Related Experiment Videos
CTSA Consortium Consensus Scientific Review Committee (SRC) Working Group Report on the SRC Processes.
Harry P Selker1, John B Buse2, Robert M Califf3
1Tufts Clinical and Translational Science Institute, Tufts Medical Center, Boston, Massachusetts, USA.
Clinical and Translational Science
|July 18, 2015
Summary
Implementing a robust scientific review process (SRC) is crucial for successful human research projects and translational impact. This framework ensures study validity, feasibility, and efficient operations before Institutional Review Board (IRB) submission.
Area of Science:
- Clinical research methodology
- Translational science
- Research administration
Background:
- Human research projects require scientifically valid designs and feasibility for translational impact.
- Current practices often lack a formal scientific review before Institutional Review Board (IRB) submission.
Purpose of the Study:
- To propose a framework for a Scientific Review Committee (SRC) process.
- To guide institutions in establishing effective SRCs for clinical research.
Main Methods:
- Development of a consensus framework by the Clinical and Translational Science Award (CTSA) Consortium Scientific Review Committee (SRC) Consensus Working Group.
- Recommendations cover institutional support, CTSA roles, protocol selection, committee composition, and application/committee processes.
Main Results:
- A comprehensive framework for SRC implementation is presented.
- Recommendations include leveraging information technology and evaluation metrics for efficiency and outcome assessment.
Conclusions:
- A structured SRC process enhances the quality and translational potential of human research.
- Institutional support and optimized processes are key to successful SRC implementation.