PERCEPTIONS OF RESEARCH EXPERTS REGARDING COMPETENCIES NEEDED TO PRACTICE SAFE RESEARCH WITH HUMAN SUBJECTS By THERESA BYCROFT Bachelor of Science University of South Alabama Mobile, Alabama 1998 Master of Science in Nursing University of South Alabama Mobile, Alabama 1999 Submitted to the Faculty of the Graduate College of Oklahoma State University in partial fulfillment of the requirements for the Degree of DOCTOR OF EDUCATION May, 2011 PERCEPTIONS OF RESEARCH EXPERTS REGARDING COMPETENCIES NEEDED TO PRACTICE SAFE RESEARCH WITH HUMAN SUBJECTS Thesis Approved: Gary J. Conti Thesis Advisor Lynna J. Ausburn C. Robert Davis Chad Depperschmidt Mark Payton Interim Dean of the Graduate College ii Table of Contents Chapter Page 1. INTRODUCTION.. 1 Events That Changed Human Subjects Research. 1 World War II.. 1 The Tuskegee Study.. 2 The National Research Act of 1974. 3 Professional Competence. 8 Problem Statement. 9 The Problem. 9 Background of the Problem. 10 Purpose of the Study.. 12 Research Questions.. 12 Conceptual Framework.. 13 Logic Model. 13 Delphi Logic Model.. 18 Limitations. 22 Assumptions. 23 2. PERSPECTIVES FROM THE LITERATURE.. 24 Regulating Research. 24 Regulations Prior to World War II. 24 The Nuremberg Code.. 24 Declaration of Helsinki. 29 Research Misconduct in the United States.. 34 Beecher’s Documentation. 34 The Tuskegee Study of Untreated Syphilis.. 35 The Belmont Report.. 36 Saturday Night Massacre. 39 Contemporary Research Misconduct.. 45 Prevention Through Education.. 47 Identifying Competencies Needed by Researchers.. 48 Elements of Competencies.. 49 Andragogy. 50 The Need to Know.. 51 The Learners’ Self-Concept.. 52 The Role of the Learners’ Experiences. 52 Readiness to Learn.. 53 Orientation to Learning. 53 Motivation.. 55 Self-Directed Learning.. 56 3. METHODOLOGY. 59 Design.. 59 Delphi Technique.. 60 Panel Members. 62 iii Elizabeth Bankert. 66 Jeffrey M. Cohen.. 67 Paul W. Goebel.. 69 Dale Hammerschmidt.. 70 Erica Heath. 72 Howard Mann. 74 Helen McGough. 76 Jon Merz.. 77 John Noble.. 80 J. Thomas Puglisi. 82 Procedures.. 83 Defining Competency. 83 The Delphi Technique Rounds. 84 4. THE DELPHI PROCEDURE.. 86 Introduction.. 86 Round 1. 87 Defining Competencies. 87 Analysis of Responses. 88 Confirmation of Competencies.. 91 Analysis of Data.. 93 Round 2. 94 Analysis of Responses. 94 Description of the Competencies. 95 Round 3. 96 Panel Members Responses. 97 5. PERSONAL COMPETENCIES. 98 Humility.. 98 Ethics.. 101 Ethical Principles of Research.. 102 Protection of Research Participants. 104 Ethical Values and Scientific Principles.. 107 Conception of Question to Study Completion.. 110 Publication Ethics.. 113 Ethical Values Commitment. 115 Avoiding Biases. 117 Respect. 123 6. KNOWLEDGE AND ABILITIES COMPETENCIES.. 125 Leadership and Management. 125 Supervision and Hiring.. 126 Delegation.. 128 Training.. 131 Data Management. 133 Budget Management. 135 Certifications.. 137 Organizational Skills. 139 iv Time Management. 140 Role Balance.. 142 7. GRASP OF METHODOLOGY.. 144 Understanding the Scientific Method. 145 Literature Review. 147 Hypothesis Development.. 149 Protocol Development and Study Design. 151 Protocol Adherence.. 156 Analysis of Data.. 160 Transparency.. 164 Communication and Communication Skills.. 167 Language Fluency.. 168 Communication with the Research Participant. 172 Receiving Input. 177 Networking.. 179 Cultural Competency. 180 8. SITUATIONAL AND ORGANIZATIONAL FACTORS.. 185 Compliance.. 185 Education and Knowledge. 186 Interaction Between Researcher and Bureaucracy.. 190 Good Clinical Practice.. 194 Following the Rules. 195 Professional Practice. 198 Research Related to the Professional Discipline. 201 General Professional Competence. 205 Biomedical Research. 209 Conflict of Interest.. 212 9. RATING OF COMPETENCIES.. 216 Introduction.. 216 Personal Competencies. 217 Knowledge and Abilities Competencies.. 220 Grasp of Methodology Competencies. 