Electronic Informed Consent in Pneumococcal Study, Malawi

Electronic consent can potentially improve accuracy, workflow, and overall patient experience in clinical research. We explored the feasibility of using electronic consent in an ongoing human infection study in Blantyre. We dual-consented participants by both electronic and paper methods to assess the feasibility of electronic consent, and then compared benefits and challenges of the two methods. The approved paper consent forms were digitized using Open Data Kit (ODK). Healthy literate adult participants with no audio-visual impairments then self-administered the e-consenting materials while accompanied by a member of staff to answer questions, and then provided an e-signature. Signed e-consent forms were exported to secure servers for archiving. A copy of the signed form was printed and given to the volunteers. We piloted 110 participants to e-consenting, it was found to be user friendly, reduced documentation errors and enhanced data safety. The challenges included difficult digitization of ethics stamped documents, volunteer unfamiliarity with tablet user interface and its requirement of a working internet and printerE-consenting was feasible but required additional resource investment. Benefits included error minimization and data security.电子知情同意（Electronic Consent）在临床研究中有望提升数据准确性、优化工作流程并全面改善受试者体验。本研究针对布兰太尔地区一项正在进行的人体感染研究，探索了电子知情同意的应用可行性。我们对受试者同时采用电子与纸质两种方式开展知情同意流程，以评估电子知情同意的可行性，并对比两种方式的优势与挑战。经伦理审批通过的纸质知情同意书通过开放数据套件（Open Data Kit, ODK）完成数字化转换。招募无视听障碍、具备读写能力的健康成年受试者，在工作人员陪同下自行完成电子知情同意材料的阅览与签署流程，工作人员可随时解答疑问，随后受试者签署电子签名。签署完成的电子知情同意书将导出至安全服务器进行归档，同时打印签署后的副本交付给受试者。本试点共纳入110名受试者参与电子知情同意流程，结果显示该流程操作便捷，可有效减少文档录入错误并提升数据安全性。本次试点遇到的挑战包括：加盖伦理审查章的文件数字化难度较高、受试者对平板用户界面不熟悉，且该流程需依赖稳定的网络与打印机设备。电子知情同意具备临床应用可行性，但需投入额外的人力与物力资源。其核心优势包括减少文档错误与提升数据安全性。