Qualitative views about REA
Theme I: Knowledge of the community about tuberculosis
Tuberculosis is well known by the community as “disease of cough” (REA-PO01). The community knows that TB is infectious. However, the majority do not know the etiological agent of TB. A TB patients and a healthy layman said that “TB is a transmissible disease and the cause is bad air” (REA-TB02, REA-HC03). All TB patients and healthy controls said that TB is not a heritable disease. This is because “in our village, it is not limited to a particular family”. One female health professional with a 3-year of experience in DOTS clinic said: “There is no small village without a TB case” (REA-HP06).
A DOTS clinician with 15-year of experience classified TB patients into rural and urban:
“Rural communities are happy when they are diagnosed with TB. This is because, they have several experiences with TB patients who become cured after taking anti-TB drugs. Moreover, rural communities knew more people dying from cancer, hypertension, HIV, and diabetes mellitus. Thus, by taking these issues into consideration, TB diagnosed patients think that their curse is uncovered and survived from death penalty. On the contrary, people from the urban area become disappointed when they were diagnosed with TB. This is because they consider TB as disease of poverty and low socio-economic classes” (REA-HP02).
The following is the story of one TB-HIV co-infected patient
“I was diagnosed with TB 10 years before and then cured. Then, I went into a remote commercial center area for private work. There, I became sick and visited several health facilities. When my health condition became deteriorate, I left my work, returned to my family and then visited this hospital. Here, I was diagnosed with TB lymphadenitis. As soon as I started taking the medicine, the swelling started to decrease and now very small nodule remained. I know that, TB can be converted to HIV. I thought that my TB is due to bad air and dirty blood. TB is not a heritable disease” (REA-TB01).
Theme II: Knowledge of community about research and the challenges
The knowledge and awareness of Amhara community about “research” is heterogeneous. The literate community know the term “research”. Otherwise, the majority of the community members do not understand the term “research” and its scope. To our surprise, the research literacy of the majority of middle level health professionals is also low.
A 35 years old researcher with field data collection experience said that
“ I don’t think that majority of Amhara community can clearly define what does research mean. People often cannot differentiate research from medical service and supportive supervision” (REA-R01). Similarly, one of the health professionals in the IDI said that “the community views research as a medical service. That is why they ask us immediate result” (REA-HP06). A young male TB patient said “I do not know the difference between research and medical service. This is because I am from the rural area and I did not obtain any training before” (REA-TB03).
The challenging perceptions with regard to research includes the following. (1) “some consider research as a means of incentive” (REA-PO01), (2) “others consider it as systematic means of harming the community” (REA-PO01), (3) “some others think research as a secret business of researchers, spy organizations and had nothing to do with the participants or to the community”(REA-HP04) and (4) “some viewed research as a mere academic duty of medical students” (REA-HP04), (5) “the issue of social desirability bias” (REA-R04). According to FGD among regional TB officers, “doing TB susceptibility genomic study in ANRS might be challenging. Especially, the elite community might interpret the finding in connection with racism and in politically motivated way. Sharing the findings to stakeholders would increase trust and considered as a sign of respect” (REA-PO01).
Theme III: Approaching the community
In ANRS, there are different types of community structures (religious, political and social). Two or more of these structures can be used depending on the target population. The approach used in carrying out facility-based research is different from that of community-based research. In both cases, it was advised to follow the administrative steps outlined below (Fig. 1). One of the health professionals who participated in this study said that “people often reserved to talk to you without a formal letter from the upper responsible institution” (REA-HP04).
The field data collector with 15 years of experience shared his experience.
“During our work in Zarima north Gondar, one police was spreading misinformation and campaigning against the research team for attacking. However, since the kebele leader and militias were with us, he was detained and advised. Hence, from security perspective, I advised researchers to include kebele leaders or militias. From voluntarism perspective, HEWs are more respected and influential in their respective community” (REA-HP04).
Other researchers in a FGD of three participants said that, “Amhara people are conservative and closed. Unless you have an arbitrator, you cannot unlock their mind” (REA-R05). In apparent contradiction to the above view, a non-TB control participants forwarded a different view; “I believe that approaching the community with the kebele leaders might make some people unhappy due to political reasons or other conflict of interests. Thus, I advised researchers to go through themselves directly” (REA-HC04). Additionally, one of the TB patients said, that, “I can participate in any research which comes through by any route. However, I recommend researchers to approach participants through local health professionals or HEW” (REA-TB02).
A biochemist researcher with 10 years of research experience said that; “it is difficult to collect data without health professional from the study unit. In my experience of facility-based study, physicians treating study participants are the right persons for information provision, obtaining consent and data collection” (REA-R01).
