Simister Samuel K, Tse Shannon, Saade Aziz, Sweeney Chancey A, Wise Barton L, Thorpe Steven W, Randall R Lor
Department of Orthopaedics, University of California, Davis, CA 95817, USA.
Department of Internal Medicine, University of California, Davis, CA 95817, USA.
J Clin Med. 2024 Mar 8;13(6):1551. doi: 10.3390/jcm13061551.
: Orthopedic oncology research is hindered by the scarcity of musculoskeletal tumors and research administrative inefficiencies. This paper introduces observational research through an innovative institution-specific methodology-termed an umbrella protocol. This protocol outlines a comprehensive standard procedure to expedite ethical approval for future aligned studies, reducing administrative barriers to research. : We developed an umbrella protocol at an academic center, involving meticulous methodological identification and coordination with the institutional review board (IRB) to adhere to local guidelines. The protocol encompasses identifying investigators, research objectives, study goals, and data and safety monitoring frameworks necessary for typical standards. : Implementation of the umbrella protocol took 110 days to achieve exemption status, following multiple discussions with the IRB and extensive revisions. At the authors institution, this protocol significantly reduces protocol review times from an average of six-to-eight weeks to nearly instantaneous, facilitating a streamlined research process. Additionally, we established a dedicated orthopedic oncology patient registry to enhance future research endeavors. : The adoption of umbrella protocols represents a pioneering strategy in orthopedic oncology. This approach mitigates research administrative burdens and broadens research scope in the field. It underscores the necessity of IRB collaboration, methodological precision, and stringent data management. The article also reflects on the ethical implications and potential biases introduced by emerging technologies like artificial intelligence, advocating for diligent ethical oversight. The establishment of an umbrella protocol marks a significant step towards more efficient research methodologies, ultimately aiming to improve patient care and outcomes for individuals with rare musculoskeletal conditions.
骨科肿瘤学研究受到肌肉骨骼肿瘤稀缺和研究管理效率低下的阻碍。本文通过一种创新的针对特定机构的方法——称为总体方案,介绍了观察性研究。该方案概述了一个全面的标准程序,以加快对未来相关研究的伦理批准,减少研究的行政障碍。
我们在一个学术中心制定了一个总体方案,包括精心的方法学识别以及与机构审查委员会(IRB)协调以遵守当地指南。该方案涵盖识别典型标准所需的研究人员、研究目标、研究目的以及数据和安全监测框架。
在与IRB进行多次讨论并进行大量修订后,总体方案的实施花了110天达到豁免状态。在作者所在机构,该方案显著将方案审查时间从平均六到八周减少到几乎即时,促进了研究过程的简化。此外,我们建立了一个专门的骨科肿瘤患者登记处,以加强未来的研究工作。
采用总体方案是骨科肿瘤学中的一项开创性策略。这种方法减轻了研究管理负担,拓宽了该领域的研究范围。它强调了IRB合作、方法学精确性和严格数据管理的必要性。文章还反思了人工智能等新兴技术带来的伦理影响和潜在偏差,倡导进行严格的伦理监督。总体方案的建立标志着朝着更高效的研究方法迈出了重要一步,最终目标是改善患有罕见肌肉骨骼疾病患者的护理和治疗结果。