My study could be exempted from full committee review?
Submit all required study documents (see Documents Checklist) to Scientific Review Committee Chair via Oncore. Chair determines review status based on protocol review and monitoring policy. If exemption decision is made, the committee will issue an exemption letter to accompany the IRB submission package. This rule applies to studies conducted by doctoral student who are working on their thesis and have no funding source for the proposed study.
I need to submit amendments of the initial submission?
Amendments for approved study do not need full committee review. Amendments or administrative changes, such as typo, wording, grammatical corrections, protocol version date, sponsor name and so forth, maybe submitted to the committee.
Amendments or changes in responses to concerns and comments raised by the committee should be addressed to the Chair of the SRC Committee, following the instruction provided in the report.
Amendments or changes for revise and resubmit studies need to be completed and included in the resubmission package.
I need to utilize tissues or data from previously SRC approved studies?
These studies are exempted from full committee review in order for the committee to provide the exemption letter and for the Clinical Trials Office to keep a record, the PI still needs to submit the study to the Chair, Steven P. Stratton, PhD.
I have responded to the committee regarding concerns on statistical design and other issues, but my responses are not sufficient for final approval. What are the alternatives for the PI, sponsor or the research team to provide further information?
Scientific Review Committee Chair and Coordinator will facilitate a meeting session for the PI, sponsor or any associated party to discuss the concerns and exchange opinion. The goal of having such meetings is to provide further understanding of the issues on all parties and work towards feasible solutions.Further actions from the research team side following the meeting are expected in lieu of the directions discussed and agreed upon. Final approval might be granted after the actions are evaluated.
I need to work on reagents with the same protein and same populations of the study that was approved by the Scientific Review Committee?
PI only needs to submit the amendments to the Human Subject Protection Program. However, if the study population is different while the study protein remains the same, the PI will have to submit a new study to the SRC, with all required documents and forms.