浅谈电子知情同意的应用
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摘要
电子知情同意在应用中具有如下优势:利于加快招募受试者、有助于文化水平较低者理解研究并招募入组、方便受试者和研究者直接沟通、可最大限度地减少人为的疏漏和错误、有效地提高临床研究效率等。但也存在一些挑战,如隐私、伦理审查监管、硬件费用等。在对上述问题进行论述的基础上,相信电子知情同意作为一种新的形式,在充满机遇和挑战的时代将为临床研究的开展提供更强有力的工具,有研究的价值与潜力。
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.
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.
引文
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[5] Hwang Min-A, Kwak, In Ja. National Library of Medicine. Description of a Mobile-based Electronic Informed Consent System Development[J]. Studies in health technology and informatics,2015,216: 897.
[6] 国家卫生健康委员会,国家中医药管理局.互联网诊疗管理办法[Z].2018.
[7] 王晓盈,姜国成.患者知情同意书移动签署管理系统的设计[J].中国数字医学,2017,12(7):58-60.
[8] Rowbotham MC, Astin J, Greene K, Cummings SR. Interactive Informed Consent: Randomized Comparison with Paper Consents[J]. PLoS One, 2013, 8(3): e58603.
[9] Rothwell E, Wong B, Rose NC, et al. A randomized controlled trial of an electronic informed consent process[J]. J Empir Res Hum Res Ethics, 2014,9(5): 1-7.
[10] Steven R. Cummings,Michael C. Rowbotham. Electronic Informed Consent and Internet-Based Trials[J]. N Engl j med, 2017,376:859-861.
[2] Simon CM, Klein DW, Schartz HA. Traditional and electronic informed consent for biobanking: a survey of U.S. biobanks[J]. Biopreservation and Biobanking, 2014, 12(6):423-429.
[3] Implementation of Electronic Consent at aBiobank: An Opportunity for Precision Medicine Research[J].J Pers Med,2016(6):2.
[4] Iain C Sandersona, Jihad S Obeidb, Kapil Chalil Madathilc. Managing clinical research permissions electronically: A novel approach to enhancing recruitment and managing consents[J]. Clinical Trials,2013(10): 604-611.
[5] Hwang Min-A, Kwak, In Ja. National Library of Medicine. Description of a Mobile-based Electronic Informed Consent System Development[J]. Studies in health technology and informatics,2015,216: 897.
[6] 国家卫生健康委员会,国家中医药管理局.互联网诊疗管理办法[Z].2018.
[7] 王晓盈,姜国成.患者知情同意书移动签署管理系统的设计[J].中国数字医学,2017,12(7):58-60.
[8] Rowbotham MC, Astin J, Greene K, Cummings SR. Interactive Informed Consent: Randomized Comparison with Paper Consents[J]. PLoS One, 2013, 8(3): e58603.
[9] Rothwell E, Wong B, Rose NC, et al. A randomized controlled trial of an electronic informed consent process[J]. J Empir Res Hum Res Ethics, 2014,9(5): 1-7.
[10] Steven R. Cummings,Michael C. Rowbotham. Electronic Informed Consent and Internet-Based Trials[J]. N Engl j med, 2017,376:859-861.