The SRC will routinely review new intervention protocols submitted for full IRB review except the following:
Research approved for federal funding (DoD, DoE, DoJ, EPA, HHS, AHRQ, CDC, FDA, NIH, etc.)
Research approved for corporation/foundation/organization/association funding utilizing an adequate peer review mechanism
Research that qualifies for expedited IRB review
Research that qualifies for exemption from IRB review
The IRB and/or the Institutional Officials may, at their discretion, forward any protocol to the SRC at any point during the review process.
Elements of Scientific Review
The SRC protocol review form contains items that will be considered by SRC reviewers in assessing the scientific rigor and merit of a study under review. However, not all items on the SRC protocol review form will apply to each protocol.
In the course of conducting its review of proposed protocols, the Scientific Review Committee (SRC) may need the assistance of members of the faculty or other expert reviewers who possess specific expertise relevant to the disease or condition in question. These questions may concern the relevance of the proposed study to the field or other technical issues beyond the expertise of the committee members. The role of the expert reviewer would be to address specific questions posed by the SRC. The reviewer will not be asked to provide written comments.
When this need is identified, either by the chair, the primary reviewer in consultation with the chair or by the committee itself, the chair or his designee will contact the Division or Department head and ask her or his assistance in identifying a willing and available expert. The department chair is responsible for identifying and contacting the reviewer. The chair should contact the expert to ensure that s/he:
possesses the requisite expertise
is not a research team member on the protocol subject to review
is available to perform the review in a timely manner
is willing to undertake the task
If this results in a delay of more than a week, the investigator will be notified that the protocol will be delayed until an expert reviewer has been identified. Once the expert has been identified, the SRC will invite the expert to attend its next meeting, at which time the protocol will be discussed. The SRC recommendation will be transmitted to the PI and the IRB.