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 Rapid Ethical Appraisal in Action

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 walkand 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?

Stigma “Previously even my friend was spitting on me when my legs were swollen and smelling bad” 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 process Cameroon Group discussion, sensitization, introduction of researchers, follow up, random selection, recruitment criteria MFTPA Head of Kebele Church leaders Health Centre Fon Quarter Head Head of Household Family Head of Household Individual Consent, Sample collection Member of Household 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

Rapid Ethical Appraisal in Action