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.

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.