Institutional Review Board (IRB) Policies and Procedures ...

The University of Chicago Division of Biological Sciences The Pritzker School of Medicine and

The University of Chicago Medical Center

Institutional Review Board (IRB) Policies and Procedures Manual

Office of Clinical Research Section of Regulatory Compliance

5841 S. Maryland Ave. I-625, MC7132

Chicago, Illinois 60637 (773) 702-6505



REVISED: April 8, 2019 EFFECTIVE: May 14, 2019

Approved IRB Committee A, May 7, 2019 Approved IRB Committee B, April 23, 2019 Approved IRB Committee C, April 16, 2019

I. INTRODUCTION AND IRB OVERVIEW _____________________________________ 1

A. IRB RESPONSIBILITIES ________________________________________________ 1 B. IRB MEMBERSHIP _____________________________________________________ 3 C. APPEAL OF IRB DECISIONS ____________________________________________ 5 D. IRB RECORDS _______________________________ _________________________ 5 E. ADDITIONAL INFORMATION OR ASSISTANCE _________________________ 6

II. PRINCIPAL INVESTIGATORS, CO-INVESTIGATORS AND OTHER RESEARCH PERSONNEL: ELIGIBILITY AND RESPONSIBILITIES ___________________________ 8

A. PI ELIGIBILITY_________________________________________________________8 B. CO-INVESTIGATORS AND OTHER RESEARCH PERSONNEL______________ 9 C. TRAINING_____________________________________________________________9 D. RESPONSIBILITIES OF PRINCIPAL INVESTIGATORS _____________________ 9

1. TERMINATION OF A PROTOCOL ________________________________________ 11 2. TRANSFERRING A PROTOCOL TO ANOTHER INVESTIGATOR __________________ 11 3. UNANTICIPATED PROBLEM REPORTING __________________________________ 11 4. REPORTING UNANTICIPATED CHANGES TO THE PROTOCOL __________________ 13 5. REPORTING DEVIATIONS _____________________________________________ 14 6. REPORTING NON COMPLIANCE ________________________________________ 15 7. REPORTING CONFLICT OF INTEREST _____________________________________ 15 8. RESEARCH RECORDS ________________________________________________ 15

III. PREPARING A NEW SUBMISSION _______________________________________ 17

A. DETERMINING "RESEARCH INVOLVING HUMAN SUBJECTS"___________ 17 1. DECEASED INDIVIDUALS ______________________________________________ 18

B. EXEMPT RESEARCH PROTOCOLS _____________________________________ 18 C. PROTOCOL SUBMISSION PROCESS ____________________________________ 21 D. PROTOCOL APPLICATION CONTENTS ________________________________ 22

1. PROTOCOL SUBMISSION FORM _________________________________________ 22 2. DETAILED PROTOCOL NARRATIVE ______________________________________ 22 3. INFORMED CONSENT PROCESS AND FORM ________________________________ 23 4. OTHER RELEVANT MATERIALS _________________________________________ 24 E. PROTOCOL SPECIFICS AND POINTS TO CONSIDER_____________________ 25 1. CHART REVIEWS: DETERMINING RETROSPECTIVE AND PROSPECTIVE USE _______ 25 2. CASE STUDIES_______________________________________________________ 26 3. GENETIC ANALYSIS __________________________________________________ 27 4. DECEPTION AND WITHHOLDING INFORMATION ___________________________ 28 F. CONFLICT OF INTEREST ______________________________________________ 29

IV. FDA REGULATED RESEARCH __________________________________________ 31

A. INVESTIGATIONAL NEW DRUG (IND) ________________________________ 31 B. USE OF FDA-APPROVED THERAPEUTIC AGENTS FOR UNAPPROVED

PURPOSES __________________________________________________________ 31 C. INVESTIGATIONAL DEVICE EXEMPTION (IDE) _______________________ 32

1. HUMANITARIAN DEVICE EXEMPTION (HDE) _____________________________ 32 D. EMERGENCY USE OF INVESTIGATIONAL DRUGS OR DEVICES _________ 33

V. DOD REGULATED RESEARCH ___________________________________________ 35

A. TRAINING REQUIREMENTS __________________________________________ 35 B. SCIENTIFIC REVIEW AND OTHER REVIEWS ___________________________ 36 C. IRB REVIEW REQUIREMENTS _______________________________________ 36

1. RESEARCH MONITOR _________________________________________________ 36 2. CONSENT __________________________________________________________ 37 3. COMPENSATION _____________________________________________________ 38 D. SPECIFIC SUBJECT PROTECTIONS: SUBORDINATES ___________________ 38 E. INSTITUTIONAL REQUIREMENTS ____________________________________ 38

