Norwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
Trials. 2024 Aug 19;25(1):550. doi: 10.1186/s13063-024-08386-1.
Interest in and use of electronic consent (e-consent) in the conduct of academic clinical trials has increased since the COVID-19 pandemic. E-consent offers advantages including increased efficiency and accessibility, and reduced burden on site staff, which can be appealing to academic trialists anticipating challenges in recruitment to complex trial designs or with limited funding. However, there are many options to consider when using e-consent in a study protocol. This paper presents five case studies from Norwich Clinical Trials Unit, demonstrating how e-consent models can be effectively tailored to the needs of different trials. These examples illustrate the options around and benefits of e-consent, the acceptability of e-consent by participants, and the design considerations that were made during the development of the trial protocols.
Five randomised trials are presented, selected from a range of different trial designs, disease areas, interventions, and patient populations. E-consent was either offered as an alternative to paper consent, according to participant preference, or as the sole method of consent. E-consent was generally used to facilitate remote consent in decentralised trials but was also chosen to increase efficiency and reduce burden in an emergency department setting. The technical implementation of e-consent and detailed participant procedures were tailored to the needs of the trial settings and patient populations. For example, accompanying participant information sheets were provided in paper or electronic form, and electronic signatures could be typed or drawn. Administrative data on uptake of e-consent is presented where available.
This paper demonstrates that the operational and technical aspects of implementing e-consent in clinical trials can be influenced by the trial design, the needs and characteristics of the trial population, financial/efficiency considerations, and level of risk. E-consent is not a one-size-fits-all tool for trials, and its use should be carefully considered during the development of the trial protocol, in conjunction with patient and public involvement contributors, site staff and other trial stakeholders.
自 COVID-19 大流行以来，学术临床研究中对电子知情同意（e-consent）的兴趣和使用有所增加。e-consent 具有提高效率和可及性、减轻现场工作人员负担等优势，这对于那些预计在复杂试验设计或有限资金的招募方面会面临挑战的学术试验者来说很有吸引力。然而，在研究方案中使用电子知情同意时有许多选项需要考虑。本文展示了诺里奇临床试验单位的五个案例研究，展示了如何有效地根据不同试验的需求定制电子知情同意模型。这些示例说明了围绕电子知情同意的选项和优势、参与者对电子知情同意的接受程度，以及在制定试验方案时所做的设计考虑。
本文介绍了五个随机试验，这些试验选自一系列不同的试验设计、疾病领域、干预措施和患者人群。根据参与者的偏好，电子知情同意可作为纸质知情同意的替代方案，也可作为唯一的同意方式。电子知情同意通常用于促进分散试验中的远程同意，但也选择用于提高效率和减轻急诊科的负担。电子知情同意的技术实施和详细的参与者程序根据试验设置和患者人群的需求进行了调整。例如，提供了纸质或电子形式的伴随参与者信息表，并且可以键入或绘制电子签名。在有可用数据的情况下，提供了电子知情同意采用的行政数据。
本文表明，临床试验中实施电子知情同意的操作和技术方面可以受到试验设计、试验人群的需求和特征、财务/效率考虑以及风险水平的影响。电子知情同意并不是适用于所有试验的一刀切工具，在制定试验方案时，应与患者和公众参与贡献者、现场工作人员和其他试验利益相关者一起仔细考虑其使用。
