The biomedical ethics of donating blood for molecular and genetics research in Saudi Arabia

338 Pages·2015·3.17 MB·English

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

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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 ................................................................................ 35
1.6 RESEARCH QUESTIONS ............................................................................................. 36
1.7 SUMMARY ................................................................................................................ 37
SECTION ONE: THE NORMATIVE ANALYSIS OF THE SELECTED GUIDELINES
...................................................................................................................................... 38
2 CHAPTER TWO: THE INTERNATIONAL GUIDELINES ....................................... 39
2.1 INTERNATIONAL GUIDELINES ON BIOETHICS: INCLUSION AND EXCLUSION CRITERIA 39
2.2 THE CONTEXT OF THE SELECTED INTERNATIONAL GUIDELINES ................................ 40
2.2.1 Nuremberg Code .............................................................................................. 40
2.2.2 Declaration of Helsinki ..................................................................................... 41
2.2.3 International Conference of Harmonisation – Good Clinical Practice (ICH-
GCP) .......................................................................................................................... 43
2.2.4 Council for International Organizations of Medical Sciences (CIOMS) ......... 45
2.2.5 Universal Declaration of Bioethics and Human Rights of UNESCO .............. 46
2.3 HOW MOLECULAR & GENETICS EPIDEMIOLOGY COULD BE REGULATED: ................ 47
2.3.1 Review by local ethics committees .................................................................. 47
2.3.1.1 Accepting only properly constituted and justified research ........................ 48
2.3.1.2 Respecting other cultural norms .................................................................. 49
2.3.1.3 Avoid exploitation of the local research subject ......................................... 50
2.3.2 Consent ............................................................................................................. 55
VII
2.3.3 Risk ................................................................................................................... 60
2.3.4 Identifiable material .......................................................................................... 63
2.4 SUMMARY ................................................................................................................ 64
3 CHAPTER THREE: THE SAUDI RESEARCH GUIDELINES .................................. 74
3.1 THE NATIONAL COMMITTEE OF BIOETHICS (NCBE): .............................................. 74
3.2 THE SAUDI NCBE GUIDELINES: ............................................................................... 77
3.2.1 Terminology defined by the NCBME .............................................................. 77
3.2.2 Sending Biological specimens out of the country: ........................................... 79
3.2.3 Accepting only properly constituted and justified research ............................. 84
3.2.4 Informed Consent: ............................................................................................ 89
3.2.5 Biobanking in Saudi Arabia ............................................................................. 94
3.3 SUMMARY ................................................................................................................ 97
4 CHAPTER FOUR: THE SAUDI AND INTERNATIONAL GUIDELINES VERSUS
THE SAUDI CULTURAL CHALLENGE .................................................................. 98
4.1 INTRODUCTION ........................................................................................................ 98
4.2 AUTONOMY-BASED BIOETHICS ............................................................................... 98
4.3 INFORMED CONSENT IN SAUDI ARABIA .................................................................. 105
4.3.1 Informed consent and the assumption of vulnerability .................................. 106
4.3.2 Informed consent and the value of trust ......................................................... 107
4.3.3 Informed consent in Saudi hospitals ............................................................... 108
4.4 STIGMA IN THE TRIBAL CONTEXT ........................................................................... 110
4.5 OWNERSHIP OF GENETIC MATERIAL ...................................................................... 115
4.6 SENDING SAUDI GENETIC MATERIALS OUTSIDE SAUDI ARABIA ............................. 117
4.7 SUMMARY .............................................................................................................. 120
VIII
SECTION ONE: SUMMARY ........................................................................................... 121
SECTION TWO: THE EMPIRICAL PROJECT .............................................................. 122
5 CHAPTER FIVE: METHOD ...................................................................................... 122
5.1 BACKGROUND........................................................................................................ 122
5.2 DESIGN .................................................................................................................. 122
5.2.1 Data Collection ............................................................................................... 123
5.2.1.1 Overview ................................................................................................... 123
5.2.2 Phase One – Observations .............................................................................. 124
5.2.2.1 Recruitment and ethical considerations ..................................................... 126
5.2.2.2 Inclusion and Exclusion criteria ................................................................ 128
5.2.2.3 Sampling .................................................................................................... 128
5.2.3 Phase Two – Interviews with patients who had been invited to donate blood for
MGE research ............................................................................................................ 129
5.2.3.1 Sampling .................................................................................................... 131
5.2.3.2 Recruitment and consent process .............................................................. 132
5.2.3.3 Inclusion and Exclusion criteria ................................................................ 133
5.2.3.4 Interviews, language and translations ........................................................ 133
5.2.4 Phase Three – Focus Groups .......................................................................... 135
5.2.5 Analysis .......................................................................................................... 138
5.2.5.1 Interim analysis: ........................................................................................ 139
5.2.5.2 Observation Data Analysis: ....................................................................... 140
5.2.5.3 Phase Two analysis:................................................................................... 142
5.2.5.4 Phase Three Analysis................................................................................. 144
5.2.6 Validation and trustworthiness ....................................................................... 145
IX