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The Impact of Regulating Social Science Research with Biomedical Regulations

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The Impact of Regulating Social Science Research with Biomedical Regulations UNLV Theses, Dissertations, Professional Papers, and Capstones 12-2011 The impact of regulating social science research with biomedical regulations Brenda Braxton Durosinmi University of Nevada, Las Vegas Follow this and additional works at: https://digitalscholarship.unlv.edu/thesesdissertations Part of the Ethics in Religion Commons, Higher Education and Teaching Commons, Other Law Commons, Philosophy Commons, and the Public Policy Commons Repository Citation Durosinmi, Brenda Braxton, "The impact of regulating social science research with biomedical regulations" (2011). UNLV Theses, Dissertations, Professional Papers, and Capstones. 1251. http://dx.doi.org/10.34917/2821184 This Dissertation is protected by copyright and/or related rights. It has been brought to you by Digital Scholarship@UNLV with permission from the rights-holder(s). You are free to use this Dissertation in any way that is permitted by the copyright and related rights legislation that applies to your use. For other uses you need to obtain permission from the rights-holder(s) directly, unless additional rights are indicated by a Creative Commons license in the record and/or on the work itself. This Dissertation has been accepted for inclusion in UNLV Theses, Dissertations, Professional Papers, and Capstones by an authorized administrator of Digital Scholarship@UNLV. For more information, please contact [email protected]. THE IMPACT OF REGULATING SOCIAL SCIENCE RESEARCH WITH BIOMEDICAL REGULATIONS By Brenda Braxton Durosinmi Bachelor of General Studies Virginia Commonwealth University, 1989 Master of Public Administration Trust: Impact for Organizational Team Building University of Nevada, Las Vegas, 1997 A dissertation submitted in partial fulfillment of the requirements for the Doctor of Philosophy in Educational Leadership College of Education The Graduate College University of Nevada, Las Vegas December 2011 Copyright by Brenda Durosinmi, 2011 All Rights Reserved THE GRADUATE COLLEGE We recommend the dissertation prepared under our supervision by Brenda Durosinmi entitled The Impact of Regulating Social Science Research with Biomedical Regulations be accepted in partial fulfillment of the requirements for the degree of Doctor of Philosophy in Higher Educational Leadership Department of Education Gerald Kops, Committee Chair Cecelia Maldonado, Committee Member Sterling Saddler, Committee Member Patrick Carlton, Committee Member LeAnn Putney, Graduate Faculty Representative Ronald Smith, Ph. D., Vice President for Research and Graduate Studies and Dean of the Graduate College December 2011 ii Abstract The Impact of Regulating Social Science Research with Biomedical Regulations: A Qualitative Study by Brenda Durosinmi Gerald C. Kops, J.D., PhD, Committee Chair Professor of Educational Leadership University of Nevada, Las Vegas Since 1974 Federal regulations have governed the use of human subjects in biomedical and social science research. The regulations are known as the Federal Policy for the Protection of Human Subjects, and often referred to as the ―Common Rule‖ because 18 Federal agencies follow some form of the policy. The Common Rule defines basic policies for conducting biomedical and social science research. Almost from the inception of the Common Rule social scientists have expressed concerns of the policy‘s medical framework of regulations having its applicability also to human research in the social sciences. The purpose of this dissertation was to investigate the impact of regulating social science research with the framework of biomedical research regulatory standards. Qualitative methodology is used to analyze the Office of Human Research Protection‘s Determination Letters, to facilitate in-depth interviews of human research protection program administrators, and to evaluate the Common Rule policy. iii The researcher reviewed 763 letters with 43 letters determined to be associated with social science research projects. The 763 determination letters represented a time span of 10 years, from 2000 to 2010. The letters were reviewed for indications of noncompliance or deficiencies to regulations specified in the Federal Regulations 45 CFR 46, Subpart A, (the Common Rule). Noncompliance or deficiencies by the IRB and HRPP support staff represented the majority of determination letter findings. In-depth interviews were conducted with HRPP administrators. The lack of flexibility of the Common Rule in its application to social science disciplines was a common theme in the responses of HRPP administrators. Evaluation of the Common Rule suggested the policy was effective and efficient for the IRB and its administrative support staff, but was less effective and not efficient for social science research projects. The assessment of the impact of regulating social science with biomedical regulations highlights the need for additional education and training of IRBs and their administrative support staff to more effectively apply a biomedical model of research regulation to the review and approval of social science research activity. The assessment additionally suggests the need for an ―update‖ of the Common Rule to address the specificity of new areas of social science research in which IRBs deliberate scrupulously with no regulatory guidance. iv Dedication In Memory of my father Manuel L. Braxton, Sr. and my brothers Manuel L. Braxton, Jr. & Michael S. Braxton v Acknowledgements My thanks and appreciation to Gerald Kops for his patience, for his guidance during the course of this dissertation, and for generously giving of his time and expertise to better my work. To the members of my dissertation committee, Cecelia Maldonado, LeAnn Putney and Sterling Saddler, I am grateful for their encouragement to endure with persistence. I must acknowledge my friends and colleagues who have helped me keep perspective on what is important in life through humor and unconditional support. Most importantly I acknowledge my family. To my children, Dawn, Lisa, Femia, and Lateef, your love and admiration propelled me when I thought I could not go any further. Your thoughts and prayers revived me when I was weary. I must acknowledge my sisters and brothers that were a constant source of inspirational encouragement, and a special acknowledgement to my sister Millicent, who provided much scripture and laughter during my times of despair. I also acknowledge my mother for her prayerful assuredness that I would survive my dissertation journey. And finally, I owe so much of this accomplishment to my husband who has supported me throughout my educational endeavors and all that I aspire to achieve. His value for educational achievement, unwavering encouragement and years of support for me to reach this goal will always be cherished. vi TABLE OF CONTENTS ABSTRACT .......................................................................................................... iii DEDICATION ....................................................................................................... v ACKNOWLEDGMENTS ....................................................................................... vi LIST OF TABLES ................................................................................................. x CHAPTER 1 INTRODUCTION ............................................................................. 1 Early Human Research Regulatory Codes ................................................ 2 Berlin Code ........................................................................................... 2 Nuremberg Code .................................................................................. 4 Unethical Human Research in the United States ....................................... 7 Tuskegee Syphilis Study ...................................................................... 7 Increased Funding for Medical Research .................................................. 8 Research with Vulnerable Populations in the United States ...................... 9 Human Research Regulatory Statutes in the United States .................... 12 National Research Act ............................................................................. 12 The Belmont Report ........................................................................... 13 The Common Rule ............................................................................. 14 Human Research Regulations and the ―New Sciences‖ .......................... 15 Social Scientists‘ Concerns of Overregulation ......................................... 17 Research Problem ................................................................................... 24 Research Questions ................................................................................ 24 Research Method .................................................................................... 25 Content Analysis ...................................................................................... 25 In-Depth Interviews ................................................................................. 27 Policy Evaluation ..................................................................................... 28 Complementary Analysis Research Method Application (CARMA) ......... 29 Limitations of the Study............................................................................ 32 Definitions ................................................................................................ 36 Significance of the Study ........................................................................
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