IRB Registration and FWA

 

Human Research Protections Program
IORG #0007199 

MHC IRB #1 -- IRB00008640
MHC FWA# 00021944   EXPIRATION 3/27/2023

Institutional Review Board Organization (IORG)

The IORG number is a unique number assigned by the Office of Human Research Protection (OHRP) to an institution or organization the first time the institution or organization registers an IRB.

Federal Wide Assurance

A 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.

McLaren Health Care (MHC) includes 10 subsidiary hospitals which conduct research under one centralized corporate institutional review board.  MHC has one FWA on which each subsidiary is listed as a component.  MHC is committed to protecting the rights and welfare of subjects in Human Research.   McLaren's Human Research Protection Program (HRPP) is a centralized system to ensure the protection of the rights and welfare of subjects and compliance with the highest legal and ethical standards in human research.  McLaren's HRPP includes specific review and oversight of research activities involving human subjects; provision and development of training and policies for researchers; conduct of quality improvement and assurance activities; and the support of the compliance responsibilities of the covered institutions and investigators.