Malawi Med J. 2008 Jun; 20(2): 57–63. Participants' refusal to take part in research is an unpleasant experience that investigators face.. This paper highlights some of the reasons why people from resource-poor settings refuse to take part in health research. This paper also highlights standards which investigators can adopt to avoid
unnecessary refusals and at the same time ensure that individuals have the right to participate and freedom to refuse. Our objective was to explore reasons why people refuse to join research studies. We conducted focus group discussions with people who had refused to take part in a number of biomedical research studies but agreed to be interviewed in this study. The study was undertaken in the peri-urban and urban areas of Blantyre district; Bangwe, Mpemba and Madziabango. We found nine key
factors that influence people to refuse to participate in biomedical research. The factors are failure to follow traditional customs, lack of study benefits, superstition, poor informed consent procedures, ignorance of health research, fear of strangers, lack of cultural sensitivity, poor timing, and previous bad research experience. People refuse to participate in health research for a number of reasons which can be overcome if researchers embark on community engagement before implementing
their studies. Ethical conduct in research involving human participants has become one of the principal challenges faced by researchers. In recent times, increasing attention has been paid to ethical implications of carrying out research in settings with low socio-economic status. This trend has become particularly central in Africa owing to an increasing number of multinational research institutions operating in
sub-Saharan African countries.1– 4 The progress of medicine today is a result of biomedical research which necessarily relies on successful recruitment of human participants in order to yield meaningful results. In
this sense, human participants are instrumental in securing data useful to researchers. A participant's refusal to participate in research is referred to as a non-response in a survey.5 For the purpose of this paper, we shall use the term ‘refuser’ to refer to individuals who declined to take part in research after being approached by research staff. At the heart of ethical
recruitment of participants in a study is the principle of informed consent. There is a general consensus amongst researchers, scientists and bioethicists that acquiring effective informed consent from research participants is a prerequisite to the conduct of an ethically sound study6. Among other things, valid informed consent requires that participation in research
should be voluntary and that individuals should be treated as autonomous agents7. The requirement for voluntary participation, however, may result in many people refusing to participate. Refusals are likely to affect the timeline of research and also compromise the generalizability of
results,8 since it is unclear how people who refuse differ from those who agree to participate. There has been limited empirical research aiming to capture the perspectives of refusers in developing countries. Many studies have investigated the reasons why people participate in biomedical
research9–12 however, there has been less research and little attention specifically on reasons why people refuse to participate in biomedical research. Most of the data available on refusals are centred on non
response13 to postal questionnaires from different surveys. In this paper we report findings from an anthropological and bioethics study of clinical research in Malawi. The study explored the reasons why people refuse to join biomedical research and examined possible strategies for minimising refusals. The participants that were interviewed in this
study had refused to participate in a number of different biomedical research projects before this study but agreed to be interviewed in this study. We believe that knowledge of participants' perspectives and concerns with their involvement in research can lead to better recruitment efforts, improve the informed consent process, and enhance the overall trust between participants and
researchers4. Many studies have investigated the reasons why people participate in biomedical research9–12
however, there has been less research and little attention specifically on reasons why people refuse to participate in biomedical research. Most of the data available on refusals is centred on non response13 to postal questionnaires from different surveys. This paper reports findings from an Anthropological and Bioethics Study of Clinical Research in
Malawi (ABSCRM). The study explored the reasons why people refuse to join biomedical research and examined possible strategies for minimising refusals. The participants that were interviewed in this study had refused to participate in a number of different biomedical research projects before this study but agreed to be interviewed in this study. Knowledge of participants' perspectives and concerns with their involvement in research will enhance recruitment efforts, improve the informed consent
process, and enhance the overall trust between participants and researchers4. For this study, a qualitative approach was adopted and data were collected through focus group discussions (FGDs). A total of 108 refusers were successfully recruited and
