使用电子知情同意的最佳实践

Informed consent is the foundation of modern clinical research, with compliance being crucial to ensure patient safety and study transparency. In recent years, electronic informed consent (eIC) has become more widely adopted, with the potential to replace printed consent forms and improve the efficiency and effectiveness of the process.

对于寻求证明合规性和拥护主题安全性和透明度的企业，电子持持续性可以帮助避免违反可能导致对公司赞助研究的信心的违规行为。反过来，这可能会影响参与和入学临床试验，这是产品注册的关键。制定一个积极的计划并教育您的潜在主题将有助于消除潜在的误解并增加主题的信心。

FDA的指导

The Food & Drug Administration's (FDA) guidance文档关于使用电子知情同意，提供了有关使用电子系统和流程的建议，这些建议可能采用多种电子媒体来获得由健康和公共服务（HHS）调节的人类学科研究的知情同意，以及包括人类药物在内的医疗产品的临床研究以及生物产品，由FDA调节的医疗设备及其组合。

对FDA指导的目的,共同引用to the use of electronic systems and processes that may employ multiple electronic media, including text, graphics, audio, video, podcasts, passive and interactive web sites, biological recognition devices and card readers, to convey information related to the study and to obtain and document informed consent.

The guidance document was released to ensure the following:

• Continuing protection of the rights, safety and welfare of human subjects
• Facilitation of the subject's comprehension of the information presented during the eIC process
• 当使用多种电子媒体的电子系统和流程获得知情同意时，可以获得适当的同意文件
• FDA应用程序中包含的EIC数据的质量和完整性，并在检查期间可用于FDA

为了维持知情同意书的完整性及其用法，以教育潜在参与者有关研究的完整性，平衡必须满足同意的原则：

• 自治（自愿给予）
• Self-determination (given by an individual who has capacity)
• 对人权的肯定和对人权尊严的尊重（由一个被充分告知利益，风险，问题和利益冲突的个人）

The informed consent process must have the following elements:

• 使用可理解的术语和详细信息
• Sufficient time to make a well-informed decision regarding participation
• 提出问题并向首席调查员发表评论或指定的能力
• 最大程度地减少不当影响或强迫 - 主题必须清楚地表明，如果他们选择不参加护理和卫生服务的接收将不会改变
• The Informed Consent Form must not use exculpatory language (it must not be written to waive rights of the patients or release the researchers and sponsors from liability due to negligence)
• 主题必须清楚地表明，参与是自愿的，他们有权撤回而无需罚款或损失

EIC的好处

当适当地使用时，EIC可以增加参与者对信息的访问，审查和理解的时间，同时通过拥有研究人员/医生的业务关系来解决利益冲突，以研究赞助商和其他资助者。

Every eIC should be easy to navigate, allowing the user to proceed forward or backward within the system and to stop and continue later. Hyperlinks may be provided where helpful. The eIC may also incorporate electronic strategies to encourage subjects to access all the consent material before documenting their consent. The eIC must adhere to all these requirements:

• The information must be in language understandable to the potential subject or the subject's Legally Authorized Representative (LAR)
• Understandable means that the information presented to subjects is in a language and at a level the subject can comprehend
• 为了确保适当地提出EIC，并且受试者将有足够的时间专门用于EIC流程，应将受试者告知该过程将花费多长时间以及向他们提供什么信息。

The eIC may use electronic signatures that comply with all applicablerequirements。电子系统还必须捕获并记录日期that the subject or subject's LAR provides consent. The法规permit a wide variety of methods to create electronic signatures, including using computer-readable ID cards, biometrics, digital signatures and user name and password combinations. FDA does not mandate or specify methods for electronic signatures, including any biometric method upon which an electronic signature may be based, as long as the system being used is secure and auditable.

All eIC documents, information and processes must be approved by an independent research ethics committee.

It is important to note that eIC may not be suitable for all subjects and that subjects may prefer one method over another. Other subjects may have difficulty navigating or using electronic systems because of, for example, a lack of familiarity with electronic systems, poor eyesight or impaired motor skills. Therefore, subjects should have the option to use paper-based or electronic informed consent methods completely or partially throughout the informed consent process. Subjects may need to be trained or assisted with the technology.

Conclusion

使用EIC可以显着改善主题在此过程中的经验。作为临床研究人员，在决定实施EIC过程（或补充或替换基于纸张的过程）之前，我们必须对法规有一定的了解。请记住，每个研究和受试者人群都是独一无二的，因此请考虑在查看如何使用EIC时。最后，考虑使用多种技术来传达您的信息，以确保包容性。