559888
research-article2014
JREXXX10.1177/1556264614559888Journal of Empirical Research on Human Research EthicsMfutso-Bengo et al.
Motivation to Participate in Research
Motivational Factors for Participation in Biomedical Research: Evidence From a Qualitative Study of Biomedical Research Participation in Blantyre District, Malawi
Journal of Empirical Research on Human Research Ethics 2015, Vol. 10(1) 59–64 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1556264614559888 jre.sagepub.com
Joseph Mfutso-Bengo1, Lucinda Manda-Taylor1, and Francis Masiye1,2
Abstract Obtaining effective informed consent from research participants is a prerequisite to the conduct of an ethically sound research. Yet it is believed that obtaining quality informed consent is generally difficult in settings with low socioeconomic status. This is so because of the alleged undue inducements and therapeutic misconception among participants. However, there is a dearth of data on factors that motivate research participants to take part in research. Hence, this study was aimed at filling this gap in the Malawian context. We conducted 18 focus group discussions with community members in urban and rural communities of Blantyre in Malawi. Most participants reported that they accepted the invitation to participate in research because of better quality treatment during study also known as ancillary care, monetary and material incentives given to participants, and thorough medical diagnosis. Keywords consent, motivation, biomedical research, focus group discussions One recent focus of ethical issues in biomedical research has been on the ethical implications of carrying out research in low socioeconomic settings such as Malawi. In all major ethical guidelines, the principle of informed consent is prominent. Obtaining effective informed consent from research participants is a prerequisite for the conduct of an ethically sound study (Lidz, Appelbaum, Grisso, & Renaud, 2004). However, it is believed that obtaining genuine informed consent is generally difficult and the problems of getting such informed consent are even greater in settings with low socioeconomic status than those with high socioeconomic status (Molyneux, Peshu, & Marsh, 2004). This is thought to be partly due to undue inducements and therapeutic misconception among research participants in low socioeconomic settings (Bentley & Thacker, 2004; Grady, 2005; Hawkins & Emanuel, 2008). Factors that motivate research participants involved in biomedical research have not been widely studied or documented (Lynöe, Hyder, Chowdhury, & Ekstrom, 2001). In a study conducted in Brazil, a middle-income country, it was reported that study participants may participate in clinical studies because they do not have access to medical care (Nappo, Iafrate, & Sanchez, 2013). A recent study conducted in India, a developing country, reported that the most common motivation among healthy participants was financial reward (65%) followed by altruism, free medical check-up, curiosity, and personal health benefits (Doshi, Kulkarni,
Ghia, Gogtay, & Thatte, 2013). However, there is a dearth of data from empirical research on factors that motivate study participants to take part in biomedical research in the developing world especially in Africa (Pace, Grady, & Emanuel, 2003). And yet the steady increase in cross-border biomedical research collaborations and funding arrangements are provoking many new ethical questions such as how to obtain genuine informed consent and what motivates research participants to enter into biomedical research (Mfutso-Bengo & Taylor, 2001). The main aim of this study was to fill this gap in the literature by contributing to the understanding of factors that motivate research participants to give their consent to participate in biomedical research in Malawi.
Method Study Setting The study was conducted in 2008 in Southern Malawi in the rural settings of Madziabango and Mpemba Health Centre 1
University of Malawi College of Medicine, Blantyre, Malawi University of Cape Town, South Africa
2
Corresponding Author: Joseph Mfutso-Bengo, University of Malawi College of Medicine, Private Bag 360, Chichiri, Blantyre 3, Malawi. Email: [email protected]
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catchment areas located in Traditional Authority Somba in Blantyre District and the urban location of Bangwe Township within Blantyre City. These locations were selected for this project because several biomedical research projects have been conducted there in the past.
individuals who had gathered for each FGD were those who had met the above criteria.
Study Design We used an exploratory qualitative research design to conduct the study. Data were collected from research participants during focus group discussions (FGDs). FGDs were chosen as the appropriate method for this study because they are quick, effective, and an inexpensive means of interviewing a homogeneous group of people at the same time. They have proven to produce rich data for anthropological, cultural, and social science research and focus on community perceptions and attitudes. Each FGD comprised 6 to 12 participants, a note taker/observer, and a moderator who facilitated the session. The note taker or observer was responsible for taking notes and assisting the moderator in probing the participants during the discussion. The study included individuals who had once participated or were still participating in biomedical research in the three sites. Both men and women participated in the FGDs. Most of the participants in this study were expectant mothers who had agreed to participate in the Prevention of Mother to Child Transmission (PMCT) Neverapine study and the Malaria in Pregnancy (MiP) study. All the discussions were recorded on audiotapes, which were then transcribed verbatim in Chichewa, the national language of Malawi and translated into English by members of the research team. Nine FGDs were conducted in Bangwe (an urban setting), and 9 others were conducted in Mpemba and Madziabango (rural settings). In total, 18 FGDs were conducted.
Sampling and Recruitment Research participants were recruited based on a purposive and convenience sampling technique. Efforts were made to take a community-based approach. First, permission was sought from the Blantyre District Health Officer (DHO) to conduct the research in the catchment areas of Bangwe, Madziabango, and Mpemba government health centers. Through the nurse and clinical officers-in-charge at each health center, the local Health Surveillance Assistants (HSAs) were then approached to mobilize community members, and a timetable of FGDs was arranged in collaboration with the study team. The HSAs were called on to assist in arranging the focus groups because of their familiarity with people living in the study communities. They identified adult respondents above 16 years of age who had once participated or were still participating in biomedical research in the settings. The research team ensured that the
Procedures and Data Collection A FGD guide was administered to participants during the discussions. The research objectives were incorporated into the FGD guide that was translated into Chichewa. The interviews were recorded and notes taken as back-up to the recorded data. To ensure collection of good quality data, the FGD guides were pretested and necessary changes were made and Field Research Assistants were trained in the conduct of FGDs as well as in the transcription of recorded data. All the transcripts were checked and rechecked after typing them. The Principal Investigator, Research Officer, and Advisors were responsible for overseeing the administration of the FGDs to address any safety and quality concerns. Participants were given an equivalent of US$2 for transport reimbursement—this was the standard amount of money that was being given to participants for transport at the time. The FGDs were held at a central place in each of the three health centers. In most cases, they were held either in a classroom at a central primary school or in a church building. The longest FGD took 1.5 hr while the shortest took 40 min.
