Faqs What is the purpose of the MHC Human Research Protection Program’s (HRPP) Education and Quality Improvement Program (EQuIP)?

The Human Research Protection Program oversees the Office of Research Compliance and Quality Assurance and the Office of Education, Training, and Resources which are jointly known as the Education and Quality Improvement Program (EQuIP).
The purpose of EQuIP is to measure, evaluate, and improve the effectiveness, quality, and compliance of HRPP with organizational policies and procedures and applicable federal regulations, state, and local laws on an ongoing basis.

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What is the relationship between the Institutional Review Board (IRB) and the EQuIP?

MHC IRB and EQuIP are both components of, but separate entities of the HRPP. EQuIP is responsible for caring out the mission of the IRB by evaluation and enhancing human research protections through education training, and monitoring.  The IRB is responsible for reviewing and overseeing human research to ensure protection of research participants.  The feedback received from QA/QI reviews is a way for the IRB to inform and improve these activities.

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What activities comprise EQuIP?

EQuIP activities focuses primarily on compliance through:

  • QA/QI Reviews and Audits
  • Assistance with site or study-specific researcher self-assessments
  • Assessment of Current Processes and Policies
  • Pre-study site or investigator assistance
  • Providing Continuing Education to Investigators, Researchers, and IRB members
  • Assistance with IRB submissions, reporting, and recordkeeping

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What is the scope of EQuIP?

The scope of the EQuIP QA/QI activities focuses primarily on, compliance through QA/QI reviews and audits, policies and procedures, education, and other activities designated by the Corporate Director of HRPP.

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 What is the difference between a “for-cause” audit and a routine Quality Improvement (QI) review?

A Directed For-Cause Audit is a systematic review, inspection, or verification of compliance regarding research and/or investigators- initiated at the request of the MHC IRB chairperson, designee or authorized official.  Directed audits may be conducted in response to subject or sponsor complaint. 

A QA/QI Routine Review is a quality assurance and quality improvement effort to ensure optimal conduct of human subject research within the framework of institutional policy and regulatory requirements and to provide educational resources to Investigators and members of the study team.

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How are studies selected for routine review?

Protocols selected for review are either:

  • Selected randomly by assigning a number to each protocol and running a random function in the Microsoft Excel program
  • Selected purposely based on the following criteria
  • Studies that involve vulnerable populations
  • Investigators who conduct studies that involve a potential high risk to subjects
  • A new PI and/or Clinical Research Coordinator
  • Past clinical trial non-compliance/problems
  • Studies involving various waivers
  • Protocols with lapses of IRB approval
  • High enrolling studies
  • Resident or student PI
  • Involvement of multiple departments, i.e. cancer, cardiology, neurology, etc.
  • Investigators who conduct studies that involve large numbers of subjects.

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 How are individuals notified when their studies are selected for routine QI review?

The QI and Education Specialist will notify the Principal Investigator (PI) and Coordinator that their study has been selected for routine review.  An email notification is sent approximately 4 weeks prior to the review. The PI will be asked to respond within 1 week of email notification.  If the EQuIP Office does not receive the PI's response within one week of the initial notification, a Reminder Routine Review Notification will be sent by email.

The McLaren Center for Research and Innovation (MCRI) will be notified if they have oversight over the study.  If the PI is a resident or student, the academic advisor and Director of Medical Education will also be notified.  The HRPP Director will be copied on the notification.

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Does the Principal Investigator and /or research staff member need to be present for the entire QI review?

The PI does not need to be present during the entire review; however, a designated member of the study team must be available via phone/page or nearby for questions and retrieval of additional material.

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What will be reviewed during a routine QI review?

The QI and Education Specialist may review the following, but not limited to:

  • Informed consent: forms, process, observation of consenting process
  • Confirmation of subject eligibility
  • Confirmation of protocol procedures and interventions
  • Collecting and reporting adverse events and UPIRSOs
  • Protocol violations or deviations
  • Confidentiality and security measures
  • IRB, Sponsor, Regulatory Agencies correspondences
  • Subject recruitment, screening, and compensation
  • Subject study and source files
  • Monitoring reports
  • Storage facilities for devices, drugs, and biologic
  • Training files
  • Discussion with any individuals involved in study activities

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 What can an investigator or research staff member do to prepare for a routine QI review?

1.   Send a list of subject IDs and indicate the status if they are screen failures, in screening phase or randomized/enrolled.  Do not include subject names or other PHI at this time.

2.   Ensure there will be available space to review study documents during the study review (quiet, private, access to electrical outlets).

3.   Have all study and subject documents, binders, and files available at time of review.

4.   Study material should be maintained in a clear and organized manner, preferably in chronological order.  Documents can be provided in hard copy or electronically. Whether a study document is electronic or paper, the reviewer must have access, ensure they exist and are reliable and stored safely.

5.   A designated member of the research team that is knowledgeable in all aspects of the project must be available to answer questions and retrieve files during the entire site visit.

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What if problems are identified when preparing for a routine QI review?

For events requiring prompt reporting, please see MHC_RP0121 Reporting Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others, MCH_RP0122 Protocol Deviations, Violations, and Exceptions, and MHC_RP0123 Complaints and Non-Compliance in Human Subject Research.  For other problems, questions, or assistance, please contact the EQuIP specialist.   

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 How are findings communicated upon completion of a routine QI review?

The QI and Education Specialist will meet with the PI and/or designee to discuss preliminary findings and to allow an opportunity to correct, explain, and/or ask questions.  Feedback will be sought regarding the IRB process, educational/training programs, as well as other aspects of the human research protections program at MHC.  The QI and Education Specialist will provide recommendations and describe the next set of steps in the process.

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 Who will receive the results of a routine QI review?

The Primary Investigator, Corporate HRPP Director, Academic Advisor and Director of Medical Education, if PI is a resident or student, and McLaren Center for Research Innovation (MCRI) management will be notified if they have oversight over the involved MHC site.

QA/QI reviews are confidential and will not be submitted to the IRB unless there is evidence of serious or continuing non-compliance.

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