they participated in 12 FGDs, each composed of 6–12 people. The FGD questionnaire guide was translated into the local language Chichewa. All FGDs were recorded on audio tapes which were then transcribed and translated from Chichewa into English by members of the research team. The study was conducted in Blantyre District, in the Southern region of Malawi. The specific sites were in the peri-urban settings of Madziabango and
Mpemba health centre catchment areas, and Bangwe Township which is a very densely populated urban area. These locations were selected for this project because several medical research projects have been conducted there in the past. Refusers were identified by project staff from the registers for the various trials which were ongoing at the time. These registers were maintained at the three sites by the project staff for
the various projects. Each project register had details of all the participants involved in the study as well as those who declined to participate after being invited to enrol. Health Surveillance Assistants (HSAs), who are part of the community, were then tasked with the responsibility of following up the refusers in their homes in order to inform them about the current project and to invite them to visit the health centres or other specific locations for the FGDs. Once the individuals had
gathered for each FGD our research team ensured that they all met the eligibility criteria for refusers… Verbal consent was obtained from those who agreed to participate in the FGDs. It was difficult to find sufficient refusers willing to take part in the focus group discussions. Therefore some FGDs had to be rescheduled. Analysis of the FGD transcripts was carried out manually and electronically using computer
software N6*. We analysed the contents of the transcribed texts to identify patterns and themes that emerged from the data.15 A comparison of major themes was then made in the final stage of analysis. The study was approved by the College of Medicine Research Ethics Committee (COMREC). ResultsDemographicsOverall, there were more women than men in the refusers' FGDs. Of the 108 participants, 21% were males and 79% were females.. There were no significant differences in average age between the male participants (31 years) and the female (30 years).. Between the peri-urban and urban respondents, there was a slight difference in the average duration of education - 7 and 9 years respectively. Description of findingsWe identified ten different self-reported reasons why people had refused to take part in various health studies. These were:
Failure to follow traditional customsThe overall perception of the participants is that traditional procedure has a big impact in making people decide whether to take part in a study or not. They reported that failure to conduct community engagement and failure to follow the right protocol during recruitment of participants would make people refuse to take part in research. The procedure they suggested as a better practice was for interested researchers to first seek consent from their chief or community leader and then conduct sensitization meetings and a community gathering where the whole community would be briefed about the study. If the chief says yes to a research project to take place in the area, his/her subjects would equally feel secure to accept and take part in it. For example one participant from Mpemba said
In response to the question ‘why is community engagement important?’ several participants self-reported that community engagement would give them a chance to understand more information about the study and be able to ask questions to the researchers before deciding whether to accept or decline the research. They also reported that people refuse to participate in studies when they are taken by surprise and not informed in advance about the study. This leaves the communities unprepared to decide whether to participate or not. One participant said
Another participant said
Participants also argued that another advantage of community engagement is that it would dispel rumours and misconceptions that circulate in their communities. Fear of strangersParticipants reported that people refuse to participate in health studies when researchers are strangers in the community. One participant reported
Another respondent reported
However, several participants reported that they would be comfortable to associate themselves with ordinary villagers and local doctors they know. Superstition and blood drawingPeople refuse and express reservations if studies constitute interventions that involve drawing of blood. This is tied to beliefs where by blood is seen as a weapon used in witchcraft for inflicting pain or sending pestilence to people. Belief in and fear of witchcraft is the norm amongst most Malawians. 16 17
Other people also associate the drawing of blood with rumours about blood sucking.18 They also fear that more blood would be drawn from their bodies. Several participants emphasized that studies that involve drawing of blood are very risky and have a greater potential for refusal. One participant observed
On the other hand, some participants said that they were discouraged to take part in studies that involved taking of blood simply because they were told that they would be given presents if they consented to donate blood. For example, one participant said
Other fears that were reported concerning drawing of blood and dispensation of drugs include drawing more blood for sale, and rumours that drugs being dispensed are intended to make people barren or sterile. Participants said that people see this as a government conspiracy to reduce population growth. For example, one participant said that;
