Abstract
The obvious issues in this case are the subordinate position of soldiers and their duties as members of the armed forces. While membership of the Armed Forces involves acceptance of a risk of injury or death in combat this does not extend to an acceptance of serious risk of injury or death in biomedical research carried out by and for the Armed Forces. This is not an extension of their ordinary duties as a member of the Armed Forces and this fact needs to be made clear to potential participants. Hence, their voluntary, informed consent is required.
Special precautions need to be taken here. The Armed Forces, no doubt, will claim that they encourage their personnel to be reflective. But soldiers are trained to respond to orders, respect or at least comply with the decisions of their superior officers, and develop a sense of allegiance to the service. This could result in less reflective consideration of the risks of research involvement and even a perceived lack of freedom to reject involvement – they may perceive it as their duty to take part.
While some theorists have argued that there is a duty to be a participant in valuable biomedical research generally, this is still a highly contested claim. Nevertheless, in the context of the Armed Forces, a soldier may perceive themselves to have such a duty. Even if it is made clear to them that the Army does not consider them to be under such a duty – as an extension of their ordinary duties as a soldier – a soldier may make a distinction between formal institutional or professional duty and their personal commitment to the service. This should not be regarded with suspicion as choosing to be involved in research out of a sense of duty is laudable. But this raises further problems.
First, as mentioned above, this may result in an individual not taking appropriate consideration of the risks of involvement. Even those who maintain that there is a general duty to participate in biomedical research for the good of others have argued that this does not hold when there is a risk of serious harm to participants. But it should be noted that participants may actually benefit themselves through involvement as well as contributing to research that could benefit others in the future. The pre-trial evidence suggests that the new HBOC could save lives. Therefore, a soldier who consents to participate may actually improve his or her chances of surviving a serious trauma incident as well as contributing to research that could benefit others. Research guidelines permit a higher degree of risk in therapeutic than non-therapeutic research.
However, the problem with previous HBOC trials was that in some cases there was a higher incidence of death in those receiving an HBOC than in those receiving saline. One cause of this was that patients continued to be administered the HBOC rather than blood after admission to hospital. This will not occur in the proposed trial. Other factors were that the HBOC could cause dangerously high blood pressure and suppressed cardiac function. The HBOC to be used in the Army’s trial has been designed to overcome this but risk still remains – this is why it is being trialled.
Nevertheless, the information given to potential participants should include this history of risk to enable them to make an informed decision and as part of the explanation of why the trial is being carried out. Soldiers may decide that given the high risk of mortality after a blast injury they are willing to take their chances with the HBOC. But that should be their informed decision. It should be emphasized to the soldiers that they are free to decline participation for any reason and with no repercussions. This potentially needs to be emphasized more than would be the case with civilians because, as explained, soldiers may perceive that their duty requires participation or that they are expected to participate.
However, this may not be sufficient to ensure voluntary consent. There may be covert or even overt pressure on non-consenting soldiers from consenting colleagues. Non-consenters may be regarded by consenters as deficient in their duty. The suggested method of identifying non-participants through a wristband will make clear who has not consented. Therefore, I would suggest that some other method of distinguishing participants be explored. However, it may be that, given the need in a trauma situation in the field to swiftly identify soldiers who have consented to receive the HBOC, confidentiality cannot be maintained. Given that confidentiality is a cornerstone of research ethics, this would be a serious concern and would, in my view, make the trial unethical.
While doctors and nurses are bound by a medical duty of confidentiality and so can be trusted with information about who has and has not consented to be administered the HBOC, they are rarely the personnel who would administer the HBOC or saline in the field. Rather it is likely to be a soldier trained to provide basic aid including administering saline, and who will carry saline and the HBOC for the purposes of the trial. It is not until the casualty is airlifted to or arrives at the field hospital, after the decision to administer the HBOC or saline needs to be made, that they are in contact with doctors and nurses. However, one possible solution is to make a duty of confidentiality part of the role of the soldier who is responsible for providing medical aid and administering saline in the field so that they can be informed of who is to receive the HBOC. This would need to be discussed with the Army as to feasibility.
Finally, the Army should cease the trial early if there is evidence, as in previous HBOC trials, of increased mortality. In connection, I would advise that potential participants be encouraged to discuss their decision with their families. In the event that the HBOC proved to be as risky as its predecessors it should not come as a shock to families that a contributory factor in their loved one’s death may have been an experimental treatment. This would likely cause considerable additional distress and could precipitate a scandal that the Army should do its best to avoid. With the history of scandals surrounding soldiers being ‘used’ in research, such as experiments at Porton Down with biochemical weapons and, more recently, the controversy around vaccines administered during the First Gulf War, which some claim caused Gulf War Syndrome, the Army has a further reason to ensure maximum transparency and ethical compliance.
If the above could be implemented I would recommend approving the study. A safe and effective HBOC would save life not only amongst the Armed Forces but also in civilian situations. But basic ethical considerations should not be sacrificed in pursuit of this benefit as arguably they were in civilian trials. Confidentiality is a major concern, and a way of overcoming the problem detailed above would need to be found.