IRB Registration and FWAs

Institutional Review Board Organization (IORG)

The IORG number is a unique number assigned by Office of Human Research Protection (OHRP) to your institution or organization the first time your institution or organization registered an IRB. This number should be provided to OHRP whenever your institution or organization subsequently updates or renews the existing registration of any of your Institutional Review Boards (IRBs) or registers a new IRB.

Federal Wide Assurance

Federal Wide Assurance (FWA) states that all organizational research activities involving human subjects will be guided by the ethical principles set forth in the Belmont Report, regardless of funding source. Whenever a McLaren subsidiary becomes engaged in human subjects research conducted or supported by any U.S. federal department or agency that has adopted the U.S. Federal Policy for the Protection of Human Subjects (also known as the Common Rule), the organization must comply with regulations found at DHHS 45 CFR 46 and Subparts B, C, and D, as applicable (unless the research is otherwise exempt from the requirements of the Common Rule or the department or agency conducting or supporting the research determines that the research shall be conducted under a separate assurance).

Each McLaren subsidiary holding with a registered FWA will assure that whenever it engages in research to which the Assurance applies, it will comply with the Terms of the Federalwide Assurance (contained in a separate document on the Office for Human Research Protections (OHRP) website). Listed below you will find the FWA for each subsidiary.

Human Research Protections Program

IORG #0007199

MHC IRB #1 – IRB00008640