According to the results of our study, the participants’ overall correct response rate for all questions in the knowledge section of the questionnaire was above 92%. The overall median attitude score was 3.41 (IQR 3.18-3.76). Respondents generally demonstrated a high level of knowledge about eIC and a positive attitude toward eIC.
The demographic characteristics showed that the majority of respondents (74.9%) had heard of the term“electronic informed consent,” but most of them (61.9%) had not used eIC. These may suggest that with the development of digital technology in clinical research, medical researchers know about the concept of eIC broadly. In practice, however, the use of eIC in clinical research is not that widespread. Most participants (98%) indicated that they frequently used smartphones or computers, and 84.5% preferred mobile devices (mobile phone/tablet) for eIC. These responses suggest that using smartphones and computers has become prevalent, and operating eIC on mobile devices is more acceptable to medical researchers. Our other study of research participants also showed that 87% of participants preferred mobile devices rather than computers for eIC[17]. This may be due to the flexibility, portability, and convenience of mobile devices compared to personal computers. This is can be empirical evidence that it may be preferable to promote eIC on mobile devices first.
The research department within a hospital was the primary place where respondents heard of eIC (67.9%). This was most likely because medical researchers had previous experience in clinical research and the research department within a hospital was more actively interested than other hospital departments in cutting-edge information related to clinical research. Informed consent is an essential part of any clinical research, so medical researchers are more likely than other hospital personnel to have access to information related to eIC. In addition, among those who use eIC, electronic documents are the dominant form of eIC, used by the majority of respondents (78.9%), followed by a mobile app or WeChat mini program (46.5%). This indicates that electronic documents are still more widespread than other forms of eIC.
Knowledge of electronic informed consent
As can be seen from Table 2, over 90% of the respondents correctly answered the questions in the knowledge section of the questionnaire. The questions respondents answered correctly included the concept of eIC, consistency of content with paper-based informed consent, diverse forms of eIC, reliability, use of electronic signatures, and requirements for ethical review. These results indicate that medical researchers generally have a good understanding of eIC. The proportion of participants (92.5%) aware of the flexibility of the location at which eIC is obtained was somewhat smaller. Some studies have shown that eIC provides location flexibility by allowing researchers to obtain informed consent from prospective research participants in an online format, such as remote videoconferencing, rather than being limited to taking place on-site[46]. The remote eIC can improve the recruitment efficiency for some clinical investigations and reduce the costs of travel and time[25]. In a randomized trial of patients with emergent large vessel occlusion strokes, eIC streamlined the consenting process by reducing distance and time[47]. eIC can bring convenience with location flexibility. Thus it is necessary to improve medical researchers’ awareness of location flexibility that can be applied to different scenarios, which is impossible with traditional paper-based informed consent. In this regard, eIC compensates for the shortcoming of paper informed consent.
Attitudes toward electronic informed consent
In terms of overall attitudes toward eIC, respondents were more likely to use eIC than to ues paper-based informed consent (69%) and found it more convenient (81.7%) and efficient (79.7%) than paper-based informed consent. These results are consistent with findings from other countries. According to a study in the United States, most researchers supported using eIC to improve participants’ understanding of the research content[30]. In addition, according to a study of researchers in Australia, eIC helped improve workflow and was more effective than paper-based methods[48]. In addition, a study of clinical researchers in USA also showed that researchers were positive toward eIC and would likely use it if allowed[31].
eIC cannot completely replace paper-based informed consent instantly
Medical researchers expressed reservations about completely replacing paper-based informed consent with eIC, suggesting that further research and experimentation are needed. Completely replacing paper-based informed consent with eIC is not widely accepted at this stage. This is likely because there are still some challenges to using eIC. According to one study, clinical researchers identified eIC users technical skills, hardware availability, and Internet connectivity as the biggest challenges to the remote consent process[31]. Moreover, a survey of researchers in the United States found that while researchers are interested in eIC, organizations considering its use need to consider issues such as subject preference and acceptance, relevant technical conditions, electronic signature capture, and which form of eIC is most appropriate to use[29]. In particular, the use of eIC in China is not yet supported by specific guiding rules. In addition, China lacks regulatory guidelines in the field of clinical research in terms of using face recognition and electronic signatures. Thus medical researchers may have concerns about eIC’s completely replacing paper-based informed consent.
Respondents felt that eIC better regulated the signing of informed consent and avoided errors and omissions (61.4%). A randomized controlled trial in Germany showed that informed consent forms were filled out completely in the group using eIC, while in the group using traditional informed consent, 11 % of the classic forms were returned with missing data[49]. This is since in traditional informed consent, human subjects are likely to skip questions or points that need to be confirmed, while in eIC, human subjects could only proceed to the next step after responding to all questions or each element of an informed consent form[49].
Remote eIC is preferred in distant scenarios
More than half of respondents (57.1%) preferred remote eIC, which is consistent with recent research findings. A study of remote eIC in the U.S. showed that researchers recruiting participants from rural areas have been looking to use remote eIC to address common difficulties and access issues with traditional informed consent; by reducing the time and travel required to obtain consent, remote eIC allows individuals in rural areas to participate in clinical research[46]. Indeed, recruitment of rural populations facilitates the expansion of the generalizability of the clinical study results. A study has shown that a higher proportion of rural populations in emergency medicine research could increase research enrollment and expose rural and non-rural populations more equally to the potential risks and benefits of participating in clinical research[50]. In addition, a small number of respondents (30.6%) would be concerned that they are not proficient in using electronic equipment and could not adapt to using eIC. Some studies have suggested that unfamiliarity with the operation of electronic devices is a potential barrier to using eIC[51]. Therefore, eIC should provide adequate support for participants with no or limited computer literacy[52]. However, nearly all the respondents in our study often used electronic devices such as smartphones or computers (98%), and just 3.3% had frequent difficulties in using them. This suggests that most medical researchers would have no difficulties operating the eIC.
