Designing User Studies in Informatics

Part of the series Health Informatics pp 153-166


Institutional Review Board (IRB) Approval

  • Gondy LeroyAffiliated withSchool of Information Systems and Technology, Claremont Graduate University Email author 

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The Institutional Review Board (IRB) has to approve most studies that involve human subjects. This chapter first discusses the origin of the Institutional Review Board, which goes back as far as World War II when experiments were conducted on prisoners, to illustrate how different historical events resulted in an official review being required for experimentation on human subjects. Then, the components of the information submitted for review are discussed. This includes the study rationale, its design and how data are to be gathered and published. In addition, special attention is paid to the need for the study participants to provide informed consent. For participants to be able to give such consent the researcher needs to provide all necessary information, participants need to be able understand it and then need to agree to taking part in the study. This process is not without its consequences and has been shown to affect the timeliness of research, the study’s recruitment success and also the representativeness of the study sample.