Analysis of the Application of Electronic Informed Consent in Clinical Research from the Perspective of Doctor and Patient
Objective"Internet+Medical"has brought new opportunities and challenges for research centers to carry out clinical trials.The traditional informed consent procedure has restricted the development of clinical re-search.The aim of this study was to explore the feasibility of the application of electronic informed consent model and provide reference for its development.Methods 57 residents and 52 doctors in Beijing and Shanghai were inter-viewed by objective sampling,and the data were analyzed qualitatively by thematic framework.Results Both physi-cians and patients showed a high acceptance of the application of electronic informed consent,with 34 residents and 45 doctors believing that it can improve the quality and efficiency of clinical research.At the same time,there were also identified risks and challenges associated with the use of electronic informed consent.41 residents and 39 doctors pointed out limitations in its scope of application,while 12 residents and 27 doctors expressed concerns about its compliance.Furthermore,31 residents and 27 doctors lacked confidence in the protection of personal priva-cy.Conclusion Both physicians and patients acknowledged that electronic informed consent facilitates the recruit-ment of participants across time and space,enhances communication between both parties,and improves the quality and efficiency of clinical research.However,it also faces challenges such as a lack of regulations to support its com-pliance,limitations in its applicability and target population,and potential risks of privacy breaches.In order to stan-dardize the application of electronic informed consent,it is necessary to address the issue from multiple aspects,such as improving legal policies,evaluating its application scenarios,enhancing internet technology,and strengthening the review of medical ethics committees.This will effectively promote the application of electronic informed consent in clinical research and achieve a win-win situation for all parties involved.
Electronic informed consentClinical researchSubject protectionQualitative research
万方数据