Poor informed consent proceduresParticipants reported that people refuse to take part in studies when researchers fail to explain clearly about the objectives of their research. One participant said
Lack of study benefitsPeople decline to participate in research that does not provide benefits which can either accrue to the individual or to the area as a whole. Participants reported that they would like to participate in studies that would benefit them and not just to join studies only for altruistic reasons. For example, one participant said
Ignorance of health researchIgnorance and lack of understanding about research are some of the factors that would influence people's refusal to participate in health research. One participant observed
Another participant questioned
Analysis of the interviewees' responses also shows that many people especially from the rural areas are ignorant about certain procedures in health research. One participant who refused to take part in a malaria study expressed discontentment over the use of medicated bed-nets. The participant said
Similarly, several participants were not aware of the rationale behind re-taking of blood samples every year especially in longitudinal studies. One participant expressed disappointment and said
Lack of cultural sensitivitySeveral participants shared the view that they refused to take part in studies where researchers were not respectful to them. Participants observed from a number of studies that researchers were either disrespectful or did not know how to approach the people. One participant said
Participants also noted that researchers overlooked the importance of approaching husbands in studies that targeted women. Researchers did not involve husbands of the women they sampled during the consent seeking process. This resulted in either many women refusing to participate or husbands deterring their wives from taking part. One participant said
Several participants were also dismayed and refused to join a Mectizan drugs studies because researchers were measuring people's heights with a rigid ruler (wooden rod) to determine dosage. Mostly a wooden rod is used to measure the height of a dead body for funeral purposes. For example, one participant said
Poor timingParticipants reported that there are certain periods of the year when they are engaged in their fields with farming activities. These moments are not convenient for rural participants to enrol in research studies. They said that most people refuse to take part during the rainy season when they work in their farms. One participant from Madziabango said
Previous bad research experienceParticipants reported that they would reject studies when they look back at what similar previous studies had done to them. If studies have not been helpful people would refuse to join them. Similarly, they would decline to participate if such studies harmed people's lives. Many people reported to have refused to take part in studies in which HIV testing was involved due to psychological reasons. One participant said
DiscussionSeveral reasons why people refuse to participate in health research have been revealed in this study. Many of these might also be applicable to refusers in other similar settings. Participants in our sample were those who had previously refused to take part in a number of different biomedical research activities. Participants in our sample reported that they would refuse to participate in a study where the researchers failed to follow the traditional custom. Figure 1 below illustrates the traditional custom that participants want researchers to follow. Following the traditional custom would benefit the researcher because it would minimise unnecessary refusals. What participants are referring to as traditional custom is in fact community engagement, which we have modified to suit the needs of all participants. This is illustrated in Figure 1. Community engagement is a process of engaging community members in research through consultation, sensitization, involvement and providing feedback. In Figure 1, the steps for community engagement show a lineal pattern with one entry point for the researcher which is the community leader. Participants agree that the researcher has to go through the community leader. If the community leader accepts the study then he or she should sensitize the community by organising a meeting to involve them in the study. The community involvement meeting should be attended by the researcher, community leader and all the community members. Among other things, during this meeting, the researcher is expected to introduce and brief the community members about the study. Community members should also have a chance to ask the researcher questions where they do not understand. The community can give its permission whether they want the study to be conducted in their community. This also ensures that the community members have ownership of the research project. Informed consent process follows community involvement. Single people can be invited to participate individually while married persons can be interviewed as a couple to facilitate joint decision making. Participants feel that when all this is successfully carried out, then the study can begin. Participants stressed the importance of observing the community engagement for successful recruitment and informed consent. This demonstrates that people would like to participate in studies if they are satisfied with the rationale and information about the study. There is wide acknowledgement of the need for community engagement