Hackensack University Medical Center Standard Operating ...

Hackensack University Medical Center Standard Operating Procedures

Human Research Protection Program (HRPP)

January 30, 2017

Table of Contents

1 Human Research Protection Program .......................................................................................................................11 1.1 Mission ........................................................................................................................................................................ 11 1.2 Organizational Authority ............................................................................................................................................. 12 1.3 Definitions ................................................................................................................................................................... 12 1.4 Ethical Principles..........................................................................................................................................................15 1.5 Regulatory Compliance ............................................................................................................................................... 15 1.6 International Conference on Harmonization-Good Clinical Practice (ICH-GCP) ..........................................................16 1.7 Federalwide Assurance (FWA) ..................................................................................................................................... 16 1.8 Research Under the Auspices of the Organization ...................................................................................................... 16 1.9 Written policies and procedures..................................................................................................................................17 1.10 Hackensack UMC HRPP Structure...........................................................................................................................18 1.10.1 Institutional Official.......................................................................................................................................18 1.10.2 Vice-President of Research ........................................................................................................................... 20 1.10.3 Director of Human Research Protection Program ........................................................................................ 20 1.10.4 HRPP Staff ..................................................................................................................................................... 21 1.10.5 Institutional Review Board (IRB) ................................................................................................................... 21 1.10.6 Counsel's Office............................................................................................................................................. 21 1.10.7 Department Chairs and/or Organizational Leaders ...................................................................................... 21 1.10.8 The Investigator ............................................................................................................................................ 22 1.10.9 Other Related Units ...................................................................................................................................... 22 1.10.9.1 Office of Research Administration ........................................................................................................... 22 1.10.9.2 Hackensack UMC Pharmacy ..................................................................................................................... 23 1.10.10 Relationship Among Components ................................................................................................................ 23 1.10.11 Study-Specific Coordination .......................................................................................................................... 24 1.11 Collaborative Research Projects ............................................................................................................................. 24

2 Quality Assurance.....................................................................................................................................................27 2.1 External Monitoring, Audit, and Inspection Reports ................................................................................................... 27 2.2 Investigator Compliance Reviews ................................................................................................................................ 27 2.3 IRB Compliance Reviews .............................................................................................................................................. 30 2.4 HRPP Quality Assessment and Improvement .............................................................................................................. 30

3 Education & Training ................................................................................................................................................32 3.1 Training / Ongoing Education of IRB Chair, Members, and Staff ................................................................................ 32 3.2 Training / Ongoing Education of Investigators and Research Team ........................................................................... 33 3.2.1 Initial Education ................................................................................................................................................. 33 3.2.2 Continuing Education and Recertification ......................................................................................................... 34

4 Institutional Review Board .......................................................................................................................................35 4.1 IRB Authority ............................................................................................................................................................... 35

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4.2 Roles and Responsibilities............................................................................................................................................36 4.2.1 Chair of the IRB .................................................................................................................................................. 36 4.2.2 Vice Chair of the IRB (if applicable)....................................................................................................................37 4.2.3 IRB Members ..................................................................................................................................................... 37 4.2.4 Alternate members............................................................................................................................................38 4.2.5 Subcommittees of the IRB ................................................................................................................................. 38

4.3 IRB Membership .......................................................................................................................................................... 38

4.4 Composition of the IRB ................................................................................................................................................ 39 4.4.1 Appointment of Members to the IRB ................................................................................................................ 40 4.4.2 IRB Registration Updates ................................................................................................................................... 40

4.5 Use of Consultants.......................................................................................................................................................40

4.6 Liability Coverage for IRB Members ............................................................................................................................ 41

4.7 Reporting and Investigation of Allegations of Undue Influence .................................................................................. 41

5 Human Subject Research Determination ..................................................................................................................42

6 Exempt Studies .........................................................................................................................................................43

6.1 Limitations on Exemptions .......................................................................................................................................... 43

6.2 Categories of Exempt Research ................................................................................................................................... 43

6.3 FDA Exemptions...........................................................................................................................................................45

6.4 Procedures for Exemption Determination ................................................................................................................... 45

7 IRB Review Process...................................................................................................................................................47

7.1 Definitions ................................................................................................................................................................... 47

7.2 Expedited Review ........................................................................................................................................................ 48 7.2.1 Categories of Research Eligible for Expedited Review.......................................................................................48 7.2.2 Expedited Review Procedures ........................................................................................................................... 51 7.2.3 Informing the IRB ............................................................................................................................................... 52

7.3 Convened IRB Meetings...............................................................................................................................................52 7.3.1 IRB Meeting Schedule ........................................................................................................................................ 52 7.3.2 Preliminary Review ............................................................................................................................................ 52 7.3.3 Primary and Secondary Reviewers .................................................................................................................... 52 7.3.4 Materials received by the IRB ............................................................................................................................ 53 7.3.5 Quorum..............................................................................................................................................................54 7.3.6 Meeting Procedures .......................................................................................................................................... 55 7.3.7 Guests ................................................................................................................................................................ 55

