Ethical standards for medical research in the Israeli military - review of the changes in the last decade

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.

Short Communication: Combining Ethics With Efficiency—Israel Defense Forces' Experience in Clinical Trials During the Coronavirus Disease 2019 Pandemic

“…One of the complexities of a military IRB is the fact that soldiers who participate in studies are serving in a hierarchical organization and their ability to give free and unconditional consent is limited in some aspects (Hassidim et al, 2016). The IDF written commands describe a system of protective measures applied during the recruitment of soldiers to a medical study.…”

Soldiers as subjects of medical research: Comments on Hassidim et al. on ethical standards of the Israel Defense Force

“…In their highly illuminating paper Hassidim et al [ 1 ] describe major parts of the IDF MC (Israel Defense Force Medical Corps) practice of conducting experiments where the subjects are mostly soldiers during conscription service in the IDF. The paper is a survey and discussion of several ethical aspects of the experimentation practice.…”

“…This is an organizational requirement that significantly enhances ethical propriety of human experimentation. The paper by Hassidim et al [ 1 ] is an example of how the IRB procedure can, and therefore should be improved for the sake of human subject protection, without thereby eliminating legitimate and most fruitful medical developments.…”

“…The present regulations, as described by Hassidim et al [ 1 ], allow participation of new conscripts in experimentation under some strict conditions. I think such an exception should be reconsidered.…”

“…Hassidim et al [ 1 ] mention an arrangement with respect to classified research. An independent physician is identified to whom subjects have unlimited access before, during or after the medical study takes place.…”