in biomedical research, particularly in developing countries. Currently, engaging communities has become a critical aspect of planning and implementing biomedical research. The current international research ethics guidelines also talk of community engagement as an ethical requirement for research involving human subjects, particularly with marginalized populations.19 Genuine community engagement offers hope of enhancing recruitment, retention, and participant satisfaction. In addition to concerns with strangers, participants also expressed discomfort with studies that involved drawing of blood. These concerns can be addressed by adhering to the village protocol in Figure 1. It would dispel any myths about the study. Furthermore, the issue of fearing strangers would not arise when researchers participate in community engagement. Our results raise an interesting point regarding the informed consent procedure: poor informed consent with vague explanation of objectives will discourage participation. This brings up a long-running debate about how much information about the study should be disclosed to prospective study participants. There is no consensus on this. If we argue that the information should be ‘as much as possible’ then we beg another question; how much is ‘as much as possible?’ According to the Belmont report, genuine informed consent requires that participants should be given sufficient comprehensive information and they should be allowed to have enough time for consideration. They should also be offered an opportunity to ask questions. This result shows that the conduct of informed consent remains a big challenge in settings with limited resources. More research is needed about participants' perceptions and experiences in health research in settings with limited resources in order to improve the informed consent processes. However, we feel that adoption of the community engagement procedure would demystify the conduct of informed consent in resource poor settings. Another important theme that emerged from this study was the importance and application of the principle of beneficence. Participants reported that they would not participate in research studies which do not either benefit them or the community. Participants also reported that some studies set bad precedents which demoralise their future participation in similar studies. Resource poor settings remain potential targets for exploitative research. Our results showed that people in peri-urban areas would refuse to participate in health research owing to ignorance and lack of understanding about certain concepts and procedures. Researchers need to know the level of understanding about health research of their potential participants. The significance of using community engagement as a way of informing the community about the study should therefore not be underestimated. During community engagement, the researcher can find out if there is need to educate potential participants about certain procedures involved in the study. Finally, another factor which contributes to people's refusal to take part is the concern that some researchers are not conscious of local culture. Results show that participants were disgruntled with researchers who were not friendly, hospitable and lacked skills to properly approach participants. Several participants from Mpemba and Madziabango said that they were not happy to see researchers measuring heights of people with a rod which is normally used to measure corpses. Researchers should know more about the aspects of culture of the people they would be investigating, and try to anticipate the ways in which their actions and props like measuring rods might be interpreted locally. A number of researchers seem to be in a hurry to implement their studies while neglecting the welfare of their participants. This compromises the ethical conduct of research. Knowing the culture, daily lifestyles, and opinions of participants would help researchers know when and how to best approach their participants. RecommendationsThe traditional customs suggested by the refusers constitute the first step towards minimising refusals. We believe that adequate community engagement will minimise refusals. We offer the following specific recommendations as principles of community engagement which we have developed as a result of this study. Four Principles of Community Engagement in Research1. Community consultation
When permission has been granted, the researchers, community leaders and members of the CAB can organize a community sensitization meeting. 2. Community sensitization
[Important: you should avoid providing information that might lead to stigma and discrimination. For example, if a research project is about HIV/AIDS and one of the recruitment criteria is that potential participants have to be HIV positive, this fact should not be made known to the whole community, as they would then know that people recruited in the study are HIV positive. A common solution to this problem is to design the study so that both HIV+ve and HIV−ve individuals are enrolled, and enrolment then does not imply any individual's HIV status.] 3. Community Ownership/partnership/involvement
4. Feedback
