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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:
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.
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
Institutions must list all Institutional Review Boards (IRB) or Independent Ethics Committees (IEC) that they will rely upon for the review of any research on their Federalwide Assurance. Reliance on the IRB/IEC of another institution or organization, or an independent IRB, must be documented by a written agreement that is available for review by the Office for Human Research Protections (OHRP) upon request. This agreement should be submitted to the Office of Human Subjects Research for review and approved before an outside Institution updates their FWA to add a JHM IRB. To request an IRB Authorization agreement contact Kat Jeter, email@example.com .
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/ohrp/policy/index.html.