Exploring understanding of research participants on their roles and responsibilities in clinical research in Southern Malawi: Expectation vs reality inpractice V1.0
| dc.contributor.author | Banda, Gertrude Mwase | |
| dc.date.accessioned | 2021-12-20T16:27:01Z | |
| dc.date.available | 2021-12-20T16:27:01Z | |
| dc.date.issued | 2021-06-02 | |
| dc.description.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 | en_US |
| dc.identifier.uri | http://rscarchive.kuhes.ac.mw/handle/20.500.12988/595 | |
| dc.language.iso | en | en_US |
| dc.publisher | Kamuzu University of Health Sciences | en_US |
| dc.relation.ispartofseries | P.04/21/3311; | |
| dc.title | Exploring understanding of research participants on their roles and responsibilities in clinical research in Southern Malawi: Expectation vs reality inpractice V1.0 | en_US |