Data Analysis All transcripts were read in their entirety to identify themes that reoccurred across all focus groups. Emerging themes or subthemes were also identified. From the themes and subthemes, a coding framework was developed and applied to the texts of the transcripts. The quotes for each code were reviewed and any texts that were not categorized with the coding framework were given a new code. The codes were identified with their relevant quotes from the texts and data summaries were produced from the texts. The research team held regular meetings to discuss the data summaries. From the discussions, we developed a charting framework with linkages to the data summaries. Each chart was given a descriptive account of each theme and had relevant quotes from the study participants. The analyzed data were also entered into NUD*IST 6 (N6), an electronic qualitative data analysis software, for further analysis. Reports were produced from the charts and the NUD*IST software, and the results are presented below.
Ethical Considerations Prior to funding being granted by the Wellcome Trust, the study was submitted for scientific and ethical review to the College of Medicine Research and Ethics Committee (COMREC) in Blantyre, Malawi, and ethics approval was granted. Throughout the execution of the study, COMREC
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Mfutso-Bengo et al. was kept informed of minor adjustments to the study methodology and all amendments to the study were reviewed and approved. All research participants who participated in the FGDs listened to an explanation of the study and had an opportunity to ask questions before being asked individually to give their consent to participate in the discussion and for their contributions to be audio-recorded with the assurance that their identities would remain anonymous in the collection and processing of data. As this was a minimal risk study, verbal consent was obtained from each of the participants in the FGDs.
Results One hundred eighty-two research participants took part in 18 FGDs. Most of the participants were women and had attended at least primary school. According to the study participants, there were a number of factors that motivated them to participate in different biomedical research projects. Three major themes emerged in the analysis of the data that form the factors that motivated research participants in both urban and rural sites in Blantyre, Malawi. These include the following: better quality treatment (availability of drugs and other medical resources) during study, monetary and material incentives given to participants during study, and thorough medical diagnosis of participants’ health status.
Better Medical Care Most participants decided to take part in biomedical research because they wanted to get better medical treatment. The participants stated that they were given the best care in research, which was not available in the public health facilities; drugs were always available when they fell sick; they received effective drugs and the reception from biomedical researchers was very good. Quotations from two participants highlight their reasons: I wanted better medical help. They told me that I was free to opt out if I wanted to. But I accepted because I wanted to receive better drugs and get well quickly. We were taken care of. We were given food we have never eaten before in our homes; we were eating the food right there.
The study participants also explained that there are limited clinical resources in public health facilities and public health workers do not respect them when they go to seek medical attention. That is why most of them would opt to take part in biomedical research to benefit from the abundant health resources.
Monetary and Material Incentives Most of the participants interviewed stated that they agreed to participate in research because researchers promised to give them money and material incentives if they accepted the invitation to participate in their research projects. The participants noted that when they took part in research, they earned money without having worked or labored for it, and hence, they did not refuse to participate in research whenever they were approached to do so. They stated that they had not been forced to participate but chose to participate on their own. In addition, most female research participants said that they had decided to participate in biomedical research because the biomedical researchers had given them mosquito nets, food, washing soap, basins, napkins, and wrappers. One female participant said, When some people refuse to take part in biomedical research they would reverse their decision later on when they saw that others had been given presents after delivery [of her child]. So, some people would be interested if there are presents given to those who participate in biomedical research.
These incentives were being given to expectant mothers who agreed to participate in the PMCT Neverapine study and MiP study in both rural and urban settings. The basins, napkins, and wrappers as well as soap were for baby use and were given to research participants after delivery. As most of them could not afford these materials for their babies, they decided to take part in the studies to receive them free of charge. In fact, some of them said the use of these materials gave them a sense of prestige and pride in the society. In addition to these material incentives, they were also given a transport allowance during each visit to the clinic. For example, another female participant said, If you were in biomedical research, they would give you K800. After giving birth, they were giving you nappies.
All these incentives motivated them to agree to participate in biomedical research. Otherwise, they could not afford to buy diapers and other materials and opted to participate to get those privileges.
Thorough Medical Diagnosis and Knowledge of Health Status The participants noted that they were given thorough diagnosis of their diseases before they received treatment when they were in biomedical research. However, in routine health care, they were usually given paracetamol and
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aspirins without any proper diagnosis. They attributed this to limited resources in public hospitals and the many patients that sought medical attention in public hospitals. Indeed, there were resource constraints in public hospitals in these settings at the time of our study; however, the few resources available could be better utilized to serve people well if patients were being given proper diagnosis and asked to buy drugs from private pharmacies. Some participants also stated that they had agreed to take part in research to know their health status. They explained that they were better examined in biomedical research than in routine health care and researchers usually followed them up. This helped them to improve their health condition and motivated them to participate in biomedical research.
