All of the scenarios in the policy suit should be considered from the perspective of a health professional in a staff appointment as the lead officer for medical policy within a Ministry of Defence (rank equivalent of OF4/Commander/Lieutenant Colonel/Wing Commander).

Step 1 – IDENTIFY THE PROBLEM(S)

• Briefly state the Scenario: You receive a letter from a drug company complaining that the research project that they were sponsoring in a military hospital is being badly managed. There is no record of this project receiving approval. What do you do?
• List the Issues that arise from the scenario.
• Identify Critical Information required and Assumptions to be made:

This scenario covers the ethics and law regarding the conduct of biomedical research within the military health system. This covers 2 issues, firstly the approvals process for conducting biomedical research and secondly the quality of the actual conduct of the research. You will need to contact both the Commanding Officer of the Hospital and the named principal investigator of the clinical trial to obtain further information. This is similar to Role 4 - Seven

Step 2 – ANALYSE

Patient: there is an institutional duty to military patients to ensure that the care that they receive is appropriate and complies with established medical practice.  

Clinical: there is a personal professional duty on the principal investigator of the clinical trial to ensure they comply with all rules regarding ethical approvals for the conduct of biomedical research and also that they actually undertake the research according to the trial protocol. They are also obliged to ensure that the patients are properly recruited and informed of their enrolment into the trial.  

Legal: All doctors have a responsibility to comply with the ethical standards for conducting medical research as stated in the Declaration of Helsinki -  https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ and any national and Ministry of Defence rules or policy.  

Societal/Military: in addition to the legal obligation to follow a military order regarding the conduct of biomedical research within the military health system, there is also a reputational risk if the research is not being conducted properly.

Step 3 – FUSE

• Summarise conclusions
• Insert citations to key reference sources for your analysis
• Determine the exact Decision(s) to be made

This scenario covers a reputationally sensitive subject. You might consider whether you have sufficient seniority and status to investigate this situation. However the scenario is valid for discussing the ethics of potential conflicts of interest.

Step 4 – DECIDE

• What is your Decision?
• Why (can you justify it)?
• Residual uncertainly, need for review?

All biomedical research projects should comply with ethical principles and be conducted according to the agreed protocols. It is likely the rules will require all military health professionals undertaking biomedical research to have had approval through the military authorities alongside approval through civilian authorities as well as the drug company. The principal investigator of the clinical trial should certainly have informed the Commanding Officer of the hospital in which they work of the trial; possibly through an Institutional Research Board or other committee. The first phase of the investigation should be to establish the facts, possibly delegated to the principal investigator’s chain of command. There should also be an acknowledgement to the drug company that the issue is being investigated. If the facts of the scenario are true, the most important aspect is to ensure patient safety; and this might require an independent review of the care of each patient that has been enrolled. The next priority is to determine the institutional obligations to the drug company including an understanding of any failings in the management of the drug trial. The final issue is to determine any fault and sanction that lie to the team undertaking the clinical trial.

Contributor – Air Vice Marshal (Rtd) Alastair Reid CB FFOM, Surgeon General UK Defence Medical Services 2019-2021