the ethical issues and challenges of medical research in low-income countries : ethiopia adamu...
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The Ethical Issues and Challenges of Medical Research in Low-Income
Countries : Ethiopia
Adamu Addissie MD MPHBSMS (Brighton) & SPH (Addis Ababa)
July 19, 2013
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Introduction
• Universal International Ethical Guidelines Vs Varied and Dynamic Contexts in Low-Income countries
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Conceptual Framework
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Study Objective
• To assess the major ethical issues and perceived gaps in the current medical research consent processes in Ethiopia
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Method
• A Mixed Methods study was conducted in July-September 2012,
• Ethiopian research institutions and universities• Quantitative: 241 self-administered interviews
http://www.surveymonkey.com• Qualitative: 19 in-depth interviews
(health researchers, ethics committee members and health research regulators
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GONDAR
JIMMA U.
AAU
EHNRI
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Profile of researchers, ethics committee members from various Ethiopian research institutions, September, 2012 (n=241)
Major Training (multiple responses) Biology Public Health Social Science Medicine Laboratory Nursing Others ()
28 90 13 63 33 19 63
11.6 37.3 5.4 26.1 13.7 7.9 26.1
Roles in research (multiple responses) Lead researcher/ PI Co-investigators Data collector Field Worker Ethics committee member Data encoder Other
198 179 92 76 62 23 19
82.2 74.3 38.2 31.5 25.7 9.5 7.9
Training on research Ethics Yes No
158 83
65.6 34.4
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Opinions of Researchers from Various Ethiopian Institutions on the Consent Processes and Development of REA, September, 2012 (n=241)
Variables
Frequency %
Consent form preparation done by (multiple responses) By the investigator With prior assessment With stakeholder participation By the sponsor Others (research advisors, collaborators, students)
142 70 41 17 13
58.9 29.0 17.0 7.1 5.2
Opinions on consent process (multiple responses) Consent is understood by participants Satisfied with the current consent process Best interest of participants is considered
97 37 35
40.2 15.4 14.5
Common challenges in consent process (multiple responses) Lack of clarity Inadequate information Language Cultural difference Undue expectations Power imbalance Coercion Others
116 82 68 66 64 50 19 11
48.1 34 28.2 27.4 26.6 20.7 7.9 4.6
Pre–assessment for Consent Process (multiple-responses) Important to contextualize consent Approach participants before the study for input Important to involve locals in consent design Rapid assessment of the situation before hand Know such initiatives already
230 196 171 95 29
95.4 81.3 71 39.4 12
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Perceived gaps and problems in the current consent process (Qualitative)
• Language:• Lack of awareness about research, health and
ethics: • Undue Expectations by participants and
Manipulation by researchers:• Undue Focus on consent and recruitment
[without adequate information]:• Undue Emphasis on rules and procedures:
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Language
“When we come to information, there is a problem of language, ... Ethiopia is a diverse country, so even when you translate to Amharic, it is hard to bring the understanding, it is hard to translate scientific words to Amharic. ..." [Researcher and ethicist, AAU]
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Lack of awareness about research, health and ethics:
" The society might be where they have no knowledge about research... People might also not understand what is written if they can’t read. These are (some) loop holes " [Researcher, EHNRI]
" Even, the participants don’t know what .. research is ... they don’t know whether the research has benefit or harm ... [they] say yes without knowing it" [ Researcher, JU]
".......In Ethiopia, most places where research is done, the people
don’t know how to read and write, so how much do the researchers need to explain? " [ Researcher and ethicist, AAU]
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Undue Expectations by participants and Manipulation by researchers:
" There is also this thing, ... there is (even with) the tone of your voice, you might emphasis mainly the benefit, there might be some persuasion. (And), they have to believe in it "
[Researcher, JU]
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Focus on consent and recruitment [without adequate information]:
" .. there is a lot of negotiation and bargaining (around consent), which is not a proper way of getting a consent or is a proper consent (process) application" [Researcher, JU]
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Emphasis on rules and procedures:
" Even the Ethiopian Civil law has been too protective to the extent of not allowing the conduct of trials – Ethics should not hamper Science!" [Researcher, AAU]
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Suggestions to improve the current consent process.
• Involvement of the community/participants:• Training:• Differentiated approach:• Pre-assessment:• Field visits:• Balanced approach, ‘not to be a hurdle for
research’:
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Conclusion
Even though there is a huge expansion of health and medical research activities in Ethiopia, the capacity of ethics review systems lags behind. There are critical gaps in ensuring a fully ethical consent process. Problems arise in three distinct areas: – 1. The health research review system, 2. Amongst researchers, and 3. Amongst potential participants.
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Acknowledgment
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አመሰግናለሁ !
Thank you !
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