the Malawian context, we feel that failure to take the offer to participate in such a biomedical research is tantamount to one harming oneself or one’s child. In other words, we feel it is reasonable and ethical for people to choose to participate in biomedical research in pursuit of better medical care. Moreover, the research projects in which people had decided to participate had been reviewed and approved by ethics committees and we assume that they would not approve such studies if they exposed participants to excessive discomforts and risks. In a scenario where the national health delivery system is overburdened and fails to adequately respond to individuals’ health needs, individuals are forced to take the best available option—in this case, joining biomedical research. We view this decision as a very rational one as it is made after considering the available options as well as the due costs of deciding not to participate in the biomedical research. We believe that in limited resource settings such as those prevailing in Malawi, biomedical research plays a very important role that has not yet been fully acknowledged. Biomedical research should complement the national health delivery systems, which are overburdened. We also feel that by complementing local delivery systems, biomedical research is indirectly working toward the improvement of people’s health in resource poor countries. Finally, some participants in this study were motivated by monetary and material incentives. In most of the research projects the participants joined, they were given an equivalent of US$2 (MK 800) as transport reimbursement and compensation for their time. This amount is more than a day’s earning for most people in rural settings. At times, the research participants also were given diapers and other materials as a token of thanks. As most of the participants in the two settings had no regular source of income and were unemployed, they considered their participation in biomedical research as a form of temporary employment because they were able to earn money, which they would otherwise not get. This is a context in which the rate of unemployment is relatively high and earning a living is hard. Therefore, the opportunity to participate in biomedical research for such communities was a privilege. We argue that the giving of monetary and material incentives to research participants was not undue inducement as long as the research participants were provided with adequate study information and understood the study objectives, procedures, potential risks, benefits, their rights, and alternatives before they joined the research. One needs to understand the social context before making any judgments about such incentives and classifying them as undue inducements. In fact, the research participants themselves stated that they were not forced by anybody to participate but chose to take part on their own. In our view, these were rational decisions by the research participants.
Discussion It is evident that the majority of participants chose to participate in biomedical research as a way of accessing better quality medical care and receiving money or needed items. These findings agree with findings of studies conducted in Brazil and India by Nappo et al. (2013) as well as Doshi et al. (2013). In situations of poor service delivery, medical care in a research setting is described in favorable terms. In Malawi, medical care in Government facilities is free, but the quality of care is very low and characterized by overcrowding and scarcity of basic medicines. According to Emanuel, Wendler, Killen, and Grady (2004), benefits of research participation should refer only to benefits derived from the research itself. However, in the Malawi context of our research, participants joined biomedical research to obtain basic health care. Therefore, the issue of therapeutic misconception did not arise at all. This is in contrast to ethical regulations, and guidelines such as the Council for International Organizations of Medical Sciences [CIOMS] Guidelines (2002) oblige investigators to ensure that health care services are made available, during and after the research, to the research participants themselves and to the community from which the participants are drawn. In Malawi, however, the health benefits of research participation are normally given in the short term and only to those who join research studies. Do direct benefits to research participants in biomedical research in limited resource settings constitute undue inducements? Is it reasonable, ethically justifiable, and acceptable to take part in biomedical research with better quality medical care as a reason for participation within the Malawian context? Here, we are of the opinion that the people made their decisions autonomously, motivated by better and excellent medical care. Deciding to participate in research on these grounds is not unethical and does not constitute an undue inducement in our view. In Emmanuel’s words, it “is not an ethical worry” (Emanuel et al., 2004). In
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Best Practices Research in developing countries such as Malawi should aim at building capacity of the national health delivery system. There are some examples in Africa where research projects are serving communities by providing or supporting clinics that are open to all members of the community and not only restricted to the patients or even the disease under study. Research in limited resource settings needs to be acknowledged for the extra role it plays, that of supplementing the national health delivery systems. We also recommend that researchers consider giving other benefits to participants other than monetary incentives. We further recommend that ancillary care continue being provided to research participants in biomedical research. In our opinion, it is ethical to give ancillary care to research participants, and ethical regulations in biomedical research oblige researchers to give medical care to ailing participants, their families, and their community members as benefits to them and their communities when it is available. However, various stakeholders need to agree on how long ancillary care ought to be provided to research participants and their communities. Research in developing countries presents one route to accessing health care, and against this background, it would be unethical for biomedical researchers to deny treatment to their sick participants when it is available.
Research Agenda We are aware that therapeutic misconception may lead prospective participants to ignore the potential risks or burdens of research when considering whether to participate or not. Further research is required to understand whether indeed therapeutic misconception exists among research participants in resource poor settings. There is also need for further research on what constitutes an undue inducement to research participants in limited recourse settings.
