S2-1 Dhai DoH Vatican

1/23/24
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MEDICAL RESEARCH TODAY: THE
GEOGRAPHICS OF VULNERABLE
POPULATIONS – AFRICA
Professor A Dhai
South African Medical Association / University of the
Witwatersrand, Johannesburg.
WMA Revision of the Declaration of Helsinki: Research in
Resource-Poor Settings – Vatican City (January 2024)
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PRESENTATION OUTLINE
• Overview of factors complicating clinical research in resource
poor settings
• Complexities specific to Africa
• African indigenous values & research
• Ethical developments since DoH 2013
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AFRICAN CONTEXT
• Africa: region of vast differences in health, education,
income between populations:
• Poverty with limited economic development
• Poor / no access to healthcare / limited options
• Low levels of formal education & literacy
• Inadequate community or cultural experience with understanding scientific
research
• Inadequate protection of human rights
• Discrimination on basis of health status
• Gender-based violence
• Corruption
• Civil war
• Digital divide
• Still recovering from colonialism, apartheid and more recently, pandemic
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AFRICA: CHALLENGES WITH RESEARCH
ETHICS
• Suspicious of researchers from HICs → reluctant to participate
in multinational clinical trials
• ethics dumping from HICS continues in Africa despite international and
local norms, standards and guidelines
• moral imperialism and colonialist thinking in some multinational clinical
trials persists and perhaps researchers from HICs see no need for ethical
guidelines to apply in regions like Africa where research that will not be
allowed in their countries can be outsourced to the continent
• Building trust amongst these communities is essential. It is
critical that local communities are consulted and engaged
with early on during the planning of research.
Dhai A Chapter 2. Equitable Access To Covid-19 Vaccines, Vaccine Research And Vaccine Apartheid On The African Continent: Challenges And Recommendations. In:Ethical Innovation for Global
Health. Pandemic, Democracy and Ethics in Research. Eds: Kurihara C, Greco D, Dhai A
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AFRICA: CHALLENGES WITH RESEARCH
ETHICS
• capacity of research Ethics Committees (RECs) to review and
approve the research in a timely manner.
• African governments and institutions have not adequately invested in
setting up RECs.
• Poor infrastructure leading to delays and inefficiencies in the
administrative processes is commonplace.
• Lack of / insufficient expertise for ethics review
• Lack of regular participation from members
• Lack of understanding of importance of REC functions – conflated with
other administrative functions
• Pressures from institutional heads, governments, sponsors, researchers –
interference with independence
• Unequal treatment of applicants – conflicts
• REC over-reach
Dhai A Chapter 2. Equitable Access To Covid-19 Vaccines, Vaccine Research And Vaccine Apartheid On The African Continent: Challenges And Recommendations. In:Ethical Innovation for Global Health.
Pandemic, Democracy and Ethics in Research. Eds: Kurihara C, Greco D, Dhai A. / D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research
and Innovation Governance, https://doi.org/10.1007/978-3-030-15745-6_6
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AFRICA: CONTEXT AFRICAN UNION, AFRICA CDC. PARTNERSHIPS
FOR AFRICAN VACCINE MANUFACTURING (PAVM) FRAMEWORK FOR ACTION.
FILE:///C:/USERS/A0004256/DOWNLOADS/PAVM-FRAMEWORK-FOR-ACTION%20(1).PDF
• Weak regulatory capacity for research, development and
production;
• Foreign donations: perpetuate dependence and add to the
impediments to development of interventions against diseases
in Africa;
• Insufficient funds to medical scientists, research and
development
• While expertise exists in Africa – spread across the continent,
with limited connections.
• Lack of open and well paid posts, graduates of training
programs frequently leave their countries for opportunities in
higher-income regions
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AFRICAN INDIGENOUS VALUES
• Underscores interconnectedness, interrelatedness and interdependence.
• African autonomy, personhood and communalism demonstrated
appropriately by Mbiti “I am because we are, we are therefore I am.”*
• indicates the importance of the community in African indigenous value systems and
what it means to be a human person – common humanity.
• In line with the Nguni and Sotho/Tswana sayings, umuntu ngumuntu
ngabantu and motho ke motho ka batho, a human being is a human
being because of other human beings. Hence, a person cannot function in
isolation and participate independently in a community of other people –
being human necessitates the affirmation of the humanity of others
• In health research, translates to the need for participating in studies
towards the greater good for all. It would also require that those
participating be protected from exploitation and other forms of harm and
wrong.
* Mbiti J. Introduction to African Religion and Philosophy. Oxford Portsmouth: Heineman Educational Books 1991
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AFRICAN INDIGENOUS VALUES
• Ubuntu standard:
• reflects living in solidarity with other people and humanness that is grounded
in social life. Engaging and getting engrossed in the life world of the Other,
without taking a stance of superiority, is a prerequisite for ethical conduct in
this context. This has particular bearing, inter alia, in the researcher-
participant relationship, international collaborative research, ethics dumping,
community engagement.
• Lekgotla:
• discussion and dialogue in the community as seen with respect to the
indigenous African tradition of lekgotla where all gather under a tree to
discuss and exhaust all the options, opportunities and risks involving a
particular topic could be likened to meaningful community engagement in
health research. There has to be a mutually respectful conversation in which
members of the community are given a chance to voice their opinions
towards reaching a consensus. Hence, the knowledge generated from the
research would not only be scientifically constructed, but also socially and
communally negotiated.
• through this type of lekgotla, the issue of the type of informed consent for the
study in question can be explored and consensus arrived at.
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2021
Example of application of
African Indigenous Values
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2016
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2016
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2018
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2021
Recommendations to:
• Governments and Regulatory authorities
• Researchers
• International Organisations & Funders
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WMA DECLARATION OF HELSINKI 2013
• “Although it may be appropriate to consult family members or
community leaders …”(art25)
• Vulnerable Groups & Individuals:
• “Some groups and individuals are particularly vulnerable and may have an
increased likelihood of being wronged or of incurring additional harm.
All vulnerable groups and individuals should receive specifically considered
protection.(art19)
• Medical research with a vulnerable group is only justified if the research is
responsive to the health needs or priorities of this group and the research
cannot be carried out in a non-vulnerable group. In addition, this group
should stand to benefit from the knowledge, practices or interventions that
result from the research.”(art20)
• General Principles & articles relevant to resource poor settings but
not sufficient
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