Ethical dilemma in Maxillofacial Surgery.pptx
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An oral surgeon conducted an unauthorized study of a new jaw replacement system by altering the study protocol without informing the Institutional Review Board or sponsor. This violated patient safety and autonomy, as well as the validity of the study results. The suggested solutions are for the sponsor to withdraw funding and file a complaint against the surgeon for failing to follow protocols and putting patients at risk, and for the surgeon to be prevented from practicing and cover costs for affected patients.
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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