Institutional Review Board (IRB) at Nationwide Children’s Hospital Standard Operating Procedure (SOP) Documents

HRP-001 - Definitions HRP-012 - Observation of Consent Process HRP-013 - LARs, Children, and Guardians HRP-020 - Incoming Items HRP-021 - Pre-Review HRP-022 - Humanitarian-Use-Devices HRP-023 - Emergency Use, Compassionate Use, Indiv Patient Expanded Access HRP-024 - New Information HRP-025 - Investigations HRP-026 - Suspension or Termination HRP-027 - Emergency Use, Comp. Use, Individual Patient Access Post Review HRP-030 - Designated Reviewers HRP-031 - Non-Committee Review Preparation HRP-032 - Non-Committee Review Conduct PRE-2018 HRP-040 - IRB Meeting Preparation HRP-041 - IRB Meeting Conduct HRP-042 - IRB Meeting Attendance Monitoring HRP-043 - IRB Meeting Minutes HRP-044 - Not Otherwise Approvable Research HRP-050 - Conflicting Interests of IRB Members HRP-051 - Consultation HRP-052 - Post-Review HRP-054 - Institutional Conflicts of Interests HRP-055 - Research Conflict of Interest HRP-060 - Annual Evaluations of the HRPP HRP-061 - Monthly Evaluations of the HRPP HRP-062 - Daily IRB Staff Tasks HRP-063 - Expiration of IRB Approval HRP-064 - NIH GDS Institutional Certification HRP-065 - Response Plan for Emergencies-Disasters Impacting the HRPP HRP-070 - IRB Records HRP-071 - Standard Operating Procedures HRP-072 - IRB Records Retention HRP-080 - IRB Formation and Registration HRP-081 - IRB Removal HRP-082 - IRB Membership Addition HRP-083 - IRB Membership Removal HRP-084 - IRB Meeting Scheduling and Notification HRP-090 - Informed Consent Process for Research HRP-091 - Written Documentation of Consent HRP-103 - NCH Investigator Manual HRP-601 - IRB Roster HRP-801 - Establishing Authorization Agreements HRP-802 - Institutional Profile Management HRP-803 - Reliance Pre-Review (formerly Site Validation) HRP-804 - External IRB Post-Review (formerly Site Pre-Review)

Institutional Review Board (IRB) at Nationwide Children’s Hospital Standard Operating Procedure (SOP) Documents

HRP-001 - Definitions HRP-012 - Observation of Consent Process HRP-013 - LARs, Children, and Guardians HRP-020 - Incoming Items HRP-021 - Pre-Review HRP-022 - Humanitarian-Use-Devices HRP-023 - Emergency Use, Compassionate Use, Indiv Patient Expanded Access HRP-024 - New Information HRP-025 - Investigations HRP-026 - Suspension or Termination HRP-027 - Emergency Use, Comp. Use, Individual Patient Access Post Review HRP-030 - Designated Reviewers HRP-031 - Non-Committee Review Preparation HRP-032 - Non-Committee Review Conduct PRE-2018 HRP-040 - IRB Meeting Preparation HRP-041 - IRB Meeting Conduct HRP-042 - IRB Meeting Attendance Monitoring HRP-043 - IRB Meeting Minutes HRP-044 - Not Otherwise Approvable Research HRP-050 - Conflicting Interests of IRB Members HRP-051 - Consultation HRP-052 - Post-Review HRP-054 - Institutional Conflicts of Interests HRP-055 - Research Conflict of Interest HRP-060 - Annual Evaluations of the HRPP HRP-061 - Monthly Evaluations of the HRPP HRP-062 - Daily IRB Staff Tasks HRP-063 - Expiration of IRB Approval HRP-064 - NIH GDS Institutional Certification HRP-065 - Response Plan for Emergencies-Disasters Impacting the HRPP HRP-070 - IRB Records HRP-071 - Standard Operating Procedures HRP-072 - IRB Records Retention HRP-080 - IRB Formation and Registration HRP-081 - IRB Removal HRP-082 - IRB Membership Addition HRP-083 - IRB Membership Removal HRP-084 - IRB Meeting Scheduling and Notification HRP-090 - Informed Consent Process for Research HRP-091 - Written Documentation of Consent HRP-103 - NCH Investigator Manual HRP-601 - IRB Roster HRP-801 - Establishing Authorization Agreements HRP-802 - Institutional Profile Management HRP-803 - Reliance Pre-Review (formerly Site Validation) HRP-804 - External IRB Post-Review (formerly Site Pre-Review)

Institutional Review Board (IRB) at Nationwide Children’s Hospital Standard Operating Procedure (SOP) Documents

