A pilot study to explore utility of electronic informed consent in a low- income setting; the case of a Controlled human infection study in Blantyre, Malawi

Ngoliwa, Clara, Chakwiya, Chikondi, Gondwe, Joel, Nsomba, Edna, Nkhoma, Vitumbiko, Reuben, Modesta, Chantunga, Linda, Liwonde, Pemphero, Mangani, Edward, Kudowa, Evaristar, Makhaza, Lumbani, Toto, Neema, Sochera, Tiferanji, Chikaonda, Tarsizio, Morton, Ben ORCID: https://orcid.org/0000-0002-6164-2854, Henrion, Marc, Dula, Dingase, Gordon, Stephen ORCID: https://orcid.org/0000-0001-6576-1116 and Chirwa, Anthony E. (2025) 'A pilot study to explore utility of electronic informed consent in a low- income setting; the case of a Controlled human infection study in Blantyre, Malawi'. Wellcome Open Research, Vol 9, p. 233.

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Abstract

Background
Electronic informed consent can improve accuracy, workflow, and overall patient experience in clinical research but has not been used in Malawi, owing to uncertainty about availability, utility, patient data security and technical support.

Objectives
We aimed to explore the utility of electronic consent (e-consent) in an ongoing human infection study in Blantyre, Malawi.

Methods
The approved paper consent forms were digitized using Open Data Kit (ODK). Following participant information giving by the research staff, healthy literate adult participants with no audio-visual impairments completed a self-administered e-consent and provided an electronic signature. We dual-consented participants by both paper-based and electronic-consenting. Signed e-consent forms were uploaded to a secure study server. Utility of e-consenting was observed by participation rate, user-friendliness, documentation error rate, and staff perception of the overall consenting process.

Results
All 109 participants offered e-consenting accepted participation. E-consenting was user-friendly, had no identifiable documentation errors as compared to 43.1% (n 47/109) error rate with paper-based consenting, and ensured data safety, and unravelled areas for consideration. Challenges with e-consenting included difficult digitization of ethics stamped documents, as well as present but infrequent delays of retrieval of e-consent forms.

Conclusion
E-consenting is feasible, has a utility benefit in a controlled human infection study in Malawi; a low-income country, and can supplement paper-based consenting. Its usefulness can improve the consenting process in research conducted in such settings. Additionally, success of e-consenting requires a careful consideration.

Item Type:	Article
Subjects:	WA Public Health > WA 20.5 Research (General) WA Public Health > WA 30 Socioeconomic factors in public health (General) WC Communicable Diseases > Infection. Bacterial Infections > General Infection > WC 195 Infection. Cross infection. Laboratory infection
Faculty: Department:	Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI):	https://doi.org/10.12688/wellcomeopenres.20770.2
SWORD Depositor:	JISC Pubrouter
Depositing User:	JISC Pubrouter
Date Deposited:	20 Mar 2025 14:30
Last Modified:	20 Mar 2025 14:30
URI:	https://archive.lstmed.ac.uk/id/eprint/26222

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