July 2023

The Johns Hopkins Surgery Centers Series (JHSCS) was formed in December 2019 under Johns Hopkins Ventures, LLC. JHSCS is a named component under the JHHS Federal Wide Assurance that names the Johns Hopkins Medicine (JHM) IRBs as the IRBs of record for JHHS. JHSCS facilities currently include Green Spring Station Pavilion III ASC, White Marsh ASC, Lutherville ASC, Fertility Center ASC, Howard County ASC, Knoll North ASC, and Bethesda ASC. Additional facilities may be added in the future. In addition to IRB review, review by the JHSCS Research Review Committee (RRC) is required before a project may be initiated at a JHSCS facility.

In order to facilitate the RRC’s review, the “Approval of Research Involving JHCSC Resources” Form must be completed and provided to the RRC. This Form is required for any research requesting the use of the JHSCS facilities and/or resources. The form is accessible here: 

Once the RRC reviews and approves, the Form will be signed. This executed Form, must be uploaded to section 10 item 1 of the JHM eIRB application before final JHM IRB approval can be granted.

Research studies that will be conducted only at a JHSCS facility by JHSCS staff or practicum students under JHHS Centralized Nursing agreements:

Applications that originate from a member of the JHSCS staff or practicum students and will involve JHSCS patients/records must be reviewed by the RRC before they are submitted to a JHM IRB for review. The JHSCS staff member or student who wishes to submit an application to the IRB should notify the RRC via email at [email protected]. If the RRC determines that the study may be conducted at a JHSCS facility the eIRB application with a signed approval Form may be submitted for JHM IRB review. If it is determined that the study may not be conducted for administrative or other reasons, the JHSCS staff member or student will be informed of the decision.

For secondary use record review applications that do not originate from a member of the JHSCS staff or practicum students and are not specifically evaluating practices/outcomes related to JHSCS locations, then the JHSCS RRC’s review and approval is not needed.

Research studies that originate from JH faculty or staff, and the application indicates a JHSCS facility as one of the proposed sites for research:

For new applications where the JHSCS is initially included as a study site, the RRC’s approval Form must be uploaded to section 10 item 1 of the eIRB application. Please note, this approval must be secured before the JHM IRB can grant final approval.

For a change in research where the JHSCS is added as a study site, the RRC’s approval Form must be uploaded to section 10 item 1 of the eIRB application. Please note, this approval must be secured before the JHM IRB can grant final approval.

JHSCS RRC process and determination:

The required RRC Form and information will be forwarded to the RRC for inclusion on an upcoming meeting agenda. The RRC will meet monthly depending upon requests in queue. The PI and/or the JHSCS co-investigator/contact person may be asked to attend a scheduled RRC meeting to discuss the project. The RRC will review whether implementation will place a burden on JHSCS staff time or resources. Only projects that are reviewed by the RRC may begin at JHSCS. If the RRC does not grant approval to initiate the protocol at JHSCS, the RRC will inform the PI via email. The RRC approval needs to be secured before the JHM IRB can grant final approval.

Research studies for which the JH faculty or staff wish only to post recruitment flyers at a JHSCS facility:

The PI should reach out to [email protected] indicating at what JHSCS locations the request to post the recruitment flyers approved by the JHM IRB is being made. JHSCS Leadership will review the application to determine if the recruitment material and posting sites are acceptable.

Who to contact for additional information about the JHSCS RRC review process?

Questions about the requirements for JHSCS RRC review process should contact [email protected].

For questions related to the IRB submission process, please contact the IRB help desk at [email protected] or410-502-2092.