Manual of Procedures and Policies

Manual of Policies and Procedures for the Institutional Review Board at the University of Mary Washington

Table of Contents

I. Introduction 

A.  Ethical Treatment of Human Subjects

1.  Basic Precepts of the Nuremberg Code

2.  Basic Precepts of the Belmont Report

B.  State, Federal, and Professional Mandates

C.  Definitions

1.  Research

2.  Human Subject

II.  Institutional Review Board (IRB) Administration at UMW  

A.  Role of the IRB

B.  Scope of the IRB

1.  Covered Research

2.  Research Conducted at UMW by Investigators from Other Institutions

3.  Student Projects:  Research vs. Pedagogy

4.  Grant Applications

5.  Pilot Studies

6.  Evaluations

C.  Institutional Oversight of the IRB

D.  IRB Membership

1.  Requirements

2.  Appointment of Members, Length of Service, and Duties

3.  Appointment of Chair, Length of Service, and Duties

4.  Conflict of Interest

5.  Use of Consultants

E.  Training of IRB Members

F.  Administrative Support

1.  Budget

2.  Administrative Responsibilities (Chair of the IRB)

3.  Administrative Responsibilities (Office of the Provost)

G.  Record Keeping and Documentation (Office of the Dean, College of Arts and Sciences)

1.  Official Records Maintained for the IRB

2.  Retention of Records&nb

III.  IRB Review Process  

A.  Exempted from Review

1.  Exempt Categories

2.  Responsibilities of Investigators Conducting Exempt Research

B.  Expedited Review

1.  Overview of Expedited Research

2.  Expedited Review Categories

C.  Full Board Review

IV.  Appendices*

A.  Application for Exempt Status (word doc)

B.  Application for Expedited Review (word doc)

C.  Informed Consent Release (word doc)

D.  Assent Form (updated 10-09)

E.  Debriefing Protocol (updated 10-09)

F.  The Nuremberg Code

G.  The Belmont Report

H.  Federal Regulations

I.  Virginia Regulations

* all appendices are in pdf format