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The Market for Ethics: Human Subjects Research Oversight in the United States and Canada

  • Author(s): Goldstein, Gabrielle
  • Advisor(s): Keller, Ann
  • et al.
Abstract

An estimated 2.5 million Americans participate in clinical research annually. Participation exposes human subjects to significant physical risks including death, as it often involves ingesting or introducing drugs and devices to the body that have not yet been proven safe or effective. In the US, a set of policies around the regulation of biomedical research emerged as a politically and contextually contingent result in the post-war years. The centerpiece for oversight of human subjects research was the local, hospital- or university-based IRB. It emerged at the height of organized medicine’s political and social power and derived from a logic of professional autonomy.

Much has changed. Today, 80% of clinical research in the US occurs outside the academic medical context, in community settings such as physicians’ offices and freestanding research clinics. These research studies are overseen by thousands of IRBs registered with the federal government, some of which are for-profit businesses. The world for which the oversight regime was built – trained clinical researchers submitting their proposed research to the scrutiny of their trained colleagues in a university setting – no longer exists. In spite of the dramatic changes in who is carrying out research and the associated changes in their motivations for doing so, the regulations governing IRBs and clinical research oversight remain stable.

Little empirical scholarship exists regarding how the IRB oversight mechanism is operating now that the research landscape has changed so substantially. Little scholarship empirically charts the entire ecology of IRBs, which now include IRBs in diverse settings such as non-teaching community hospitals, health systems, government facilities, universities and teaching hospitals, as well as independent, central, and commercial IRBs. There exists no full accounting of how many IRBs there are, of which types, in which locations – and few analytical accounts of variations between IRBs based on organizational or environmental factors.

This dissertation reports on the results of an original qualitative research study that involved interviews with IRB members and administrative professionals from commercial IRBs, nonprofit healthcare organization IRBs, academic and government IRBs in the US and Canada. The chapters explore various aspects of the current IRB ecology, in light of drastic changes to the institutional and economic environments in which clinical research occurs over recent decades. After a brief introduction, the second chapter explores IRB professionals’ experiences with, and responses to, the legal and regulatory environment in which these professionals and their organizations operate. The third chapter explores variation between types of IRBs, identifying governance gaps and best practices. The fourth chapter explores the attitudes of IRB professionals toward the commercialization of research ethics review in the United States and Canada. The fifth chapter provides some conclusions and steps for future research.

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