Abstract
BackgroundThe 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.MethodsWe 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.ResultsIn 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.ConclusionsGuided 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.
Highlights
The Israel Defense Forces Medical Corps (IDF Israel defense forces medical corps (MC)) institutional review board (IRB) is one of approximately 50 IRBs active in Israel
We aim to present the history of the IDF regulations on human research that led to the creation of the unique advisory and preparatory process (APP); describe the qualitative characteristics of the IDF’s IRB; and provide quantitative data on the IRB’s throughput and output, in order to provide a benchmark for other IRBs
We reviewed all relevant IDF regulations and orders pertaining to the structure, activity and oversight of the IRB and of medical research conducted in the IDF
Summary
The Israel Defense Forces Medical Corps (IDF MC) institutional review board (IRB) is one of approximately 50 IRBs active in Israel. The Geneva declaration of 1948 [2] further underscored the physician’s responsibilities towards his patients and the guaranteeing of his health and well-being, while only in 1964, during the 18th meeting of the World Medical Association, was a declaration issued addressing the guiding principles of human research [3]. This “Helsinki Declaration” underwent several revisions over time, until the concept of an independent institutional review board (IRB) was introduced in 1975. In 1981, the requirement of an IRB was included in US federal law [4]
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