Research Compliance and Quality Improvement

The Office of Research Compliance and Quality Improvement supports and promotes ethical and compliant research practices at McLaren Health Care. Joint efforts with the Office of Education, Training, and Resources combine to form the Education and Quality Improvement Program (EQuIP) of the Human Research Protections Program (HRPP). 

EQuIP is a program dedicated to the research community to enhance the quality of human research and support improvement of the HRPP.  We offer a variety of education and study related services and activities designed to ensure investigators, research staff, and the IRB are compliant with regulations, guidance, institutional policies, and best practices for human research protections. Our staff is available to help address issues and questions that may arise during the conduct a study, as well as to provide quality improvement recommendations on the best practices for conducting a research study.

The Office of Research Compliance and Quality Improvement provides research templates and resources to ensure human subjects protection and overall data integrity.  In addition, our staff is willing to tailor existing services to meet your study's needs (i.e. reviewing specific study documents, preparing for an audit, etc.).

Please feel free to contact us if you have any research-related questions or would like to request any EQuIP services:


Patricia Ivery, RN, MSN
QI and Education Specialist

2701 Cambridge Court, Suite 110
Auburn Hills, MI 48326

Phone: (248) 484-4955
Fax: (248) 276-9732

Services and Activities Links for the Office of Compliance and Quality Improvement
Routine QA/QI Reviews (click to open)

QA/QI routine reviews are part of a McLaren Health Care (MHC) institutional-wide research education initiative, designed to help investigators identify standards of excellence and potential areas for improvement.   The routine reviews also provide a mechanism for the MHC Human Research Protection Program (HRPP) to provide internal oversight of the conduct of human research studies that are reviewed and approved by the MHC Institutional Review Board.  Routine QA/QI reviews are initiated by EQuIP or the study site. 

Our FAQs section can answer questions you may have regarding the review process and how studies are selected for a review.

Directed For-Cause Audits (click to open)

Directed For-Cause Audits are initiated due to an identified concern or allegations of non-compliance that affects the rights, safety, or welfare of research subjects or the integrity of the research data. Specific reasons include serious non-compliance, repeated non-compliance, complaints, etc. Directed audits can be initiated at the request of the IRB, IRB Chair, HRPP Director, or regulatory agency.

Investigator Requested Study Reviews and Consultations (click to open)

Reviews are required when randomly selected or IRB-requested, but may be voluntarily requested by PI/staff (e.g. early-stage QA/QI review to ensure compliance, review of self-assessment review, during staff changes, to prepare for external audit, consultation on developing documents or corrective action plan, evaluate study conduct, organization, record-keeping and documentation). The EQuIP office aims to help investigators implement tools and strategies to improve identified problem areas. 

To request services, the primary investigator or designee can complete a service request form.

Filing Research Related Complaint (click to open)

Lana Gevorkyan, BS, CM, CCRP
Corporate Director
(248) 484-4951