Researchers seek your feedback about new study on patients with acute traumatic brain injury
Researchers would like your feedback about a research study that may be conducted at Michigan Medicine. This is a national multi-center study funded by the National Institutes of Health (NIH) about the emergency care for patients with severe traumatic brain injury (TBI). The study is called BOOST3.
BOOST3 is a research study designed to learn if either of two alternative strategies for monitoring and treating patients with TBI in the intensive care unit (ICU) is more likely to help them get better.
Both of these alternative strategies are used in standard care. In both strategies, doctors monitor the patient’s brain and modify the medical care provided in order to try to improve some measure of the brain’s health. However, it is not known which measure of the brain’s health is more important. The results of this study will help doctors discover if one of these methods is more safe and effective.
Normally, researchers get permission (consent) before a person can be included in a study. A person with a severe TBI, however, will be comatose. Patients with severe TBI will not be able to give consent at the time of injury. When possible, consent to participate in the study is sought from the family member or legal representative of a patient with severe TBI before including the patient in a study. However, since emergency care for a patient with severe TBI must start quickly, there might not be enough time to locate and talk to the person’s family member or legal representative about the study. In this situation, a patient with severe TBI might be enrolled in this study without his/her family member or representative providing consent. This is called Exception from Informed Consent (EFIC) for emergency research. Once the family member or legal representative is located, they will be asked to give their permission for the patient with severe TBI to continue in the study.
Before researchers may do a study using EFIC, they must provide information about the study to the community and get their feedback.
If you would like more information about the study and/or to provide information about how you feel about the study, please click here.