The Israel Medical Corps accepted PHR-Israel's demand to reject experiments that have not been proven to benefit the soldier population; a set of directives will ensure that participants consent of their own free will. For example, soldiers will be allowed to take a leave at home before consenting to participate in an experiment.
The Medical Corps has recently formulated a new order regulating the issue of experiments on soldiers. Formulation of the order was initiated following PHR-Israel's petition to the High Court of Justice, which was submitted after the Omer 2 Anthrax experiment was publicized and it was discovered that no external control existed over experiments conducted in the military. Instead, the Medical Corps alone approved and supervised the experiments. The new order, formulated in consultancy with PHR-Israel's experts, places these experiments under Ministry of Health supervision and approval, enables soldiers to consult with their parents before deciding whether or not to participate and ensures that experiments are not conducted on soldiers unless the research is intended for soldiers' benefit. While PHR-Israel welcomes the order's publication, we continue to demand that experiments on soldiers be regulated by law and that a state inquiry commission be established to examine the failures that occurred in initiation and implementation of the Omer 2 anthrax experiment on soldiers.
In its response to the High Court of Justice, the state announced that a new directive would soon receive the status of a Chief Medical Officer directive and its principles recognized as a Supreme Command order. PHR-Israel believes that the new order's directives improve the anarchic situation that existed at the time the petition was filed, as regards experiments on soldiers; however, the order fails to define soldiers as a "vulnerable population", which PHR-Israel intends to demand. Such a definition would provide an additional protective guard for soldiers who participate in experiments, ensuring that no experiment is done unless its implementation on this group is necessary. At the same time, the new order stipulates that conducting an experiment involving soldiers' participation may only be approved in cases where the investigators have proven that the experiment's goal is to contribute to promotion of soldiers' health. The anthrax experiment was done on soldiers despite the fact that it involved a vaccine that was intended to serve the population at large and no grounds existed for conducting it on soldiers.
Among the anthrax experiment's main flaws, exposed on "Uvda" ["Fact" television program], were the defective procedure by which participants consented to participate in the experiment. The law requires that an experiment on humans be conducted only on those who have consented to participate after having received all relevant information on the experiment's conditions and risks, free of external pressures. The procedure whereby solders' consent was obtained for the anthrax experiment was flawed. Soldiers did not receive adequate explanation as to the vaccine's known side-effects and they were not allowed to consult with anyone who did not participate in the experiment, which was classified confidential. Some of the participants were young soldiers who had been recruited to the experiment directly from training courses or even immediately following basic training. It was also discovered that during soldiers' recruitment for the experiment, commanders were frequently present at the signing by soldiers on consent forms; soldiers were also told that the experiment would contribute to state security. All of these seriously compromised the free will involved in soldiers' consent to participate in the experiment.
The new Chief Medical Officer order will make all experiments on soldiers contingent upon new demands that were not previously existent before the petition was filed. For example, the procedure for free consent was changed, whereby only medical personnel, not commanders, are to be present during explanation to potential soldier participants. Following this explanation, soldiers will be given leave to consult with their families before giving their consent to participate in an experiment. The order also forbids commanders or the soldier's fellow unit members from being present at the time that information is provided. Refusal to participate in the experiment will not be cause for punishment or worsening of military service conditions, nor will consent be cause for any kind of benefit.
In addition, the new Chief Medical Officer order will change the composition of the military Helsinki Committee (that approves experiments in the military), adding an internist and a public representative, who may be either a religious figure or a legal expert.
The New Directives:
• The Supreme Helsinki Committee (a civil committee operating within the Ministry of Health) and the Director-General of the Ministry of Health are authorized to approve high-risk studies
• The Ministry of Health will receive reports on all medical experiments on soldiers and decide whether it wishes to conduct its own additional approvals process
• It must be proven that the experiment will benefit the soldier population
• To avoid dependency, the recruiting physician for the study may not be a physician who treats the soldier
• Removing marks of authority: the recruiting physician will not wear his rank but will rather identify himself as a researcher and indicate his medical specialization
• Soldiers will go on leave prior to granting their consent
• A independent supervisor will be appointed to speak with soldiers at training courses and basic training without commanders' presence
• A cap will be placed on number of participating soldiers: no more than 80% of soldiers to whom the study is presented
• Changing the composition of the military Helsinki committee: public representatives will comprise one-third of the committee
• In the case of confidential experiments, soldiers may consult with a civil physician with appropriate security clearance
"We welcome the changes but will continue to fight for recognition of soldiers as a vulnerable population under the Law of Experiments in Humans that is currently under legislation," said PHR-Israel member Dr. Ze'ev Weiner. "The military and some members of Knesset are refusing to define soldiers as a vulnerable population. We believe that it is necessary to perform controlled studies for the soldiers' benefit, but at the same time limitations must be placed prior to conducting an experiment on young highly motivated, subservient soldiers."
Hadas Ziv, Executive Director of PHR-Israel: "We are concerned about the fact that the state has not yet allowed the establishment of an independent inquiry commission to investigate the experiment's procedure. Only a state inquiry commission will be able to expose the truth about the motives behind the scandalous Omer 2 experiment."
Attorney Michael Sfard: "Experiments on humans are always a complex, sensitive issue. Experiments on IDF soldiers, which have to date enjoyed military confidentiality and absence of external supervision, are a recipe for catastrophe, such as in the anthrax experiment. In the previous era, it was easier for the military to obtain approval for studies on humans than for studies on animals (for which some measure of external supervision existed), therefore misuse of power was a real danger in experiments on soldiers. Let us hope that this era is gone."
Attached is the state's response describing the new model. For more information, please contact Ran Goldstein, 052-7481500. | 
