Exploring understanding of research participants on their roles and responsibilities in clinical research in Southern Malawi: Expectation vs reality inpractice V1.0
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Date
2021-06-02
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Kamuzu University of Health Sciences
Abstract
This is a cross-sectional study employing qualitative research methods through in-depth interviews
and focus group discussions.
The roles and responsibilities of researchers, research institutions, sponsor and ethics review
boards are cited in several publications, including international and national guidelines and
regulations. There are universally recognized and accepted guidelines for research practice, such as
the Belmont Report and the declaration of Helsinki, which are applied to evaluate research's ethical
conduct versus researchers' roles and responsibilities 1. However, there is very little literature on
the responsibilities of research participants, and the meaning and significance research participants
attach to their obligations when they participate in research. It is essential for both researchers and
participants to know and understand the responsibilities of research participants when deciding to
participate in the study. Literature reveals a shared common theme among researchers of wanting
to know how volunteers make sense of their participation in research and the implications of this
understanding for research practice2.
This study focuses on exploring what participants understand as their responsibilities in research
and whether their understanding may be different from the assumptions of researchers and the
research ethics committees. It will also look at what implications understanding of these
responsibilities has on research practice and how understanding the duties from the research
participants perspective may help inform varied approaches to the review of study protocols by the
ethics committees. As Grady3 notes, "without evaluative data, it is unclear to what extent IRBs
achieve their goal of enhancing participant protection."
objectives
1. To describe research participants' knowledge and understanding of their roles and
responsibilities in research.
2. To describe factors enabling understanding of research participants roles and
responsibilities
3. To assess the implications of research participants this of their role
on research practice
4. To understand investigators expectations regarding the roles and responsibilities of
participants.
5. To assess views of research participants on research practice
6. To identify any similarities or differing views between groups participating in the study.
This is a qualitative research study and will use purposive sampling. We plan to conduct 25 in-depth
interviews; 19 with research participants and 6 with researchers. 4 focus group discussions where
2 FGDs will be done with participants in interventional studies and 2 with participants in non interventional
studies.
We anticipate to generate an in depth understanding of how participants interpret their trial task
and establish gaps in equipping participants with knowledge regarding research participation
which will later inform the conduct of research and the governance of research ethics .This study
aims to establish what both participants and researchers understand as the roles and
responsibilities of research participants and how understanding the research participants'
obligations may help inform varied approaches to reviewing study protocols by the ethics
committees.
The findings will be shared among researchers and ethics committees in Malawi (COMREC) and
Liverpool (LSTM) and the Ministry of Health in Malawi. The results will be presented through
journal articles, the College of Medicine research dissemination conference, relevant international
ethics conferences and all stakeholders in this study