Khairat Saif, Tirtanadi Katie, Ottmar Paige, Sleath Betsy, Obeid Jihad
The Carolina Health Informatics Program, The University of North Carolina at Chapel Hill, North Carolina, United States.
The Gillings School of Global Public Health, The University of North Carolina at Chapel Hill, North Carolina, United States.
Eur J Biomed Inform (Praha). 2019 Aug;15(2). Epub 2019 Jul 5.
Obtaining informed consent from research study participants continues to meet difficulties. New ways to connect with potential participants are necessary to address barriers, expand enrollment and offer more services to underserved populations.
Electronic consent is designed to complete consenting sessions remotely and may help combat the obstacles inherent in the traditional informed consent process. We investigate the implementation of an electronic consent platform, Teleconsent, to broaden and diversify recruitment for clinical research.
Semi-structured interviews were conducted with community members to assess their perceptions regarding the acceptability and usability of Teleconsent, a form of electronic consent. Interviews were structured to determine the main benefits, challenges and concerns as detailed by each participant. Participants were divided into rural and urban groupings.
We interviewed 40 participants to gather first-time perceptions of Teleconsent. We found overall positive results. Predominately in urban communities, participants possessed the technological skills and amenities to support smooth implementation of this technology. However, many participants reflect on the challenges regarding logistics, privacy and reliability of utilizing Teleconsent in underserved, rural areas. 5 of 19 participants, more than a quarter for the rural group, experienced Teleconsent software problems. During these sessions, an alternative process with paper templates was employed to complete interviews.
Perceptions regarding Teleconsent demonstrate current challenges along with potential acceptance within different communities. This is despite the fact that on its own it will not be able to overcome the barriers currently found in the informed consent process. Still, investment in electronic consent, including the development of enhanced and interactive content, can potentially revolutionize this process. Our findings offer a preliminary step towards determining the feasibility and acceptance of Teleconsent, a form of electronic consent, in different communities. More research surrounding the logistics of adoption is necessary in order to determine success.
从研究参与者处获得知情同意仍然面临困难。需要新的方式来与潜在参与者建立联系,以克服障碍、扩大招募范围并为服务不足的人群提供更多服务。
电子同意旨在远程完成同意过程,可能有助于应对传统知情同意过程中固有的障碍。我们研究了一个电子同意平台Teleconsent的实施情况,以扩大临床研究招募范围并使其多样化。
对社区成员进行了半结构化访谈,以评估他们对电子同意形式Teleconsent的可接受性和可用性的看法。访谈旨在确定每位参与者详细阐述的主要益处、挑战和担忧。参与者分为农村和城市两组。
我们采访了40名参与者,以收集他们对Teleconsent的初次看法。我们发现总体结果是积极的。主要在城市社区,参与者具备支持该技术顺利实施的技术技能和便利设施。然而,许多参与者反映了在服务不足的农村地区使用Teleconsent时在后勤、隐私和可靠性方面的挑战。19名参与者中有5名,超过农村组的四分之一,遇到了Teleconsent软件问题。在这些环节中,采用了带有纸质模板的替代流程来完成访谈。
对Teleconsent的看法表明了当前的挑战以及在不同社区的潜在接受度。尽管它本身无法克服目前在知情同意过程中发现的障碍。不过,对电子同意的投资,包括开发增强型和交互式内容,有可能彻底改变这一过程。我们的研究结果为确定电子同意形式Teleconsent在不同社区的可行性和接受度迈出了初步步伐。为了确定成功与否,围绕采用后勤方面的更多研究是必要的。