Duke University, Durham, NC, USA.
Oregon Health & Science University, Portland, OR, USA.
Contemp Clin Trials. 2022 Nov;122:106953. doi: 10.1016/j.cct.2022.106953. Epub 2022 Oct 4.
Single Institutional Review Boards (sIRB) are not achieving the benefits envisioned by the National Institutes of Health. The recently published Health Level Seven (HL7®) Fast Healthcare Interoperability Resources (FHIR®) data exchange standard seeks to improve sIRB operational efficiency.
We conducted a study to determine whether the use of this standard would be economically attractive for sIRB workflows collectively and for Reviewing and Relying institutions. We examined four sIRB-associated workflows at a single institution: (1) Initial Study Protocol Application, (2) Site Addition for an Approved sIRB study, (3) Continuing Review, and (4) Medical and Non-Medical Event Reporting. Task-level information identified personnel roles and their associated hour requirements for completion. Tasks that would be eliminated by the data exchange standard were identified. Personnel costs were estimated using annual salaries by role. No tasks would be eliminated in the Initial Study Protocol Application or Medical and Non-Medical Event Reporting workflows through use of the proposed data exchange standard. Site Addition workflow hours would be reduced by 2.50 h per site (from 15.50 to 13.00 h) and Continuing Review hours would be reduced by 9.00 h per site per study year (from 36.50 to 27.50 h). Associated costs savings were $251 for the Site Addition workflow (from $1609 to $1358) and $1033 for the Continuing Review workflow (from $4110 to $3076).
Use of the proposed HL7 FHIR® data exchange standard would be economically attractive for sIRB workflows collectively and for each entity participating in the new workflows.
单一机构审查委员会（sIRB）并未实现美国国立卫生研究院（NIH）预期的收益。最近发布的健康水平 7 层（HL7®）快速医疗互操作性资源（FHIR®）数据交换标准旨在提高 sIRB 的运营效率。
我们进行了一项研究，以确定该标准的使用是否对 sIRB 工作流程整体以及对审查和依赖机构具有经济吸引力。我们在一家机构中检查了四个与 sIRB 相关的工作流程：（1）初始研究方案申请，（2）批准的 sIRB 研究的站点添加，（3）持续审查，和（4）医疗和非医疗事件报告。任务级别的信息确定了人员角色及其完成任务所需的相关小时数。确定了可以通过数据交换标准消除的任务。使用按角色划分的年薪估算人员成本。在使用拟议的数据交换标准时，初始研究方案申请或医疗和非医疗事件报告工作流程中不会消除任何任务。站点添加工作流程的小时数将减少 2.50 小时/站点（从 15.50 小时减少到 13.00 小时），持续审查的小时数将减少 9.00 小时/站点/研究年（从 36.50 小时减少到 27.50 小时）。相关的成本节省为站点添加工作流程节省了 251 美元（从 1609 美元降至 1358 美元），持续审查工作流程节省了 1033 美元（从 4110 美元降至 3076 美元）。
拟议的 HL7 FHIR®数据交换标准的使用对 sIRB 工作流程整体以及参与新工作流程的每个实体都具有经济吸引力。
