Balestra Martina, Shaer Orit, Okerlund Johanna, Westendorf Lauren, Ball Madeleine, Nov Oded
Department of Technology Management & Innovation, Tandon School of Engineering, New York University, Brooklyn, NY, United States.
J Med Internet Res. 2016 Jul 20;18(7):e197. doi: 10.2196/jmir.5662.
Social media, mobile and wearable technology, and connected devices have significantly expanded the opportunities for conducting biomedical research online. Electronic consent to collecting such data, however, poses new challenges when contrasted to traditional consent processes. It reduces the participant-researcher dialogue but provides an opportunity for the consent deliberation process to move from solitary to social settings. In this research, we propose that social annotations, embedded in the consent form, can help prospective participants deliberate on the research and the organization behind it in ways that traditional consent forms cannot. Furthermore, we examine the role of the comments' valence on prospective participants' beliefs and behavior.
This study focuses specifically on the influence of annotations' valence on participants' perceptions and behaviors surrounding online consent for biomedical research. We hope to shed light on how social annotation can be incorporated into digitally mediated consent forms responsibly and effectively.
In this controlled between-subjects experiment, participants were presented with an online consent form for a personal genomics study that contained social annotations embedded in its margins. Individuals were randomly assigned to view the consent form with positive-, negative-, or mixed-valence comments beside the text of the consent form. We compared participants' perceptions of being informed and having understood the material, their trust in the organization seeking the consent, and their actual consent across conditions.
We find that comment valence has a marginally significant main effect on participants' perception of being informed (F2=2.40, P=.07); specifically, participants in the positive condition (mean 4.17, SD 0.94) felt less informed than those in the mixed condition (mean 4.50, SD 0.69, P=.09). Comment valence also had a marginal main effect on the extent to which participants reported trusting the organization (F2=2.566, P=.08). Participants in the negative condition (mean 3.59, SD 1.14) were marginally less trusting than participants exposed to the positive condition (mean 4.02, SD 0.90, P=.06). Finally, we found that consent rate did not differ across comment valence conditions; however, participants who spent less time studying the consent form were more likely to consent when they were exposed to positive-valence comments.
This work explores the effects of adding a computer-mediated social dimension, which inherently contains human emotions and opinions, to the consent deliberation process. We proposed that augmenting the consent deliberation process to incorporate multiple voices can enable individuals to capitalize on the knowledge of others, which brings to light questions, problems, and concerns they may not have considered on their own. We found that consent forms containing positive valence annotations are likely to lead participants to feel less informed and simultaneously more trusting of the organization seeking consent. In certain cases where participants spent little time considering the content of the consent form, participants exposed to positive valence annotations were even more likely to consent to the study. We suggest that these findings represent important considerations for the design of future electronic informed consent mechanisms.
社交媒体、移动和可穿戴技术以及联网设备显著拓展了在线开展生物医学研究的机会。然而，与传统的同意程序相比，收集此类数据的电子同意书带来了新的挑战。它减少了参与者与研究人员之间的对话，但为同意审议过程从单独环境转向社交环境提供了契机。在本研究中，我们提出，嵌入同意书中的社交注释能够帮助潜在参与者以传统同意书无法做到的方式，对研究及其背后的机构进行思考。此外，我们考察了评论的效价对潜在参与者的信念和行为的作用。
本研究特别关注注释效价对围绕生物医学研究在线同意的参与者认知和行为的影响。我们希望阐明如何将社交注释以负责任且有效的方式纳入数字介导的同意书。
在这个被试间对照实验中，向参与者展示一份个人基因组学研究的在线同意书，该同意书在页边空白处嵌入了社交注释。个体被随机分配去查看在同意书文本旁带有积极、消极或混合效价评论的同意书。我们比较了不同条件下参与者对已获告知和理解材料的认知、他们对寻求同意的机构的信任以及他们实际的同意情况。
我们发现评论效价对参与者的已获告知感有微弱显著的主效应（F(2)=2.40，P = 0.07）；具体而言，处于积极条件下的参与者（均值4.17，标准差0.94）比处于混合条件下的参与者（均值4.50，标准差0.69，P = 0.09）感觉自己了解的信息更少。评论效价对参与者报告的信任该机构的程度也有微弱的主效应（F(2)=2.566，P = 0.08）。处于消极条件下的参与者（均值3.59，标准差1.14）比接触积极条件的参与者（均值4.02，标准差0.90，P = 0.06）信任程度略低。最后，我们发现不同评论效价条件下的同意率没有差异；然而，花费较少时间研读同意书的参与者在接触到积极效价评论时更有可能同意。
这项工作探索了在同意审议过程中添加计算机介导的社交维度（其本身包含人类情感和观点）的效果。我们提出，扩充同意审议过程以纳入多种声音能够使个体利用他人的知识，这揭示出他们自己可能未曾考虑过的问题、疑问和担忧。我们发现，包含积极效价注释的同意书可能会使参与者感觉了解的信息更少，同时对寻求同意的机构更信任。在某些参与者几乎没有花时间考虑同意书内容的情况下，接触积极效价注释的参与者甚至更有可能同意参与该研究。我们认为这些发现为未来电子知情同意机制的设计提供了重要的考量因素。
