Document Type

Article

Publication Title

Narrative Inquiry in Bioethics

Publisher

The Johns Hopkins University Press

Publication Date

Spring 2013

Volume

3

Issue

1

Disciplines

Psychology

First Page

51

Last Page

65

Abstract

Clinical research is increasingly conducted in settings that include private physicians’ offices, clinics, community hospitals, local institutes, and independent research centers. The migration of such research into this new, non–academic environment has brought new cadres of researchers into the clinical research enterprise and also broadened the pool of potential research participants. Regulatory approaches for protecting human subjects who participate in research have also evolved. Some institutions retain their own Institutional Review Boards (IRBs), but Independent IRBs, community hospital IRBs and community–based IRBs also fulfill oversight responsibilities. This article sheds light on this evolving world by discussing the findings gleaned from two studies: a study of the decision making processes used by members who serve on different kinds of IRBs and a study of the decision making processes employed by research participants. The article then discusses how the key findings may inform proposed revisions to the Common Rule.

Keywords

human subject research, IRBs, clinical trials, protection of human subjects, Common Rule

Rights

©2013 The John Hopkins University Press

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