Quality Improvement (QI) and Quality Assurance (QA) consist of activities that are undertaken to measure the effectiveness of standard accepted processes, programs, or services. QI/QA projects cannot expose individuals to any additional risks. IRB oversight may be required in some NON-research projects, for the protection of participants and/or personal information, and for documentation of support by affiliated organizations and sites.
In contrast, human research consists of a systematic investigation that is designed to develop or contribute to generalizable knowledge, the results of which are to be shared with both individuals associated with and individuals unassociated with the investigation.
IRB Review of QI/QA Projects
All students, staff, and faculty at MSOE planning to conduct quality improvement/quality assurance projects must first register their project with MSOE IRB in order to determine that the project plan is not designed as human subjects research.
Prior to completing and submitting a protocol application to MSOE IRB, investigators should fulfill human subject research certification. MSOE IRB requires proof of CITI Program certification on file in your IRBNet user profile’s training and credentials section. Contact IRB@msoe.edu to determine the level of training appropriate for your planned research and to receive CITI Program registration instructions.
Prepare a PDF of your certificate to upload and submit to MSOE IRB via IRBNet.
Acceptable current certification falls within two calendar years preceding a corresponding protocol's submittal date. ALL training expires with MSOE IRB three years after the effective date stated on the certificate.
A letter of support from the non-MSOE healthcare organization providing guidance for your nursing-related QI/QA project is required prior to MSOE IRB administrative review of the proposed QI/QA project.
Affiliation letters are accepted as a PDF attachment via email to IRB@msoe.edu from the healthcare professional's work email address. An acceptable affiliation letter is complete with the healthcare professional's signature, full name, credentials, contact information at their Milwaukee-area institution including e-mail address, phone number and USPS mailing address, plus a brief summary of the person's understanding of the proposed project and their level of involvement in it.