223 Situational and Organizational Factor Competencies . 225 Summary. 228 10. SUMMARY, CONCLUSIONS, AND RECOMMENDATIONS.. 229 Summary of the Study.. 229 Summary of Findings. 230 Conclusions. 231 Increased Knowledge for the Field. 232 Foundational Competencies. 232 Avoiding Bias. 234 Personal Competencies. 237 Methodology. 241 v Professional Practice. 243 Research Training. 245 Adult Learning Principles. 247 Change by Curriculum.. 252 Institutional Change.. 253 Organizational Accreditation.. 254 Mentoring. 255 Certification. 256 Recommendations for Further Inquiry. 258 Implications for Educators.. 258 Implications for Researchers.. 261 Recommendations for Organizations. 262 Recommendations for Further Inquiry. 263 REFERENCES. 265 vi Table of Tables Table Page 1 Humility Competencies. 101 2 Ethical Principles of Research Subgroup of the Ethics Competencies.. 103 3 Protection of Research Participants in the Ethics Competencies. 107 4 Ethical Values and Scientific Principles in the Ethics Competencies.. 110 5 Conception of Question to Study Completion of the Ethics Competencies.. 113 6 Publication Ethics of the Ethics Competencies. 115 7 Ethical Values Commitment in the Ethics Competencies.. 117 8 Avoiding Biases Competencies. 123 9 Respect Competency. 124 10 Supervision and Hiring Group of Leadership and Management Competencies. 128 11 Delegation Group of Leadership and Management Competencies. 131 12 Training Group of Leadership and Management Competencies. 133 13 Data Management Group of Leadership and Management Competencies. 135 14 Budget Management Group of Leadership and Management Competencies.. 137 15 Certification Subgroup of Leadership and Management Competencies. 139 16 Time Management Group of Organizational Skills Competencies. 142 17 Role Balance Group of Organizational Skills Competencies. 143 18 Understanding the Scientific Method in the Grasp of Methodology Group Competencies. 147 19 Competency in the subgroup of Literature Review in the Grasp of Methodology group Competency.. 149 20 Hypothesis Development in the Grasp of Methodology Group Competencies.. 151 21 Protocol Development and Study Design in the Grasp of Methodology Competencies. 156 22 Protocol Adherence Subgroup of Understanding the Scientific Method Competencies.. 158 23 Protocol Adherence Subgroup of Understanding the Scientific Method Competencies.. 164 24 Transparency Subgroup of the Understanding the Scientific Method Competencies.. 167 vii 25 Language Fluency Subgroup of Communication and Communication Skills.. 172 26 Communication With the Research Participant Subgroup of Communication and Communication Skills Competencies. 177 27 Ability to Receive Input Subgroup of Communication and Communication Skills Competencies.. 179 28 Networking Subgroup of Communication and Communication Skills Competencies. 180 29 Cultural Competency Competencies. 184 30 Education and Knowledge Subgroup of Compliance Competencies. 190 31 Interaction Between the Researcher and the Bureaucracy Subgroup of Compliance Competencies. 194 32 Good Clinical Practice Subgroup of Compliance Competencies. 195 33 Following the Rules Subgroup of Compliance Competencies. 198 34 Research Related to the Professional Discipline Subgroup of Communication and Communication Skills Competencies.. 205 35 General Professional Competence Subgroup of Professional Competence Competencies. 209 36 Biomedical Research Subgroup of Professional Competence Competencies.. 212 37 Conflicts of Interest Competencies. 215 38 Distribution of Rating of Experts on Humility Competencies.. 218 39 Distribution of Rating of Experts on Ethics Competencies. 219 40 Distribution of Rating of Experts on Avoiding Biases Competencies.. 220 41 Distribution of Rating of Experts on Leadership and Management Competencies.. 221 42 Distribution of Rating of Experts on Organizational Skills Competencies.. 222 43 Distribution of Rating of Experts on Communication and Communication Skills Competencies. 222 44 Distribution of Rating.