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Effective with new Sponsored studies (ie: commercial, industry) received on or after October 1, 2009, a $500 fee will be implemented for Amendment applications (certain exceptions apply).  See the attached memo for details.

Human Research Protections Office & the Human Research Review Committee

Note: Only HRRC members and staff are allowed to access documents. All other must request copies from the HRPO

Table of Contents

  1. The Membership of the Human Research Review Committee
  1-01 Composition of the HRRC
  1-02 Appointment of Chairpersons
  1-03 Appointment of HRRC Members
  1-04 Alternate HRRC Members
  1-05 Composition and Purpose of the HRRC Executive Committee
  1-06 Performance Review of HRRC Members
  1-07 Performance Review of HRRC Chairs



  1. The Human Research Review Committee (HRRC) Roles and Authorities
2-01 Authority of the HRRC
  2-02 Ethical Obligations of the HRRC Members and Staff



  1. HRRC Record Keeping and Documentation
3-01 Record Retention
  3-02 Access to HRRC Records
  3-03 HRRC Study Records Management
  3-06 Standard Operating Procedures - Preparation, Issue and Revision
  3-12 Documentation of Convened HRRC Meetings - Minutes
  3-19 Documentation of Independent IRB and/or Scientific Review Board Review



  1. HRRC Review
4-02 Emergency Use Review
  4-03 New Application Review by the Convened HRRC
  4-04 Continuing Review by the Convened HRRC
  4-05 Primary Review System
  4-06 Expedited Review of Research
  4-07 Exemption Determination and Review
  4-08 Human Subjects Research Determination and Review
  4-09 Investigator Reporting and HRRC Review of Unanticipated Problems
  4-10 Review of Non-Reportable Events
  4-11 Procedure for Managing Findings of Non-Compliance
  4-12 Procedure for Managing Allegations of Non-Compliance
  4-13 Expiration of Approval Period
  4-14 Suspension or Termination of HRRC Approved Research
  4-15 Reporting Procedures
  4-16 NCI CIRB Local Institution Procedures



  1. HRRC Review and Approval Considerations
5-01 Review of Planned Emergency Research Using Exception from Informed Consent
  5-07 Review of Research Involving Children & Viable Neonates
  5-08 Review of Research Involving Prisoners
  5-10 Observation of the Informed Consent Process



  1. Central Campus IRB
8-01 New Application Review by the Convened IRB
  8-02 Continuing Review by the Convened IRB
  8-03 IRB Primary Review System
  8-04 Expedited Review of Research
  8-05 Exemption Determination and Review
  8-06 Human Subject Research Determination and Review
  8-07 Suspension and Termination of IRB Approved Research
  8-09 Expiration of Approval Period


 


 

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