{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,12]],"date-time":"2026-07-12T13:05:58Z","timestamp":1783861558931,"version":"3.55.0"},"update-to":[{"DOI":"10.12688\/wellcomeopenres.20770.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2025,2,5]],"date-time":"2025-02-05T00:00:00Z","timestamp":1738713600000}}],"reference-count":16,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2025,2,5]],"date-time":"2025-02-05T00:00:00Z","timestamp":1738713600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100010269","name":"Wellcome Trust","doi-asserted-by":"publisher","award":["211433"],"award-info":[{"award-number":["211433"]}],"id":[{"id":"10.13039\/100010269","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["wellcomeopenresearch.org"],"crossmark-restriction":false},"short-container-title":["Wellcome Open Res"],"abstract":"<ns5:p>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.<\/ns5:p>","DOI":"10.12688\/wellcomeopenres.20770.2","type":"journal-article","created":{"date-parts":[[2025,2,5]],"date-time":"2025-02-05T07:02:23Z","timestamp":1738738943000},"page":"233","update-policy":"https:\/\/doi.org\/10.12688\/wellcomeopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["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"],"prefix":"10.12688","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-8041-9350","authenticated-orcid":false,"given":"Clara","family":"Ngoliwa","sequence":"first","affiliation":[{"name":"Blantyre Malawi-Liverpool-Wellcome Trust Clinical Research Programme"},{"name":"Department of Medicine Blantyre Queen Elizabeth Central 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peer review: 2 approved].","volume":"6","author":"B Morton","year":"2022","journal-title":"Wellcome Open Res."},{"key":"ref-12","doi-asserted-by":"publisher","first-page":"e683-e691","DOI":"10.1016\/S2666-5247(23)00178-7","article-title":"Effect of 13-valent pneumococcal conjugate vaccine on experimental carriage of Streptococcus pneumoniae serotype 6B in Blantyre, Malawi: a randomised controlled trial and controlled human infection study.","volume":"4","author":"D Dula","year":"2023","journal-title":"Lancet Microbe."},{"key":"ref-13","doi-asserted-by":"publisher","first-page":"228","DOI":"10.5210\/ojphi.v5i3.4996","article-title":"Android and ODK based data collection framework to aid in epidemiological analysis.","volume":"5","author":"A Tridane","year":"2014","journal-title":"Online J Public Health Inform."},{"key":"ref-14","doi-asserted-by":"publisher","first-page":"529-534","DOI":"10.1016\/j.jogn.2018.04.134","article-title":"Electronic informed consent to facilitate recruitment of pregnant women into research.","volume":"47","author":"J Phillippi","year":"2018","journal-title":"J Obstet Gynecol Neonatal Nurs."},{"key":"ref-15","doi-asserted-by":"publisher","first-page":"1-8","DOI":"10.1200\/CCI.17.00041","article-title":"Leveraging mobile technology to improve efficiency of the consent-to-treatment process.","volume":"1","author":"V Chhin","year":"2017","journal-title":"JCO Clin Cancer Inform."},{"key":"ref-16","article-title":"Econsent_pids20240403"}],"container-title":["Wellcome Open Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-233\/v2\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-233\/v2\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-233\/v2\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,12]],"date-time":"2026-07-12T12:24:10Z","timestamp":1783859050000},"score":1,"resource":{"primary":{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-233\/v2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,2,5]]},"references-count":16,"URL":"https:\/\/doi.org\/10.12688\/wellcomeopenres.20770.2","relation":{"has-version":[{"id-type":"doi","id":"10.12688\/wellcomeopenres.20770.1","asserted-by":"subject"}],"has-review":[{"id-type":"doi","id":"10.21956\/wellcomeopenres.26056.r118171","asserted-by":"subject"},{"id-type":"doi","id":"10.21956\/wellcomeopenres.26056.r118168","asserted-by":"subject"},{"id-type":"doi","id":"10.21956\/wellcomeopenres.26056.r118699","asserted-by":"subject"},{"id-type":"doi","id":"10.21956\/wellcomeopenres.26056.r118168","asserted-by":"object"},{"id-type":"doi","id":"10.21956\/wellcomeopenres.26056.r118699","asserted-by":"object"},{"id-type":"doi","id":"10.21956\/wellcomeopenres.26056.r118171","asserted-by":"object"}]},"ISSN":["2398-502X"],"issn-type":[{"value":"2398-502X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,2,5]]},"assertion":[{"value":"Indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-233\/v2#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.21956\/wellcomeopenres.22987.r82476, Dr. Francis Masiye, Malawi University of Science and Technology, Limbe, Southern Region, 08 Jun 2024, version 1, 4 approved with reservations","URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-233\/v1#referee-response-82476","order":0,"name":"referee-response-82476","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Clara Ngoliwa<\/b>; \n<i>Posted: 21 Jan 2025<\/i>; This paper presents exciting results of a study piloted by e-consent\/digital consent. It is well-written and presented. However, the following issues need to be addressed by the authors: 1. Please provide the NHSRC reference number for the study in the methods section under &quot;Ethics&quot;   Thank you very much. The NHSRC reference number has been added to the article.   There are discrepancies in how potential participants provided consent during their recruitment into the study; under the section on &quot;Recruitment to the study of consenting methods&quot;, it is stated that verbal consent was obtained from participants, and yet under the section on &quot;Procedure for comparing consent methods in the HIS&quot;, it states that both participants and study staff signed the consent form respectively. Please confirm whether verbal consent or written consent was obtained from participants. If verbal consent was obtained from potential participants, please justify why verbal consent was sought.   Thank you. We agree that this indeed is a discrepancy we have revised the sentence under \u201cRecruitment to the study of consenting methods\u201d to read \u201cParticipants underwent dual consenting (paper-based and electronic consenting in that order).&quot;&nbsp;to clarify how the consenting processes went.   Under the section on&nbsp;&quot;Procedure for comparing consent methods in the HIS&quot;, it is stated that participants were quizzed with 10 questions to assess understanding, please explain how the data collected from the 10 questions was analysed.