Scientific Review Committee (SRC) Processes Pilot Study
It is widely agreed that to ethically include human participants, biomedical research must be of sufficiently high scientific quality and locally feasible to yield meaningful results (whether positive or negative). To ensure that studies meet acceptable standards of scientific rigor and feasibility, the Clinical and Translational Science Award (CTSA) Steering Committee decided that SRCs should be considered for wider use across the CTSA Consortium.
From September 2014-February 2015, Tufts CTSI assembled the CTSA Consortium SRC Consensus Working Group, which included a diverse group of experts and stakeholders from nine CTSAs and the National Institutes of Health (NIH). This Working Group developed consensus-based scientific review processes considered to be practical, effective, and ethical. The consensus plan accounts for a range of clinical studies, including internally funded investigator-initiated projects, as well as those with federal, industry, or other funding.
With the guidance developed, the next step was demonstration and evaluation of the SRC processes. Starting in September 2015, the CTSA Consortium Demonstration and Evaluation of SRC Processes Project began a pilot at 10 CTSA-associated institutions with the objective to evaluate the performance of the recommended SRC processes as likely to be implemented in actual practice. From a clinical trial perspective, this is analogous to the difference between a controlled efficacy trial and a “usual practice” effectiveness trial. The study hypothesizes that implementing the recommended SRC process will increase the scientific quality of research with human participants without a meaningful impact on the efficiency of the review process. Results will inform a final recommended SRC process for broader dissemination.
Evaluation Study Details
- Pre/post design
- Mixed methods data collection
- Quantitative data evaluate:
- Adoption of recommended SRC criteria
- Short-range outcomes, including change in protocol quality, feasibility, and the efficiency of the review process
- Qualitative data assess the process of implementation (e.g., barriers and facilitators, institutional context)
- To be completed in Winter 2017
- Baseline Period – Data collection with existing policies and procedures: February 1-July 31, 2016
- Implementation Period – Implement new policies and procedures: August 1-September 30, 2016
- Intervention Period – Data collectoin with new policies and procedures: October 1, 2016-March 31, 2017
- Appendix A: CTSA Consortium Consensus Scientific Review Committee Working Group Report on SRC Processes (PDF)
- Appendix B: Pilot Study Model and Metrics (PDF)