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Standard Operating Procedures

Introduction to Rex IRB
Table of Contents
Definitions
1.0 Principles, Roles, Responsibilities
2.0 Roles in the Protection of Human Subjects
3.0 IRB Purpose, Responsibility and Authority
4.0 IRB Organization and Administration
5.0 IRB Record Requirements
6.0 Meeting Minutes
7.0 Determination if an Activiy Constitutes Human Research Subject to Rex IRB Review
8.0 Applications for IRB Review
9.0 Determination of Type of Review
10.0 Review by Convened IRB
11.0 IRB Actions Following Review by the Convened IRB
12.0 Expedited Review of Research
13.0 IRB Actions Following Expedited Review
14.0 Exemption from Continuing IRB Review
15.0 Modifications to Previously Approved Research
16.0 Continuing Review for Renewal
17.0 Study Completion, Closure, or Termination
18.0 Reporting of Unanticipated Problems and Adverse Events to IRB
19.0 Emergency Use of an Investigational or Unlicensed Test Article
20.0 Exceptions from Informed Consent Requirements for Emergency Research
21.0 Allegations of Noncompliance, Subject Complaints and Other Concerns
22.0 Protocol Violations, Deviations and Exceptions
23.0 IRB Evaluation Criteria
24.0 Recruitment
25.0 Recruitment Incentives
26.0 Investigator Conflict of Interest
27.0 Informed Consent
28.0 HIPAA and IRB Review
29.0 Special Topics- Research Design and Context
30.0 Special Topics- Research Subject Groups
31.0 Research Involving Pregnant Women, Human Fetuses and Neonates
32.0 Research Involving Prisoners
33.0 Research Involving Children
34.0 Reporting to Institutional Officials and External Agencies-Unanticipated Problems Terminations Suspensions and Non-Compliance