S4-1 Enabulele DoH Vatican
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CONDUCTING MEDICAL
RESEARCH IN LOW-
RESOURCED SETTINGS
UNDERTHE DOH.
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DR. OSAHON ENABULELE
Immediate Past President, World Medical Association.
Presented by:
Venue: Aula Vecchia del Sinodo, Vatican City.
Date: Thursday, January 18, 2024.
At the WMA DoH Revision Session
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Definitions
History and Gains of Research
Research in LMICs
Some Ethical considerations
Conclusion
Recommendations
OUTLINE
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SETTING THE
SCENE
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v Research is not new to humans.
v Benefits not in doubt.
v Troubling reality of disparities in conduct of
medical research across countries.
v This conversation is a welcome idea,
especially as Research has great impact on
population health and the DoH.
SETTING THE SCENE
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“A process of systematic inquiry or study of
the materials and behaviours of the physical
and natural world through observation,
experimentation, and testing of theories
against evidence.”
It involves the collection of data through
defined methodologies, analysis, and
interpretation of the data to generate findings
Research
DEFINITION
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HISTORY AND GAINS OF RESEARCH
• Observations of trends by humans.
• Advances in Modern Biology.
• 19th Century: Cellular Biology.
• 20th and 21st Century: Advanced
Scientific discoveries and Technological
developments.
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HISTORY AND GAINS OF RESEARCH
• Genetic engineering and advances
in Cloning technologies
• Genetically Modified Organisms
(GMOs): GM crops
• The Human Genome Project
• AI and Big Data.
• mRNA Technologies/Vaccines.
• Antimicrobials.
• Space travels/holidays.
• Renewable Energy.
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POSSIBLE
INTERVENTIONS
IN 2050
(Credit to Nikhil Adithyan)
• AI-enabled Human Robots and
Reincarnation or Rebirth of
People.
• Superhuman Clothing.
• Entire Dependency on
Renewable Energy.
• Space Vacations.
• Drone Solutions.
• Hyperloop.
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New/Improved Diagnostic
methods, Therapeutics & Vaccines
New/Improved medical
devices/ Health infrastructure
Better patient experience/ quality
of care
Improved health outcome/Life
Expectancy
Better job satisfaction/reduction
Of burnout
BENEFITS OF
RESEARCH
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THE CASE OF LOW RESOURCED SETTINGS
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Countries with a GNI per Capita of
between $1, 045 and $4, 095.
– World Bank
LMICs
DEFINITION
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LADEN WITH OPPORTUNITIES
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BUFFETED WITH CHALLENGES
• Poor Priority.
• Inadequate Funding.
• Resource/Logistical Constraints.
• Political interference/views.
• Poor awareness/Perception.
• Trust deficit/ Opposition.
• Legal/Regulatory framework.
• Ethical challenges/Misuse/Breach.
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RESEARCH CHALLENGES
• Unfair access to the benefits of Research/inequitable allocation.
• Cultural/Religious dogmas/superstitions/myths.
üDisruption of socio-cultural ethos.
• Deliberate distortions by ideologues/conspiracy theorists.
üInfodemia/unregulated social media/amorphous advisers.
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DoH & ETHICAL CONSIDERATIONS
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DoH AND ETHICAL CONSIDERATIONS
q Research Ethics Committees–DoH 23
ü Legal/ Reg/Policy framework (NHA).
ü Provision of monitoring info to REC.
ü Capacity: Approvals & Monitoring.
ü Submission of final report to REC.
q Informed Consent—DoH 26
ü Sufficient/Adequate information on the
aims, methods, etc.
ü Specific information needs of subjects.
ü Information about the general outcome
and results of the study.
q Vulnerable Groups–DoH 23
ü Equity: DoH GP 13.
ü Risk assessment & Mgt: DoH 18
ü Post-trial provisions: DoH 22 & 34
q Rights & Interests of Individual
research subjects–DoH GP 8
ü Kano drug trials
q Privacy & Confidentiality–DoH GP9
ü Physician’s responsibility.
ü Quality of Med Records Staff.
ü Lack of EMR.
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DoH AND ETHICAL CONSIDERATIONS
q Risks, Burden, & Benefits–DoH 18
ü Risk assessment.
