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These documents are generally for use by the IRBs and OIA staff. They do not need to be completed or submitted by researchers.


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

311 Engagement Determination

312 Exemption 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

334 Reliance Agreement

335 Minutes Quality Improvement Assessment

344 IRB Membership Addition


401 Pre-Review

402 Non-Committee Review

410 Waiver or Alteration of the Consent Process

411 Waiver of Written Documentation of Consent

412 Pregnant Subjects

413 Non-Viable Neonates

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

443 External IRB Review Acceptance

445 IRB Member Evaluation

446 IRB Chair and Vice Chair Evaluation