Paradox in information understanding
More than half of the respondents (57.4%) were concerned that eIC would make it difficult for subjects to understand information about the research. In fact, studies have yielded mixed results on whether eIC can improve subjects’ understanding of research information. These findings are consistent with the results of our study. Respondents had reservations regarding the ability of eIC to make it easier for subjects to decide whether to participate in clinical research. Some findings have suggested that eIC makes it easier for participants to understand the information and thus make a decision about whether to consent[53-55]. A study in the U.S. investigated the extent to which eIC helped participants decide whether to participate in clinical research. The study showed that the ease of deciding to join was related to trust in and lack of frustration using eIC, and the ability to spend a limited time on eIC[7]. However, some studies have shown that multimedia interventions do not always result in significant improvements in comprehension[56,57]. This suggests that there may well be other factors that influence subjects’ comprehension and thus decision making.
At the same time, respondents were optimistic (77.2%) that setting up interactive sessions in the eIC would help improve subjects’ understanding of the information, which confirms the results of previous studies. A randomized controlled study in the United States comparing paper-based informed consent documents with an interactive, presentation-based eIC using iPads showed that the latter improved subjects’ and researchers’ understanding of study procedures and risks[58]. Furthermore, some studies have shown that when the eIC includes interactive components, online quizzes, personalized materials, and annotations, participants are more knowledgeable about the information presented to them than they would be without these interactive sessions[54,59-61]. In contrast, our findings indicate that the majority of respondents (63.4%) felt that the traditional informed consent interaction was better than the online interaction of eIC. A randomized multicenter controlled trial in the United States suggested that subjects’ confidence in their understanding of the study and their experience of the consent process may be hampered by technical interruptions in eIC use, such as time spent managing unfamiliar interfaces or delays in video calls[62]. This suggests that interactivity is correlated with comprehension and satisfaction. Ethics committees may need to consider the need for alternatives to traditional informed consent in which researchers explain information about the research on site in eIC, whether in the form of multimedia or video calls or otherwise[63]. Therefore, there is a considerable need to investigate further how to design an effective interactive eIC.
Ethical and legal concerns associated with eIC application
The majority of medical researchers expressed concerns about the security and confidentiality of the eIC (60.7%) and the need for more detailed confidentiality instructions (87.5%), which is consistent with the results of existing studies. An Australian study of data privacy aspects of eIC has shown the importance researchers place on data security and protection in eIC[64]. Researchers emphasized the need to describe in detail how they ensure the privacy and protection of participants’ personal data[64]. Other studies also have shown a clear concern among researchers about security and privacy protection associated with eIC[24,30]. These concerns may make researchers reluctant to implement eIC in clinical research[52]. Furthermore, subjects’ satisfaction with eIC is also related to data privacy and protection. A study in the United States showed that eIC, which provides detailed data protection measures, satisfied subjects more[65]. Therefore, it is critical to design a kind of eIC that is ideal in terms of identifying security risks and protecting data security.
In addition, respondents had reservations about the legal validity and rights protection aspects of eIC. Internationally, eIC in places such as the U.S., U.K., Belgium and Austria is already supported by relevant regulatory guidelines. However, adoption of the eIC has been slow due to technical, legislative and regulatory barriers to establishing and implementing the eIC platform[66]. These include concerns about data security and the legal validity of electronic signatures[28,30,52]. In China, the Data Security Law of 2021 states that data processing activities should comply with laws and regulations, respect social morality and ethics, and fulfil data security protection obligations[67]. However, there are no regulations specifically related to the use of eIC in clinical research, and it is important to deepen the understanding of Chinese data security-related laws and improve eIC rules. Since there are no regulations specifically for using eIC in clinical research, the respondents generally believe that the laws and regulations related to eIC need to be further improved (89.7%).
Factors associated with attitudes of medical researchers toward eIC
Our findings show that respondents who occasionally have difficulty using electronic devices had lower attitude scores than those who never do (p < 0.05). This suggests that the ability to use electronic devices affects the attitudes of medical researchers toward eIC. Previous studies have suggested that eIC requires adequate digital literacy and that lower digital literacy affects hospital staff attitudes toward information systems or technology[54,68]. Prior to implementing eIC, it is necessary to train medical researchers to master the eIC system. This will help to fully understand their attitudes towards eIC and seek their advice on eIC.
In addition, our research results show that the scores of respondents who prefer mobile devices were greater than those of respondents who prefer PC devices (p < 0.05). This suggests that mobile devices, rather than PC devices, are more likely to make medical researchers more positive about eIC when using them. This preference is most likely due to the small size, convenience, and short start-up time of mobile devices[69]. Moreover, because mobile devices are more portable and flexible, they allow medical researchers to access information online anytime and anywhere. Not only that, but our previous research has shown that research participants also preferred mobile devices over PC devices[17]. Therefore, future eIC designers should pay more attention to the design of mobile terminals while considering the compatibility of different devices.