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# |
Title |
Action Taken |
| 1-2 | Reviewing and Making Changes to Standard Operating Procedures. | Developed: 04-02-99 Revision 9: 02-23-11 |
| 1-5 | Reviewing and Making Changes to Administrative Guidance | Developed: 05-01-08 |
Section #2: IRB-HSR Functions
| 2-1 | Selection and Appointment of Members of the IRB for Health Sciences Research | Developed: 02-11-00 Revision 9: 01-18-12 |
| 2-3 | Education for IRB-HSR Members | Developed: 02-11-00 Revision 8: 04-21-10 |
| 2-4 | Conduct and Agenda of IRB-HSR Meetings | Developed: 02-11-00 Revision 14: 02-23-11 |
| 2-5 | Minutes of IRB-HSR Meetings | Developed: 03-07-00 Revision 16: 12-19-11 |
| 2-7 | Notification of Federal Regulatory Agencies, Institutional Officials and Funding Agencies | Developed: 02-11-00 Revision 17: 01-18-12 |
| 2-8 | Post-approval Monitoring | Developed: 02-11-00 Revision 13: 05-21-10 |
| 2-9 | Job Summaries, Orientation and Continuing Education for IRB-HSR Staff Members | Developed: 03-27-00 Revision 11: 02-23-11 |
| 2-10 | IRB-HSR Website | Developed: 03-27-00 Revision 7: 02-23-11 |
| 2-11 | IRB-HSR Protocol File Documentation and Database Security | Developed: 03-27-00 Revision 9: 02-23-11 |
| 2-12 | Inspections of IRB-HSR by Outside Agencies | Developed: 03-27-00 Revision 5: 09-27-08 |
| 2-14 | Receipt of Allegations of Non-Compliance | Developed: 07-20-00 Revision 7: 06-12-09 |
| 2-15 | Education for Investigators and Coordinators | Developed: 09-07-00 Revision 4: 04-30-08 |
| 2-16 | IRB Departmental Coordinators | Developed: 12-13-00 Revision 2: 04-30-08 |
| 2-17 | IRB-HSR Confidentiality Statement | Developed: 01-01-02 Revision 3: 01-18-12 |
| 2-19 | Consent Observation | Developed: 09-29-03 Revision 4: 04-30-08 |
| 2-20 | Verification of Research Activities Since Previous IRB Review | Developed: 09-21-05 Revision 4: 09-27-08 |
| 2-25 | IRB-HSR Office Management During a Flu Pandemic | Developed: 09-28-09 |
| 2-26 | IRB-HSR Naming Nomenclature | Developed: 05-01-08 Revision 2: 02-23-11 |
| 2-27 | Updating and Maintaining OHRP/ FDA IRB Registration/Authorization | Developed: 05-01-08 Revision 4: 02-23-11 |
| 2-28 | Exit Procedures for IRB-HSR Researchers | Developed: 10-31-08 Revision 3: 01-18-12 |
| 2-29 | Protocol Development Process | Developed: 11-07-08 Revision 1: 02-23-11 |
| 2-30 | GWAS Certifications | Developed: 04-23-09 Revision 2: 09-17-10 |
| 2-31 | Correcting Assurance/Approval Forms and Minutes | Developed: 04-13-09 |
| 2-32 | Protocol Builder Administrative Processes | Developed: 09-17-10 |
| 2-33 | IRB-HSR Communication with Upper Administration | Developed: 04-02-10 |
| 2-34 | IRB-HSR In-person Education | Developed: 03-18-11 |
| 2-35 | IRB Online Education: Learning Shots | Developed: 03-18-11 |
Section #3: Types of Approvals
| 3-1 | Exempt Studies | Developed: 03-06-00 Revision 24: 02-23-11 |
|
| 3-2 | Approval of Expedited Studies | Developed: 02-11-00 Revision 23: 01-18-12 |
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| 3-3 | Approval of New Study by Full Board | Developed: 02-11-00 Revision 28: 01-18-12 |
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| 3-4 | Modifications | Developed: 03-07-00 Revision 18: 02-23-11 |
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| 3-5 | Continuations | Developed: 03-07-00 Revision 20: 10-31-11 |
|
| 3-6 | Protocol Closure | Developed: 02-11-00 Revision 13: 12-19-11 | |
| 3-7 | Waiver of Consent/Waiver of HIPAA Authorization Approval | Developed: 02-11-00 Revision 10: 03-17-11 |
|
| 3-9 | Advertisements | Developed: 02-11-00 Revision 17: 10-26-11 |
|
| 3-10 | Grant Applications | Developed: 05-16-00 Revision 18: 01-25-12 |
