Human Research Review Committee (HRRC-IRB)

Supported by the Human Research Protections Office

 

HRRC Home > HRPO Standard Operating procedures

    

    Human Research Protections Office & the Human Research Review Committee

                                          Standard Operating Procedures

 

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

 

 

                                        TABLE OF CONTENTS
 

1          The Membership of the Human Research Review Committee (HRRC)

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

4-01   HRRC Meeting Schedule

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   Data and Safety Monitoring of Clinical Trials

4-12   Conduct of HRRC Meetings

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

13        Investigational Drugs, Devices and Biologics

13-01  Oversight of Investigator Initiated Research using FDA Regulated Investigational Articles

14        HRPO Staff

14-01  Staff Education and Training

14-02  HRRC Review of Participant Concerns