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Important Notice: Updated Documents Posted

June 8, 2020

Dear Research Community,

The IRB Office recently updated documents per the Huron HRPP Toolkit update.

Relevant updates have been made to the Biomedical Protocol template, as well as the English Short Form Consent template. Please utilize these versions for any new projects and at the time of any modification involving protocol or consent form updates. Protocol and consent templates can be found on our Templates &Forms page. 

Additional updates to the following documents were made:

SOPs:

  • HRP-001 – SOP Definitions
  • HRP-020 – SOP Incoming Items
  • HRP-021 – SOP Pre-Review
  • HRP-024 – SOP Reportable New Information
  • HRP-026 – SOP Suspension or Termination Issued Outside of Convened IRB
  • HRP-029 – SOP Suspension or Termination of IRB Approval by Convened Panel
  • HRP-031 – SOP Non-Committee Review Preparation
  • HRP-032 – SOP Non-Committee Review Conduct
  • HRP-041 – SOP IRB Meeting Conduct
  • HRP-060 – SOP Annual HRPP Evaluations
  • HRP-063 – SOP Expiration of IRB Approval
  • HRP-070 – SOP IRB Records
  • HRP-082 – SOP IRB Membership Addition (Appointment and Re-Appointment)
  • HRP-801 – SOP Establishing Authorization Agreements

Worksheets:

  • HRP-303 – WORKSHEET Communication of Review Results
  • HRP-306 – WORKSHEET Drugs and Biologics
  • 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-318 – WORKSHEET Additional Federal Agency Criteria
  • HRP-320 – WORKSHEET Scientific or Scholarly Review
  • HRP-322 – WORKSHEET Emergency Use
  • HRP-323 – WORKSHEET Criteria for Approval for HUD
  • HRP-325 – WORKSHEET Compassionate Use of an Unapproved Medical Device
  • HRP-830 – WORKSHEET Communication and Responsibilities

Checklists:

  • HRP-410 – CHECKLIST Waiver or Alteration of Consent Process
  • HRP-411 – CHECKLIST Waiver of Written Documentation of Consent
  • HRP-416 – CHECKLIST Children
  • HRP-441 – CHECKLIST HIPAA – Waiver Authorization
  • HRP-1408 – CHECKLIST Principal Investigator (PI) Transfer of Responsibilities (NEW)

Please also review the updated Human Research Protection Program Plan (HRP-101) and the Investigator Manual (HRP-103). Both guidance documents can be found on our Human Research Policies, Guidance, & Oversight page. 

Email the IRB at irb@northwestern.edu with any questions or concerns.

The website should be your first source for all documents. It is recommended to refrain from saving frequently used documents and to always access them from the website.

Thank you,

Northwestern IRB Office