Just published in the Journal of Trauma and Acute Care Surgery (Vol 81, No 3), “The National Trauma Institute: Lessons learned in the funding and conduct of sixteen trauma research studies” analyzes and discusses how funded researchers approached obtaining regulatory approval, enrolling patients, navigating the Exception from Informed Consent process, coordinating multiple study sites and more.
The article offers some solutions for reducing challenges and lag times inherent in the study completion timeline. Among the insights, 40 percent of the funded investigators reported delays in obtaining regulatory approval at one or more institutional levels, which had serious impacts on study management. “The time required to obtain approvals delayed the funding awards considerably and resulted in the loss of study sites, turnover in research trainees, and the need to use alternate sources of funds for research staff salaries, protocol review, and community consultation costs,” NTI found.
NTI’s insights about navigating the regulatory environment square with the findings of the National Academies of Sciences, Engineering and Medicine (NASEM) in its June 2016 report: A National Trauma Care System: Integrating Military and Civilian Trauma Systems to Achieve Zero Preventable Deaths After Injury. “To accelerate progress toward the aim of zero preventable deaths after injury and minimizing disability, regulatory agencies should revise research regulations and reduce misinterpretation of the regulations through policy statements” is one of the recommendations of the NASEM Committee on Military Trauma Care’s Learning Health System and Its Translation to the Civilian Sector. [Read a summary of the NASEM report HERE].
In all, NTI reports lessons that are instructive for trauma researchers in four key areas: regulatory processes, multisite coordination, adequate funding, and research infrastructure.