Introduction

Prospective medical research participants may have experienced a range of traditions of healthcare and hold various beliefs about illness and causation of illness. Participants will often be unfamiliar with the concept of research and may be sensitive to some practices, such as taking blood samples. Local, social, cultural and economic contexts are therefore critically important when research is designed [1,2].

International research collaborations now commonly include investigators and participants from developing countries. While international ethical guidelines may govern these collaborations, in reality, these take very little account of the different social structures, cultural norms, legal frameworks and methods of communication to individual study participants or the wider community [3].

In Ethiopia, research is governed mainly by principles and regulations established by regulatory authorities such as the Ethiopian Science and Technology Commission (ESTC), now Ministry. The problem is not lack of regulation, rather the generic nature of international guidance on informed consent form content. This has given rise to criticism of the western approach to identifying and addressing ethical issues related to research in developing country settings [4]. The inflexible use of international ethical guidelines in health research has prompted investigators to seek an approach to adapting these guidelines to local situations [5,6].

Information gathered from patients, researchers, fieldworkers and potential participants can help to shape the research agenda as well as the consent process for subsequent studies. This information may suggest how to explain a research project, how decisions to participate may be reached, and how true respect for participants can be fostered [2]. Various studies conducted in developing countries have emphasized the importance of addressing the local context while respecting absolutely the universal ethical standards[7], especially in the developing world where there is a difference between what is assumed by researchers and the practical reality on the ground [2,8,9]. A major challenge for researchers is to deliver complex information at the right time in appropriate language and style. To this effect, informed consent documents should be adapted to the local culture and the educational level of the population [10]. Bull and Farsides recognized that problems often arose when ethics committees in low-income countries made decisions based on international guidance that either missed issues of importance locally or over-emphasized issues that had little ethical importance outside a western perspective [9].

A qualitative study done in Ghana used a rapid assessment tool designed to inform the adaptation of interventions to local cultures and conditions. Result of the study showed that MalariaGEN participants and field staff seeking consent were generally satisfied with their understanding of the project and were familiar with aspects of the study relating to malaria [8]. This tool has become known as Rapid Ethical Appraisal or Assessment (REA—a brief qualitative intervention designed to map the ethical terrain of a research setting).

More recently, the Rapid Ethical Assessment approach was used prior to genetic studies in Southern Ethiopia and North West Cameroon, to inform consent form development and the processes of seeking consent from the community and individual participants. Approaching study subjects via locally trusted individuals and preceding individual consent with community sensitization were considered the optimal means of communication [2,11,12].

The current study aimed to explore the effects of social, cultural, and religious factors in the informed consent process of a HPV-serotype prevalence study. The parent study planned to use vaginal swabs and blood collection [13], which together with possible gender and culture related barriers suggested that Rapid Ethical Assessment would be essential before the actual study.

Ethical considerations

Ethical clearance was first obtained from the Research Ethics Committee (REC) of Addis Ababa University School of Public Health(AAUSPH). Following endorsement by the REC, the Tigray Regional Health Bureau (RHB) was informed about the objectives of the study through a support letter from AAUSPH. After reviewing the proposal, the Tigray RHB wrote a permission and support letter to Hintalo-wajirat district. Then Key Informants were asked for verbal consent to confirm informed voluntary participation. Both the current study and the proposed parent study were approved by Research Ethics Committee (REC) of AAU, who considered that since the current study was non-invasive and used only interviewing of participants, verbal consent would be adequate. An independent community member acted as witness for voluntary informed decision making of participants to take part in the study.

Methods and Materials

Data collection and analysis

Data were collected by a multi-disciplinary team composed of one MSc in social anthropology and two MPH graduates. The local leaders suggested key informants and guided the team on socio-cultural events in the community. Three of the team members were native speakers of Tigrigna, the local language, and two of them were familiar with the study area. The data collectors had substantial qualitative experience and were given orientation about the interview and the parent study. Study team introduced themselves and objective of the study before each interviews and group discussions. All data collectors were male except one female community health workers leader who was involved to guide the team but no role in data collection and analysis.

