Institutional Review Board (IRB)
The Institutional Review Board for the Protection of Human Subjects (IRB) is a Marian University committee charged to protect human subjects in research by ensuring the adequacy of research conducted with human subjects, and to minimize risks and maximize the potential for benefit from human subjects’ participation in research. The Marian University IRB has received a Federal-wide Assurance Number (FWA) through the Department of Health and Human Services (HHS). Marian’s FWA is FWA00014929, and approved through January 2022.
The IRB requires all Marian faculty, staff, and students involved in research to complete CITI training in the ethical use of human participants in research. Beginning January 2009, all researchers submitting IRB applications must have completed the initial education and certification through the CITI web-based training program. Please note that although every student has a Marian University email account, registration can be done with any email address as long as the institutional affiliation is set to Marian University.
IRB Policies, Forms and Templates
All documents related to the IRB can be found on the MyMarian website; please click here to go to the appropriate folder.
Other important links for further guidance:
- Office of Human Research Protections (OHRP) – Office of the federal government that oversees regulations related to research involving human subjects.
- 45 CFR 46 – Federal regulations governing human research protections.
- FDA Regulations – Federal regulations involving the testing of medical devices or drugs in humans.
- FERPA – Federal law related to the confidentiality of, and access to, student education records.
- HIPAA – Regulations related to the privacy and use of medical records.
Level of Review
The Federal Government has developed a decision tool to assist researchers with determining the level of review for research projects. This Decision Chart provides guidance on the appropriate level of review (Exempt, Expedited, Full Review) and specific category of review based on the type of research and subject population. Final determination regarding level of review is made by the Marian University IRB.
2018-2019 Institutional Review Board
Sean Fitzpatrick, College of the Professions, Chairperson
Ciara Kidder, College of Arts, Sciences and Letters, Vice-Chairperson
Jessica Brandt, College of Arts, Sciences, and Letters
S. Cyndi Nienhaus, College of the Professions
Lalitha Ramamoorthy, College of Arts, Sciences and Letters
Kimberly Udlis, College of the Professions
Russell Mayer, VPAA, Human Protections Officer (ex-officio, non-voting)
Pat Immel, IRB secretary (ex-officio, non-voting)
|Institutional Review Board
45 S. National Ave.
Fond du Lac, WI 54935
Printed versions of documents on this page are available upon request. Please contact email@example.com