medethics-2020-107011.full.pdf (2.59 MB)
Investigation of post-trial access views among study participants and stakeholders using photovoice and semistructured interviews
Version 2 2023-06-12, 09:54
Version 1 2023-06-10, 00:08
journal contribution
posted on 2023-06-12, 09:54 authored by Ngwenya Nothando, Collins IwujiCollins Iwuji, Nabeel Petersen, Nompilo Myeni, Samukelisiwe Nxumalo, Ursula Ngema, Janet SeeleyPurpose We examine the levels of post-trial responsibility ascribed to different stakeholders, following a community-based clinical trial and how the ‘responsibility’ is understood. Methods We employed photovoice, unstructured observations and key informant interviews to gain insights into contexts of access to care following transition to the public health system post trial. We used an inductive narrative analysis to explore experiences and understandings of post-trial access (PTA). Results In their photovoice stories, many participants expressed a sense of abandonment after the trial. This was viewed as a contributing factor to failing to re-engage with care available in the public health system. This led to the experiences of loss as some trial participants defaulted and died. Research investigators, department of health participants and sponsor agreed that PTA was especially important for communities in resource-limited settings. The government has an obligation towards its citizens while researchers have a responsibility to ensure a smooth transition of patients to public clinics. Sponsors have a responsibility to ensure that the trial is conducted in accordance with the protocol and post-trial agreements are in place and adhered to. Research partnerships among stakeholders were affected by power imbalances making it difficult to negotiate and plan for post-trial care responsibilities. Conclusions The research community still struggles with understanding the scope of PTA responsibilities. Power dynamics between public health actors and research sponsors need to be managed to ensure that government involvement is not tokenistic. The responsibility of trial participants and ethics committees needs to be investigated further.
History
Publication status
- Published
File Version
- Published version
Journal
Journal of Medical EthicsISSN
0306-6800Publisher
BMJ Publishing GroupExternal DOI
Page range
1-6Department affiliated with
- Global Health and Infection Publications
Full text available
- Yes
Peer reviewed?
- Yes
Legacy Posted Date
2021-06-17First Open Access (FOA) Date
2021-06-29First Compliant Deposit (FCD) Date
2021-06-16Usage metrics
Categories
No categories selectedKeywords
Licence
Exports
RefWorks
BibTeX
Ref. manager
Endnote
DataCite
NLM
DC