We conducted the Rapid Ethical Assessment based on eight thematic areas: knowledge about biomedical research and treatment, terminologies of cervical cancer, the consent procedure, sample collection, communication channels, gender dynamics of decision making to participate in research, participant selection, and their expectations from taking part in the study. These thematic areas were developed priori to data collection and analysis. Out of the 45 participants included in this study: three were administrative leaders, three were religious leaders (two Orthodox and one Muslim), six RHEWs, two field supervisors, one women’s association leader and the rest 30 were non-leader residents of Hintalo-wajirat district. We assumed that minority segment of the community somehow represented by the non-leader residents who were interviewed while they were visiting health facilities, attending community meetings, participating in community development activities, and collecting fertilizer from agricultural offices.

We did a total of 11 recorded IDI (at least one from each segment of the community mentioned above) and 5 FGDs(includes two women groups, one men group, one mixed group, and one group of RHEWs and field supervisors). Each group included 6–8 participants of different age group. We used both homogeneous and heterogeneous groups for the FGDs to enhanced credibility through free discussion among the participants and to check any gender based differences. We looked at consistencies of concepts between the one to one interviews and group discussions, and among the different FGDs. Transferability were also checked by triangulation of interviews with observation data. A tape recorder was used for recording the IDI and FGDs. At the end of each day, the team debriefed the assessment, took corrective measures where necessary and planned for the next day. Team members also participated in a range of social activities, including markets and local meetings, to collect socio-cultural data by observation. After sufficient data had been collected, they were transcribed in Tigrigna and then translated into English.

Data analysis was done as a separate stage following data collection and used open coding software[15–17]. Although the study period is short we used a kind of explorative ethnographic study focusing on subjective experience and interpretation of research and treatment in relation to parent study in the particular setting and context. First the PI read the complete transcripts and generated a list of codes. Then after aggregating and defining concept, the PI developed memos to elaborate the concepts or categories developed. The findings from observation and notes from debriefing were also included in the analysis. Finally, integration of categories was done by linking them to the themes by using techniques including rereading memos, immersion in the data, creating descriptive sentences and drawing diagrams.

Results

Discussion

The rapid ethical assessment described here revealed a number of issues relevant to the ‘parent’ study, a survey of HPV- serotype prevalence. Problems regarding informed consent are usually created when the researchers and the potential participants are from different cultural and religious backgrounds [18]. Identifying and addressing such issues is part of the investigators’ responsibility. Researchers should pay great attention to these issues so that participants are well informed and have good comprehension of the informed consent documents that they are required to sign. Furthermore, researchers should take all the steps necessary to ensure that participants fully understand what is being stated in the consent form [19].

The rapid assessment enabled us to modify the information sheet and consent procedure to the local culture and the educational level of the study population. Other researchers have employed the same approach to optimize consent information for research in low income and resource limited settings[2,8,9,11,12].

One of the difficulties that investigators and other research personnel often encounter during informed consent process is “therapeutic misconception” which can render informed consent invalid [20]. The therapeutic misconception occurs when a research subject fails to grasp the distinction between clinical research and ordinary treatment and attributes therapeutic intent to research procedures [21]. The therapeutic misconception matters ethically because it is incompatible with truly informed consent and thus undermines the research enterprise. Disregarding, fostering, or taking advantage of misplaced trust may affect subjects’ self-trust and their perception of researchers, disturb other trust relationships, and erode public confidence in biomedical research [22]. In our study, therapeutic misconception was a big deal in rural resident participants, farmers, house wives and religious leaders. Most of the participants understand health research in terms of laboratory investigation to diagnose a disease, while others has explained research relating to land and agricultural farming, which coincides with other study findings[11,12,23]. This could be due to the fact that most of the people in Ethiopia are engaged in agriculture and have experience related to agricultural research and best practice expansion among farmers. In the other hand, administrative leaders, community health workers and supervisors had better understanding of research and treatment. This could be due to their previous exposure to a research as a participant or as a facilitator of community based research. These findings were in line with an interventional study conducted in Malawi; information was given in the context of the language, culture and beliefs of the society where the proposed research would be conducted [24,25]. Explaining health research in terms of agricultural studies, for example sowing in lines and using fertilizer to make farmland more productive, may be helpful for participants to understand what health research mean in the rural parts of Ethiopia.

