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Federalwide Assurances and IRB Registration

Federalwide Assurances

Johns Hopkins Medicine operates under Federalwide Assurances (FWAs) in accordance Subpart A 46.103a which requires any institution engaged in non-exempt human subjects research conducted or supported by HHS to submit a written assurance of compliance to OHRP.

Renewal is required every 5 years. Any updates made to the FWAs begins a new 5-year effective period. Any updates/renewals to the FWAs requires approval from the Associate Dean for Human Research Protections and Director of the Human Research Protections Program.

  • The Johns Hopkins University School of Medicine, FWA00005752-expires 10/1/2023
  • The Johns Hopkins Hospital and Johns Hopkins Health Systems, FWA00006087-expires 10/1/2023

IRB Registrations

All of the JHM IRBs listed under the FWAs are registered electronically in accordance with 45 CFR 46,§ 501-505. Renewal is required every 3 years. Any updates made to the IRB registration begins a new 3-year registration period. Any changes to the IRB registrations requires approval from the Associate Dean for Human Research Protections and Director of the Human Research Protections Program.

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.

IORG Number

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. 

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/

Reliance Agreements

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!

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