We conducted feedback sessions about the results in our study sites. We wrote a letter to the Clinical Officer-in-charge of each of the health centres, informing them about our schedule for the dissemination of results. We also requested the local HSAs who had helped us with the recruitment of participants to inform all the five categories of people we had recruited. We prepared power point presentation slides together with printed handouts in the local language, Chichewa. About 80% of the participants were present during the dissemination of results. Participants appreciated this feedback. They reported that this was the first time they had seen researchers disseminating results to the community in which they had conducted their research. ConclusionWe believe that most ‘refusers’ would have been willing to participate in research if the above principles had been carefully followed. Our findings require validation in a larger sample from other settings in Malawi and other developing countries, but meanwhile researchers need to take into account the concerns raised by the refusers we interviewed. Most of these concerns could be minimised by engaging the community, both before research is initiated and after it has been completed. AcknowledgementsWe would like to express our sincerely thanks and gratitude to The Wellcome Trust for funding this study. References1. Benatar SR. Reflections and recommendations on research ethics in developing countries. Social Science & Medicine. 2002;54:1131–1141. [PubMed] [Google Scholar] 2. Zulfiqar AB. Ethics in international health research: a perspective from the developing world. Bull World Health Organ. 2002;80:114–120. [PMC free article] [PubMed] [Google Scholar] 3. Shapiro HT, Meslin EM. Ethical issues in the design and conduct of clinical trials in developing countries. N Engl J Med. 2001;345:139–142. [PubMed] [Google Scholar] 4. Khalil SS, et al. Attitudes, understanding, and concerns regarding medical research amongst Egyptians: A qualitative pilot study. BMC Medical Ethics. 2007;8(9):1472–6939. [PMC free article] [PubMed] [Google Scholar] 5. McCall N, Trofimovich L, Bonito A. Estimation and Analysis of Non-Response Bias in Medicare Surveys. RTI International. 2004 Aug [Google Scholar] 6. Lidz WS, et al. “Therapeutic misconception and the appreciation of risks in clinical trials” Social Science and Medicine. 2004;58:1689–1697. pg 1689. [PubMed] [Google Scholar] 7. The Belmont report. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979. Apr 18, http://ohsr.od.nih.gov. 8. Jones J. The effects of non-response on statistical inference. J Health Soc Policy. 1996;8:49–62. [PubMed] [Google Scholar] 9. Brody J L, Waldron H B. Ethical issues in research on the treatment of adolescent substance abuse disorders. Journal of Addictive Behaviors. 2000;25(2):217–228. www.emhr.net. [PubMed] [Google Scholar] 10. Smith A, King E, Hindley N, Barnetson L, Barton J, Kim A. The experience of research participation and the value of diagnosis in dementia: implications for practice. Journal of Mental Health. 1998;7:309–321. [Google Scholar] 11. Farre M, Lamas X, Cami J. Sensation seeking amongst healthy volunteers participating in phase I clinical trials. British Journal of Clinical Pharmacology. 1995;39:405–409. [PMC free article] [PubMed] [Google Scholar] 12. Harrison D A. Volunteer motivation and attendance decisions: competitive theory testing in multiple samples from a homeless shelter. Journal of Applied Psychology. 1995;80:371–385. [Google Scholar] 13. Ygge B-M, Arnetz JE. A study of non-response in a questionnaire survey of parents' views of paediatric care. Journal of Nursing Management. 2004;12:5–12. [PubMed] [Google Scholar] 14. Pace C, Grady C, Emanuel EJ. What we don't know about informed consent? 2003. www.scidev.net. 15. Bernard H. Social Research Methods: Qualitative and Quantitative Approaches. London, UK: Sage Publications; 2000. [Google Scholar] 16. Guiley R E. The Encyclopedia of Witches and Witchcraft. second edition. New York: Facts on File; 1999. p. 26. [Google Scholar] 17. Mather GA, Nichols LA. Dictionary of Cults, Sects, Religions and the Occult. Michigan: Zondervan Publishing House; 1993. p. 40. [Google Scholar] 19. Sapienza J N, et al. Community engagement in Epidemiological Research. 2007 May-Jun;7(3):247–252. Ambulatory Pediatric Association. p. 252. [PMC free article] [PubMed] [Google Scholar] Articles from Malawi Medical Journal are provided here courtesy of Kamuzu University of Health Sciences and Medical Association of Malawi What are some reasons researchers are reluctant to conduct interviews and social science research?What are some reasons researchers are reluctant to conduct interviews in social science research? You cannot easily sample a large population. Because surveys are standardized, which of the following can be an issue? Validity.
What are some reasons researchers conduct interviews in social science research?They can be used when there is a more sensitive topic that may not be appropriate for a focus group or survey; Information is often more in depth when obtained from interviews; Interviews can facilitate the screening process of appropriate participants in a research study.
What is a disadvantages of conducting focus groups in qualitative social science research?A particular disadvantage of a focus group is the possibility that the members may not express their honest and personal opinions about the topic at hand. They may be hesitant to express their thoughts, especially when their thoughts oppose the views of another participant.
What are some advantages of conducting interviews for a study select one?Interviews are most effective for qualitative research:
They help you explain, better understand, and explore research subjects' opinions, behavior, experiences, phenomenon, etc. Interview questions are usually open-ended questions so that in-depth information will be collected.
|