Research in developing counties is influenced by many barriers to ensure participant understanding. Language barriers often present difficulties during informed consent in developing countries. Problems can arise not only during the process of obtaining consent from an individual participant, but also in the process of translating the documents. Misunderstandings can occur because of incorrect or inadequate language translations [26,27]. Efforts to improve the quality of informed consent, like simplifying and adapting consent protocols are necessary, especially when dealing with cultures and languages in communities with previously unexposed to biomedical concepts and terminology [28]. There is no logical reason to insist that informed consent be identical in countries with markedly different cultures, socio-traditions, and literacy [29]. Ethiopia is a country having more than eighty ethnic groups with different language, culture and traditional believes in which ethical appraisal and socio-culture mapping might be important for research and health care practice.

In our study we found several local terminologies used for cancer. ‘Menkersa’ and ‘kintarot’ were most frequently mentioned. These terms were used for any externally visible malignancy on the body for which herbal ointments are used. The name ‘Menkersa’ is also related to something bad which cannot be avoided easily. Breast cancer was the type of cancer that most participants were familiar with, through television programmes, but they had little awareness about cervical cancer. There were also misconceptions surrounding the genesis of cancer, including beliefs that any wound changes to cancer unless treated rapidly. Other participants trusted in herbal ointments to treat any surface malignancy, which might have a negative impact on early management of cancer. Other studies have shown that misconceptions related to the etiology of cancers have a negative impact on health seeking behavior in Ethiopia [30,31].

A bond of trust should develop between researchers and the community as complementary partners in the research enterprise to improve informed comprehension of research participant and ideally lead to increased recruitment and retention rates [4]. Respect for cultural traditions builds such a foundation of trust between researchers, study participants and the local community. Researchers should identify concerns that are culturally tailored and develop strategies to address them in a meaningful way. If possible, investigators should consider developing alternative methods for achieving successful results[32,33].

The most accepted way of information dissemination to and communication with the communities were through religious leaders. Health professionals and community leaders (Bayto,Tena-fana) were also good channels for information dissemination to the community. The researcher going alone to the community may experience difficulty in communication and lose the trust of the community, who may be suspicious of hidden agendas behind the research objectives. On the other hand, over-reliance on religious leaders and health professionals might result in undue influence to participate in the study without genuine understanding. In our case, participants explained that they did not need to ask who we were, if we approached them with local health professionals.

Obtaining valid and appropriate informed consent is both an ethical and legal requirement to protect the rights and welfare of human subjects. The method by which consent is confirmed (written or verbal) is left open by many ethical review committees. Participants generally advised not insisting on signatures as this might act as a restraint on what participants would divulge, and also stated that signing the consent form was less important than ensuring that they understood what was involved in the research.

Verbal consent may be acceptable for research participants who are illiterate and, therefore, cannot read or sign informed consent forms. In some regions, participants may be unwilling to sign consent forms in the belief that they are signing away rights, or that other adverse repercussions may follow. If requesting that participants to sign consent forms is inappropriate, other means of recording their consent to participation is required; for example, audio taping or use of an independent witness to observe the verbal consent. Sometimes the research worker who is informing the participant will sign a form stating that the appropriate information was given and verbal consent received [3,34,35]. Tekola, et al. found that the use of written consent forms in less literate populations may unfairly exclude potential participants who cannot read or write, and may create confusion and anxiety particularly for potential participants who are unaccustomed to signing documents [2]. Performing Rapid Ethical Assessment may be helpful in order to identify the optimal approach for a given community, which can then be approved by the respective ethical review committee.

