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Rear-end collisions
DEPARTMENTS
Letters to the Editor Rear-End Collisions The study, “Clinical Response of Human Subjects to RearEnd Automobile Collisions,” by Brault and colleagues,’ raises considerable ethical questions that do not appear to have been addressed by the researchers, The study involved exposing 42 volunteers to controlled rear-end automobile collisions to assess the presence and severity of whiplash-associated disorders (WAD). The collisions were conducted at impact speedsof 4.86 and lO.O2km/h to produce changes in velocity of 4 and Skm/h, respectively. Subjects were volunteers “recruited by local newspaper and university job-line advertisements” and were given detailed pretest examinations to rule out prior injuries within the previous 3 years. Each subject (unless they dropped out) underwent a single trial at both speedsin randomized order, with a minimum of 7 days between collisions. By definition, the purpose of the study was to expose subjects to collision forces sufficient to produce injury, and to measure incidence, severity, and duration of such symptoms. The ethics of deliberately producing injury to subjects in such a study must be questioned. Many research protocols expose subjects to medications, devices, or conditions that have potential to cause or produce harm, and the FDA has defined risk categories for rating such protocols. In such protocols, however, the risk exists as a by-product of an attempt to develop an intervention that will be beneficial. Researchers and institutional review boards are ethically bound (eg, The Helsinki Declaration, The Nuremberg Code) to evaluate whether the potential risk of participation in a study can be justified by the anticipated benefits (either to the subject or society). This study does not appear to have met criteria for benefit that would have justified the potential harm to the subjects. It is rather surprising that this protocol received institutional review board approval. The authors even noted that in prior studies involving low-speed collisions, subjects were either the investigators or individuals associated with the investigators. While this is cited as a potential source of investigator bias, there seems to be an obvious reason why such studies did not solicit volunteers from the community. The impact speeds in Brault’s study may seem trivial. However, according to the data presented in table 3, the duration of symptoms extended as far as 4.6 days for the lo-km/h impact. There are numerous other questions that could be raised about how thorough the informed consent process was, but such issues are based on the presumption that the study methodology was justifiable. William Garmoe, PhD National Rehabilitation Hospital Washington, DC 20010
correctly states that the study’s anticipated benefits to the subject or society must outweigh the potential risks of participation. These concerns necessitated rigorous adherence to human subject protection protocols for this study. The study was part of a much larger project to identify how and why cervical spine injuries occur in rear-end automobile collisions through the analysis of occupant kinematics and kinetics. The magnitude of the problem to society was addressed in our introduction. The study incorporated accelerometry, high-speed video, anthropometric measurements, electromyography, and clinical examinations to test our hypotheses. While it was not a specific aim of the study to produce injuries in human subjects, we were aware of the potential risk of causing whiplash-associated disorders. The magnitude of the risk of injury was assessedby performing a thorough review of previous human subject testing in rear-end automobile and bumper car impacts. The human subject injury response in similar studies of impact severity ranged from no injury to a maximum of 4 days of minor cervical symptoms that required no medical attention.‘” Researchers analyzing the impact severity of amusement park bumper cars concluded that the riders were repeatedly exposed to a speed change of approximately 8kmlh, which was the maximum speed change used in our study. While acknowledging the limitations of previous studies, we determined that the potential risk of injury to human subjects exposed to our protocol would be minimal. We took additional precautions to minimize injury risk and improve protection for our subjects. These precautions, which were not taken in previous human subject testing, included cervical magnetic resonance imaging exclusionary criteria, adequate head restraint protection, a detailed medical history evaluation, and pretest and posttest clinical examinations. The manuscript documents that an independent ethics committee reviewed and approved the protocol, insuring that the subjects’ rights were protected and that the testing procedures were acceptable on scientific, ethical, and moral grounds. Before their participation, all subjects visited the test facility and were shown the instrumentation and automobiles to be used in the study. Their informed consent was obtained, at which time we explained the purpose of the study, the risks involved, and the benefits of their participation. In hindsight, we believe that the benefits of this project outweighed the risks, legitimatizing the use of human subjects. Our subjects sustained, at most, minor transient symptoms that required no medical attention. The data we obtained provide the medical community and automotive safety industry with the human subject response to this societal problem, making possible advances in treatment and prevention.
Reference 1. Brault JR, Wheeler JB, Siegmund GP, Brault EJ. Clinical response of human subjects to rear-end automobile collisions. Arch Phys Med Rehabil 1998:79:72-80.
