Launching human studies can be complicated and can take many months, and the complex research protocol review process can contribute substantially to delays. In addition to institutional review board review and approval, a Scientific Review Committee (SRC) may evaluate some proposed clinical studies or trials to ensure that the scientific question of interest is relevant and the design of the protocol is appropriate.

To improve the efficiency of SRC reviews and enhance the quality of human subjects research, NCATS is funding a new Clinical and Translational Science Awards (CTSA) program initiative to develop consensus recommendations for SRCs. This guidance will help ensure that ethical and scientific standards are upheld for CTSA-funded protocols and that proposals are aligned with NCATS’ focus on translation. Specific aims include maximizing the quality of CTSA investigator-initiated pilot projects and clinical protocols implemented by mentored research scholars as part of their KL2 awards.

Harry Selker, M.D., M.S.P.H., principal investigator (PI) of the Tufts University CTSA hub, is leading the SRC initiative in collaboration with nine CTSA PIs and representatives from two NIH Institutes and Centers. The team will address the following key questions:

• What criteria should the SRC use when reviewing protocols?
• When should the SRC ask for input from outside the institution?
• What should the role of CTSAs be prior to SRC review?

The team already has developed plans for SRC operational processes and procedures, information technology infrastructure, and evaluation (including pilot sites and metrics for assessment). Stay tuned for more information about this and other CTSA program collaborations.

Source: NCATS Newsletter; Volume 04 • Issue 01 • January 27, 2015