7.4 Criteria for IRB Approval of Research .......................................................................................................................... 55 7.4.1 Risk/Benefit Assessment....................................................................................................................................56 7.4.1.1 Scientific or Scholarly Review...................................................................................................................57 7.4.2 Equitable Selection of Subjects..........................................................................................................................58 7.4.2.1 Recruitment of Subjects ........................................................................................................................... 58 7.4.3 Informed Consent .............................................................................................................................................. 58 7.4.4 Data and Safety Monitoring...............................................................................................................................59 7.4.5 Privacy and Confidentiality ................................................................................................................................ 60 7.4.5.1 Definitions ................................................................................................................................................ 60 7.4.5.2 Privacy ...................................................................................................................................................... 61

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7.4.5.3 Confidentiality .......................................................................................................................................... 61 7.4.6 Vulnerable Populations......................................................................................................................................62

7.5 Additional Considerations ........................................................................................................................................... 62 7.5.1 Determination of Risk ........................................................................................................................................ 62 7.5.2 Period of Approval ............................................................................................................................................. 62 7.5.3 Review More Often Than Annually....................................................................................................................62 7.5.4 Independent Verification That No Material Changes Have Occurred ............................................................... 63 7.5.5 Consent Monitoring ........................................................................................................................................... 64 7.5.6 Investigator Qualifications ................................................................................................................................. 65 7.5.7 Conflicts of Interest (COI) .................................................................................................................................. 65 7.5.8 Advertisements and Recruitment Materials......................................................................................................66 7.5.9 Payments to Research Subjects ......................................................................................................................... 67 7.5.10 Non-Monetary Gifts and Incentives .............................................................................................................. 68 7.5.11 State and Local Laws ..................................................................................................................................... 68

7.6 Possible IRB Actions ..................................................................................................................................................... 68

7.7 Continuing Review ....................................................................................................................................................... 70 7.7.1 Approval Period ................................................................................................................................................. 70 7.7.2 Continuing Review Process ................................................................................................................................ 71 7.7.3 Approval Considerations....................................................................................................................................72 7.7.4 Convened Board Review .................................................................................................................................... 72 7.7.5 Expedited Review............................................................................................................................................... 73 7.7.6 Possible IRB Actions after Continuing Review ................................................................................................... 73 7.7.7 Lapses in Continuing Review.............................................................................................................................. 74

7.8 Modification of an Approved Protocol ........................................................................................................................ 75 7.8.1 Procedures ......................................................................................................................................................... 75 7.8.2 Convened Board Review of Modifications.........................................................................................................76 7.8.3 Expedited review of Modifications .................................................................................................................... 76 7.8.4 Possible IRB Actions after Modification Review ................................................................................................ 77 7.8.5 Protocol/Research Plan Exceptions ................................................................................................................... 77

7.9 Closure of Research Studies.........................................................................................................................................77

7.10 Reporting IRB Actions ............................................................................................................................................. 78

7.11 Failure to Respond .................................................................................................................................................. 79

7.12 Appeal of IRB Decisions .......................................................................................................................................... 79

7.13 Research Previously Approved By Another IRB ....................................................................................................... 79

8 Study Suspension, Termination and Investigator Hold..............................................................................................81

8.1 Suspension/Termination..............................................................................................................................................81

8.2 Investigator Hold ......................................................................................................................................................... 82 8.2.1 Procedures ......................................................................................................................................................... 82

8.3 Protection of Currently Enrolled Participants .............................................................................................................. 83

9 Off-site IRB Policies and Procedures .........................................................................................................................84

9.1 Independent IRB and/or Central IRB............................................................................................................................ 84 9.1.1 Investigator Responsibilities .............................................................................................................................. 84 9.1.2 Hackensack UMC Responsibilities Prior to Accepting External Oversight for a Study.......................................84 9.1.3 Hackensack UMC Responsibilities: Post External IRB Approval.........................................................................85

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9.2 National Cancer Institute's Central IRB Adult and Pediatrics Initiative ....................................................................... 85

10 Documentation and Records ....................................................................................................................................89 10.1 IRB Records ............................................................................................................................................................. 89 10.2 IRB Study Files.........................................................................................................................................................89 10.3 The IRB Minutes......................................................................................................................................................91 10.4 IRB Membership Roster .......................................................................................................................................... 93 10.5 Documentation of Exemptions ............................................................................................................................... 93 10.6 Documentation of Expedited Reviews .................................................................................................................... 94 10.7 Access to IRB Records ............................................................................................................................................. 94 10.8 Record Retention .................................................................................................................................................... 94