Educational Implications Researchers need to adopt innovative methods of teaching communities and individuals about research. Researchers need to engage communities adequately before implementing their biomedical research projects. One way of doing this is to establish community advisory boards (CABs) in the communities where they intend to conduct their research. CABs act as a bridge between researchers and community members. Members of CABs should educate community members about biomedical research, about the rights and responsibilities of research participants and dispel any rumors that circulate in their communities about biomedical research. They can also address any misconceptions that
community members might have about biomedical research. In this way, potential research participants would be informed in advance about a specific biomedical research before they are approached to take part. One way to reduce the extent of the therapeutic misconception is to use community engagement, ethics review committees, researchers, and CABs to educate individuals and communities about research and how research is different from routine care. Ethical codes and guidelines such as CIOMS stipulate that payments to prospective research participants should not be so large or medical services so extensive as to induce them to consent to participate in the research against their better judgment. However, they do not elaborate on what constitutes a large payment or extensive medical services to research participants. Although ethics review committees are mandated to decide what constitutes a large payment or an extensive medical service, in cross-border biomedical research, it becomes difficult to agree on what a large payment or an extensive medical service is—a judgment from an ethics review committee in a developing country may differ from that of a committee in a developed country on the two issues as they are from different sociocultural contexts. This becomes even more problematic when dealing with unemployed persons rather than with employed persons. Yet using research participants without compensating them for their time and transport costs as well as other expenses incurred in participating in the biomedical research would be perceived as exploitation of the research participants. Therefore, ethics committees in resource poor settings need to come up with reasonable payment standards to research participants in their settings. Researchers in such settings need to adhere to such payment standards. Finally, there is indeed a need to engage in critical debates when ethical questions such as those mentioned above are raised. It is through these debates that researchers learn to conduct their biomedical research ethically. Acknowledgments We are grateful to the following for their contribution toward the activities that led to the production of this article:
•• The Wellcome Trust, for funding the research project; •• Members of the management and advisory team who provided advice and guidance to keep the research project on target: Professor Cam Bowie, Dr. Chiwoza Bandawe, and Ms. Pam Shephard; •• The Bioethics Biomedical research team who organized and coordinated the project activities: Dr. Elsbeth Robson (Social Scientist), Mrs. Matilda Mkunthi-Maluza (Research Officer), and Mr. Vincent Jumbe (Assistant Research Officer);
64 •• Fieldworkers who assisted in conducting the interviews: Ms. Sheila Jussa, Ms. Esther Sanga, and Mr. Owen Nalivata; •• Secretarial support: Mrs Thandie Kamwendo; •• The project driver: Mr Samson Wiskesi; •• College of Medicine IT department staff who helped solve technical computing problems: Mr Chisomo Kaundama and Mr Phillip Chimutu; and •• The Communities and Health Staff of Mpemba, Madziabango, and Bangwe for participating in the focus group discussions of this study.
Journal of Empirical Research on Human Research Ethics 10(1)
Funding
Lynöe, N., Hyder, Z., Chowdhury, M., & Ekstrom, L. (2001). Obtaining informed consent in Bangladesh. The New England Journal of Medicine, 344, 460-461. doi:10.1056/ NEJM200102083440617 Mfutso-Bengo, J. M., & Taylor, T. E. (2001). Ethical aspects of clinical biomedical research in developing countries. Malawi Medical Journal, 13(2), 24-25. Molyneux, C. S., Peshu, N., & Marsh, K. (2004). Understanding informed consent in a low-income setting: Three case studies from the Kenyan coast. Social Science & Medicine, 59, 2547-2559. Nappo, S. A., Iafrate, G. B., & Sanchez, Z. M. (2013). Motives for participating in a clinical research: A pilot study in Brazil. Biomedical Central Public Health, 13, Article 19. doi:10.1186/1471-2458-13-19 Pace, C., Grady, C., & Emanuel, E. J. (2003, August 28). What we don’t know about informed consent. Science and Development Network. Retrieved from http://www.scidev.net/global/ health/opinion/what-we-dont-know-about-informed-consent. html
The author(s) received no financial support for the research, authorship, and/or publication of this article.
Author Biographies
Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
References Bentley, J. P., & Thacker, P. G. (2004). The influence of risk and monetary payment on the research participation decision making process. Journal of Medical Ethics, 30, 293-298. doi:10.1136/jme.2002.001594 Council for International Organizations of Medical Sciences. (2002). International ethical guidelines for biomedical research involving human subjects. Geneva, Switzerland. Retrieved from http://www.cioms.ch/publications/guidelines/ guidelines_nov_2002_blurb.htm Doshi, M. S., Kulkarni, S. P., Ghia, C. J., Gogtay, N. J., & Thatte, U. M. (2013). Evaluation of factors that motivate participants to consent for non-therapeutic trials in India. Journal of Medical Ethics, 39, 391-396. doi:10.1136/medethics-2012-100755 Emanuel, E. J., Wendler, D., Killen, J., & Grady, C. (2004). What makes clinical research in developing countries ethical? Journal of Infectious Diseases, 189, 930-937. doi:10.1086/381709 Grady, C. (2005). Payment of clinical research subjects. Journal of Clinical Investigation, 115, 1681-1687. doi:10.1172/JCI25694 Hawkins, J., & Emanuel, E. (2008). Exploitation and developing countries: The ethics of clinical research. Princeton, NJ: Princeton University Press. Lidz, C. W., Appelbaum, P. S., Grisso, T., & Renaud, M. (2004). Therapeutic misconception and the appreciation of risks in clinical trials. Social Science & Medicine, 58, 1689-1697. doi:10.1016/S0277-9536(03)00338-1
Joseph Mfutso-Bengo is a professor of bioethics in the School of Public Health and Family Medicine at the University of Malawi, College of Medicine in Malawi, and director of the Center for Bioethics in Eastern and Southern Africa (CEBESA) at the College of Medicine. His research interests include social health research, KAP surveys, social and ethical determinants of health, ethical issues in clinical trials, and public health intervention. His contributions to this research include the conception, design, and survey tools of the study; oversight of the conduct of the interviews; and review of several drafts of the manuscript. Lucinda Manda-Taylor is the COMREC (IRB) administrator at the University of Malawi, College of Medicine, deputy director of CEBESA, and an honorary senior lecturer of bioethics in the School of Public Health and Family Medicine. Her research interests include applied ethics, bioethics, women’s health, community engagement, and health systems. She contributed to the analysis of the results and made substantial intellectual contributions to the writing of the manuscript. Francis Masiye is a junior research fellow (bioethics) in the Department of Medicine at the University of Cape Town, and also affiliated with the Centre for Bioethics in Eastern and Southern Africa at the College of Medicine in Malawi. His research interests include bioethics, research ethics in developing countries, public health ethics, and medical anthropology. He conducted the interviews, transcribed them, translated them into English, analyzed the results, and was significantly involved in the drafting and writing of the manuscript.
