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PURPOSE: Measuring head kinematics data is important to understand and develop methods and standards to mitigate head injuries in contact sports. Instrumented mouthguards (iMGs) have been developed to address coupling issues with previous sensors. Although validated with anthropomorphic test devices (ATDs), there is limited post-mortem human subjects (PMHS) data which provides more accurate soft tissue responses. This study evaluated two iMGs (Prevent Biometrics (PRE) and Diversified Technical Systems (DTS) in response to direct jaw impacts. METHODS: Three unembalmed male cadaver heads were properly fitted with two different boil-and-bite iMGs and impacted with hook (4 m/s) and uppercut (3 m/s) punches. A reference sensor (REF) was rigidly attached to the base of the skull, impact kinematics were transformed to the head center of gravity and linear and angular kinematic data were compared to the iMGs including Peak Linear Acceleration, Peak Angular Acceleration, Peak Angular Velocity, Head Injury Criterion (HIC), HIC duration, and Brain Injury Criterion. RESULTS: Compared to the REF sensor, the PRE iMG underpredicted most of the kinematic data with slopes of the validation regression line between 0.72 and 1.04 and the DTS overpredicted all the kinematic data with slopes of the regression line between 1.4 and 8.7. CONCLUSION: While the PRE iMG was closer to the REF sensor compared to the DTS iMG, the results did not support the previous findings reported with use of ATDs. Hence, our study highlights the benefits of using PMHS for validating the accuracy of iMGs since they closely mimic the human body compared to any ATD's mandible.
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OBJECTIVE: This study aims to establish best practices and guidelines to ensure that experimental research utilizing Postmortem Human Subjects (PMHS) for injury prevention adheres to relevant ethical principles, which are also commonly accepted in research involving human tissues and living subjects. Furthermore, it reviews existing literature to underscore the pivotal role of PMHS testing in evaluating the efficacy of safety systems, with a particular focus on airbag performance. METHODS: This paper conducts an examination of the primary ethical principles governing human subject research as outlined in the Declaration of Helsinki (1965) and traces their evolution up to the latest framework proposed by the Council for International Organizations of Medical Sciences (CIOMS) in 2002. Input was solicited from international experts and laboratories experienced in PMHS testing to understand how these ethical principles are implemented in practice. This is complemented by a comprehensive review of literature that assesses the contribution of PMHS testing to airbag performance enhancements in frontal impacts. RESULTS: The findings underscore the importance of informed consent from donors or their next-of-kin, as highlighted in CIOMS declarations, to ensure the ethical integrity of the donation process in line with international standards. The study also finds it customary for an independent review board to evaluate the research methodology and the necessity of employing PMHS tissue over alternative methods, such as computational models or crash test dummies. Despite various national regulations on human subject participation and living tissue research, no specific legal framework governing PMHS tissue use was identified. The systematic literature review revealed that PMHS testing has been crucial in identifying potential injury mechanisms not detected by Anthropomorphic Test Devices (ATD), significantly contributing to the enhancement of computer human body models and the biofidelity of crash test dummies. CONCLUSION: The International Council on the Biomechanics of Injury (IRCOBI) recognizes the need to provide guidance for research involving human cadaveric tissue to be conducted with the highest ethical standards. This study proposes five recommendations to ensure adherence to these ethical principles in PMHS testing, highlighting the paramount importance of obtaining informed consent and securing independent committee approval. Moreover, IRCOBI emphasizes that until a thorough understanding of tissue damage tolerance levels is achieved and human surrogates, such as ATDs or Human Body Models (HBM), reach full biofidelity, the use of human cadavers remains indispensable for developing effective injury prevention strategies and measures.