Abstract 1856P
Background
The Electronic Informed Consent (eIC) was introduced with the aim of optimizing time and costs, providing the essential characteristics of a clinical study in an easy-to-use format thus enhancing patient understanding.
Methods
During the second quarter of 2020, the Working Group “Clinical Research Coordinators” of the Medical Oncology Italian Association (AIOM) has developed a survey on the knowledge, use and opinion of eIC. The questionnaire was an anonymous web-based survey, consisting in 16 multiple-choice questions, aimed at clinical research stakeholders and disseminated through AIOM social channels.
Results
The survey was completed by 99 people: 49 physicians, 41 study coordinators, 4 research nurses, 5 Others. Only 17% of the total participants has a personal experience with eIC (67% for direct use at the center, 33% through theoretical training). The most used tool (69%) is the tablet and eIC is almost always (86%) administered by the clinician. There are few cases (35%) of use of the electronic version alone, while in most centers (65%) the use of the paper version in parallel is preferred. The survey showed a different patient approach towards the eIC: 40% did not express any difference in dealing with the eIC compared to the paper version; 41% reported initial perplexity, that in most cases was overcome after an interview with the physician while in 6% of cases remained throughout the study. According to participants’ experience, the use of eIC has little influence on patient's possible refusal to participate in the study (average score 3.5 on a scale of 0 not at all - 10 a lot). At a regulatory level, the use of eIC seems to have some negative effects, such as longer time frames for study approval (26% of respondents) and the need for additional information in order to express an opinion (48%). On a scale of 0 to 10, participants expressed a median score of 6 with respect to the possibility that the eIC can completely replace the paper form.
Conclusions
The experience of Italian centers with respect to the use of eIC is still very limited, although there are no major hesitations from clinicians orpatients. Surely the tool could be very useful in cases where, as during the pandemic, patient access to the hospital may not be the best option for his well-being and safety.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
AIOM.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.