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The Biomedical Ethics of Donating Blood for Molecular and Genetics Research in Saudi Arabia

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The Biomedical Ethics of Donating Blood for Molecular and Genetics Research in Saudi Arabia THE BIOMEDICAL ETHICS OF DONATING BLOOD FOR MOLECULAR AND GENETICS RESEARCH IN SAUDI ARABIA By Abdallah Adlan Awad Adlan A thesis submitted to the University of Birmingham for the degree of DOCTOR OF PHILOSOPHY Medicine, Ethics, Society and History School of Health and Population Sciences College of Medical and Dental Sciences June 2014 University of Birmingham Research Archive e-theses repository This unpublished thesis/dissertation is copyright of the author and/or third parties. The intellectual property rights of the author or third parties in respect of this work are as defined by The Copyright Designs and Patents Act 1988 or as modified by any successor legislation. Any use made of information contained in this thesis/dissertation must be in accordance with that legislation and must be properly acknowledged. Further distribution or reproduction in any format is prohibited without the permission of the copyright holder. Abstract My main thesis is that Saudi culture, in the context of the field of Molecular Genetics Epidemiology (MGE) research, poses many challenges to the currently used biomedical research regulations developed by the Saudi National Committee of Bioethics (NCBE). The NCBE regulations are informed by selected international research ethics guidelines, and they are influenced by a set of assumptions about how we ought to think about ethics. The overall focus is on a version of liberalism, where there is a strong commitment to autonomy, there is a significant focus on informed consent, the harm principle guides the justification of action, and paternalism is seen as something that is to be avoided. There are no specific guidelines that regulate MGE research in Saudi Arabia. Therefore, it was important as a first step in the thesis to analyse the relevant regulations (both the Saudi and the selected international ones) and explore the related normative issues. One of the main empirical findings of this project was an observed and reported lack of adherence to the requirements of the NCBE regulations. There are a number of different ways to interpret this finding. One way, and this was suggested by some members of the focus groups, is that this research demonstrates a clear failure of researchers to abide by the appropriate guidance, and that the relevant response is to act aggressively to correct such research practice in the hospitals where the data was collected. This would ensure compliance with the guidelines. An alternative view is that the problem emerges from a mismatch between the liberal international guidelines and the nature of the Saudi context. One possible way to address this tension is to formulate a set of guidelines and research practices that build upon the nature of Saudi social relations and norms. This may result in a focus on what we can call trust-based, rather than the currently promoted autonomy-based, bioethics. II To those who loved me unconditionally, who accepted me as I am, who felt my pain and suffered it with me, who believed in me even when I doubted myself to my family. “Here's to the crazy ones. The misfits. The rebels. The troublemakers. The round pegs in the square holes. The ones who see things differently. They're not fond of rules. And they have no respect for the status quo. You can quote them, disagree with them, glorify or vilify them. About the only thing you can't do is ‘ignore’ them. Because they change things. They push the human race forward. And while some may see them as the crazy ones, we see genius. Because the people who are crazy enough to think they can change the world, are the ones who do.” Apple Inc. III Acknowledgments This has been a very long journey. It was full of emotions, and important life lessons. A journey in which all my weakness and challenges has been challenged to unprecedented levels. However, I would never have been able to take that journey without being blessed by an incredible “family” of tireless and dedicated people who helped me along with the challenge of bringing together this work. I will not be able to list all the names but I will try. First of all, my greatest gratitude is to my lead supervisor Prof. Heather Draper, who rescued this project after a very tough time. Also special thanks to my second supervisor Professor Angus Dawson for the never-ending support. You both provided me with inspiration and knowledge and with your help I survived the most stressful moments. I also thank you for your continuous professional and personal support, guidance and patience. I would also like to thank both His Excellency Dr. Mohammad Al Jumah, the former Executive Director of King Abduallah Medical International Research Centre and His Excellency Prof. Abdulaziz Al Suwailem, the vice president of King Abulaziz City for Science and Technology and the Chairman of the National Committee for Bioethics for their support and help through the way. I would like to thank my colleagues at King Khaled Eye Socialist Hospital, National Guard Health affair, and the Scholarship Department in King Saudi bin Abdulaziz University for Health Science for all the help and support. Also I am indebted to all my friends Abdurrahman Al Biladi, Ahmad Bokhari, Ghaiath Hussein, Najwa Adlan (my beloved Sister), Nofal Al Nahdi, Gregory Moorlock, and Simon Jenkins for their greatest support when I needed it. IV I am in speechless in thanks to my father, Mr. Adlan Awad Adlan, who is my role model in this life, my father equipped me with the most important tools to face all the great challenges and to conquer them by high self-esteem and believing in my ability to do it, and to my mother Asia Hashim Makkawi, who never stops encouraging and believing in me. She is the one who seeded and nurtured my power with her sacrifices and self-denial, providing us (i.e. her sons and daughters) with the best possible life style and dignity. I am also very thankful for Najwa Adlan (again!), Nesrren Adlan, Mohammad Adlan, and Nuha Adlan, my brother and three sisters. I am honoured to acknowledge and thank my beloved sweet wife Dr. Samar Al- Qahtani, the one who always provide me with unceasing support. She is the one who shared every second of this project, good and bad, thick and thin. She is also the one who lifts my spirit when I feel down, encourages me when I feel weak, stands by me when I feel lonely, and supports me with her unconditioned love. With all my love I am truly thankful for God for blessing my life with her. V Table of Contents ABSTRACT .......................................................................................................................... II TABLE OF CONTENTS ..................................................................................................... VI TABLE OF TABLES ........................................................................................................ XV TABLE OF FIGURES ...................................................................................................... XVI 1 CHAPTER ONE: GENERAL INTRODUCTION .......................................................... 1 1.1 SETTING THE SCENE ................................................................................................... 2 1.1.1 Informed consent ................................................................................................ 3 1.1.2 General introduction to DNA (the genetics material) ........................................ 4 1.1.2.1 Genetic Epidemiology ................................................................................... 5 1.1.2.2 Genetic Exceptionalism ................................................................................. 8 1.1.2.3 Molecular and Genetic Epidemiology (MGE) .............................................. 9 1.2 THE SAUDI ARABIAN CONTEXT ................................................................................. 9 1.2.1 The social context in Saudi Arabia ................................................................... 11 1.2.2 The Saudi cultural and political climate ........................................................... 11 1.2.3 Health-related research in Saudi Arabia ........................................................... 12 1.2.4 The emergence of bioethical debate in Saudi Arabia ....................................... 13 1.3 CHALLENGES OF MGE IN SAUDI ARABIA ................................................................ 16 1.3.1 Consanguinity ................................................................................................... 16 1.3.2 Premarital genetic testing in Saudi Arabia ....................................................... 19 1.3.3 Stigmatisation ................................................................................................... 22 1.3.4 Blood purity ...................................................................................................... 24 1.3.5 Patient vulnerability .......................................................................................... 25 VI 1.3.6 Conclusion of the Saudi Context ...................................................................... 27 1.4 THE NEED FOR EMPIRICAL DATA .............................................................................. 27 1.4.1 Normative policy- or practice-oriented bioethics ............................................. 32 1.4.2 The is/ought fallacy .......................................................................................... 33 1.5 THESIS AIMS AND OBJECTIVES ...............................................................................
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