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research-article2014
JREXXX10.1177/1556264614559888Journal of Empirical Research on Human Research EthicsMfutso-Bengo et al.
Motivation to Participate in Research
Motivational Factors for Participation in Biomedical Research: Evidence From a Qualitative Study of Biomedical Research Participation in Blantyre District, Malawi
Journal of Empirical Research on Human Research Ethics 2015, Vol. 10(1) 59–64 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1556264614559888 jre.sagepub.com
Joseph Mfutso-Bengo1, Lucinda Manda-Taylor1, and Francis Masiye1,2
Abstract Obtaining effective informed consent from research participants is a prerequisite to the conduct of an ethically sound research. Yet it is believed that obtaining quality informed consent is generally difficult in settings with low socioeconomic status. This is so because of the alleged undue inducements and therapeutic misconception among participants. However, there is a dearth of data on factors that motivate research participants to take part in research. Hence, this study was aimed at filling this gap in the Malawian context. We conducted 18 focus group discussions with community members in urban and rural communities of Blantyre in Malawi. Most participants reported that they accepted the invitation to participate in research because of better quality treatment during study also known as ancillary care, monetary and material incentives given to participants, and thorough medical diagnosis. Keywords consent, motivation, biomedical research, focus group discussions One recent focus of ethical issues in biomedical research has been on the ethical implications of carrying out research in low socioeconomic settings such as Malawi. In all major ethical guidelines, the principle of informed consent is prominent. Obtaining effective informed consent from research participants is a prerequisite for the conduct of an ethically sound study (Lidz, Appelbaum, Grisso, & Renaud, 2004). However, it is believed that obtaining genuine informed consent is generally difficult and the problems of getting such informed consent are even greater in settings with low socioeconomic status than those with high socioeconomic status (Molyneux, Peshu, & Marsh, 2004). This is thought to be partly due to undue inducements and therapeutic misconception among research participants in low socioeconomic settings (Bentley & Thacker, 2004; Grady, 2005; Hawkins & Emanuel, 2008). Factors that motivate research participants involved in biomedical research have not been widely studied or documented (Lynöe, Hyder, Chowdhury, & Ekstrom, 2001). In a study conducted in Brazil, a middle-income country, it was reported that study participants may participate in clinical studies because they do not have access to medical care (Nappo, Iafrate, & Sanchez, 2013). A recent study conducted in India, a developing country, reported that the most common motivation among healthy participants was financial reward (65%) followed by altruism, free medical check-up, curiosity, and personal health benefits (Doshi, Kulkarni,
Ghia, Gogtay, & Thatte, 2013). However, there is a dearth of data from empirical research on factors that motivate study participants to take part in biomedical research in the developing world especially in Africa (Pace, Grady, & Emanuel, 2003). And yet the steady increase in cross-border biomedical research collaborations and funding arrangements are provoking many new ethical questions such as how to obtain genuine informed consent and what motivates research participants to enter into biomedical research (Mfutso-Bengo & Taylor, 2001). The main aim of this study was to fill this gap in the literature by contributing to the understanding of factors that motivate research participants to give their consent to participate in biomedical research in Malawi.
Method Study Setting The study was conducted in 2008 in Southern Malawi in the rural settings of Madziabango and Mpemba Health Centre 1
University of Malawi College of Medicine, Blantyre, Malawi University of Cape Town, South Africa
2
Corresponding Author: Joseph Mfutso-Bengo, University of Malawi College of Medicine, Private Bag 360, Chichiri, Blantyre 3, Malawi. Email: [email protected]
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Journal of Empirical Research on Human Research Ethics 10(1)
catchment areas located in Traditional Authority Somba in Blantyre District and the urban location of Bangwe Township within Blantyre City. These locations were selected for this project because several biomedical research projects have been conducted there in the past.
individuals who had gathered for each FGD were those who had met the above criteria.
Study Design We used an exploratory qualitative research design to conduct the study. Data were collected from research participants during focus group discussions (FGDs). FGDs were chosen as the appropriate method for this study because they are quick, effective, and an inexpensive means of interviewing a homogeneous group of people at the same time. They have proven to produce rich data for anthropological, cultural, and social science research and focus on community perceptions and attitudes. Each FGD comprised 6 to 12 participants, a note taker/observer, and a moderator who facilitated the session. The note taker or observer was responsible for taking notes and assisting the moderator in probing the participants during the discussion. The study included individuals who had once participated or were still participating in biomedical research in the three sites. Both men and women participated in the FGDs. Most of the participants in this study were expectant mothers who had agreed to participate in the Prevention of Mother to Child Transmission (PMCT) Neverapine study and the Malaria in Pregnancy (MiP) study. All the discussions were recorded on audiotapes, which were then transcribed verbatim in Chichewa, the national language of Malawi and translated into English by members of the research team. Nine FGDs were conducted in Bangwe (an urban setting), and 9 others were conducted in Mpemba and Madziabango (rural settings). In total, 18 FGDs were conducted.
Sampling and Recruitment Research participants were recruited based on a purposive and convenience sampling technique. Efforts were made to take a community-based approach. First, permission was sought from the Blantyre District Health Officer (DHO) to conduct the research in the catchment areas of Bangwe, Madziabango, and Mpemba government health centers. Through the nurse and clinical officers-in-charge at each health center, the local Health Surveillance Assistants (HSAs) were then approached to mobilize community members, and a timetable of FGDs was arranged in collaboration with the study team. The HSAs were called on to assist in arranging the focus groups because of their familiarity with people living in the study communities. They identified adult respondents above 16 years of age who had once participated or were still participating in biomedical research in the settings. The research team ensured that the
Procedures and Data Collection A FGD guide was administered to participants during the discussions. The research objectives were incorporated into the FGD guide that was translated into Chichewa. The interviews were recorded and notes taken as back-up to the recorded data. To ensure collection of good quality data, the FGD guides were pretested and necessary changes were made and Field Research Assistants were trained in the conduct of FGDs as well as in the transcription of recorded data. All the transcripts were checked and rechecked after typing them. The Principal Investigator, Research Officer, and Advisors were responsible for overseeing the administration of the FGDs to address any safety and quality concerns. Participants were given an equivalent of US$2 for transport reimbursement—this was the standard amount of money that was being given to participants for transport at the time. The FGDs were held at a central place in each of the three health centers. In most cases, they were held either in a classroom at a central primary school or in a church building. The longest FGD took 1.5 hr while the shortest took 40 min.
