Help available to navigate human subject clinical research process
AURORA, Colo. – A new organization at the Anschutz Medical Campus is designed to help researchers focus more on their research and less on the administrative hurdles they face. The Clinical Research Support Center (CRSC) offers researchers no-cost assistance with budgeting, assessing study feasibility, process review and Institutional Review Board (IRB) pre-review.
From offices in Building 500, CRSC services are available to researchers doing human subject research. Support is provided for researchers needing to win initial approval for their projects, but also for ongoing research. Support areas include subject recruitment, audit prep, compliance review and document pre-review.
“The Center is designed to allow researchers to do more research,” said Alison Lakin, RN, PhD, assistant vice chancellor for Regulatory Compliance. “We will judge the success of the effort by examining how long it takes researchers to achieve the required regulatory approvals. On a less analytical level, we will be looking for more smiles on our researcher’s faces.”
With overall research funding of $4.34 million, the Colorado Multiple Institutional Review Board (COMIRB) approves more than 1,200 initial protocols per year. The office currently is responsible for oversight of more than 3,800 active protocols.
COMIRB administration provides office support for the five IRB panels and processes protocols submitted for review under the expedited or exempt process.
“Regulations exist because clinical research must be done responsibility, but as an academic community we can’t afford to let bureaucracy limit our ability to do cutting-edge research,” Lakin said. “The Center allows us to do research responsibly, and not get tripped-up by the rules.”