Rapid Ethical Appraisal in Action
Fasil Tekola1,2, Jonas Kengne3, Susan Bull4, Bobbie Farsides1,
Melanie Newport1, Samuel Wanji3, Mossy Foot Treatment and
Prevention Association5, Gail Davey1
1Brighton
and Sussex Medical School, UK
2School of Public Health, Addis Ababa University, Ethiopia
3Research Foundation in Tropical Diseases and Environment, Buea,
Cameroon
4The Ethox Centre, University of Oxford, UK
5Mossy Foot Research Project, Soddo, Ethiopia
Genetic susceptibility to podoconiosis
Challenges
• Explaining complex genetics research to
communities will little formal education
• Guidelines focus on individual-based
consent but family members become part
of the study without their consent
• Podo families are stigmatised as a result
of the genetic nature of the condition:
external research interest may heighten
stigma
Study sites
Study Design
• In-depth interviews with various
stakeholders including:
–
–
–
–
–
researchers
fieldworkers
Staff of local NGOs (MFTPA & MVIFAD*)
Community leaders
Community members
• Focus group discussions with
community members
• Two sites in Ethiopia and Cameroon
*Mossy Foot Treatment and Prevention Association
Mbebah Vigilantic Farming and Development Association
Sitting in my house God sent this organization [MFTPA] for me and I am
now very well. Now I can comfortably walk and work. [Female participant]
Themes
• Basic knowledge of the concept of research
• Language, content and comprehension of information
provided
• Perceptions of informed consent
• Factors facilitating or hindering recruitment to research
• Preferred approaches and communication style with the
community including authority structures
Basic knowledge of the concepts of
research and informed consent
“It helps us relieve from our suffering; it will give us rest from this
day and night burning disease” (community member E)
“Research is a process through which observations and
investigations are made in order to discover, to find out
something” (community member C)
“I think to come and take part in this work; we need to know the
reason of the study; to know the objectives, and to be sure that
you people are doing the right thing” (community member C)
“Research and health care are not the same. As health comes up
after research to care or treat a patient” (Male Community
member C)
Factors facilitating or hindering
recruitment to research
• Views of family, neighbours, community
• Language & forms
• Absence of a cure - a curse from God
• Stigma
• Confidentiality
• Trust – who is asking them to consent?
“Previously
even my friend
was spitting on
me when my
legs were
swollen and
smelling bad”
Stigma
They see people
from leg to head, not
up down. A healthy
person never likes to
marry a
podoconiosis
patient.
“It is better to die
than catching this
disease because it
keeps you at
home so that you
starve and thirst
while you are
alive”
Disclosure of Personal Health Information
“I am not happy when other people know about my
disease. Why should I tell people who undermine? Why
should I make those people laugh at me? I tell people
like you because I can be helped and cured” (Female
community member E)
“They (MFTPA) also keep our secret that is why right now I
am telling you the truth” (Male community member E)
“No, I will not mind somebody to know my illness provided
he/she will be secretive. Any medical personnel can
check my illness” (male community member C)
Preferred approaches and communication
style with the community
“…people rely on the traditional council and the traditional council is
under the Fon. So when you contact the Fon and the traditional
council, the people will know that it is something good” (Health
worker C)
“The family head should give consent because he is the custodian of
the family and if anything happens to any member of the family he is
the one to answer any questions that will come after it.” (male
community member C)
“Usually, for research that involves any family member, particularly
children, the father gives permission, as males are usually head of
households. However, your study is sensitive. It supposes genetic
transmission within a family. If I decide on behalf of my child, she
may be disappointed one day when she grows old if the study
touches the pride of her family” (Female community member E)
“...it is clear that it is the father who always takes the
decision, but that does not mean that he is always right.
Sometimes, the father may say ‘no’ but after arguing with
him (convincing him), he can change his decision.” Adult
female community member C)
“I don’t think somebody should decide for me now, so
anything concerning consent or research should be
determined and decided by me because I am old enough
now to know what is good for me.” Young male
community member C)
Recommendations
• Build on words, narratives and metaphors used in
the community: avoid technical language
• Use non-verbal materials e.g. videos
• Focus on issues of most interest to participants –
e.g. the benefits, issues of confidentiality
• Develop a relationship with prospective participants
showing them respect and a desire to help
• Work in partnership with those who are trusted and
respected by the community
– e.g. NGO such as MFTPA or authority structures
identified by the community
• Test comprehension of participant to ensure ‘true
voluntariness’
Hierarchical informed consent process
Ethiopia
MFTPA
Head of Kebele
Church leaders
process
Group discussion,
sensitization, introduction of
researchers, follow up,
random selection,
recruitment criteria
Cameroon
Health Centre
Fon
Quarter Head
Head of Household
Family
Head of Household
Member of Household
Individual Consent,
Sample collection
Member of Household
Discussion points
• Some common themes identified
• Also important differences - no ‘one size
fits all’
– Related to previous research experience,
local support groups
– Need to undertake REA in research-naïve
communities or when undertaking complex
studies such as genetics or clinical trials