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)

Permanent URL: https://etd.library.emory.edu/concern/etds/fj236212d?locale=en


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



Table of Contents

Acronyms and Terminologies


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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