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 November 2018.
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
When submitting a project for review by the IRB, any research project, sponsored or unsponsored, originated at or supported by the University that involves human subjects must be reviewed and approved by the IRB. Please refer to the Marian University IRB Policies and the Guidelines for Completing the Marian IRB Protocol Submission Form before submitting the Protocol Submission Form (a fillable Word file). 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.
- Wisconsin Department of Corrections – Regulations related to the use of employees, inmates, youthful offenders, parolees or probationers as human subjects of research.
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.
Timeline for Full Board Review
Only protocols requiring full board review (typically protocols with high potential risk) must be submitted in accord with posted deadlines. Protocols which qualify for review as expedited or exempt from further IRB oversight may be submitted at any time.
If the deadline falls on a weekend or holiday, proposals must be received in the Institutional Review Board by email by 4:30 p.m. the next business day.
|Full Board Meeting Dates||Submission Deadlines for Full Review|
|October 18, 2016||October 1, 2016|
|November 16, 2016||November 1, 2016|
|December 7, 2016||December 1, 2016|
Questions about meeting dates or protocol submissions may be emailed to firstname.lastname@example.org or call 920.923.8952
2016-2017 Institutional Review Board
Janet S. McCord, School of Nursing & Health Professions, Chairperson
Sean Fitzpatrick, School of Nursing & Health Professions
KiErrin Phillips, School of Nursing & Health Professions
Jessica Brandt, School of Arts & Sciences
Lalitha Ramamoorthy, School of Arts & Sciences
S. Cyndi Nienhaus, School of Education
S. Catherine Steward, School of Education
Amber Kilawee, Community member, non-scientist
Dale Nelson, Community member, non-scientist
Russell Mayer, VPAA, Human Protections Officer (ex-officio, non-voting)
Pat Immel, IRB secretary (ex-officio, non-voting)
- The NIH has released several findings of Research Misconduct:
|Institutional Review Board
45 S. National Ave.
Fond du Lac, WI 54935
Regina Hall 007