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Worksheets

These worksheets are used for initial review, continuing review, and review of modifications to previously approved Human Research.  Investigators and their research teams are encouraged to use the worksheets to write their protocols in a way that addresses the criteria for approval (HRP-314).

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 and Biologics

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 (Recruitment Materials)

HRP-316 WORKSHEET Payments

HRP-317 WORKSHEET Short Form Consent Documentation

HRP-318 WORKSHEET Additional Federal Agency Criteria

HRP-319 WORKSHEET Limited IRB Review

HRP-320 WORKSHEET Scientific or Scholarly Review

HRP-321 WORKSHEET Reportable New Information Items

HRP-322 WORKSHEET Emergency Use

HRP-323 WORKSHEET Criteria for Approval for HUD

HRP-325 WORKSHEET Compassionate Use of an Unapproved Medical Device

HRP-330 WORKSHEET HIPAA Authorization

HRP-331 WORKSHEET FERPA Compliance

HRP-332 WORKSHEET NIH-GDS Certification

HRP-333 WORKSHEET Certificate of Confidentiality

HRP-334 WORKSHEET Media Relations

HRP-335 WORKSHEET GDPR Data Protection

HRP-336 WORKSHEET Mobile Apps and Mobile Medical Apps

HRP-830 WORKSHEET Communication and Responsibilities

HRP-1301 WORKSHEET Industry Sponsored Agreement Guidelines

HRP-1801 WORKSHEET Authorization Agreement Review