Investigator Handbook

Contents

I:  Research Subject to Institutional Review Board (IRB) Review

A.  Scope of IRB Review
B.  Research Conducted by "Affiliated" Faculty
C.  Projects for which the Researcher is a Consultant
D.  Research Conducted in Courses
E.  Individual Research Projects Conducted by Students
F.  Research Conducted at non-UIUC Sites
G.  Research in Multicenter Clinical Trials
H.  Pilot and Feasibility Studies
I.  Research involving a Secondary Use of Data
J.  Research using "Waste" or "Extra" Material
 
II: Fundamental Guidelines
A.  Ethical Principles
B.  Definitions and Policies
Human Subject
Research
Responsible Project Investigator
Voluntariness and Recruitment
Informed Consent
Confidentiality
Research Risks and Benefits
Adverse Events and Unanticipated Problems
Adverse Events from Exercise Testing
Record Retention
C.  UIUC Policy Statement

III:  Distribution of Responsibility

A.  Responsible Project Investigator
B.  Departmental Executive Officer
C.  Institutional Review Board(s)
D.  Institutional Oversights
E.  Individual or Institution Providing Access to Subjects

IV:  Review Procedures

A.  Review of Human Subjects Research
B.  Exempt Research
C.  Grant Submissions that Involve Human Subjects

V:  Research Involving Special Subject Groups

A.  Children
B.  Prisoners
C.  Pregnant Women, Human Fetuses (and fetal material), and Neonates
D.  Research in Foreign Countries

VI:  Glossary of Terms

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