This manual outlines the research protocols for human subject research at American Public University System
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This manual outlines the research protocols for human subject research at American Public University System. APUS IRB Institutional Review Handbook 
APUS IRB
Table of ContentsTable of Contents 2 INTRODUCTION 4 APUS POLICY ON RESEARCH INVOLVING HUMAN SUBJECTS 5 Scope of Research Subject to IRB Approval 6 TRAINING: Collaborative IRB Training Initiative (CITI) Training 6 Research Involving APUS Staff, Students, and/or Faculty 6 Working With De-Identified Data Not Collected Through Interaction or Intervention 7 IRB Considerations for Class Activities 7 Student Research Requiring IRB Approval 7 Program Improvement, Assessment of Quality Improvement Studies 8 Research Exempt from IRB Review 8 Criteria for Approval of Research Not Exempt from Committee Review 9 IRB Decisions are Final and Binding 10 PREPARING AND SUBMITTING IRB PROPOSALS 10 INVESTIGATOR RESPONSIBILITIES 10 Study Changes 10 Adverse Events 11 What to Report 11 Annual Renewal 11 Addition or Deletion of PERSONNEL OR Investigators 12 IRB COMPOSITION, PROCEDURES AND RESPONSIBILITIES 12 Full Board 12 Expedited and Exempt Applications 12 Procedures for Review of Research 12 Committee Records 13 UNIVERSITY POLICY ON ETHICAL CONDUCT IN RESEARCH, SCHOLARSHIP AND EDUCATIONAL ACTIVITIES 13 Procedures 14 Appendix A: The IRB Checklist 16 Appendix B: IRB Applications 18 American Public University System Faculty/Staff IRB Application 18 Appendix C: Sample Consent Forms: 37 Appendix D: Data Usage, Storage, and Destruction Agreement 40 Appendix E: Protocol Amendment Form 41 Appendix F: Form for Reporting to the IRB Unanticipated Problems that May Involve Risks to Subjects or Others (UPIRTSO) 43 Appendix G: Extension Request for Approved Research 46
Table of Contents 2 INTRODUCTION 4 APUS POLICY ON RESEARCH INVOLVING HUMAN SUBJECTS 5 Scope of Research Subject to IRB Approval 6 TRAINING: Collaborative IRB Training Initiative (CITI) Training 6 Research Involving APUS Staff, Students, and/or Faculty 6 Working With De-Identified Data Not Collected Through Interaction or Intervention 7 IRB Considerations for Class Activities 7 Student Research Requiring IRB Approval 7 Program Improvement, Assessment of Quality Improvement Studies 8 Research Exempt from IRB Review 8 Criteria for Approval of Research Not Exempt from Committee Review 9 IRB Decisions are Final and Binding 10 PREPARING AND SUBMITTING IRB PROPOSALS 10 INVESTIGATOR RESPONSIBILITIES 10 Study Changes 10 Adverse Events 11 What to Report 11 Annual Renewal 11 Addition or Deletion of PERSONNEL OR Investigators 12 IRB COMPOSITION, PROCEDURES AND RESPONSIBILITIES 12 Full Board 12 Expedited and Exempt Applications 12 Procedures for Review of Research 12 Committee Records 13 UNIVERSITY POLICY ON ETHICAL CONDUCT IN RESEARCH, SCHOLARSHIP AND EDUCATIONAL ACTIVITIES 13 Procedures 14 Appendix A: The IRB Checklist 16 Appendix B: IRB Applications 18 American Public University System Faculty/Staff IRB Application 18 Appendix C: Sample Consent Forms: 37 Appendix D: Data Usage, Storage, and Destruction Agreement 40 Appendix E: Protocol Amendment Form 41 Appendix F: Form for Reporting to the IRB Unanticipated Problems that May Involve Risks to Subjects or Others (UPIRTSO) 43 Appendix G: Extension Request for Approved Research 46
INTRODUCTIONAmerican Public University System (APUS, this includes American Public University APU and American Military University AMU, hereafter referred to as APUS), like many other universities, maintains a research program that is in compliance with the U. S. Department of Health and Human Services (HHS) Office for Human Research Protection's (OHRP) Federalwide Assurance (FWA) guidelines. At APUS, all human subjects research is guided by ethical principles as described in the federal regulation, the Belmont Report, and “common rule” regulations 45CFR46. Compliance with these regulations is assured through approval and oversight of all institutionally affiliated research by APUS faculty, staff and student researchers. The APUS Institutional Review Board (IRB) is the committee responsible for ensuring the protection of human subjects in research studies. Specifically, the committee:
The purpose of this handbook is to explain the IRB, outline the process for completing an application, and explain the review and approval processes. In this handbook, you will find:
APUS POLICY ON RESEARCH INVOLVING HUMAN SUBJECTSIt is the policy of American Public University System (APUS) that all research involving human subjects and conducted under the aegis of APUS, must be conducted in accordance with accepted ethical and professional standards, and must be in compliance with federal regulations. All such research involving human subjects (unless it is specifically exempt from review as outlined within this handbook) must be reviewed and approved by the University's Institutional Review Board (IRB) before it is conducted. It is the policy of APUS that the IRB committee has the authority to approve, require modifications in, or disapprove any research conducted under aegis of APUS involving human subjects. The term "research" refers to that which
The term "human subject" is defined by Federal Regulations as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information” (45 CFR 46.102(f)).
The IRB reviews research that involves living individuals (1) about whom "an investigator conducting research obtains data through intervention or interaction with the individual" or (2) which contains "identifiable private information" (Title 45 CFR, Part 46.102.f). Secondary analysis of existing datasets where participants are individually identifiable should be reviewed by the IRB. Directory: documents documents -> Concept stage documents -> Concept stage documents -> The great global switch-off documents -> Nonprofit grant application documents -> The Truth about the Rwandan Genocide documents -> Annual InStructional unit plan documents -> Chaos equipment included Download 190.54 Kb. Share with your friends:
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