Hassidim Ayal, Kayouf Raeed, Yavnai Nirit, Panush Naomi, Dagan David, Bader Tarif, Hartal Michael
Israel Defense Forces Medical Corps, Ramat Gan, Israel.
Department of Plastic and Reconstructive Surgery, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.
Isr J Health Policy Res. 2016 Dec 1;5:53. doi: 10.1186/s13584-016-0113-4. eCollection 2016.
The Israel Defense Forces Medical Corps (IDF MC) institutional review board (IRB) is one of approximately 50 IRBs active in Israel. In addition to routine IRB considerations it must also address in its deliberations specific safeguards in place in the IDF to protect research volunteers in the military environment. In this report, we present the characteristics of the IDF IRB, including the unique circumstances that led to a 2008 change in the pre-IRB advisory and preparatory process (APP). We also present quantitative data on the IRB's throughput and outcomes, in order to provide a benchmark for other IRBs.
We reviewed all relevant IDF regulations, both historical and current, pertaining to the structure, activity and oversight of the IRB and of medical research conducted in the IDF. Additionally, we analyzed the ethical review process for all research proposals submitted to the IDF APP between January 1, 2013 and December 31, 2015.
In 2008 the IDF implemented several major changes which have had a substantial impact on the ethical regulation of military medical research. The period following these changes has seen a rise in the number of research proposals submitted to the IDF IRB annually. During the years 2013-2015, 377 research proposals entered the APP, of which 329 were deemed appropriate for IRB deliberation. Eight study protocols were granted waivers, 19 were rejected, and the remaining 302 were authorized. Overall, 345 of the 377 research proposals submitted (92 %) were ultimately cleared for execution; 310 of 329 proposals (94 %) deliberated by the IRB were authorized. The IRB required protocol revisions for 47 % of the research proposals, one-third of which were revisions directly associated with military-specific ethical precautions.
Guided by the principles of protecting personal autonomy in the complex military setting, the IDF has implemented several unique measures aimed at maintaining the highest ethical standards in medical research. By sharing research approval process data similar to those presented here, medical institutions can help build and support a peer-based benchmarking process through which individual IRBs can appraise their own processes and approval rates.
以色列国防军医疗队（IDF MC）机构审查委员会（IRB）是以色列约50个活跃的IRB之一。除了常规的IRB审议外，它还必须在审议中考虑IDF为保护军事环境中的研究志愿者而制定的特定保障措施。在本报告中，我们介绍了IDF IRB的特点，包括导致2008年IRB前咨询和准备程序（APP）发生变化的独特情况。我们还提供了关于IRB的工作量和结果的定量数据，以便为其他IRB提供一个基准。
我们审查了所有与IDF IRB的结构、活动和监督以及IDF中进行的医学研究相关的历史和现行法规。此外，我们分析了2013年1月1日至2015年12月31日期间提交给IDF APP的所有研究提案的伦理审查过程。
2008年，IDF实施了几项重大变革，这些变革对军事医学研究的伦理规范产生了重大影响。这些变革之后的时期，每年提交给IDF IRB的研究提案数量有所增加。在2013 - 2015年期间，377项研究提案进入APP，其中329项被认为适合IRB审议。8项研究方案被豁免，19项被拒绝，其余302项获得批准。总体而言，提交的377项研究提案中有345项（92%）最终获批执行；IRB审议的329项提案中有310项（94%）获得批准。IRB要求47%的研究提案进行方案修订，其中三分之一的修订与特定军事伦理预防措施直接相关。
在复杂军事环境中保护个人自主权原则的指导下，IDF实施了几项独特措施，旨在维持医学研究的最高伦理标准。通过分享与此处所示类似的研究批准过程数据，医疗机构可以帮助建立和支持一个基于同行的基准评估过程，通过该过程各个IRB可以评估自己的流程和批准率。
