Human Subjects Protection Tutorial

Protection of Human Subjects in
Non-Biomedical Research: A Tutorial
November 2006
Contents
1 Who should take this tutorial? ............................................................2
2 Objectives ...........................................................................................2
3 A Brief History of Research Ethics ....................................................3
3.1 Abuses in Biomedical Research .................................................. 3
3.2 Abuses in Non-Biomedical Research .......................................... 4
3.3 The National Research Act and the Belmont Report................... 5
4 Current Regulations ............................................................................6
4.1 Federalwide Assurance................................................................ 7
4.2 Enforcement of the Regulations in Non-Biomedical Research ... 8
4.3 What is Research? ....................................................................... 8
4.4 What is a Human Subject?........................................................... 9
4.5 Some Equivocal Cases............................................................... 10
4.5.1 Oral History 10
4.5.2 Quality Improvement, Quality Assurance.......................... 10
4.5.3 IU Classroom Assignments................................................ 11
4.5.4 Existing Data...................................................................... 12
5 An Overview of the Institutional ...