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Inclusion of Howard County General Hospital as a study site

June 2007

The Howard County General Hospital (HCGH) became part of Johns Hopkins Medicine in 1997.  HCGH maintains a separate Federal Wide Assurance that names the JHM IRBs as the IRBs of record that will review applications that involve HCGH as a study site.  In addition to IRB review, the HCGH requires review and approval by the Medical Review Committee (MRC) before a project may be initiated at HCGH.  Outlined below are the MRC review requirements.

Research studies that will be conducted only at HCGH by HCGH staff:

Applications that originate from a member of the HCGH staff and will involve only HCGH patients/records must be reviewed by the MRC before they are submitted to a JHM IRB for review.  The HCGH staff member who wishes to submit an application to the IRB should notify the administrator of the HCGH MRC at 410-740-7720 to schedule a meeting with the MRC.  If the MRC determines that the study may be conducted at HCGH, the application may be submitted to the IRB for review.  If, however, the MRC determines that the study may not be conducted at HCGH for administrative or other reasons, the HCGH staff member will be informed of the decision and the application may not be submitted for IRB review.

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

  • For studies involving intervention or interaction with subjects at HCGH, the PI should identify the HCGH co-investigator or contact person. If the PI does not have a contact at HCGH, the compliance team member will contact the HCGH Office of the Executive Vice President and COO at HCGH to obtain contact information.  The PI should explain whether any study procedures are to be conducted at HCGH; 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 HCGH to review records or will request copies of records. 

The required MRC information will be forwarded to the MRC for inclusion on a meeting agenda.  The MRC meets once each month.  The PI and/or the HCGH co-investigator/contact person will be asked to attend a scheduled MRC meeting to discuss the project.  The MRC will review whether implementation will place a burden on HCGH staff time or resources. Only projects that are approved by the MRC may begin at HCGH.  If the MRC does not grant approval to initiate the protocol at HCGH, 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 HCGH:

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

The outcome from HCGH MRC review will be provided to the PI by a member of the OHSR compliance team.

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

HCGH staff who have questions about the requirements for MRC review prior to submission of an application to the IRB should contact the administrator of the MRC at 410-740-7720.

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