The parent, HPV-serotype prevalence study, required collection of blood and vaginal secretion samples. In the REA participants explained that prospective parent study participants would be more comfortable if samples, particularly the vaginal secretion samples, were collected by female health professionals. There was no particular gender preference for blood sample collection; however, some had reservations about giving blood for the HPV test as they associated this with past experience of giving blood samples for HIV testing. We did not find a precise local term for Human Papilloma Virus (HPV), and the acronym ‘HPV’ was confused with ‘HIV’, so it was unsurprising that the test for HIV came to mind when people were asked for a sample for HPV testing. Participants were also afraid that their HPV test result might show cancer which could not be treated.

The results of the rapid ethical assessment were used to shape the information sheet used for the parent study, in particular to minimize confusion between HIV and HPV. Data collectors were trained to explain the difference and then ask potential participants to explain this back to them. They used phrases like “…I am not talking about HIV, unlike for HIV, you will not get back your HPV test result. The benefit of this HPV sero-prevalence study is to produce a vaccine against HPV so that the next generation of girls can be protected from cervical cancer…”

In low-literacy settings, potential study participants can be helped to understand key components of consent information using innovative tailored local narratives [24]. In our case, measles is a well-known disease in Tigray, and in the study district. Most of the communities were also familiar with agriculture research to test a new seed, a new fertilizer, and a new method of ploughing. Based on such findings of the rapid ethical assessment, the team developed a narrative explanation to help potential participants in the parent study easily understand the consent form (Annex II).

Obtaining genuine informed consent from research participants is best thought of as a process of sharing information and addressing questions and concerns, rather than simply obtaining a signature on a prescribed form. It starts with the researcher developing an awareness of national or regional guidelines, and may involve discussions with the community and/or family members of potential participants. Participants must then give their individual consent to participate on an informed consent form developed specifically for the research project. Obtaining the agreement of local community leadership for the proposed research is almost always good research practice and is mandatory in some communities [36].

In this rapid ethnographic assessment study, we found that prospective participant(pregnant women) of the parent study could decide alone. Even though the decision is the right of the participant, there were a lot of circumstances that the male partner should be involved; for example, during choosing family planning method, testing for HIV and other investigations. Many participants agreed on their partner involvement or asking their opinion would be help full during female recruitment for the study. This is an important finding of this study in contrary to the current notion which gives emphasis on individual autonomy for decision making for participation. Studies showed that women were more than likely to reporting obtaining permission from someone else before participating than men do [37, 38]. Biomedical research participants from developing countries need to discuss with their spouse, families and friends before decision made for participation. This can be done by giving time for discussion with or through invitation of the person they assumed that should be involved in the informed consent process. Therefore, it is worthy to consider partner or family involvement during informed consent decision making process based on the socio-cultural and gender dynamics on decision making of the study setting.

Other factors needing emphasis during participant recruitment are the participant selection process and participant expectations from the study. Groups or communities invited to participate in research should be selected in such a way that the burdens and benefits of the research will be equitably distributed. The exclusion of groups or communities that might benefit from study participation must be justified. Subjects should be drawn from the qualifying population in the general geographic area of the study without regard to race, ethnicity, economic status or gender unless there is a sound scientific reason to do otherwise [7]. In our study we found that participant selection could result a negative consequences among both those included participants and excluded community members. Those included one may think that they were selected based on their health condition and suspect that they have the disease to be studied. The excluded community members may also feel they are being unfairly treated if they are unable to receive the benefits from participation. This may disturb the researcher and community relationship in future research activities. These community misperceptions about participant selection may be handled through awareness creation about the research, its purpose and participant selection method by using health extension workers, religious and community leaders.

Participants of biomedical research could have different expectations of their involvement in research. Some may simply want to help the researcher by giving information that they think the researcher is looking for, while others may expect some benefits from their participation. In the current study setting, participants didn’t expect any immediate benefits like incentives or money for their participation. Instead, they were more worried about their test results and the need for treatment according to the result. Some interviewees complained that studies done previously had not given feedback as the researchers promised.

The Rapid Ethical Assessment enabled the parent study to use the most important findings to modify the information sheet, consent form and consent process. Based on the study findings, the research team suggested alternative local terminologies that could be used for cancer, explained ways of minimizing confusion between HPV with HIV, justified taking verbal consent over written consent, recommended that data collectors were female, and suggested a way of explaining the main aim of the study. Other researchers have used Rapid Ethical Assessment to inform the consent process for parent studies in similar ways [2,3,8,11,12].

