Human Research Protections Program (HRPP)

AAHRPP seal

Welcome to the Human Research Protections Program (HRPP). The HRPP is a centralized corporate-wide system to ensure the protection of the rights and welfare of subjects participating in research. All research programs administered through McLaren Health Care and its subsidiary hospitals are overseen by the centralized Human Research Protections Program (HRPP) to protect the rights and welfare of human subjects participating in research.

COMMON RULE CHANGES

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Changes to the Common Rule, the primary rule regulating human subjects research, are scheduled to go into effect on January 21, 2019. A number of MHC IRB policies, procedures, and systems will be updated as a result of the changes to the rule. Please note that only studies approved or altered after 1/21/2019 will be governed by the new rule; existing studies will need to be amended in order to transition to the new rule.

The Common Rule regulations are separate from FDA regulations. The FDA regulations have NOT changed.

MAJOR REGULATION CHANGES:

  • Continuing Review – no longer required for some minimal risk research including studies where the only remaining activity is the analysis of identifiable data/bio specimens or activity to obtain follow-up clinical data. IRB will still require an update every year through an Institutional Annual Status Report form. Remember that the requirement to submit modifications, reportable events, and final reports to the IRB has not changed. – Effective January 21, 2019
  • Informed Consent - A new information section and a rearrangement of content is designed to facilitate a potential subject's decision to participate or not. Consent forms and discussions will now require a concise summary of study activities, risks, and benefits presented to research participants in advance of the body of the consent document. The IRB will not require re-consent, except when other significant changes are made. Please see the end of this document for examples of the concise summary language. - Effective January 21, 2019
  • Exemptions - New categories and clarification of existing categories. Effective January 19, 2018, the current federally-defined exemption categories for human subjects’ research will change. Some exemptions may require "limited IRB review" (similar to an expedited review process). - Effective January 21, 2019
  • Single IRB-of-Record (sIRB) - IRB oversight for most federally-funded collaborative research projects located in the U.S. will be required to use a single IRB (commercial, academic, or hospital-based)- Effective January 20, 2020.

You can find a list of FAQs by clicking here.


The mission of the HRPP is to:

To safeguard and promote the health and welfare of human research subjects by ensuring that their rights, safety and well-being are protected;  
To provide timely and high quality education, review and monitoring of human research projects; and
To facilitate excellence in human subjects research.
research matters newsletter

hrpp mission
The program consists of research leadership, investigators and their research staff, and administration.  The following units of the Human Research Protections Program include:
  • MHC Institutional Review Board (a group of people who review research projects to ensure the protection of human subjects participating in research).
  • Office of Research Education, Development, Training and Resources
  • Office of Research Compliance and Quality Assurance

McLaren Healthcare has a corporate Federalwide Assurance (FWA) registered with the Office of Human Research Protections (OHRP) within the Department of Health and Human Services (DHHS); on which each subsidiary hospital is listed as a component. The FWA identifies an institutional official who is responsible for the McLaren corporate HRPP.

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The McLaren corporate HRPP is responsible for oversight of all research involving human subjects conducted within any of the McLaren Healthcare subsidiaries.

Click here for the HRPP Manual.

HRPP Office Location and Hours:

2701 Cambridge Court, Suite 110
Auburn Hills, MI 48326
Hours of Operation: 8:00 - 4:30 p.m. Monday to Friday
HRPP Staff Directory

HRPP Main Line: (248) 484-4950
HRPP Fax: (248) 276-9732

HRPP Administration

Markeda Richards, BS
HRPP Coordinator
Markeda.Richards@mclaren.org
(248) 484-4952

IRB Operations

Katherine Pittel, JD
IRB Analyst
Katerine.Pittel@mclaren.org
(248) 484-4954

M. Ammar Hatahet, MD, MPH, FACP
IRB Chairman
ammarhat@aol.com
(248) 484-4956

Office of Research Compliance/Office of Education

Marybeth McCarthy, RN, BSN
QI and Education Specialist
Marybeth.McCarthy@mclaren.org
(248) 484-4987