Data Analysis All transcripts were read in their entirety to identify themes that reoccurred across all focus groups. Emerging themes or subthemes were also identified. From the themes and subthemes, a coding framework was developed and applied to the texts of the transcripts. The quotes for each code were reviewed and any texts that were not categorized with the coding framework were given a new code. The codes were identified with their relevant quotes from the texts and data summaries were produced from the texts. The research team held regular meetings to discuss the data summaries. From the discussions, we developed a charting framework with linkages to the data summaries. Each chart was given a descriptive account of each theme and had relevant quotes from the study participants. The analyzed data were also entered into NUD*IST 6 (N6), an electronic qualitative data analysis software, for further analysis. Reports were produced from the charts and the NUD*IST software, and the results are presented below.
Ethical Considerations Prior to funding being granted by the Wellcome Trust, the study was submitted for scientific and ethical review to the College of Medicine Research and Ethics Committee (COMREC) in Blantyre, Malawi, and ethics approval was granted. Throughout the execution of the study, COMREC
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Mfutso-Bengo et al. was kept informed of minor adjustments to the study methodology and all amendments to the study were reviewed and approved. All research participants who participated in the FGDs listened to an explanation of the study and had an opportunity to ask questions before being asked individually to give their consent to participate in the discussion and for their contributions to be audio-recorded with the assurance that their identities would remain anonymous in the collection and processing of data. As this was a minimal risk study, verbal consent was obtained from each of the participants in the FGDs.
Results One hundred eighty-two research participants took part in 18 FGDs. Most of the participants were women and had attended at least primary school. According to the study participants, there were a number of factors that motivated them to participate in different biomedical research projects. Three major themes emerged in the analysis of the data that form the factors that motivated research participants in both urban and rural sites in Blantyre, Malawi. These include the following: better quality treatment (availability of drugs and other medical resources) during study, monetary and material incentives given to participants during study, and thorough medical diagnosis of participants’ health status.
Better Medical Care Most participants decided to take part in biomedical research because they wanted to get better medical treatment. The participants stated that they were given the best care in research, which was not available in the public health facilities; drugs were always available when they fell sick; they received effective drugs and the reception from biomedical researchers was very good. Quotations from two participants highlight their reasons: I wanted better medical help. They told me that I was free to opt out if I wanted to. But I accepted because I wanted to receive better drugs and get well quickly. We were taken care of. We were given food we have never eaten before in our homes; we were eating the food right there.
The study participants also explained that there are limited clinical resources in public health facilities and public health workers do not respect them when they go to seek medical attention. That is why most of them would opt to take part in biomedical research to benefit from the abundant health resources.
Monetary and Material Incentives Most of the participants interviewed stated that they agreed to participate in research because researchers promised to give them money and material incentives if they accepted the invitation to participate in their research projects. The participants noted that when they took part in research, they earned money without having worked or labored for it, and hence, they did not refuse to participate in research whenever they were approached to do so. They stated that they had not been forced to participate but chose to participate on their own. In addition, most female research participants said that they had decided to participate in biomedical research because the biomedical researchers had given them mosquito nets, food, washing soap, basins, napkins, and wrappers. One female participant said, When some people refuse to take part in biomedical research they would reverse their decision later on when they saw that others had been given presents after delivery [of her child]. So, some people would be interested if there are presents given to those who participate in biomedical research.
These incentives were being given to expectant mothers who agreed to participate in the PMCT Neverapine study and MiP study in both rural and urban settings. The basins, napkins, and wrappers as well as soap were for baby use and were given to research participants after delivery. As most of them could not afford these materials for their babies, they decided to take part in the studies to receive them free of charge. In fact, some of them said the use of these materials gave them a sense of prestige and pride in the society. In addition to these material incentives, they were also given a transport allowance during each visit to the clinic. For example, another female participant said, If you were in biomedical research, they would give you K800. After giving birth, they were giving you nappies.
All these incentives motivated them to agree to participate in biomedical research. Otherwise, they could not afford to buy diapers and other materials and opted to participate to get those privileges.
Thorough Medical Diagnosis and Knowledge of Health Status The participants noted that they were given thorough diagnosis of their diseases before they received treatment when they were in biomedical research. However, in routine health care, they were usually given paracetamol and
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aspirins without any proper diagnosis. They attributed this to limited resources in public hospitals and the many patients that sought medical attention in public hospitals. Indeed, there were resource constraints in public hospitals in these settings at the time of our study; however, the few resources available could be better utilized to serve people well if patients were being given proper diagnosis and asked to buy drugs from private pharmacies. Some participants also stated that they had agreed to take part in research to know their health status. They explained that they were better examined in biomedical research than in routine health care and researchers usually followed them up. This helped them to improve their health condition and motivated them to participate in biomedical research.
