A Researcher's Guide to Human Subjects Protection

Table Of Contents

Chapter 1 Introduction
Chapter 2 Institutional Administration
2.2 Institutional Regulations and Policies
2.3 Authority of the Institutional Review Board
2.4 Where to Get the Application Packet
2.5 Staff
2.6 Membership
Chapter 3 Basic IRB Review
3.1 Introduction
3.2 Risk/Benefit Analysis
3.3 Comments on Research Design
3.4 Responsibilities of Investigators
3.5 Researcher Non-Compliance
3.6 Privacy and Confidentiality
3.7 Selection of Subjects
3.8 Incentives for Participation
3.9 Informed Consent
3.10 Deception
3.11 Monitoring and Observation
3.12 Continuing Review
3.13 Information Needed When Conducting Research Off-Campus
3.14 Information Needed When Using Human Blood or Tissue
3.15 Information Needed When Applying for External Funding
Chapter 4 Research with Special Classes of Subjects
4.1 Children
4.2 Pregnancy
4.3 Prisoners
4.4 Cognitively Impaired Persons
4.5 Disadvantaged Persons
4.5 Minorities
4.5 Elderly
4.5 Students, Employee and Patients
Chapter 5 General Bibliography
Chapter 6 Appendices
6.1 The Federal Policy: 45 CFR 46, 21 CFR 50, 56
6.2a The Nuremberg Code
6.2b The Declaration of Helsinki
6.2c The Belmont Report
6.3 UM Federalwide Assurance
6.4 Glossary of Terms
6.5 UM Application Packet
6.6 Sample Consent Forms
6.7 IBC Memorandum of Understanding and Agreement
6.8 Information for Graduate Students and Their Advisors