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1. Ethical dilemma in
Maxillofacial Surgery
Khalid Binsaeed

2. Case scenario
• An oral and maxillofacial surgeon was given a grant to study a new “Total
TMJ replacement” system
• The sponsor provided a well-written and detailed protocol.
• Implementation of the protocol was difficult in the local circumstances
• the subjects found the informed consent information overlong, with
serious risks and complications. The surgeon noticed refusal to sign
consent from multiple participants, The surgeon made alterations in the
protocol that he thought were simple and did not affect study validity or
patient safety, and saw no reason to inform IRB. The sponsor sent
monitors, who discovered the discrepancy. The surgeon ignored their
observations and continued the study without documenting the changes
he had made.

3. • Surgeon not adhering to the protocol can violate patient safety, the
validity of the study and the outcome

4. Suggested solution
• 1- Protection of patient safety, (Beneficence and Non-maleficence)
• 2- Patient freedom of withdrawal from the study (autonomy) shouldn’t
be manipulated and should be respected
• 3- changes should be discussed with Sponsor, documented, approved by
IRB

5. Suggested solution
• The company should withdraw the sponsorship, File a complaint against
the doctor who didn’t follow the recommended protocol, set the
company’s reputation down by giving a false report, made
subjects/patients more prone to complications and danger
• The doctor should be stopped from practicing, bear the costs for all
affected subject, company’s reputation
• Setup a committee to discuss the possible correction for the affected
subject

6. References
• Professional Dilemmas of Oral And Maxillofacial Surgeons Pak Armed
Forces Med J 2019; 69 (4): 870-75
• Professionalism and ethics handbook a practical guide 2015 by SCFHS