As with all research, several steps are required to conduct sleep research at the Johns Hopkins Medical Institutions. The CISRE staff has considerable experience in navigating this process, and is glad to assist researchers complete the necessary paperwork. We offer our experience in completing requirements for both single and multi-site studies, in addition to those related to testing new devices. Researchers should also be aware that approval is required from both the IRB and the Clinical Research Unit (CRU) to begin utilizing the CISRE.
1.1 Request CISRE Sleep Resources
When submitting a protocol to the CRU that involves utilization of CISRE resources, a CISRE Resource Requisition Form must be completed. All auxiliary services that will be needed should be identified on this form. The CRU will send the form to CISRE leadership to review, and CISRE leadership will contact the investigator for clarification, if necessary.
1.2 Request Letters of Support
If an investigator is submitting a project for extramural funding, it is often helpful to have a letter of support from the CISRE indicating that we are available, the resources that we can provide, and the cost of these resources. We will provide such letters in advance of IRB and CRU approval, although provision of the resources will require IRB and CRU approval.
1.3 Getting Started
Once IRB and CRU approval for a protocol has been obtained, the CISRE team will request to meet with the research team for a “startup” meeting, at which time sleep-related and protocol-specific logistics will be finalized prior to study initiation.