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Defining Research with Human Subjects

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Introduction

The federal regulations define both "research" and "human subject." Studies must be reviewed by an Institutional Review Board (IRB) only if both definitions apply. A study that meets the definition of research, but does not involve human subjects, does not need IRB review. Similarly, a study may involve human subjects, but not meet the definition of research and would, therefore, not require an IRB review. This module interprets words and phrases used in the definition of research and of human subject from the perspective of research in the social and behavioral sciences, education, and the humanities.

Learning Objectives

By the end of this module, you should be able to:

Explain the definition of research.
Explain the definition of human subject.
Describe the differences between private and public information and behavior.
Defining Research

Research is defined by federal regulations at 45 CFR 46.102 (Protection of Human Subjects 2009), as "a systematic investigation including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."

Systematic Investigation

A systematic investigation is the opposite of a disorganized, random venture. In other words, researchers need to have constructed a research plan with ideas about what they want to learn and how best to do that. Both qualitative and quantitative researchers use systematic investigation in the course of their research. Both types of research are organized, albeit around differing notions about the role of the researcher, the purpose of the research, the nature of the data collected, and so on. Quantitative researchers may test hypotheses and theories with the data they collect, while qualitative researchers may generate hypotheses or theories based on the data they gather. Quantitative researchers may focus on statistical

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