Although efforts were made to ensure credibility, dependability and transferability of the study by using qualified reach team, different participant groups and good methodological triangulation, this study has potential limitations. In this study we used only male data collectors, which may have made some female participants less likely to discuss gender-sensitive issues. The study covers a limited geographical setting over a short period of time, but this was deliberate given the specific needs of the parent study. Other ‘parent’ studies may require Rapid Ethical Assessment in other geographic and cultural settings to explore the factors affecting informed decision making relevant to these studies.

Conclusion

The Rapid Ethical Assessment in this study revealed a number of issues concerning knowledge and perception of research, gender dynamics, decision-making, and information communication channels. Understanding the socio-cultural dynamics of a study setting, approaching participants through trusted community members and using local narration techniques can all optimize informed decision making.

Annex I

Interview guide questionnaire for IDI and FGD used for Rapid Ethical Assessment.

Introduce yourself and about the study:—Hello /Greetings! my name is __________. I ama researcher and member of a team from Addis Ababa University School of Public Health. There is a proposed study to know more about cancer diseases in Ethiopian women. Now we are collecting a base line assessment before conducting the actual study. So we are going to discuss with you about the proposed study regarding to this society. The information you give us will be recorded to put on words later. All the information you give us and the records will be kept confidentially.

1. Would you please tell us your age, job, educational level and duration for how long you live here? No need to mention your name.
2. What do you know about research? How you understand medical research? What about medicine or treatment mean?
3. What do you know about cancer? What about cervical cancer?
4. Would you please tell us the local name given to cancer if any!
5. As I explained you earlier there is a proposed study to find out more about cancer disease in Ethiopian women. Cervical cancer is the most prevalent and mostly associated with human papilloma virus and other co-infections of the genital or reproductive organ. For this study pregnant women who have antenatal follow up in health facilities will be interviewed, and small drop blood and vaginal fluid will be collected. The findings of the study will help the government to introduced vaccine against cervical cancer in the country. Therefore, future generation of girls will be benefit. How could we get volunteer pregnant women participant in this study?
6. Which type of consenting method do you think preferable? Verbal or signed consent? Why?
7. Who decide for participation in a research in the family members? Who decide the pregnant women to participate in this proposed study? In general what is the decision making power of women in this society?
8. What could be the possible barriers for pregnant women to give a small amount blood and vaginal secretion? Cultural or religious effect if any.
9. How can we help pregnant women to understand consent and participate voluntary? Who do you thing better to collect the samples? Male or female health professional?
10. During participants selection what could be the effect of including some participant in the study and others not? What about the participant expectation in response to participation in a research?

Annex II

Narrative explanation to be annexed with the information sheet in the parent study.

Research: is a work trying to find new facts. For example a farmer wants to use new method of farming like sowing in line or to use fertilizer to make his farm land more productive. So first he tries the new method or the fertilizer in a plot of land. If the product is better enough then he use this method for the whole of his farm land. This best experience will be expanded to his neighbors.

Medical research: In a medical research is also the similar. If the findings from few study subjects are important for health, then these will be used for the general public. It is different from treating of the individual patient. As you know before many years there was no vaccine for measles (Nifyo, local language). Many children got blind and died due to this disease. Now, after research did vaccine for measles has found and many children saved from blindness and death by vaccination. Similarly this study is to introduce vaccine against “Human Papilloma Virus” and to prevent cervical cancer. Then future generation girls could be saved forms this incurable disease. Though you are not directly benefited from involving in this study, you are paying remarkable contribution for your daughters and next generations.

Used local words for cancer: “Menkersa” (very common), cancer (sometimes) “Kintarot” (rarely)

Acknowledgments

Our special gratitude goes to all our study participants and members of the multidisciplinary team. We acknowledge the Tigray Regional Health Bureau and Hintalo-Wajirat district for their support and community facilitating for the study.