Checklists & Worksheets | Review Flowcharts

The Human Research Protection Program has draft checklists, worksheets, and review flowcharts that are currently under review. Once these items are ready for release, they will be posted on this site as final. In the meantime, you may follow draft versions as they apply to your assigned reviews. These tools are used in the review of submissions in order to ensure that all regulatory requirements are met. As part of the IRB review process you should use these forms during your reviews.  

Please note that some numbers are reserved for future  development. Although some numbers are not listed, the items below are presented in their entirety as they currently exist..

Checklists

 Checklist #

 Checklist TItle
 401  Pre-Review
 402  Non-Committee Review
 412  Exemption Determination
 413  Eligibility for Review Using the Expedited Procedure
 415  Waiver or Alteration of the Consent Process
 416  Waiver of Written Documentation of the Consent Process
 417  Research Involving Prisoners
 418  Research Involving Pregnant Women
 420  Research Involving Neonates of Uncertain Viability
 421  Research Involving Children
 422  Research Involving Adults Unable to Consent
 423  Non-Signigificant RIsk Device
 424  Waiver of the Consent Process for Planned Emergency Research
 430  Investigator Quality Improvement Assessment
 431  Minutes Quality Improvement Assessment

Worksheets

 Worksheet #

 Worksheet Title
 301  Agenda Packet Contents
 302  Calculation of Approval Intervals and Expiration Dates
 303  Communication of Review Results
 304  Submission Materials
 305  Evaluation of Quorum and Expertise
 306  Review of Information Items
 307  Scientific or Scholarly Review
 308  IRB Composition
 309  Human Research Determination
 310  Engagement Determination
 311  Criteria for Approval and Additional Considerations
 312  Advertisements
 313  Payments
 314  Criteria for Approcal and Additional Consideration for Humanitarian Use Device
 315  Drugs
 316  Devices
 317  Emergency Use of a Test Article
 318  Short Form of Consent Documentation
 321  Contract Items Related to Human Subject Protections
 330  FERPA Compliance

Review Flow Charts