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.