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| 3-11 | Emergency Use Notifications | Developed: 03-27-00 Revision 11: 01-18-12 |
|
| 3-12 | Treatment Use | Developed: 03-27-00 Revision: 4: 05-01-08 |
|
| 3-13 | Device Studies | Developed: 04-19-00 Revision 9: 01-18-12 |
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| 3-14 | Waiver of Documentation of Consent | Developed: 06-01-00 Revision 7: 02-06-09 |
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| 3-15 | Surrogate Consent | Developed: 07-17-00 Revision 9: 02-23-11 |
|
| 3-16 | Protocols Involving Specimen Banking and/or High Risk Genetic Testing | Developed: 12-01-00 Revision 6: 02-23-11 |
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| 3-17 | Humanitarian Device Exemption (HDE) | Developed: 09-05-02 Revision 7: 01-25-12 |
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| 3-18 | NCI CIRB Protocol Approvals | Developed: 03-01-04 Revision 16: 01-18-12 |
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| 3-19 | WIRB Protocol Approvals | Developed: 04-29-04 Revision 5: 02-23-11 |
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| 3-20 | Research Involving Coded Private Information or Biological Specimens | Developed: 11-16-04 Revision 9: 04-02-10 |
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| 3-22 | Protocol Violations and Enrollment Exceptions | Developed: 04-01-06 Revision 6: 12-10-08 |
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| 3-23 | Investigator-Initiated Investigational New Drug Application (IND) | Developed: 05-01-08 |
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| 3-24 | Engagement in Human Subject Research | Developed: 01-10-07 Revision 11: 02-23-11 |
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| 3-25 | Expanded or Continued Access | Developed: 01-04-07 Revision 5: 01-18-12 |
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| 3-26 | Compassionate Use | Developed: 01-24-08 Revision 2: 02-23-11 |
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| 3-27 | Authorization Agreements | Developed: 06-17-08 Revision 5: 01-18-12 | |
| 3-28 | Determination of Human Subjects Research | Developed: 01-06-10 Revision 1: 06-07-10 |
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| 3-29 | Public Data Set | Developed: 01-07-10 Revision 1: 02/23/11 |
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| 3-30 | Decedent Research | Developed: 09-28-10 |
Section #4: Adverse Events
| 4-1 | Adverse Event/Unanticipated Problem Reporting & Review | Developed: 04-02-99 Revision 23: 06-10-10 |
Section #5: Quality Control of IRB-HSR SOPs
| 5-1 | QC of AE Reporting to IRB-HSR | Developed: 02-11-00 Revision 6: 04-04-09 |
| 5-2 | QC of Expiration Dates for Active Studies | Developed: 02-11-00 Revision 4: 04-04-09 |
| 5-3 | Audits of IRB-HSR | Developed: 02-11-00 Revision 7: 02-23-11 |
| 5-4 | Annual Review of SOPS | Developed: 03-07-00 Revision 3: 04-30-08 |
| 5-5 | QC of Inactive Protocols Without Closed Events | Developed: 04-18-01 Revision 4: 07-06-09 |
| 5-6 | Internal Administrative Assessment | Developed: 05-03-06 Revision 3: 02-23-11 |
5-7 |
QC of Protocols and Grants with Incorrect or Duplicate Approval/Closure Events | Developed: 04-04-09 |
| 5-8 | QC of the IRB-HSR database | Developed: 07-08-09 Revision 1: 02-23-11 |
| 5-9 | QC of Scanned Files | Developed: 12-10-09 |
| 5-10 | IBC Verification | Developed: 02-08-10 |
| 5-11 | Verification of Approval Dates | Developed: 02-23-11 |
| 5-12 | PRC Registration Report | Developed: 05-05-11 |
| 5-13 | Wards of the State Verification | Developed: 06-21-11 |
| 5-14 | Alternative Payment Verification | Developed: 01-18-12 |
Phone: (434)-924-2620
Fax: (434)-924-2932