VI. INFORMED CONSENT__________________________________________________ 40

A. INFORMED CONSENT AND DOCUMENTATION CATEGORIES __________ 41

1. WRITTEN CONSENT FORM _____________________________________________ 41

2. SHORT FORM CONSENT _______________________________________________ 47

3. ORAL CONSENT (WAIVER OF DOCUMENTATION REQUIREMENTS) _____________ 47

4. ALTERATION OF INFORMED CONSENT IN NON-EMERGENCY SITUATIONS _______ 48

5. WAIVER OF INFORMED CONSENT IN NON-EMERGENCY SITUATIONS ____________50

6. WAIVER OF AUTHORIZATION

____________50

B. GENERAL CONSIDERATIONS IN OBTAINING CONSENT________________ 51

C. ELEMENTS OF INFORMED CONSENT _________________________________ 52

1. REQUIRED ELEMENTS ________________________________________________ 52

2. ADDITIONAL ELEMENTS _______________________________________________ 54

3. ELEMENTS FOR PROTOCOLS WITH SPECIAL POPULATIONS ____________________ 57

4. PROHIBITED ELEMENTS _______________________________________________ 58

D. CONSENT FORM RECORDS___________________________________________ 59

VII. SPECIAL POPULATIONS _______________________________________________ 61

A. CHILDREN __________________________________________________________ 61 1. WARDS OF THE STATE ________________________________________________ 63

B. PREGNANT WOMEN AND FETUSES ___________________________________ 63 C. NONVIABLE NEONATES AND NEONATES OF UNCERTAIN VIABILITY _ 64

1. NONVIABLE NEONATES _______________________________________________ 65 2. NEONATES OF UNCERTAIN VIABILITY ___________________________________ 65 D. PLACENTA, DEAD FETUS, OR FETAL MATERIAL ______________________ 66

E. PRISONERS _________________________________________________________ 66 F. OTHER POPULATIONS _______________________________________________ 69

1. UNDERGRADUATE STUDENTS AND EMPLOYEES ___________________70

VIII. IRB PROCEDURES FOR THE REVIEW OF PROTOCOLS ____________________ 71

A. COMMITTEE REVIEW OF NEW PROTOCOLS __________________________ 71 B. POST-REVIEW STATUS _______________________________________________ 73

1. APPROVED OR APPROVED WITH STIPULATION(S) ___________________________ 74 2. PENDING-CONDITIONAL ______________________________________________ 74 3. PENDING-DEFERRAL _________________________________________________ 74 4. REJECTED __________________________________________________________ 75 5. TABLED ____________________________________________________________ 75 C. REQUESTS FOR EXPEDITED APPROVAL OF NEW PROTOCOLS _________ 75 1. LIMITED IRB REVIEW _________________________________________________ 79

IX. IRB PROCEDURES FOR THE REVIEW OF AMENDMENTS ___________________ 80

A. AMENDMENT SUBMISSION __________________________________________ 80 B. AMENDMENT POST-REVIEW STATUS_________________________________ 80

1. APPROVED OR APPROVED WITH STIPULATION(S) ___________________________ 80 2. PENDING-CONDITIONAL ______________________________________________ 81 3. PENDING-DEFERRAL _________________________________________________ 81 4. REJECTED __________________________________________________________ 81 5. TABLED ____________________________________________________________ 82 C. REQUESTS FOR EXPEDITED APPROVAL OF AMENDMENTS ____________ 82

X. IRB PROCEDURES FOR THE CONTINUED MONITORING OF APPROVED PROTOCOLS ______________________________________________________________ 83

A. CONTINUING REVIEW AND RENEWAL ______________________________ 83 1. CONTINUING REVIEW SUBMISSION AND TIMELINE _________________________ 83 2. REVIEW AT MEETING _________________________________________________ 84 3. EXPEDITED CONTINUING REVIEWS ______________________________________ 85

B. MONITORING OF APPROVED PROTOCOLS ____________________________ 85 1. CONTINUING REVIEW ________________________________________________ 85 2. OUTSIDE MONITORING _______________________________________________ 86 3. SURVEILLANCE COMMITTEE ___________________________________________ 86 4. SUSPENSION OF A PROTOCOL ___________________________________________ 87 5. IRB AUDITING ___________________________________________________________ 87

C. INVESTIGATING NONCOMPLIANCE__________________________________ 87 1. STUDY SUSPENSION __________________________________________________ 88 2. NONSERIOUS AND NONCONTINUING ____________________________________ 89 3. SERIOUS OR CONTINUING _____________________________________________ 89 4. CORRECTIVE ACTION STEPS ____________________________________________ 90

XI. OTHER RESEARCH OVERSIGHT COMMITTEES ___________________________ 91

A. RADIOACTIVE DRUG RESEARCH ADVISORY COMMITTEE (RADRAC) __ 91 B. NURSING RESEARCH COMMITTEE (NRC) _____________________________ 91 C. INSTITUTIONAL BIOSAFETY COMMITTEE (IBC) _______________________ 91 D. CLINICAL TRIALS REVIEW COMMITTEE (CTRC)_______________________ 92 E. PATHOLOGY BIOSPECIMEN UTILIZATION COMMITTEE _______________ 92 F. CLINICAL RESEARCH CENTER (CRC) _________________________________ 93

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