Table of Contents

1.0 Introduction

2.0 The Institutional Review Board

2.1 Purpose Of The Institutional Review Board 2.2  IRB Scope And Authority
2.3 Activities Requiring IRB Review And Approval
2.4 Principles Governing The IRB
2.5 Selection And Composition Of The IRB
2.6 IRB Meetings
2.7 Education Of IRB Members
2.8 IRB Records

3.1 The Institutional Official
3.2 The IRB Chair
3.3 The IRB
3.4 The Principal Investigator

4.1 Program Objective
4.2 Initial Certification Requirements
4.3 Who Is Required To Complete The Program
4.4 Who Is Exempt From Human Subjects Research Education Requirements
4.5 Ongoing Education And Recertification
4.6 Additional Education

5.1 When Is IRB Review Required

5.1.1 Student Classroom Research Projects
5.1.2 New Projects
5.1.3 Changes To Previously Approved Projects
5.1.4 Continuing Review Of Ongoing Projects

5.1.5 - 5.1.7

5.1.5 For Determination Of Exempt Status
5.1.6 Expedited Review
5.1.7 Full Board Review

5.2 Submission Requirements And Review Process

5.2.1 Determination Of Exempt Status
5.2.2 Expedited Review
5.2.3   Full Board Review

5.2.4 - 5.5

5.2.4 Changes To Previously Approved Projects
5.2.5 Continuing Review Of Ongoing Projects
5.2.6 Submitting A Project Previously Reviewed By One IRB To A Different IRB

5.3 Provost Review Option

5.4 IRB Review Criteria

5.5 IRB Suspension Or Termination Of A Protocol

6.1 Protocol Preparation Requirements

6.2 Special Research Issues

6.2.1 Use Of Protected Health Information For Research
6.2.2 Gender Differences In Clinical Evaluation Of Drugs
6.2.3 Genetic Research
6.2.4 Studies Involving Investigational New Drugs
6.2.5 Use Of Biohazardous Materials
6.2.6 Use Of Radioisotopes, Radiation, And Radioactive Drugs
6.2.7 Studies Involving Investigational New Devices

7.1 General Requirements
7.2 Exceptions From Informed Consent Requirements
7.3 Elements Of Informed Consent
7.4 Documentation Of Informed Consent
7.5 Assent Of Minors And Consent Of Parent(S)/Guardian(S)
7.6 Retention Of Signed Consent Documents
7.7 Iowa Law

8.0  Recruiting Research Subjects

8.1 Advertising For Research Subjects
8.2 Finder's Fees

9.1 Research Involving Children
9.2 Research Involving Pregnant Women, Fetuses Or Neonates
9.3 Research Involving Prisoners
9.4 Research Involving Other Vulnerable Populations

9.4.1 Members Of Native American Tribes
9.4.2 Mentally Disabled Persons Or Economically/Educationally Disadvantaged Persons

10.1 Adverse Event Reporting
10.2 Notification Of Procedures Performed In Variance With The Protocol
10.3 Protection For Whistleblowers

11.1 Notification Of Conclusion Of Research Project
11.2 Retention Of Records