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IRB Home > For IRB Staff > Administrative Guidance

 

 

 

 

 

 


Administrative Guidance.

Section #1: Oversight of IRB SOPS and Administrative Guidance

#

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 18: 05-09-13
2-7 Notification of Federal Regulatory Agencies, Institutional Officials and Funding Agencies Developed: 02-11-00
Revision 18: 07-06-12
2-8 Post-approval Monitoring Developed: 02-11-00
Revision 14: 07-06-12
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  Files:  Content, Storage, Security and Destruction Developed: 03-27-00
Revision 10: 01-25-13
2-12 Inspections of IRB-HSR by Outside Agencies Developed: 03-27-00
Revision 6: 07-02-13
2-14 Receipt of Concerns, Complaints or Allegations of Non- Compliance Developed: 07-20-00
Revision 8: 05-31-13
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 5: 07-06-12
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 4: 06-04-13
2-31 Correcting Assurance/Approval Forms and Minutes Developed: 04-13-09
Revision 1: 09/13/13
2-32 Protocol Builder Administrative Processes Developed: 09-17-10
Revision 1: 09/09/13
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 26: 09-09-13
3-2 Approval of Expedited Studies Developed: 02-11-00
Revision 26: 11-01-13
3-3 Approval of New Study by Full Board Developed: 02-11-00
Revision 31: 09-09-13
3-4

Modifications Developed: 03-07-00
Revision 19: 07-23-13
3-5 Continuations Developed: 03-07-00
Revision 25: 01-16-14
3-6 Grant or Protocol Closure Developed: 02-11-00
Revision 19: 10-23-13
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 22: 07-22-13
3-11 Emergency Use Notifications Developed: 03-27-00
Revision 12: 09-09-13
3-12 Treatment Use Developed: 03-27-00
Revision: 4: 05-01-08
3-13 Device Studies Developed: 04-19-00
Revision 11: 03-12-13
3-14 Waiver of Documentation of Consent Developed: 06-01-00
Revision 8: 09-09-13
3-15 Use of Legally Authorized Representative (LAR) Developed: 07-17-00
Revision 11: 01-10-14
3-16 Protocols Involving Specimen Banking and/or High Risk Genetic Testing Developed: 12-01-00
Revision 7: 09-09-13
3-17 Humanitarian Device Exemption (HDE) Developed: 09-05-02
Revision 7: 01-25-12
3-18 NCI CIRB Protocol Approvals Developed: 03-01-04
Revision 20: 08-14-13
3-19 WIRB Protocol Approvals Developed: 04-29-04
Revision 6: 09-09-13
3-20 Research Involving Coded Private Information or Biological Specimens Developed: 11-16-04
Revision 10: 06-01-12
3-22 Protocol Violations and Enrollment Exceptions Developed: 04-01-06
Revision 6: 12-10-08
3-23 Investigator-Initiated Investigational New Drug Application (IND) Developed: 05-01-08
3-24 Engagement in Human Subject Research Developed: 01-10-07
Revision 12: 09-09-13
3-25 Expanded or Continued Access Developed: 01-04-07
Revision 5: 01-18-12
3-26 Compassionate Use Developed: 01-24-08
Revision 4: 12-12-13
3-27 IRB Agreement Authorizations Developed: 06-17-08 Revision 10: 03-05-14
3-28 Determination of Human Subjects Research Developed: 01-06-10
Revision 5: 03-21-14
3-29 Public Data Set Developed: 01-07-10
Revision 2: 03-30-12
3-31 UVa Agent Determination Developed: 02-20-12
3-32 NeuroNEXT Approvals Developed: 07-15-13
3-33 Reopening Previously Closed/Expired Protocols or Grants Developed: 05-30-12
Revision 1: 10-23-13
3-34 Additional Protections for Prisoners Developed: 05-10-13
3-35 Fred Hutchinson Cancer Research Center IRB Approvals for CITN Protocols Developed: 09-09-13

Section #4: Adverse Events

4-1 Serious Adverse Event (SAE) Reporting Developed: 04-02-99
Revision 25: 02-05-14
4-2 Unanticipated Problems Developed: 11-15-13
Revision 1: 02-05-14

Section #5: Quality Control of IRB-HSR SOPs

5-1 QC of AE Reporting to IRB-HSR Developed: 02-11-00
Revision 7: 06-05-12
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 2: 04-19-13
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
Revision 2: 08-22-13
5-14 Alternative Payment Verification Developed: 01-18-12
Revision 2: 02-07-13
5-15 QC of IRB-HSR Agenda and Minutes Developed: 03-19-13