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

2. 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

3. 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

4. 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

5. 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

8. 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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