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Research Microscope Lab
Human Research Protection Program

Medical College of Wisconsin Human Research Protection Program Quality Improvement

The HRPP Quality Improvement/Quality Assurance staff work with investigators, research teams, and MCW IRBs to ensure safe, compliant and ethical conduct of human subject research. 

HRPP Objectives:

  • Provide accurate, complete, ongoing information regarding the safe, compliant and ethical conduct of research.
  • Identify and promote standards of good clinical practices in the conduct of research.
  • Provide feedback to investigators, research team members, MCW IRBs regarding the conduct of research.
  • Liaise between the investigator and the research team members, and the IRB Staff to ensure accurate information is clearly communicated and, if applicable, corrective actions implemented.

HRPP Services:

  • Conduct routine reviews of IRB approved research projects.
  • Observe research consent process.
  • Conduct for-cause audits authorized by the HRPP Director.
  • Provide updated information to investigators, and research team members reflecting MCW policies, federal regulations, and good clinical practice regarding the conduct of research.
  • Assist in the development of quality assurance activities for department use.
  • Provide guidance and consultation regarding quality improvement in the conduct of ongoing or new research.
  • Assist in preparation for an external audit by a sponsor or federal agency.
  • Provide checklists for creation and organization of regulatory and subject files.
  • Serve as the Research Subject Advocate for received complaints from research subjects.

Contact Us

For questions about consent observations, routine reviews, sponsor audits, regulatory audits, or to schedule a study start up visit. 

QI Manager

Roxanne Pritchard
rpritcha@mcw.edu  |  (414) 955-8844


QI Specialists

Mala Bobade
mbobade@mcw.edu  |  (414) 955-8447

 

Kathy Lee-Hang
kleehang@mcw.edu | (414) 955-4687

 

For General Questions
HRPP-QIOffice@mcw.edu

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