ü Guarantee that the risk can be
satisfactorily managed.
q Compensation–DoH GP 15
ü Appropriate compensation and
treatment for subjects who are harmed
as a result of participation in research.
q Regulatn/Mgt of Biosamples/BioBanks
–DoH GP 32
ü ???Approval by REC
q Research Publication/Dissemination.
—DoH 35
ü Adherence to accepted guidelines on
ethical reporting—News media.
ü Publication of –ve, +ve, and inconclusive
findings.
q Unproven interventions in Clinical
practice—DoH 37
ü If it offers hope of saving life, re-
establishing health, or alleviating
suffering.
ü This intervention should be subsequently
researched to evaluate its safety &
efficacy—GNLD.
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RECOMMENDATIONS
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AWARENESS
CREATION
• Political/Community/ Public engagement.
• Benefits of research.
• The imperatives of the DoH and other
ethical norms and standards.
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RESEARCH
SHOULD BE
WELL FUNDED
• Adequate budgeting for research.
• Responsible investments in research.
• PPP support.
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ADVOCACY • Political/Institutional commitment to research
and its outcomes.
• Priority for research, its processes and
outcomes.
• Establishment of legal and regulatory
frameworks.
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RESEARCH
SHOULD BE
ETHICAL AND
REGULATED
• Responsible & protects humanity.
• Upholds ethical and moral obligations – DoH
• Abhors compromise of its processes.
• Strict enforcement of ethical and regulatory
codes.
• Monitors and evaluates its
findings/developments.
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BUILD PUBLIC
TRUST
Public interest Vs Interest Grp Approach
• Transparently communicates its
results/developments
• Appreciates the Socio-cultural context.
• Discourages abuse of research/ Bad research.
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CAPACITY
BUILDING &
MENTORSHIP
• Training and retraining.
• Curriculum development and review.
• Opportunities for mentorship.
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COLLABORATION
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§ Research that collaborates.
§ Promotes equitable sharing
of data/findings/ benefits.
§ Responsive and delivers
effective, affordable and
equitable solutions.
RESEARCH THAT COLLABORATES
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Quest for security of lives and welfare of Physicians: The First Anti-Kidnapping Street Protest March by Nigerian
Physicians Conducted in Benin City, Edo State, Nigeria, on August 5, 2009, under the leadership of the then
Chairman of Edo State branch of Nigerian Medical Association, Dr. Osahon Enabulele.
RESEARCH THAT SECURES THE LIVES OF RESEARCHERS:
A DEDICATION TO ALL PHYSICIANS AND RESEARCHERS
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CONCLUSION
The significance of research, particularly
human research, and its discoveries in
shaping human existence cannot be over-
emphasized.
It has been a major contributor to the
reduction of morbidities and mortalities,
and improvement in life expectancy in many
countries of the world.
Despite the opportunities that abound for
research in low resourced settings, they are
still buffeted by challenges which have
impacted on the pace and ethical integrity
of the research processes and outcomes.
For the global population to maximally benefit
from the research opportunities in low resourced
settings, the identified barriers need to be
addressed. In this regard, appropriate funding
and logistical support, awareness creation on the
benefits of research and the imperatives of the
DoH, capacity building and North-South
collaboration, as well as the emplacement of
adequate legal and regulatory standards need to
be given expression.
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APPRECIATION
Our Creator.
The WMA Leadership.
The DoH Revision Team.
Ms. Sunny Parks.
My Wife & Family.
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THANK YOU!
DR. OSAHON
ENABULELE
M.B;B.S,MHPM, FWACP,FNMA, FCMA
Email: osahoncmavp@gmail.com
lion_killer123@yahoo.com
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§ Pexels.com
§ Unsplash.com
§ Freepik.com
§ The Conversation, Sophia, the best
example of an AI-enabled Human-
Robot
§ New Atlas
§ The Lancet
§ www.cest.org.uk
PHOTO CREDITS
§ Knowledge People Creators
§ HistoryExtra
§ zdnet.com
§ lens.monash.edu
§ The Guardian
§ Science News
§ Business Standard
§ Robotics Business Review
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