&nbsp;  Thank you. The quiz was in relation to the CHIM study as stated that this was a sub study, the quiz was marked in real time to assess participant comprehension. Pass mark was at least 80%. This data was not analysed.  Under the section on &quot;Setting up e-consenting in ODK&quot;, it is explained that data was collected using the ODK application, please explain how data collected via the ODK platform was analyzed and how the results were arrived at.  Thank you very much. This data was not analysed. The electronic consent form included all components of the physical paper- based consent. We checked for any missing consents, incomplete consents and documentation errors. These have been defined and clarified in the new version of the revised manuscript.  Please clarify why none of the authors declares any conflict of competing interests or lack of it.  Thank you very much. It was a pilot to inform feasibility of e-consenting in an LMIC setting. This was a sub study conducted by same investigators. The pilot was not designed for any commercialisation.  &nbsp;","URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-233\/v2#referee-comment-6007","order":1,"name":"referee-comment-6007","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/wellcomeopenres.26056.r118171, Evelyne Kestelyn, Oxford University Clinical Research Unit, Ho Chi Minh City, 25 Feb 2025, version 2, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-233\/v2#referee-response-118171","order":2,"name":"referee-response-118171","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/wellcomeopenres.22987.r90965, Muhammed Afolabi, London School of Hygiene and Tropical Medicine, London, 12 Aug 2024, version 1, 4 approved with reservations","URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-233\/v1#referee-response-90965","order":3,"name":"referee-response-90965","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Clara Ngoliwa<\/b>; \n<i>Posted: 21 Jan 2025<\/i>; The authors reported the findings of their pilot study on the feasibility and usefulness of e-consenting among research participants enrolled in a parent trial in Malawi, a low-income country with an adult literacy level of 68%, according to the 2024 World Bank\/UNESCO report&nbsp;(1). Given this relatively high literacy level among adult population in Malawi, the authors did NOT support their exclusion of study participants who were not literate in English, with empirical evidence. This selection bias is a major methodological flaw that might have impacted the study findings adversely, as the findings could not be generalised to the adult population in Malawi. Similarly, the inclusion of a large number of students in the study further underscored the skewness and non-generaliseability of the study findings.  Thank you very much. Traditionally most CHIMs have been done in HICs and are recently expanding into low and middle income countries. One ethical concern for conducting CHIMs in LMICs is the challenge of obtaining voluntary informed consent especially in participants who are not literate, who may thus be considered as vulnerable (Informed consent for Controlled Human Infection Studies in low- and middle&nbsp; income countries: Ethical challenges ad proposed solutions (doi: 10.1111\/bioe.12795. Epub 2020 Aug 10) The transferred protocols included only the literate. The pilot was a sub-study, the main trial under which the pilot was conducted was the first CHIM in Malawi and it excluded illiterate participants. We agree this method excludes a population which would have otherwise been included. Future CHIMs should conduct prior community consultation on inclusion of illiterate participants. We Agree with the reviewer and we have clarified in paper that this was a sub-study of an ongoing trial that involved only literate participants  Also, objective comparisons could not be undertaken with the study design adopted by the authors, as the study participants had already undergone the traditional paper consenting before requesting them to repeat the same process using electronic consenting. This introduced a procedural bias into the process. An individually randomised controlled trial would have minimised this bias and could have generated reliable findings that might have shaped future research or implementation of e-consenting in Malawi.&nbsp;   Thank you. We agree that prior paper based consenting might have improved observations seen in e-consenting. This has been clarified in the findings of the paper.   The authors did not indicate in their manuscript whether they provided some basic information about e-consenting to the study participants before requesting them to undertake the electronic procedure. The authors' statement that&nbsp;'Participants were required to simply select I AGREE with a single tap'&nbsp;suggests an over-simplification of the process and procedures involved in e-consenting. Therefore, this might not have wholly captured the process of e-consenting.   Information was given verbally. The select option was to make the process easier and faster but participants had to go through each step\/ question prior to selecting I AGREE. This has been revised in the paper.   I was also expecting to see in the results factors that might have shaped the positive results on e-consenting reported by the authors. Could factors such as age, gender, education levels, previous computer experience, ownership of a smartphone, etc, have affected the participant's ability or performance to undertake e-consenting without errors?   Thank you very much. We agree but unfortunately we did not explore these factors.","URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-233\/v2#referee-comment-6006","order":4,"name":"referee-comment-6006","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/wellcomeopenres.26056.r118168, Erisa Sabakaki Mwaka, School of Biomedical Sciences, College of Health Sciences, Makerere University, Kampala, Central Region, 12 Feb 2025, version 2, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-233\/v2#referee-response-118168","order":5,"name":"referee-response-118168","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/wellcomeopenres.26056.r118699, Melissa McCradden, The University of Adelaide, Adelaide, South Australia, 06 Mar 2025, version 2, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-233\/v2#referee-response-118699","order":6,"name":"referee-response-118699","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This work was supported by Wellcome (211433). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":7,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}