HRP-001 - Definitions HRP-012 - Observation of Consent Process HRP-013 - LARs, Children, and Guardians HRP-020 - Incoming Items HRP-021 - Pre-Review HRP-022 - Humanitarian-Use-Devices HRP-023 - Emergency Use, Compassionate Use, Indiv Patient Expanded Access HRP-024 - New Information HRP-025 - Investigations HRP-026 - Suspension or Termination HRP-027 - Emergency Use, Comp. Use, Individual Patient Access Post Review HRP-030 - Designated Reviewers HRP-031 - Non-Committee Review Preparation HRP-032 - Non-Committee Review Conduct PRE-2018 HRP-040 - IRB Meeting Preparation HRP-041 - IRB Meeting Conduct HRP-042 - IRB Meeting Attendance Monitoring HRP-043 - IRB Meeting Minutes HRP-044 - Not Otherwise Approvable Research HRP-050 - Conflicting Interests of IRB Members HRP-051 - Consultation HRP-052 - Post-Review HRP-054 - Institutional Conflicts of Interests HRP-055 - Research Conflict of Interest HRP-060 - Annual Evaluations of the HRPP HRP-061 - Monthly Evaluations of the HRPP HRP-062 - Daily IRB Staff Tasks HRP-063 - Expiration of IRB Approval HRP-064 - NIH GDS Institutional Certification HRP-065 - Response Plan for Emergencies-Disasters Impacting the HRPP HRP-070 - IRB Records HRP-071 - Standard Operating Procedures HRP-072 - IRB Records Retention HRP-080 - IRB Formation and Registration HRP-081 - IRB Removal HRP-082 - IRB Membership Addition HRP-083 - IRB Membership Removal HRP-084 - IRB Meeting Scheduling and Notification HRP-090 - Informed Consent Process for Research HRP-091 - Written Documentation of Consent HRP-103 - NCH Investigator Manual HRP-601 - IRB Roster HRP-801 - Establishing Authorization Agreements HRP-802 - Institutional Profile Management HRP-803 - Reliance Pre-Review (formerly Site Validation) HRP-804 - External IRB Post-Review (formerly Site Pre-Review)

Institutional Review Board (IRB) at Nationwide Children’s Hospital Standard Operating Procedure (SOP) Documents

  • HRP-001 - Definitions
  • HRP-012 - Observation of Consent Process
  • HRP-013 - LARs, Children, and Guardians
  • HRP-020 - Incoming Items
  • HRP-021 - Pre-Review
  • HRP-022 - Humanitarian-Use-Devices
  • HRP-023 - Emergency Use, Compassionate Use, Indiv Patient Expanded Access
  • HRP-024 - New Information
  • HRP-025 - Investigations
  • HRP-026 - Suspension or Termination
  • HRP-027 - Emergency Use, Comp. Use, Individual Patient Access Post Review
  • HRP-030 - Designated Reviewers
  • HRP-031 - Non-Committee Review Preparation
  • HRP-032 - Non-Committee Review Conduct PRE-2018
  • HRP-040 - IRB Meeting Preparation
  • HRP-041 - IRB Meeting Conduct
  • HRP-042 - IRB Meeting Attendance Monitoring
  • HRP-043 - IRB Meeting Minutes
  • HRP-044 - Not Otherwise Approvable Research
  • HRP-050 - Conflicting Interests of IRB Members
  • HRP-051 - Consultation
  • HRP-052 - Post-Review
  • HRP-054 - Institutional Conflicts of Interests
  • HRP-055 - Research Conflict of Interest
  • HRP-060 - Annual Evaluations of the HRPP
  • HRP-061 - Monthly Evaluations of the HRPP
  • HRP-062 - Daily IRB Staff Tasks
  • HRP-063 - Expiration of IRB Approval
  • HRP-064 - NIH GDS Institutional Certification
  • HRP-065 - Response Plan for Emergencies-Disasters Impacting the HRPP
  • HRP-070 - IRB Records
  • HRP-071 - Standard Operating Procedures
  • HRP-072 - IRB Records Retention
  • HRP-080 - IRB Formation and Registration
  • HRP-081 - IRB Removal
  • HRP-082 - IRB Membership Addition
  • HRP-083 - IRB Membership Removal
  • HRP-084 - IRB Meeting Scheduling and Notification
  • HRP-090 - Informed Consent Process for Research
  • HRP-091 - Written Documentation of Consent
  • HRP-103 - NCH Investigator Manual
  • HRP-601 - IRB Roster
  • HRP-801 - Establishing Authorization Agreements
  • HRP-802 - Institutional Profile Management
  • HRP-803 - Reliance Pre-Review (formerly Site Validation)
  • HRP-804 - External IRB Post-Review (formerly Site Pre-Review)