the Malawian context, we feel that failure to take the offer to participate in such a biomedical research is tantamount to one harming oneself or one’s child. In other words, we feel it is reasonable and ethical for people to choose to participate in biomedical research in pursuit of better medical care. Moreover, the research projects in which people had decided to participate had been reviewed and approved by ethics committees and we assume that they would not approve such studies if they exposed participants to excessive discomforts and risks. In a scenario where the national health delivery system is overburdened and fails to adequately respond to individuals’ health needs, individuals are forced to take the best available option—in this case, joining biomedical research. We view this decision as a very rational one as it is made after considering the available options as well as the due costs of deciding not to participate in the biomedical research. We believe that in limited resource settings such as those prevailing in Malawi, biomedical research plays a very important role that has not yet been fully acknowledged. Biomedical research should complement the national health delivery systems, which are overburdened. We also feel that by complementing local delivery systems, biomedical research is indirectly working toward the improvement of people’s health in resource poor countries. Finally, some participants in this study were motivated by monetary and material incentives. In most of the research projects the participants joined, they were given an equivalent of US$2 (MK 800) as transport reimbursement and compensation for their time. This amount is more than a day’s earning for most people in rural settings. At times, the research participants also were given diapers and other materials as a token of thanks. As most of the participants in the two settings had no regular source of income and were unemployed, they considered their participation in biomedical research as a form of temporary employment because they were able to earn money, which they would otherwise not get. This is a context in which the rate of unemployment is relatively high and earning a living is hard. Therefore, the opportunity to participate in biomedical research for such communities was a privilege. We argue that the giving of monetary and material incentives to research participants was not undue inducement as long as the research participants were provided with adequate study information and understood the study objectives, procedures, potential risks, benefits, their rights, and alternatives before they joined the research. One needs to understand the social context before making any judgments about such incentives and classifying them as undue inducements. In fact, the research participants themselves stated that they were not forced by anybody to participate but chose to take part on their own. In our view, these were rational decisions by the research participants.
Discussion It is evident that the majority of participants chose to participate in biomedical research as a way of accessing better quality medical care and receiving money or needed items. These findings agree with findings of studies conducted in Brazil and India by Nappo et al. (2013) as well as Doshi et al. (2013). In situations of poor service delivery, medical care in a research setting is described in favorable terms. In Malawi, medical care in Government facilities is free, but the quality of care is very low and characterized by overcrowding and scarcity of basic medicines. According to Emanuel, Wendler, Killen, and Grady (2004), benefits of research participation should refer only to benefits derived from the research itself. However, in the Malawi context of our research, participants joined biomedical research to obtain basic health care. Therefore, the issue of therapeutic misconception did not arise at all. This is in contrast to ethical regulations, and guidelines such as the Council for International Organizations of Medical Sciences [CIOMS] Guidelines (2002) oblige investigators to ensure that health care services are made available, during and after the research, to the research participants themselves and to the community from which the participants are drawn. In Malawi, however, the health benefits of research participation are normally given in the short term and only to those who join research studies. Do direct benefits to research participants in biomedical research in limited resource settings constitute undue inducements? Is it reasonable, ethically justifiable, and acceptable to take part in biomedical research with better quality medical care as a reason for participation within the Malawian context? Here, we are of the opinion that the people made their decisions autonomously, motivated by better and excellent medical care. Deciding to participate in research on these grounds is not unethical and does not constitute an undue inducement in our view. In Emmanuel’s words, it “is not an ethical worry” (Emanuel et al., 2004). In
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Best Practices Research in developing countries such as Malawi should aim at building capacity of the national health delivery system. There are some examples in Africa where research projects are serving communities by providing or supporting clinics that are open to all members of the community and not only restricted to the patients or even the disease under study. Research in limited resource settings needs to be acknowledged for the extra role it plays, that of supplementing the national health delivery systems. We also recommend that researchers consider giving other benefits to participants other than monetary incentives. We further recommend that ancillary care continue being provided to research participants in biomedical research. In our opinion, it is ethical to give ancillary care to research participants, and ethical regulations in biomedical research oblige researchers to give medical care to ailing participants, their families, and their community members as benefits to them and their communities when it is available. However, various stakeholders need to agree on how long ancillary care ought to be provided to research participants and their communities. Research in developing countries presents one route to accessing health care, and against this background, it would be unethical for biomedical researchers to deny treatment to their sick participants when it is available.
Research Agenda We are aware that therapeutic misconception may lead prospective participants to ignore the potential risks or burdens of research when considering whether to participate or not. Further research is required to understand whether indeed therapeutic misconception exists among research participants in resource poor settings. There is also need for further research on what constitutes an undue inducement to research participants in limited recourse settings.
