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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 5: 09-27-08
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
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 25: 11-01-12
3-2	Approval of Expedited Studies	Developed: 02-11-00 Revision 24: 08-02-12
3-3	Approval of New Study by Full Board	Developed: 02-11-00 Revision 30: 08-02-12
3-4	Modifications	Developed: 03-07-00 Revision 18: 02-23-11
3-5	Continuations	Developed: 03-07-00 Revision 22: 06-05-13
3-6	Grant and Protocol Closure	Developed: 02-11-00 Revision 15: 07-12-12
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 21: 07-30-12
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 11: 03-12-13
3-14	Waiver of Documentation of Consent	Developed: 06-01-00 Revision 7: 02-06-09
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
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 19: 05-31-13
3-19	WIRB Protocol Approvals	Developed: 04-29-04 Revision 5: 02-23-11
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 11: 02-23-11
3-25	Expanded or Continued Access	Developed: 01-04-07 Revision 5: 01-18-12
3-26	Compassionate Use	Developed: 01-24-08 Revision 3: 11-16-12
3-27	Authorization Agreements	Developed: 06-17-08 Revision 7: 05-24-13
3-28	Determination of Human Subjects Research	Developed: 01-06-10 Revision 3: 04-09-13
3-29	Public Data Set	Developed: 01-07-10 Revision 2: 03/30/12
3-30	Decedent Research	Developed: 09-28-10
3-31	UVa Agent Determination	Developed: 02-20-12
3-33	Reopening Previously Closed/Expired Protocols or Grants	Developed: 05-30-12
3-34	Additional Protections for Prisoners	Developed: 05-10-13

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 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 1: 06-21-12
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