The authors reply Dr. Garmoe raises valid issues regarding
the ethical consider-
ations of exposing human subjects to rear-end collisions. He Arch
Phys
Med
Rehabil
Vol
79, August
1998
John R. Brault, MS Jeffrey B. Wheeler, MS Gunter P. Siegmund, BASC Elaine J. Brault, MS, PT Biomechanics Research and Consulting El Segundo, CA 90245
Letters to the Editor Rear-End Collisions The study, “Clinical Response of Human Subjects to RearEnd Automobile Collisions,” by Brault and colleagues,’ raises considerable ethical questions that do not appear to have been addressed by the researchers, The study involved exposing 42 volunteers to controlled rear-end automobile collisions to assess the presence and severity of whiplash-associated disorders (WAD). The collisions were conducted at impact speedsof 4.86 and lO.O2km/h to produce changes in velocity of 4 and Skm/h, respectively. Subjects were volunteers “recruited by local newspaper and university job-line advertisements” and were given detailed pretest examinations to rule out prior injuries within the previous 3 years. Each subject (unless they dropped out) underwent a single trial at both speedsin randomized order, with a minimum of 7 days between collisions. By definition, the purpose of the study was to expose subjects to collision forces sufficient to produce injury, and to measure incidence, severity, and duration of such symptoms. The ethics of deliberately producing injury to subjects in such a study must be questioned. Many research protocols expose subjects to medications, devices, or conditions that have potential to cause or produce harm, and the FDA has defined risk categories for rating such protocols. In such protocols, however, the risk exists as a by-product of an attempt to develop an intervention that will be beneficial. Researchers and institutional review boards are ethically bound (eg, The Helsinki Declaration, The Nuremberg Code) to evaluate whether the potential risk of participation in a study can be justified by the anticipated benefits (either to the subject or society). This study does not appear to have met criteria for benefit that would have justified the potential harm to the subjects. It is rather surprising that this protocol received institutional review board approval. The authors even noted that in prior studies involving low-speed collisions, subjects were either the investigators or individuals associated with the investigators. While this is cited as a potential source of investigator bias, there seems to be an obvious reason why such studies did not solicit volunteers from the community. The impact speeds in Brault’s study may seem trivial. However, according to the data presented in table 3, the duration of symptoms extended as far as 4.6 days for the lo-km/h impact. There are numerous other questions that could be raised about how thorough the informed consent process was, but such issues are based on the presumption that the study methodology was justifiable. William Garmoe, PhD National Rehabilitation Hospital Washington, DC 20010
correctly states that the study’s anticipated benefits to the subject or society must outweigh the potential risks of participation. These concerns necessitated rigorous adherence to human subject protection protocols for this study. The study was part of a much larger project to identify how and why cervical spine injuries occur in rear-end automobile collisions through the analysis of occupant kinematics and kinetics. The magnitude of the problem to society was addressed in our introduction. The study incorporated accelerometry, high-speed video, anthropometric measurements, electromyography, and clinical examinations to test our hypotheses. While it was not a specific aim of the study to produce injuries in human subjects, we were aware of the potential risk of causing whiplash-associated disorders. The magnitude of the risk of injury was assessedby performing a thorough review of previous human subject testing in rear-end automobile and bumper car impacts. The human subject injury response in similar studies of impact severity ranged from no injury to a maximum of 4 days of minor cervical symptoms that required no medical attention.‘” Researchers analyzing the impact severity of amusement park bumper cars concluded that the riders were repeatedly exposed to a speed change of approximately 8kmlh, which was the maximum speed change used in our study. While acknowledging the limitations of previous studies, we determined that the potential risk of injury to human subjects exposed to our protocol would be minimal. We took additional precautions to minimize injury risk and improve protection for our subjects. These precautions, which were not taken in previous human subject testing, included cervical magnetic resonance imaging exclusionary criteria, adequate head restraint protection, a detailed medical history evaluation, and pretest and posttest clinical examinations. The manuscript documents that an independent ethics committee reviewed and approved the protocol, insuring that the subjects’ rights were protected and that the testing procedures were acceptable on scientific, ethical, and moral grounds. Before their participation, all subjects visited the test facility and were shown the instrumentation and automobiles to be used in the study. Their informed consent was obtained, at which time we explained the purpose of the study, the risks involved, and the benefits of their participation. In hindsight, we believe that the benefits of this project outweighed the risks, legitimatizing the use of human subjects. Our subjects sustained, at most, minor transient symptoms that required no medical attention. The data we obtained provide the medical community and automotive safety industry with the human subject response to this societal problem, making possible advances in treatment and prevention.
Reference 1. Brault JR, Wheeler JB, Siegmund GP, Brault EJ. Clinical response of human subjects to rear-end automobile collisions. Arch Phys Med Rehabil 1998:79:72-80.
The authors reply Dr. Garmoe raises valid issues regarding
the ethical consider-
ations of exposing human subjects to rear-end collisions. He Arch
Phys
Med
Rehabil
Vol
79, August
1998
John R. Brault, MS Jeffrey B. Wheeler, MS Gunter P. Siegmund, BASC Elaine J. Brault, MS, PT Biomechanics Research and Consulting El Segundo, CA 90245