The NYU H+H Clinical and Translational Science Institute recognized a need to improve its scientific review standards and practices and to make better use of resources at the institution and at its Institutional Review Board. In implementing the Common Metric Initiative (CMI), the hub developed a strategy to broaden its Scientific Review Committee to conduct pre-reviews of studies before being reviewed by a fully convened IRB. The process is modeled after the Protocol Review & Monitoring Committee at the NYU Langone Health’s Perlmutter Cancer Center.
The hub established the expanded SRC (eSRC) to assess research studies funded by a department, foundation or grant that have not been reviewed by the IRB. Composed of nine members, including two investigators, a nurse manager from the clinical research center, CTSI leadership, a biostatistician, two representatives from recruitment and retention, and two members of the IRB, the committee meets virtually every Tuesday for a half hour to screen studies and alert investigators to changes needed to avoid their submission being delayed — to help fix things before they become a problem. A checklist of items required for IRB evaluation and review was created, ranging from clearly defined objectives, to data management plans and staffing/resource requirements. Turnaround time on a submission is fast, as the eSRC takes 1.5 days to review and provide feedback.
“A lot of the issues that are identified with these studies may be very small things that can be taken care of before a request is even sent to the IRB … a form was missing or something was spelled incorrectly, or you didn't have a data sharing plan,” said Deborah Chavis-Keeling, Executive Director of Administration and Finance, NYU CTSI. “It just wastes a lot of time. And this can save that time and help get things going a lot faster and get research done faster and hopefully benefit the greater population by having studies roll out faster.”
Keeling noted that, in addition to identifying smaller problems, the eSRC reviewed proposals for more significant issues as well, such as scientific validity and biostatistics plans.
The eSRC process is especially beneficial to junior investigators who are working on department-sponsored projects or NIH-funded projects. Junior investigators — many of whom are working in small departments with limited bandwidth — receive mentorship and support that they would not get otherwise.
While another layer of approval might add to the proposal review time, NYU found that the opposite is true. Establishing the eSRC actually streamlined the review process and made the IRB more efficient. Because minor issues are addressed prior to IRB full review, the IRB’s review time is reduced, saving resources.
During the five years that the eSRC has been in existence, the committee has reviewed 137 protocols. Out of those, only four submissions have been deferred.
NYU’s eSRC became invaluable during COVID-19 as well. The committee is promoted all across the university, through word-of-mouth referrals, websites, a monthly newsletter and departmental meetings. IRB members themselves will also refer investigators to the CTSI for help.
When the coronavirus crisis began, the eSRC was inundated with as many as 40 data requests per day. The committee was able to review these requests in a timely manner, alleviating frustration among investigators. Without the eSRC, investigators would have waited much longer for their requests to be reviewed because the IRB turnaround time would have been significantly lengthened, and it would have been a drain on already limited resources.
According to Chavis-Keeling, the eSRC evolved into a complete resource for investigators. “They may come in with one purpose, but we let them know about all of the resources. So, it is one-stop shopping, but they are shopping for things they didn't even know they needed.”
- The eSRC helped improve the quality and efficiency of IRB review process and turnaround times
- eSRC review can reduce IRB review time by providing a better submission beforehand, thus saving resources
- Early-stage investigators greatly benefited from the eSRC process, providing them with needed mentoring and support
- The process was especially beneficial during the COVID-19 crisis, allowing for the rapid review of study proposals
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