognitively Impaired Adults
418 Non-Significant Risk Device
419 Waiver of the Consent Process for Emergency Research
430 Staff Quality Improvement Assessment
441 HIPAA Waiver of Authorization
442 External IRB Review Clearance