Analysis on the Current Status and Ethics Review Key Points of Electronic Informed Consent / 中国医学伦理学

Informed consent is one of the key elements to protect the rights and welfare of the patients or research subjects. With the development of electronic information technology, the diversity and convenience brought by the electronization makes the electronic informed consent (E-Consent) come into being. European and American countries have begun to apply E-Consent in the field of clinical trials, established a relatively perfect E-Consent platform and software system, and initially formed the guiding principles and recommendations of E-Consent. However, the implementation of E-Consent is still less in China, and there is no targeted legal basis and guidelines for ethical review. Therefore, this paper explored the implementation potential of E-Consent domestically by analyzing the application scenarios, advantages and disadvantages, and feasibility of E-Consent, and tried to establish the practical ethic review points of E-Consent based on the basic principles of ethical principles, to ensure that clinical trials have an appropriate E-Consent process.

Comparative analysis of multiple models of electronic informed consent in clinical research / 中华医学科研管理杂志

Objective:To provide decision-making support for electronic informed consent selection and promotion in clinical research, and lay a possible theoretical foundation for better protection of subjects′ rights and interests, as well as promotion of clinical research quality and efficiency.Methods:This paper summarized the relevant laws and regulations of electronic informed consent, analyzed the advantages and challenges of the application of electronic informed consent in clinical research, sorted out several common electronic informed consent modes in domestic clinical research, explored their operational processes and applications, and discussed their advantages and limitations.Results:At present, three electronic informed consent modes were mainly used in domestic clinical studies. Each had their own advantages and limitations in terms of convenience of operation, data security, privacy protection of subjects, cost input, popularization degree and so on.Conclusions:Electronic informed consent needs continuing improvement of relevant laws and regulations and the joint efforts of all stakeholders engaged in clinical research. The sponsor and the researcher should take full consideration of the cost, safety, security, feasibility, and ofters, and make the selection according to the actual needs of the research.

Supervision of Electronic Informed Consent in International Clinical Research and Its Implications for China / 中国医学伦理学

At present, China is still in the exploratory stage in the field of electronic informed consent (eIC), and relevant policies, regulations and application guidelines have not yet been established and improved. While the traditional informed consent supervision system is difficult to meet the needs of the innovative development of eIC, such as subject privacy and data security. Through sorting out and analyzing the legal norms and construction system of eIC supervision in Europe and the United States, combined with the current development status, problems, and challenges of eIC in China, this paper targeted proposed the path to construct the supervision of eIC in clinical research in China from the aspects of restricting the signing form and process of eIC, adjusting the ethical review paradigm of eIC, enhancing the strength of eIC ethical review, improving the construction of eIC legal system, and strengthening the training of relevant researchers.

Challenges and Suggestions for Improvement of the Electronic Informed Consent System in Clinical Application / 中国医学伦理学

The electronic informed consent (eIC) system is a product of modernization development of electronic and intelligent technology. In the context of COVID-19, the eIC system can adapt to the epidemic prevention and control requirements, showing its time-space advantages. By introducing the concept, form and the use of eIC system, this paper analyzed the challenges of acceptance, understanding, consent and information security faced by the eIC system. Based on this, some suggestions were put forward, including strengthening the training of the relevant personnel involved in the eIC system, enhancing and improving the functions of the eIC system, and perfecting the relevant laws and regulations of the eIC system, so as to provide reference for the future research and application of eIC.

The Application of Electronic Informed Consent / 中国医学伦理学

The application of electronic informed consent has the advantages of speeding up the recruitment of subjects, helping the less educated to understand research and recruit groups, facilitating direct communication between subjects and researchers, minimizing human omissions and errors, and effectively improving the efficiency of clinical research. However, there are also some challenges, such as privacy, ethical censorship, hardware costs and so on. On the basis of the above discussion, this paper believed that electronic informed consent, as a new form, would provide a more powerful tool for clinical research in an era full of opportunities and challenges, with research value and potential.