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1 Purpose
The purpose of this manual is to provide an overview of this Organization’s structure regarding the conduct, administration and evaluation of the McLaren Human Research Protections Program. Standard Operating Policies and Procedures are created for day-to-day operations of the HRPP.
This HRPP Manual and all the standard operating procedures are made available to all MHC investigators and research staff and will be posted on the HRPP website (www. Mclaren.org)
2 Executive Summary
McLaren Health Care (MHC) is a regional healthcare provider that services 29 counties throughout central Michigan. This non-profit system includes twelve regional hospitals: McLaren Bay Regional and McLaren Bay Special Care in Bay City; McLaren Greater Lansing and McLaren Orthopedic Hospital in Lansing, McLaren Lapeer Region in Lapeer; McLaren Flint in Flint: McLaren Macomb in Mt. Clemens; McLaren - Oakland in Pontiac, McLaren Central Michigan located in Mt. Pleasant McLaren Port Huron in Port Huron and McLaren Northern Michigan in Petoskey. In addition, McLaren Healthcare Corporation operates the McLaren Health Care Village in Clarkson, the McLaren Health Plan, the McLaren Homecare Group, the McLaren Medical Group and the Karmanos Cancer Institute/Karmanos Cancer Hospital.
Until January 2012, McLaren hospitals conducted human research under their local Institutional Review Boards (IRBs) with approximately 400 total protocols under review. Some of the same projects were conducted at more than one hospital and were reviewed by more than one IRB. To reduce the burden of duplicate reviews and to save corporation time and resources, it was decided to develop a centralized IRB to review and make decisions concerning all human research conducted at McLaren Healthcare Corporation (MHC) through its subsidiaries. Moreover, as part of its strategic plan, McLaren Healthcare Corporation decided to develop a centralized Human Research Protection Program (HRPP) to ensure the protection of human subjects participating in research.
MHC is committed to protecting the rights and welfare of subjects in Human Research. McLaren’s Human Research Protection Program 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. The 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
Human Research Protections Program Manual McLaren Health Care
Revised 12/1/16
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