LATEST UPDATES ON FALL 2021 PLANNING, VACCINES, COVID-19 TESTING AND MORE LATEST UPDATES ON FALL 2021 PLANNING, VACCINES, COVID-19 TESTING AND MORE
MSU Denver

Checklists & Worksheets

Checklists are meant to document the process of review for each project.  HRP-402 is to be used and submitted by IRB members for all reviews.  Other checklists may be used and submitted as needed.

A note on Checklists that require a “signature”: There is no requirement to provide a hand-signed, scanned copy on any IRB review materials.  Your ‘electronic’ signature (typed name) is sufficient for all materials in the review process, as these forms are uploaded into IRBNet and associated with your unique profile and access.

HRP-401 CHECKLIST: Pre-Review

** HRP-402 CHECKLIST: Non-Committee Review **

HRP-410 CHECKLIST: Waiver or Alteration of Consent Process

HRP-411 CHECKLIST: Waiver of Written Documentation of Consent

HRP-412 CHECKLIST: Pregnant Women

HRP-415 CHECKLIST: Prisoners

HRP-416 CHECKLIST: Children

HRP-417 CHECKLIST: Adults who are Cognitively Impaired

HRP-418 CHECKLIST: Non-Significant Risk Device

HRP-419 CHECKLIST: Waiver of Consent Process for Emergency Research

HRP-430 CHECKLIST: Investigator Quality Improvement Assessment

HRP-441 CHECKLIST: HIPAA Waiver of Authorization


 

A reminder about HSPP Worksheets: Worksheets are meant to be used in the review processes to aid in making determinations on submissions. Worksheets are not documentation of a determination or of the review process (refer to Checklists).  Do not upload worksheets into IRBNet.

HRP-301 WORKSHEET: Review Materials

HRP-302 WORKSHEET: Approval Intervals

HRP-303 WORKSHEET: Communication of Review Results

HRP-304 WORKSHEET: IRB Composition

HRP-305 WORKSHEET: Quorum and Expertise

HRP-306 WORKSHEET: Drugs

HRP-307 WORKSHEET: Devices

HRP-308 WORKSHEET: Pre-Review

HRP-310 WORKSHEET: Human Research Determination

HRP-311 WORKSHEET: Engagement Determination

HRP-312 WORKSHEET: Exemption Determination

HRP-313 WORKSHEET: Expedited Review

HRP-314 WORKSHEET: Criteria for Approval

HRP-315 WORKSHEET: Advertisements

HRP-316 WORKSHEET: Payments

HRP-317 WORKSHEET: Short Form of Consent Documentation

HRP-318 WORKSHEET: Additional Federal Agency Criteria

HRP-320 WORKSHEET: Scientific or Scholarly Review

HRP-321 WORKSHEET: Review of Information Items

HRP-322 WORKSHEET: Emergency Use

HRP-323 WORKSHEET: Criteria for Approval HUD

HRP-324 WORKSHEET: Contracts

HRP-330 WORKSHEET: HIPAA Authorization

HRP-331 WORKSHEET: FERPA Compliance

Human Research Protections Plan - Policies & Procedures

Human Research Protection Plan

HSPP Policies & Procedures

IRBNet Training

To access IRBNet, go to www.irbnet.org.


IRB Members should maintain a current CITI certificate and CV or résumé in their IRBNet profile, while submitting any new or updated documents.  Refer to the IRBNet: How to Upload CV & CITI Training for guidance on managing training and credentials in IRBNet.


Review IRBNet Screenshots for Reviewers for information on how to:

  • Manage your “Submission Manager” workspace
  • Review project submission details, including documents and PI training & credentials
  • Communicate with HSPP staff and IRB members
  • Add comments, decisions, and reviewer documents to a submission
  • Manage your review work queue

Please contact HSPP staff for any assistance with IRBNet review procedures or access.