All of the scenarios in the Role 4 suit should be considered from the perspective of a health professional working in a military hospital receiving casualties from military operations with responsibility for the clinical care of patients and management of the facility. The primary supporting reference for this suit is the World Medical Association International Code of Medical Ethics (WMA Code) at: https://www.wma.net/policies-post/wma-international-code-of-medical-ethics/ supported by the WMA Declaration of Lisbon on the Rights of the Patient at: https://www.wma.net/policies-post/wma-declaration-of-lisbon-on-the-rights-of-the-patient/#:~:text=Every%20person%20is%20entitled%20without,with%20his%2Fher%20best%20interests. You should also consider your national professional ethical codes and relevant military law or guidance.

Step 1 – IDENTIFY THE PROBLEM(S)

• Briefly state the Scenario: At a routine meeting, one of your consultants proudly announces the publication of a research paper reporting outcomes of patients treated in your unit. This project had not been submitted to the unit Research Ethics Committee. 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 medical research including oversight by Institutional Review Boards or Research Ethics Committees.

Step 2 – ANALYSE

Patient: Patients should be treated according to standard medical practice. They should always be informed and provide their consent if they are to be the subjects of medical research programme.

Clinical: WMA Code Para 36 - The physician must support sound medical scientific research in keeping with the WMA Declaration of Helsinki and the WMA Declaration of Taipei.

Legal: it is likely that there will be strict rules regarding the conduct of medical research including oversight of all research programmes by appropriate research ethics committees.

Societal/Military: in addition to general rules, there may be specific requirements for ethical oversight for medical research conducted within military medical institutions or on military subjects because of the additional risks regarding coercion and consent due to military hierarchy.

Step 3 – FUSE

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

There is a clear requirement for this research to have been approved by an appropriate Research Ethics Committee.

Step 4 – DECIDE

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

You might initiate an investigation to establish how this research was conducted with appropriate oversight by a Research Ethics Committee. It would be a grave error if the consultant had failed to follow national and military regulations regarding the ethical conduct of medical research. If this is the case, you will need to inform senior medical authorities and to consider the cultural and reputational impacts.

Contributor – Group Captain (Rtd) Teresa Griffiths CBE ARRC. Military Chief Nurse, Royal Centre for Defence Medicine (2010 - 2013) and Commanding Officer Defence Medical Rehabilitation Centre Headley Court/Stanford Hall (2016-2018).