June 11, 2009
The Office of Research Services (ORS) offers a comprehensive package of services to support investigators in all phases of the process of carrying out clinical and translational research. One of its most important goals is to streamline services and eliminate institutional redundancies and delays. During the past year, ORS has focused on the Human Subject protocol review timeline and has reduced the average number of days from protocol submission to approval by 35 days.
“We spent about a year evaluating the review process,” said YCCI deputy director William Tamborlane, M.D., professor of pediatrics, who is also the director of the ORS. “If there was a step that didn’t add value in terms of the safety of our study volunteers or scientific improvement, we decided it wasn’t needed and could be eliminated.”
This was a joint project with all the institutional stakeholders: the Yale Cancer Center Protocol Review Committee, the Pediatric Protocol Review Committee and the Institutional Review Board (IRB). A major part of this undertaking included reformulating the former GCRC Advisory Committee into what is now known as the Science and Safety Committee (SSC) and redefining the studies that require full SSC approval to include only those considered to be moderate to high risk. In addition, ORS administration worked with the IRB and other committees to develop new approaches to streamlining their review processes and to ensure that the IRB had the expertise needed to conduct all reviews. “We couldn’t have accomplished such a significant reduction in the research timeline without the IRB’s partnership and willingness to engage in the process,” said Tamborlane.
YCCI has also taken steps to ensure that protocols are sound before undergoing the review process. Tamborlane, who has more than 30 years of clinical research experience, and ORS Administrator Stacey Scirroco now conduct individualized study design meetings with investigators who are new to clinical and translational research to ensure that they are on track. ORS has also added trained regulatory staff to work with investigators to prepare better submissions.
Other ORS efforts over the past year include working with the IRB on the implementation of a new protocol submission and IRB review and tracking system utilizing the COEUS IRB module. This system enables investigators to submit research protocols electronically and provides a single source for submitting, tracking and monitoring them. The system also includes a feature for pre-review committees such as the Cancer Center, Pediatrics and the SSC. YCCI provided input for this aspect of the system so that COEUS has both defined review paths and the flexibility to allow the definition of new pathways. It is expected that the new electronic protocol submission system will result in further improvements in the research timeline.
Now that the review process has been refined and is showing substantial improvements, YCCI is turning its attention to other processes in the study continuum. At the First Annual Clinical Research Management Conference sponsored by the National Center for Research Resource and the Clinical and Translational Science Award (CTSA), reducing protocol and contracting timelines were both identified as priorities. YCCI was one of the first of 39 centers to provide data on improving the protocol review process and will next focus on reducing contracting timelines, an area that ORS is eager to address. This initiative will involve a close collaboration with Grants & Contracts, which has already been working with ORS. Penny Cook, executive director of Grants & Contracts, is confident that the joint effort will result in improvements in the time it takes to execute contracts. “We look forward to doing whatever we can to help investigators quickly put all the elements in place so that they can get started on their research,” she said.