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UPDATE: By November 1, 2017 we will make changes to streamline the number of FWAs held by the institution and ensure that each legal entity has one FWA. This will require closing out some existing FWAs assigned to organizations that are components under either the Johns Hopkins School of Medicine FWA number or The Johns Hopkins Health System FWA number. Functionally nothing else regarding IRB review or our human research protections program will change. However, organizational components should please take note of the new FWA that will be affiliated with each component and ensure only the two FWAs listed below are referenced moving forward. For more information...
HHS human subject protection regulations and policies require that any institution engaged in non-exempt human subjects research conducted or supported by HHS must submit a written assurance of compliance to OHRP. The Federalwide Assurance (FWA) is the only type of new assurance accepted and approved by OHRP. FWAs are approved by the Office for Human Research Protections (OHRP) for federalwide use, which means that other federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may rely on the FWA for the research that they conduct or support. Institutions engaging in research conducted or supported by non-HHS federal departments or agencies should consult with the sponsoring department or agency for guidance regarding whether the FWA is appropriate for the research in question. More information on the FWAs can be found at the OHRP website.
The Johns Hopkins Institutions had been operating under Multiple Project Assurance # M-1011 for the period of 11/01/98 to 10/31/03. The MPA was replaced by Federal-Wide Assurances associated with each of the organizations linked to the JHM IRBs. The specific Federal-Wide Assurance numbers and expiration dates are as follows:
- All Children's Hlth System, Inc., FWA00000977 - expires10/17/18
- The Johns Hopkins University School of Medicine, FWA00005752-expires 9/16/2020
- The Johns Hopkins University School of Nursing, FWA00006088-expires 6/4/2019
- The Johns Hopkins Hospital and Johns Hopkins Health Systems, FWA00006087-expires 9/16/2020
- Johns Hopkins Bayview Medical Center, FWA00006089-expires 3/6/2022
- The Johns Hopkins University Applied Physics Laboratory, FWA00018613 - expires 3/6/2022
- Johns Hopkins Community Physicians, FWA00002251-expires 3/13/2022
- Howard County General Hospital, FWA00005743-expires 1/27/2020
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc., FWA00005719-expires 07/27/21
- Sibley Memorial Hospital, FWA00003508 - expires 8/13/18
- Suburban Hospital and Health System - FWA00005924 - expires 3/6/2022
- DoD - Air Force F50459 (covers all DoD supported research) - expires 10/17/18
The Institution or Organization (IORG) number is a unique number assigned by OHRP to an institution or organization the first time an institution or organization registers an IRB. The IORG number for The Johns Hopkins University School of Medicine is IORG0000019.
IRB Registration Number
Each IRB registered under an FWA has a unique registration number. The IRB registration numbers for the JHM IRBs are listed on the IRB membership rosters.
FDA Registration Requirements
Sponsors and CROs have been requesting documentation that the JHM IRBs have met the new FDA regulatory requirement for registration of IRBs. Currently, all JHM IRBs are registered on the OHRP website. Letter of confirmation for sponsors.
For more information: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM171256.pdf
For more information on the federal guidelines that determine the kind of research the JHM IRB is required to approve please visit http://www.hhs.gov/
Interested in IRB reliance? Click Here for more information about the JHM IRB reliance process.
Johns Hopkins University School of Medicine IRB is a signatory to the SMART IRB reliance agreement platform. Interested in learning more about SMART IRB? Click Here!