Friedman Emma, Michelson Kelly Nicole, Sehgal Shruti, Steans Russell, Hosseini Mohammad, Baumann Matthew J, Venables Amanda K, Walunas Theresa L, Starren Justin
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States of America.
Ann & Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois, United States of America.
PLoS One. 2025 Apr 1;20(4):e0318533. doi: 10.1371/journal.pone.0318533. eCollection 2025.
Current challenges in the clinical research landscape include insufficient enrollment of study participants, lack of study participant diversity, protracted study progression, and the siloing of research within academic medical centers. Recent advances in technology could minimize barriers to producing effective, timely, and comprehensive clinical research by addressing issues from study design to dissemination of results. Particularly, the Fast Health Interoperability Resources standards and Clinical Decision Support Hooks could support data acquisition, sharing, and expansion of research across organizations and disparate electronic health records. We developed a novel approach, Precision Accelerated Clinically Embedded Research (PACER), that leverages these advances in healthcare technology to integrate very short, minimal-risk research activities into clinical encounters. PACER could enable scalable, efficient, and cost-effective clinical research and has enormous potential. However, PACER also presents potential ethical, sociotechnical, and implementation quandaries. The current study aimed to obtain insights on these matters from relevant individuals. We conducted 47 qualitative semi-structured interviews with patients, clinicians, research experts (individuals involved in developing and conducting research), and bioethicists. We sought participants' perspectives on the potential ethical, sociotechnical, and implementation issues raised by PACER. We identified five key domains: impacts on clinical research, consent, compensation, impacts on people and organizations, and implementation. We examined interview participants' views using bioethical principles of autonomy, justice/fairness, beneficence, and nonmaleficence. While participants had diverse views, these insights highlight important considerations for PACER implementation and suggest areas for future empirical work.
临床研究领域当前面临的挑战包括研究参与者招募不足、研究参与者缺乏多样性、研究进展缓慢以及学术医疗中心内部研究的孤立性。技术上的最新进展可以通过解决从研究设计到结果传播等问题，将产生有效、及时且全面的临床研究的障碍降至最低。特别是，快速健康互操作性资源标准和临床决策支持挂钩可以支持跨组织和不同电子健康记录的数据采集、共享及研究扩展。我们开发了一种新颖的方法，即精准加速临床嵌入式研究（PACER），该方法利用医疗技术的这些进展，将非常简短、风险极小的研究活动整合到临床诊疗过程中。PACER可以实现可扩展、高效且具有成本效益的临床研究，具有巨大潜力。然而，PACER也带来了潜在的伦理、社会技术和实施方面的难题。当前的研究旨在从相关人员那里获取对这些问题的见解。我们对患者、临床医生、研究专家（参与研究开发和实施的人员）以及生物伦理学家进行了47次定性半结构化访谈。我们征求了参与者对PACER引发的潜在伦理、社会技术和实施问题的看法。我们确定了五个关键领域：对临床研究的影响、同意、补偿、对人员和组织的影响以及实施。我们运用自主、正义/公平、行善和不伤害等生物伦理原则来审视访谈参与者的观点。虽然参与者观点各异，但这些见解突出了PACER实施的重要考量因素，并为未来的实证研究指明了方向。
