September 2011

The Suburban Hospital (SH) became part of Johns Hopkins Medicine in 2009.  SH maintains a separate Federal Wide Assurance that names the JHM IRBs as the IRBs of record for non-NIH intramural research that involve SH as a study site.  In addition to IRB review, the SH requires review and approval by the Research Review Committee (RRC) before a project may be initiated at SH.  Outlined below are the RRC review requirements.

Research studies that will be conducted only at SH by SH staff or JHCP staff at SH:

Applications that originate from a member of the SH staff or JHCP staff at SH and will involve only SH patients/records must be reviewed by the RRC before they are submitted to a JHM IRB for review.  The SH staff member who wishes to submit an application to the IRB should notify the administrator of the SH RRC at 301-896-3122 to schedule a meeting with the RRC.  If the RRC determines that the study may be conducted at SH, the application will be scheduled for JHM IRB review.  If, however, the RRC determines that the study may not be conducted at SH for administrative or other reasons, the SH staff member will be informed of the decision and the application will be returned to the PI and IRB review will be done.

Research studies that originate from JH faculty or staff, and the application indicates SH 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 SH.  Upon IRB approval, a member of the OHSR compliance team will contact the PI to obtain the following information for RRC review purposes:

• For studies involving intervention or interaction with participants at SH, the PI should identify the SH co-investigator or contact person. If the PI does not have a contact at SH, the compliance team member will contact the SH liaison to obtain contact information. The PI should explain whether any study procedures are to be conducted at SH; and if they will be, explain by whom and where.
• For studies that involve access to medical records only, the PI should explain whether or not the PI (study team) will travel to SH to review records or will request copies of records. 

The required RRC information will be forwarded to the RRC for inclusion on a meeting agenda.  The RRC meets once each month.  The PI and/or the SH 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 SH staff time or resources. Only projects that are approved by the RRC may begin at SH.  If the RRC does not grant approval to initiate the protocol at SH, 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 SH:

The PI should indicate at what SH locations she/he wishes to post the recruitment flyers approved by the JHM IRB.  The RRC will review the application to determine if the recruitment material and posting sites at SH are acceptable.  Approval of the appropriate clinical director at SH is required before postings are approved for clinical sites.

The outcome from SH RRC review will be posted in eIRB and the PI will receive a memorandum to confirm approval for the site.

Who to contact for additional information about the SH MRC review process?

All research to be conducted only at SH must complete the required prospective reimbursement analysis and Clinical Research Management System (CRMS) training, as applicable.

SH staff who have questions about the requirements for RRC review prior to submission of an application to the IRB should contact the administrator of the RRC at 301-896-3122.

JHM faculty who have questions about the requirements for extension of an IRB approved project to SH as a study site should contact a member of the OHSR Compliance team at 410-955-3008.