Examining study participants’ decision-making and ethics-related experiences in a dietary community randomized controlled trial in Malawi
Abstract Background The participant recruitment process is a key ethical pivot point when conducting robust research. There is a need to continuously review and improve recruitment processes in research trials and to build fair and effective partnerships between researchers and participants as an im...
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| Format: | Article |
| Language: | English |
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BMC
2021-12-01
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| Series: | BMC Medical Ethics |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12910-021-00729-w |
| _version_ | 1819043061043298304 |
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| author | Limbanazo Matandika Kate Millar Eric Umar Edward Joy Gabriella Chiutsi-Phiri Joseph Mfutso-Bengo |
| author_facet | Limbanazo Matandika Kate Millar Eric Umar Edward Joy Gabriella Chiutsi-Phiri Joseph Mfutso-Bengo |
| author_sort | Limbanazo Matandika |
| collection | DOAJ |
| description | Abstract Background The participant recruitment process is a key ethical pivot point when conducting robust research. There is a need to continuously review and improve recruitment processes in research trials and to build fair and effective partnerships between researchers and participants as an important core element in ensuring the ethical delivery of high-quality research. When participants make a fair, informed, and voluntary decision to enroll in a study, they agree to fulfill their roles. However, supporting study participants to fulfill study requirements is an important ethical obligation for researchers, yet evidenced as challenging to achieve. This paper reports on participants’ motivations to volunteer and remain part of a dietary study conducted in Kasungu District, Malawi. Methods We conducted twenty in-depth interviews (with chiefs, religious leaders, trial participants, and health surveillance assistants), five systematic ethnographic observations, and fourteen focus group discussions with trial participants and their partners. Interviews were audio-recorded and transcribed verbatim. We used a grounded theory methodology to analyse data that included coding, detailed memo writing, and data interpretation. Findings The findings reveal that many participants had concerns during the trial. Thematically, experiences included anxieties, mistrust of researchers, rumours, fears of exploitation, and misconceptions. Anonymous concerns collected from the participants were reported to the trial team which enabled the researchers to appropriately support participants. Despite initial concerns, participants described being supported and expressed motivation to take up their role. Conclusion These findings highlight a diverse map of multiple notions of what is ethically relevant and what can impact participation and retention within a study. The study has revealed how embedding a responsive approach to address participants’ concerns and ethical issues can support trust relationships. We argue for the need to employ embedded ethics strategies that enhance informed consent, focus on participants’ needs and positive experiences, and support researchers to fulfill their roles. This work highlights the need for research ethics committees to focus on the risks of undue influence and prevent exploitation especially in settings with a high asymmetry in resources and power between researcher and participant groups. Trial Registration: The Addressing Hidden Hunger with Agronomy (Malawi) trial was registered on 5th March 2019 (ISCRTN85899451). |
| first_indexed | 2024-12-21T09:50:47Z |
| format | Article |
| id | doaj.art-1637d254cd8843d6a5a2d1620a2cf945 |
| institution | Directory Open Access Journal |
| issn | 1472-6939 |
| language | English |
| last_indexed | 2024-12-21T09:50:47Z |
| publishDate | 2021-12-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medical Ethics |
| spelling | doaj.art-1637d254cd8843d6a5a2d1620a2cf9452022-12-21T19:08:12ZengBMCBMC Medical Ethics1472-69392021-12-0122111410.1186/s12910-021-00729-wExamining study participants’ decision-making and ethics-related experiences in a dietary community randomized controlled trial in MalawiLimbanazo Matandika0Kate Millar1Eric Umar2Edward Joy3Gabriella Chiutsi-Phiri4Joseph Mfutso-Bengo5Center for Bioethics in Eastern and Southern Africa, College of Medicine, University of MalawiCentre for Applied Bioethics, Schools of Biosciences and Veterinary Medicine and Science, University of NottinghamHealth Systems and Policy Department, College of Medicine, University of MalawiFaculty of Epidemiology and Population Health, London School of Hygiene & Tropical MedicineFaculty of Life Science and Natural Resources, Natural Resources College, Lilongwe University of Agriculture and Natural ResourcesCenter for Bioethics in Eastern and Southern Africa, College of Medicine, University of MalawiAbstract Background The participant recruitment process is a key ethical pivot point when conducting robust research. There is a need to continuously review and improve recruitment processes in research trials and to build fair and effective partnerships between researchers and participants as an important core element in ensuring the ethical delivery of high-quality research. When participants make a fair, informed, and voluntary decision to enroll in a study, they agree to fulfill their roles. However, supporting study participants to fulfill study requirements is an important ethical obligation for researchers, yet evidenced as challenging to achieve. This paper reports on participants’ motivations to volunteer and remain part of a dietary study conducted in Kasungu District, Malawi. Methods We conducted twenty in-depth interviews (with chiefs, religious leaders, trial participants, and health surveillance assistants), five systematic ethnographic observations, and fourteen focus group discussions with trial participants and their partners. Interviews were audio-recorded and transcribed verbatim. We used a grounded theory methodology to analyse data that included coding, detailed memo writing, and data interpretation. Findings The findings reveal that many participants had concerns during the trial. Thematically, experiences included anxieties, mistrust of researchers, rumours, fears of exploitation, and misconceptions. Anonymous concerns collected from the participants were reported to the trial team which enabled the researchers to appropriately support participants. Despite initial concerns, participants described being supported and expressed motivation to take up their role. Conclusion These findings highlight a diverse map of multiple notions of what is ethically relevant and what can impact participation and retention within a study. The study has revealed how embedding a responsive approach to address participants’ concerns and ethical issues can support trust relationships. We argue for the need to employ embedded ethics strategies that enhance informed consent, focus on participants’ needs and positive experiences, and support researchers to fulfill their roles. This work highlights the need for research ethics committees to focus on the risks of undue influence and prevent exploitation especially in settings with a high asymmetry in resources and power between researcher and participant groups. Trial Registration: The Addressing Hidden Hunger with Agronomy (Malawi) trial was registered on 5th March 2019 (ISCRTN85899451).https://doi.org/10.1186/s12910-021-00729-wEthical rolesEmbedded ethicsInformed consentSelf-efficacyVoluntarilyRumours |
| spellingShingle | Limbanazo Matandika Kate Millar Eric Umar Edward Joy Gabriella Chiutsi-Phiri Joseph Mfutso-Bengo Examining study participants’ decision-making and ethics-related experiences in a dietary community randomized controlled trial in Malawi BMC Medical Ethics Ethical roles Embedded ethics Informed consent Self-efficacy Voluntarily Rumours |
| title | Examining study participants’ decision-making and ethics-related experiences in a dietary community randomized controlled trial in Malawi |
| title_full | Examining study participants’ decision-making and ethics-related experiences in a dietary community randomized controlled trial in Malawi |
| title_fullStr | Examining study participants’ decision-making and ethics-related experiences in a dietary community randomized controlled trial in Malawi |
| title_full_unstemmed | Examining study participants’ decision-making and ethics-related experiences in a dietary community randomized controlled trial in Malawi |
| title_short | Examining study participants’ decision-making and ethics-related experiences in a dietary community randomized controlled trial in Malawi |
| title_sort | examining study participants decision making and ethics related experiences in a dietary community randomized controlled trial in malawi |
| topic | Ethical roles Embedded ethics Informed consent Self-efficacy Voluntarily Rumours |
| url | https://doi.org/10.1186/s12910-021-00729-w |
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