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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Autores principales:	Limbanazo Matandika, Kate Millar, Eric Umar, Edward Joy, Gabriella Chiutsi-Phiri, Joseph Mfutso-Bengo
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Ethical roles Embedded ethics Informed consent Self-efficacy Voluntarily Rumours Medical philosophy. Medical ethics R723-726
Acceso en línea:	https://doaj.org/article/1637d254cd8843d6a5a2d1620a2cf945
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spelling	oai:doaj.org-article:1637d254cd8843d6a5a2d1620a2cf9452021-12-05T12:03:32ZExamining study participants’ decision-making and ethics-related experiences in a dietary community randomized controlled trial in Malawi10.1186/s12910-021-00729-w1472-6939https://doaj.org/article/1637d254cd8843d6a5a2d1620a2cf9452021-12-01T00:00:00Zhttps://doi.org/10.1186/s12910-021-00729-whttps://doaj.org/toc/1472-6939Abstract 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).Limbanazo MatandikaKate MillarEric UmarEdward JoyGabriella Chiutsi-PhiriJoseph Mfutso-BengoBMCarticleEthical rolesEmbedded ethicsInformed consentSelf-efficacyVoluntarilyRumoursMedical philosophy. Medical ethicsR723-726ENBMC Medical Ethics, Vol 22, Iss 1, Pp 1-14 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ethical roles Embedded ethics Informed consent Self-efficacy Voluntarily Rumours Medical philosophy. Medical ethics R723-726
spellingShingle	Ethical roles Embedded ethics Informed consent Self-efficacy Voluntarily Rumours Medical philosophy. Medical ethics R723-726 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
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).
format	article
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
title	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_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_sort	examining study participants’ decision-making and ethics-related experiences in a dietary community randomized controlled trial in malawi
publisher	BMC
publishDate	2021
url	https://doaj.org/article/1637d254cd8843d6a5a2d1620a2cf945
work_keys_str_mv	AT limbanazomatandika examiningstudyparticipantsdecisionmakingandethicsrelatedexperiencesinadietarycommunityrandomizedcontrolledtrialinmalawi AT katemillar examiningstudyparticipantsdecisionmakingandethicsrelatedexperiencesinadietarycommunityrandomizedcontrolledtrialinmalawi AT ericumar examiningstudyparticipantsdecisionmakingandethicsrelatedexperiencesinadietarycommunityrandomizedcontrolledtrialinmalawi AT edwardjoy examiningstudyparticipantsdecisionmakingandethicsrelatedexperiencesinadietarycommunityrandomizedcontrolledtrialinmalawi AT gabriellachiutsiphiri examiningstudyparticipantsdecisionmakingandethicsrelatedexperiencesinadietarycommunityrandomizedcontrolledtrialinmalawi AT josephmfutsobengo examiningstudyparticipantsdecisionmakingandethicsrelatedexperiencesinadietarycommunityrandomizedcontrolledtrialinmalawi
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Examining study participants’ decision-making and ethics-related experiences in a dietary community randomized controlled trial in Malawi

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