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. Clinical research, a major part of the vast biomedical research enterprise within academic health centers, is framed by institutional administrative structures developed to manage a complex web of policies, procedures, and regulations that affect thousands of personnel. Given heightened concerns about compliance, accountability, and liability, along with a concurrent movement toward administrative integration within academic health centers, education and training programs are undergoing assessment and change.

While education and training was originally focused on the ethical conduct of research, today education and training includes a broad range of topics from the basics of protocol and study design to budgeting, billing grids, and billing compliance. Education and training programs have expanded to include technical and operational topics designed to ensure that faculty and staff are knowledgeable about the myriad institutional policies and practices, as well as state and federal regulations, which apply to clinical research, thus making education and training a major link between all research and compliance functions.

To read the entire Issue Brief please download the attached pdf file.

Attached Files

Research Compliance Education and Training Programs: Responding to a New Regulatory World