11 Obtaining Informed Consent from Research Subjects...............................................................................................95 11.1 Definitions...............................................................................................................................................................95 11.2 Basic Requirements ................................................................................................................................................ 95 11.3 Informed Consent Process ...................................................................................................................................... 96 11.4 Determining a potential adult subject's ability to consent to research .................................................................. 97 11.5 Basic Elements of Informed Consent ...................................................................................................................... 98 11.6 Documentation of Informed Consent ................................................................................................................... 100 11.7 Special Consent Circumstances.............................................................................................................................101 11.7.1 Enrollment of persons with limited English-language proficiency..............................................................101 11.7.2 Braille consent.............................................................................................................................................102 11.7.3 Consenting in American Sign Language (ASL) ............................................................................................. 102 11.7.4 Oral Consent ............................................................................................................................................... 102 11.8 Subject Withdrawal or Termination ..................................................................................................................... 102 11.9 Waiver of Informed Consent ................................................................................................................................. 103 11.10 Waiver of Documentation of Informed Consent ................................................................................................... 104 11.11 Waiver of Informed Consent for Planned Emergency Research ........................................................................... 105 11.11.1 Definitions...................................................................................................................................................105 11.11.2 Procedures .................................................................................................................................................. 106 11.11.2.1 FDA-regulated Planned Emergency Research ................................................................................... 108 11.11.2.2 Planned Emergency Research Not Subject to FDA Regulations ........................................................ 108

12 Vulnerable Subjects in Research .............................................................................................................................109 12.1 Definitions.............................................................................................................................................................109 12.2 Involvement of Vulnerable Populations ................................................................................................................ 110 12.3 Responsibilities ..................................................................................................................................................... 111 12.4 Procedures ............................................................................................................................................................ 111 12.5 Research Involving Pregnant Women, Human Fetuses and Neonates ................................................................. 112 12.5.1 Research Involving Pregnant Women or Fetuses .......................................................................................112 12.5.1.1 Research Not Conducted or Supported by DHHS................................................................................... 112

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12.5.1.2 Research Conducted or Supported by DHHS ......................................................................................... 113 12.5.2 Research involving Neonates of Uncertain Viability or Nonviable Neonates ............................................. 114

12.5.2.1 Research Not Conducted or Supported by DHHS................................................................................... 114 12.5.2.2 Research Conducted or Supported by DHHS ......................................................................................... 115 12.5.3 Viable Neonates .......................................................................................................................................... 116 12.5.4 Research Involving, After Delivery, the Placenta, the Dead Fetus or Fetal Material .................................. 117 12.5.5 Research Not Otherwise Approvable..........................................................................................................117 12.5.5.1 Research Not Conducted or Supported by DHHS...................................................................................117 12.5.5.2 Research Conducted or Supported by DHHS ......................................................................................... 117

12.6 Research Involving Prisoners ................................................................................................................................ 117 12.6.1 Applicability.................................................................................................................................................118 12.6.2 Incarceration of Enrolled Subjects .............................................................................................................. 118 12.6.3 Additional Duties of the IRB ........................................................................................................................ 118 12.6.4 Certification to DHHS .................................................................................................................................. 120 12.6.5 Waiver for Epidemiology Research ............................................................................................................. 120

12.7 Research Involving Children .................................................................................................................................. 121 12.7.1 Allowable Categories .................................................................................................................................. 121 12.7.2 Parental Permission and Assent..................................................................................................................123 12.7.2.1 Parental Permission................................................................................................................................ 123 12.7.2.2 Assent from Children..............................................................................................................................124 12.7.2.3 Children Who are Wards ........................................................................................................................ 125

12.8 Adults with Impaired Decision Making Capacity .................................................................................................. 126

13 FDA-Regulated Research.........................................................................................................................................128

13.1 Definitions.............................................................................................................................................................128

13.2 FDA Exemptions .................................................................................................................................................... 129

13.3 Procedures ............................................................................................................................................................ 129

13.4 Investigator Responsibilities ................................................................................................................................. 130

13.5 Dietary Supplements.............................................................................................................................................132

13.6 Clinical Investigations of Drugs and Devices.........................................................................................................133 13.6.1 IND/IDE Requirements ................................................................................................................................ 133 13.6.1.1 IND Exemptions ...................................................................................................................................... 133 13.6.1.2 IDE Exemptions ...................................................................................................................................... 135 13.6.1.3 Significant and Non-Significant Risk Device Studies...............................................................................136

13.7 Humanitarian Use Devices....................................................................................................................................137 13.7.1 Definitions...................................................................................................................................................137 13.7.2 IRB Review Requirements ........................................................................................................................... 138 13.7.3 Procedures .................................................................................................................................................. 138 13.7.4 Emergency Uses of HUDs ............................................................................................................................140

13.8 Expanded Access to Investigational Drugs, Biologics, and Devices ...................................................................... 140 13.8.1 Expanded Access to Investigational Drugs and Biologics............................................................................140 13.8.2 Expanded Access to Investigational and Unapproved Medical Devices ..................................................... 141

13.9 Emergency Use ..................................................................................................................................................... 142 13.9.1 Emergency Exemption from Prospective IRB Approval ..............................................................................142 13.9.2 Emergency Exception from the Informed Consent Requirement...............................................................143 13.9.3 Waiver of Informed Consent for Planned Emergency Research.................................................................144

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