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Inclusion of Sibley Memorial Hospital as a study site in JHM IRB Approved Research
Sibley Memorial Hospital (SMH) became an affliliate of Johns Hopkins Medicine on November 1, 2010. SMH maintains a separate Federal Wide Assurance that names the JHM IRBs as the IRBs of record that involves SMH as a study site. In addition to IRB review, SMH requires review and approval by the Sibley Research Review Committee (SRRC) before a project may be initiated at SMH. Outlined below are the steps to be taken to initiate the SRRC review process.
Research studies that will be conducted only at SMH by SMH staff or JHCP staff at SMH:
Applications that originate from a member of the SMH staff or JHCP staff at SMH and will involve only SMH patients/records must be reviewed by the SRRC before they are submitted to a JHM IRB for review. The SMH staff member who wishes to submit an application to the IRB should notify the staff liaison of the SRRC at 202-243-2376 to schedule a meeting discussion with the SRRC. The SRRC will determine either that the study may or may not be conducted at SMH. When the SRRC determines the study may be conducted at SMH, an eIRB application should be submitted for JHM IRB review. All research activity at SMH must await final JHM IRB approval before it is initiated. When the SRRC determines the study may not be conducted at SMH, the SMH staff member will be informed of the decision and JHM IRB review will not be conducted.
Research studies that originate from JH faculty or staff, and the application indicates SMH is one of the proposed sites for research:
Applications from JH faculty or staff will be scheduled for IRB review in the standard fashion. After IRB review, the JHM IRB may approve a project for all sites except for SMH. Upon IRB approval, a member of the OHSR compliance team will contact the PI to obtain the following information required to initiate SRRC review:
- For studies involving intervention or interaction with participants at SMH, the PI should identify the SMH co-investigator or contact person. If the PI does not have a contact at SMH, the compliance team member will contact the SMH liaison to obtain contact information. The PI should explain whether any study procedures are to be conducted at SMH; and if they will be, explain by whom and where.
- For studies that involve access only to medical records and/or pathology specimens, the PI should explain whether or not the PI (study team) will travel to SMH to review records or will request copies of records or specimens to be sent to JHM.
The required SRRC information will be forwarded to the SRRC liaison for inclusion on a meeting agenda. The SRRC meets once each month. The PI and/or the SMH co-investigator/contact person may be asked to attend a scheduled SRRC meeting to discuss the project. The SRRC will review whether implementation at SMH may place a burden on SMH staff time or resources. Only projects that are approved by the SRRC may begin at SMH. The outcome of the SRRC review will be recorded in eIRB. If the SRRC does not grant approval to initiate the protocol at SMH, the IRB will inform the PI that this site must be removed from the eIRB application.
Research studies for which the JH faculty or staff wish only to post recruitment flyers at SMH:
The PI should indicate at what SMH locations she/he wishes to post the recruitment flyers approved by the JHM IRB. The SRRC will review the application to determine if the recruitment material and posting sites at SMH are acceptable. Approval of the appropriate clinical director at SMH is required before postings are approved for clinical sites.
The outcome from SRRC review will be posted in eIRB and the PI will receive a memorandum to confirm approval for posting flyers at the SMH site(s).
All research team members for applications to be conducted only at SMH must complete the required prospective reimbursement analysis and Clinical Research Management System (CRMS) training, as applicable.
SMH physicians who wish to serve as the Principal Investigator (PI) on an eIRB application submitted for JHM IRB review must be credentialed to practice medicine at SMH. The SRRC liaison will confirm that this requirement is met for the SMH PI.
Who to contact for additional information about the SRRC review process?
SMH researchers who have questions about the requirements for SRRC review prior to submission of an application to the JHM IRB should contact the SRRC liaison at 202-243-2376.
JHM researchers who have questions about the requirements for extension of a JHM IRB approved project to SMH as a study site should contact a member of the OHSR Compliance team at 410-955-3008.