Human Research Protection Program

Frequently Asked Questions

General FAQs

1. Why does the Medical College of Wisconsin have a Quality Improvement (QI) Program?
2. What is the relationship between the MCW/FH IRB and the Quality Improvement (QI) Program?
3. What is the difference between a for-cause audit and a routine review?
4. What studies are subject to audit and/or review by the Quality Improvement (QI) Program staff?
5. As the study coordinator, what can I do to ensure that my study subject files and regulatory files are complete?

Routine Review FAQs

1. Why are routine reviews of studies conducted?
2. How are studies identified for routine review?
3. Does the PI and/or study coordinator need to be present during the entire review?
4. What does the study team need to do to prepare for an upcoming routine review?
5. What should I do if I identify problems when preparing for the routine review?
6. How are findings conveyed upon completion of the review?

General FAQs

1. Why does the Medical College of Wisconsin have a Quality Improvement (QI) Program?
   The Quality Improvement (QI) Program started in 2003. The purpose of the program is to provide feedback regarding the conduct of human subject research. QI provides feedback and information through many activities including routine reviews, for cause audits, and summaries of activities at other institutions as reported by federal agencies. Recipients of the feedback and other information include the MCW/FH investigators and study team members, and MCW/FH IRBs.
   
   
2. What is the relationship between the MCW/FH IRB and the Quality Improvement (QI) Program?
   The IRB and QI Program are components of the Human Research Protection Program within the Office of Research.
   
   The IRB is charged by OHRP with overseeing IRB approved human subject research including the observation of the consent process and research; the feedback received from QI reviews is a way for the IRB to observe these activities.
    
3. What is the difference between a for-cause audit and a routine review?
   A for-cause audit is based upon a concern, complaint, or an allegation that has been brought to the attention of the IRB/Assistant Dean of Clinical Research (David Clark, PhD). The Assistant Dean of Clinical Research determines the need for further assessment of the situation and a directive to conduct the for-cause audit is given. Findings are subject to internal and external reporting as required by OHRP & FDA.
   
   A routine review is a service offered to investigators for review of study activities and study documentation with provision of feedback regarding the practices associated with the conduct of the study. Feedback includes confirmation of good clinical practices, and 1:1 educational information related to the conduct of the study. Participation in a routine review is voluntary. Findings from a routine review are reported internally only.
   
   
4. What studies are subject to audit and/or review by the Quality Improvement (QI) Program staff?
   Any studies involving human subjects that have received full or expedited review by the MCW/FH IRB are subject to audit and/or review by QI. The majority of studies audited or reviewed will be open and active, however, QI may be asked to conduct a for-cause audit of a study that is in any stage, including closed studies.
   
   Any study that is suspended by the Director of the Human Research Protection Office or an IRB Committee may be subject to an audit, in accordance with the MCW/FH IRB action guidelines.
    
5. As the study coordinator, what can I do to ensure that my study subject files and regulatory files are complete?
   Know your protocol, make checklists for the subject files based on the procedures of the study and applicable visit schedule, etc. Create a system to maintain current and complete regulatory, and if applicable, study subject files and train the study staff on the maintenance and use of the system. Use the template checklists on QI’s website and review your files for the appropriate contents.

Routine Review FAQs

1. Why are routine reviews of studies conducted?
   The goals of a routine review are:

• To review the study conduct in regards to federal regulations and institutional policies
• To provide feedback to the PI, study team, and MCW/FH IRB
• Ensure quality assurance

2. How are studies identified for routine review?
   Once QI has identified the MCW/FH IRB approved studies in eBridge, an email is sent to the principal investigator requesting permission to conduct a routine review of one of his/her current studies. The PI has several options available: (1) to accept or decline the invitation for review, (2) to select the study for review, and (3) identify preferred time for review. It is QI’s goal to conduct a routine review within each department and division every year.
    
3. Does the PI and/or study coordinator need to be present during the entire review?
   No. However, before the QI staff begins a review of study documentation we ask to meet with the PI and/or study coordinator to discuss the conduct of the study. The QI staff will make arrangements to meet with the PI and/or study coordinator after the review for further discussion, feedback and debriefing. The PI may delegate the study coordinator to meet with QI.
    
4. What does the study team need to do to prepare for an upcoming routine review?
   Ensure documents are available for review. In a routine review the QI staff will always review signed consent forms and the regulatory file. Periodically QI will review other documents such as study subject files, enrollment logs, product accountability records and other research records. QI will discuss the scope of the review in conjunction with your acceptance of the invitation.
   
   For more information, please contact a Quality Improvement Specialist.
    
5. What should I do if I identify problems when preparing for the routine review?
   If any errors, omissions or other problems are identified while preparing for a review, please contact a Quality Improvement Specialist for guidance.
    
6. How are findings conveyed upon completion of the review?
   Findings in the form of a draft report are emailed to the PI and study coordinator usually within 1 to 2 weeks of the review. The PI and coordinator will have one week to review the draft report and follow-up with the QI staff regarding questions or concerns. After feedback is addressed, QI will issue the final report in hard copy. The report is addressed to the PI and copies of the report are forwarded to the study coordinator, Chair and Coordinator of the overseeing MCW/FH IRB, and, if applicable, the Translational Research Unit (TRU) research subject advocate.
   
   If QI does not receive a response or feedback from the study team or PI after sending the draft report, we will issue the final report after one week has passed.