What is Research in Public Health Practice? Social Construction and Cultural Interpretation of Research and Practice at the Centers for Disease Control and Prevention Open Access
Lor, Aun (2014)
Abstract
Anthropological theories and methods have been indispensable for understanding how organizational culture influences institutional behavior, policy and decision-making. This dissertation uses anthropological theories and methods to examine how institutional culture and historical events shape the Centers for Disease Control and Prevention (CDC). It focuses on one specific activity within the organization the process of distinguishing public health research from nonresearch as the initial critical step in the federally-mandated Human Subjects Protection system. The research/non-research determination process is used as a window into the institutional culture of CDC as it developed in the past two decades. A central question was whether CDC employees share a set of beliefs and behaviors about human subjects protection, research/non-research determination process, and the more complex and time-consuming formal procedures of the Institutional Review Board (IRB). A multi-method data collection strategy included: ethnographic participant-observation, archival study, case studies, interviews, focus group discussions, and an online survey (N=432). The historical development of this cultural pattern is described. The culture of Public Health values the population interests over individual rights. It therefore tends to define activities as Public Health practice rather than research. The dissertation describes how this cultural pattern was influenced by sociocultural, political and economic forces through the close examination of Measles and HIV studies, both of which triggered negative public reaction and resulted in the restriction of CDC project assurance in 1995 and suspension of its international studies in 1997. Findings included: there was no general agreement on how research is distinguished from nonresearch; general familiarity with the regulatory definition of research; agreement among CDC employees that the research determination process and IRB procedures are burdensome; widespread agreement of the difficulty of distinguishing research from practice; and a consensus that, ethical oversight of public health activities should be based on the level of risk to the participants. However, the critical issue is that only a vague definition of "minimal risk," exists as a general guidelines for determining risk level. In conclusion, the tensions within the CDC human subjects protection system reflect the same sociocultural, political, and economic forces that define CDC as an institution.
Table of Contents
Abstract
Acknowledgements
Table of Contents
Acronyms and Terminologies
Preface
Chapter 1: Introduction
Research Determination in Public Health: A Problematic Beginning 1
Chapter 2: A Cultural History
The history of CDC and regulatory ethics from the early 1940s ,
Research Determination Problems and Practice at CDC in the 1990s 35
Chapter 3: Research Determination in Regulations and Policies 86
Chapter 4: Research Determination in Practice 140
Chapter 5: Research Determination Case Examples 184
Chapter 6: Conclusion: Moving Beyond Regulatory Compliance 211
Appendix A: Interview Guide 232
Appendix B: Survey Questionnaires 237
Appendix C: Excerpts Comparison of CDC 1999 Guidance to 2010 Policy 247
Appendix D: Key Findings from an Agency-wide Survey 251
Appendix E: Sample Research Determination Form 254
References Cited 256
List of Tables
Table 1: CDC IRB Actions from 1997-1999 70
Table 2: Survey Response on Perception of the
Advantageous if Determined Nonresearch 82
Table 3: Survey Response on the Regulatory Definition 89
Table 4: General and Shared Characteristics of Research
& Nonresearch 90
Table 5: What does federally-supported mean? 104
Table 6: Types of Research Determination Requests
Received by CGH in 2013 108
Table 7: CDC Human Subjects Contacts Salaries 2010 146
Table 8: Project Determinations at CDC July 1, 2010 - June 30, 2011 160
Table 9: CGH Project Determination Requests for Calendar Year 2013 170
Table 10: CGH Research Protocols Submitted to HRPO in 2013 171
Table 11: Public Health Ethics Consultation Process 229
Table 12: Key Survey Findings 253
List of Figures
Figure 1: Human Subjects Review and
Research Determination Process 15
Figure 2: Events leading to OPRR's Investigation of CDC 50
Figure 3: Lessons from the L.A. Measles Study 60
Figure 4: Letter from Surgeon General Thomas Parran 69
Figure 5: CDC Organizational Chart, September 320, 1977 75
Figure 6: CDC Organizational Chart, March 32, 1981 76
Figure 7: CDC Organizational Chart from 2005-2009 77
Figure 8: CDC Current Organizational Chart 79
Figure 9: Center for Global Health Organizational Chart 80
Figure 10: Complete Protocol for Research and Nonresearch 96
Figure 11: EIS Logo 117
Figure 12: CDC Survey Response: Generalizability 132
Figure 13: Intent to Publish 139
Figure 14: Human Research Protections Structure 144
Figure 15: Early Determination Process 1997 148
Figure 16: Most used Resources in Research Determination Practice 149
Figure 17: Example of Early Email Research Determination 150
Figure 18: Emory University IRB Human Subjects Decision Chart 163
Figure 19: Comments from HSC 192
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