(2009) Education and training programs have long been integral to clinical research at academic health centers. However, a new world of regulation, with an ever-increasing number of mandates and requirements for institutions and staff, is changing the nature and scope of the education and training function…
(2009) Management of clinical trial operations, viewed as critical to the sustainability and growth of the research enterprise, is among the challenging tasks for academic health centers because of the multitude of regulatory requirements and administrative procedures that must be addressed before, during, and after a clinical trial takes place…
(2009) Research was not intended to be governed by the HIPAA Privacy Rule, but neither was it exempted from the regulation. However, the new constructs and restrictions on information mandated by the Rule have had untold consequences for the conduct of research and the advance of science and discovery in the United States…
(2008) What is often not recognized beyond the research community is the negative impact—often unintended—of the myriad regulations and mandates such as HIPAA. Ultimately, societal interests are at stake when unintended barriers hamper research processes and progress…
(2007) Given the growth and expansion of clinical trials at many academic health centers, data on the volume, scope, and finances of clinical trials operations is of interest when examining research, compliance, or financial administrative infrastructure within the academic health center enterprise. This report provides a snapshot of the state of clinical trials based on an academic health center survey…
(2007) The number of clinical trials is rapidly increasing both in the U.S. and throughout the world given the need for new treatments and cures for disease and disability. Simultaneous expansion of regulations governing such trials is placing tremendous strain on the administration and management of clinical trials and their associated compliance functions within academic health centers. Where should academic health centers focus resource allocations?
(2007) This report examines the scope and growth of collaborative research along with the current shortcomings in the patent system, which may necessitate the pursuit of IP bundling to maintain economic value…