Educational Implications Researchers need to adopt innovative methods of teaching communities and individuals about research. Researchers need to engage communities adequately before implementing their biomedical research projects. One way of doing this is to establish community advisory boards (CABs) in the communities where they intend to conduct their research. CABs act as a bridge between researchers and community members. Members of CABs should educate community members about biomedical research, about the rights and responsibilities of research participants and dispel any rumors that circulate in their communities about biomedical research. They can also address any misconceptions that
community members might have about biomedical research. In this way, potential research participants would be informed in advance about a specific biomedical research before they are approached to take part. One way to reduce the extent of the therapeutic misconception is to use community engagement, ethics review committees, researchers, and CABs to educate individuals and communities about research and how research is different from routine care. Ethical codes and guidelines such as CIOMS stipulate that payments to prospective research participants should not be so large or medical services so extensive as to induce them to consent to participate in the research against their better judgment. However, they do not elaborate on what constitutes a large payment or extensive medical services to research participants. Although ethics review committees are mandated to decide what constitutes a large payment or an extensive medical service, in cross-border biomedical research, it becomes difficult to agree on what a large payment or an extensive medical service is—a judgment from an ethics review committee in a developing country may differ from that of a committee in a developed country on the two issues as they are from different sociocultural contexts. This becomes even more problematic when dealing with unemployed persons rather than with employed persons. Yet using research participants without compensating them for their time and transport costs as well as other expenses incurred in participating in the biomedical research would be perceived as exploitation of the research participants. Therefore, ethics committees in resource poor settings need to come up with reasonable payment standards to research participants in their settings. Researchers in such settings need to adhere to such payment standards. Finally, there is indeed a need to engage in critical debates when ethical questions such as those mentioned above are raised. It is through these debates that researchers learn to conduct their biomedical research ethically. Acknowledgments We are grateful to the following for their contribution toward the activities that led to the production of this article:
•• The Wellcome Trust, for funding the research project; •• Members of the management and advisory team who provided advice and guidance to keep the research project on target: Professor Cam Bowie, Dr. Chiwoza Bandawe, and Ms. Pam Shephard; •• The Bioethics Biomedical research team who organized and coordinated the project activities: Dr. Elsbeth Robson (Social Scientist), Mrs. Matilda Mkunthi-Maluza (Research Officer), and Mr. Vincent Jumbe (Assistant Research Officer);
64 •• Fieldworkers who assisted in conducting the interviews: Ms. Sheila Jussa, Ms. Esther Sanga, and Mr. Owen Nalivata; •• Secretarial support: Mrs Thandie Kamwendo; •• The project driver: Mr Samson Wiskesi; •• College of Medicine IT department staff who helped solve technical computing problems: Mr Chisomo Kaundama and Mr Phillip Chimutu; and •• The Communities and Health Staff of Mpemba, Madziabango, and Bangwe for participating in the focus group discussions of this study.
Journal of Empirical Research on Human Research Ethics 10(1)
Funding
Lynöe, N., Hyder, Z., Chowdhury, M., & Ekstrom, L. (2001). Obtaining informed consent in Bangladesh. The New England Journal of Medicine, 344, 460-461. doi:10.1056/ NEJM200102083440617 Mfutso-Bengo, J. M., & Taylor, T. E. (2001). Ethical aspects of clinical biomedical research in developing countries. Malawi Medical Journal, 13(2), 24-25. Molyneux, C. S., Peshu, N., & Marsh, K. (2004). Understanding informed consent in a low-income setting: Three case studies from the Kenyan coast. Social Science & Medicine, 59, 2547-2559. Nappo, S. A., Iafrate, G. B., & Sanchez, Z. M. (2013). Motives for participating in a clinical research: A pilot study in Brazil. Biomedical Central Public Health, 13, Article 19. doi:10.1186/1471-2458-13-19 Pace, C., Grady, C., & Emanuel, E. J. (2003, August 28). What we don’t know about informed consent. Science and Development Network. Retrieved from http://www.scidev.net/global/ health/opinion/what-we-dont-know-about-informed-consent. html
The author(s) received no financial support for the research, authorship, and/or publication of this article.
Author Biographies
Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
References Bentley, J. P., & Thacker, P. G. (2004). The influence of risk and monetary payment on the research participation decision making process. Journal of Medical Ethics, 30, 293-298. doi:10.1136/jme.2002.001594 Council for International Organizations of Medical Sciences. (2002). International ethical guidelines for biomedical research involving human subjects. Geneva, Switzerland. Retrieved from http://www.cioms.ch/publications/guidelines/ guidelines_nov_2002_blurb.htm Doshi, M. S., Kulkarni, S. P., Ghia, C. J., Gogtay, N. J., & Thatte, U. M. (2013). Evaluation of factors that motivate participants to consent for non-therapeutic trials in India. Journal of Medical Ethics, 39, 391-396. doi:10.1136/medethics-2012-100755 Emanuel, E. J., Wendler, D., Killen, J., & Grady, C. (2004). What makes clinical research in developing countries ethical? Journal of Infectious Diseases, 189, 930-937. doi:10.1086/381709 Grady, C. (2005). Payment of clinical research subjects. Journal of Clinical Investigation, 115, 1681-1687. doi:10.1172/JCI25694 Hawkins, J., & Emanuel, E. (2008). Exploitation and developing countries: The ethics of clinical research. Princeton, NJ: Princeton University Press. Lidz, C. W., Appelbaum, P. S., Grisso, T., & Renaud, M. (2004). Therapeutic misconception and the appreciation of risks in clinical trials. Social Science & Medicine, 58, 1689-1697. doi:10.1016/S0277-9536(03)00338-1
Joseph Mfutso-Bengo is a professor of bioethics in the School of Public Health and Family Medicine at the University of Malawi, College of Medicine in Malawi, and director of the Center for Bioethics in Eastern and Southern Africa (CEBESA) at the College of Medicine. His research interests include social health research, KAP surveys, social and ethical determinants of health, ethical issues in clinical trials, and public health intervention. His contributions to this research include the conception, design, and survey tools of the study; oversight of the conduct of the interviews; and review of several drafts of the manuscript. Lucinda Manda-Taylor is the COMREC (IRB) administrator at the University of Malawi, College of Medicine, deputy director of CEBESA, and an honorary senior lecturer of bioethics in the School of Public Health and Family Medicine. Her research interests include applied ethics, bioethics, women’s health, community engagement, and health systems. She contributed to the analysis of the results and made substantial intellectual contributions to the writing of the manuscript. Francis Masiye is a junior research fellow (bioethics) in the Department of Medicine at the University of Cape Town, and also affiliated with the Centre for Bioethics in Eastern and Southern Africa at the College of Medicine in Malawi. His research interests include bioethics, research ethics in developing countries, public health ethics, and medical anthropology. He conducted the interviews, transcribed them, translated them into English, analyzed the results, and was significantly involved in the drafting and writing of the manuscript.
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