The Ethical Issues and Challenges of
Medical Research in Low-Income
Countries : Ethiopia
Adamu Addissie MD MPH
BSMS (Brighton) & SPH (Addis Ababa)
July 19, 2013
Introduction
• Universal International Ethical Guidelines Vs
Varied and Dynamic Contexts in Low-Income
countries
2
Conceptual Framework
3
Study Objective
• To assess the major ethical issues and
perceived gaps in the current medical research
consent processes in Ethiopia
4
5
Method
• A Mixed Methods study was conducted in JulySeptember 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
6
7
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 ()
Roles in research (multiple responses)
Lead researcher/ PI
Co-investigators
Data collector
Field Worker
Ethics committee member
Data encoder
Other
Training on research Ethics
Yes
No
28
90
13
63
33
19
63
11.6
37.3
5.4
26.1
13.7
7.9
26.1
198
179
92
76
62
23
19
82.2
74.3
38.2
31.5
25.7
9.5
7.9
158
83
65.6
34.4
8
Opinions of Researchers from Various Ethiopian Institutions on the Consent Processes
and Development of REA, September, 2012 (n=241)
Variables
Consent form preparation done by (multiple responses)
By the investigator
With prior assessment
With stakeholder participation
By the sponsor
Others (research advisors, collaborators, students)
Opinions on consent process (multiple responses)
Consent is understood by participants
Satisfied with the current consent process
Best interest of participants is considered
Common challenges in consent process (multiple responses)
Lack of clarity
Inadequate information
Language
Cultural difference
Undue expectations
Power imbalance
Coercion
Others
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
Frequency
%
142
70
41
17
13
58.9
29.0
17.0
7.1
5.2
97
37
35
40.2
15.4
14.5
116
82
68
66
64
50
19
11
48.1
34
28.2
27.4
26.6
20.7
7.9
4.6
230
196
171
95
29
95.4
81.3
71
39.4
12
9
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:
10
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]
11
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]
12
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]
13
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]
14
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]
15
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’:
16
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.
17
Acknowledgment
18
አመሰግናለሁ !
Thank you !
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