Taken together, different types of conflict of interests and conspiracy theories are common in Ethiopia which make research and field works challenging. For instance, one Ph.D student was killed in West Gojam Zone of ANRS and two vehicles owned by Armaur Hansen Research Institute were burned out while collecting research data. Thus, the participants advised researchers to respect local regulations and recommendations (Fig. 1). According to a closer source to the two incidents mentioned above, “the causes were failure to adhere to the recommended local regulations” (REA-IRB03).
Information provision
A health professional participant and TB program officer said that “Verbal-based information provision at individual level is a preferred way” (REA-HP01). Another DOTS clinic physician said that “both verbal and written based information is preferable and we usually use both ways in community health education” (REA-HP06).
Another researcher in the FGD said that:
“The culture of reading is low in our community. Hence, I suggest verbal based information and giving the reading material can have an extra value that can be considered as a sign of respect and transparency. Additionally, group based information provision is good for learning and understanding. The limitation of group based information provision is that it can be dominated by a few people and might create an unnecessary argument which might divert the idea of major participants” (REA-R05).
Almost all participants agreed that the community was unable to understand common terms related to TB genetic study such as ”genetic”, “DNA”, “evolution” and “co-evolution”. No one told us phrases that can easily be understood and replace the above key words. A field epidemiologist in a FGD said that “our people do not know evolution, genomics, and co-evolution. Not only the English words, but also the Amharic version of the same words are jargon” (REA-R05). The community does not understand evolution. But, they explained evolution through “phenomena” (REA-R04), “change of time” (REA-PO01), “change of regimen, by history of war and famine” (REA-HP06), “comparing the changes in their crop seeds” (REA-R05).
In one FGD of researchers, they pointed out critical points which must be emphasized. “During information provision, interpretation of words has a significant impact in refusal. A standardized Amharic version might be desirable for providing balanced information” (REA-R04).
Theme V: Consent process
All participants said that, consent must be obtained at individual level and no one can give consent on behalf of another person in the context of ANRS. The big problem in consent process is the time when participants are asked to sign on the consent sheet.
“Obtaining a written consent is a must, especially when collecting clinical samples and doing genetic research”(REA-R04). Researchers in the FGD concluded that, “not only refusal, signature based interview is also likely to be biased. As a remedy, data collectors must be compassionate, friendly and be able to listen the participant’s idea that the participant want to say. Additionally, the researcher must explain clearly and adequately about the confidentiality of the data” (REA-R05).
Contrary to the above perceptions, one of the healthy controls said that, “asking a signature might be considered as a sign of respect” (REA-HC-04). Moreover, the TB program officer and DOTS clinician said that, “when you provide adequate and clear information about consent, some participants even thank us for being part of the study” (REA-PO01, REA-HP06).
Theme VI: Blood sample collection
Obtaining clinical samples from study participants is a challenge. The rural and urban communities have different perceptions about giving blood sample.
“Rural community avoids giving blood due to fear of the injection pain and said that I have no enough blood to give” (REA-HP02). A health professional said that “obtaining blood from healthy person and children is really challenging. However, if they are sick, they can give easily” (REA-HP02). One of the researchers shares his experience by saying: “in rural communities, not only for a research, they also refused giving blood for life saving transfusion to their family” (REA-01R).
The urban and elite groups of the community believe that blood is the main source of identity marker. As such, they fear for being traced by their blood.There is also fear for misuse of their blood samples for screening to stigmatizing diseases” (REA-R03). “They are also suspicious about the sterility of the syringe and possible nerve damage” (REA-R05). Thus, unless trust is built ahead of the data collection time, blood collection is not a simple procedure.
Explaining the amount of blood required for the research is also challenging and confusing for study participants to understand it. As such, the study explored an alternative volume measuring device that is simple and easily understood by the local community. The recommendations are to inform the participant
“by using small syrup measuring cap ”, “to recall their previous experience if they gave blood for diagnostic purpose”, “by marking the test tube or the syringe” and “to use common terms like two to three saliva or tear drops”.
Theme VII: Genomic incidental findings and incentives
Questions related to genomic incidental findings and incentives were forwarded to IRB members only. In an Ethiopian context, human genomic study is ethically reviewed at the national level by Ministry of Education. Based on IDI with IRB members. “Researchers do not adhere to the basic ethical principles. The rights and dignity of participants are not maintained” (REA-IRB03). “Since regional state and university IRB are level B, most of the recommendations for genomic study and reporting of genomic incidental findings are not known by level B IRBs” (REA-IRB01).
Research incentive is the causes for several conspiracy theories and paralyzing the whole research system. “As indicated in Amhara Regional IRB guideline, payment is made to participants if they spend over one and half hour within the research, have travel associated expense, and food is served” (REA-IRB03). In general, research associated incentives, reimbursement and compensation have to be well managed to avoid conflicts.