Institutional Review Board
The Marian University Institutional Review Board (IRB) ensures that research conducted at or sponsored by Marian University that involves human participants complies with the ethical standards set by the federal Office for Human Research Protections (OHRP), which operates within the Department of Health and Human Services (DHHS). Protocols for biomedical or behavioral research to be conducted at or supported by Marian University are subject to review by the IRB and such research may not be conducted without IRB approval.
If your research results in generalizable knowledge and you intend to publish those results in a journal article or presentation, your project qualifies as research and is subject to IRB review if you are using human subjects. If you are a principal investigator (PI) from outside of the university who wishes to recruit Marian University faculty, staff, or students as research subjects, the Marian University IRB may accept primary IRB review and approval from a federally registered IRB with Federal Wide Assurance (FWA).
Structure and Governance of the Marian University IRB
The Marian University Institutional Review Board is federally registered with an FWA and is empowered by the Provost to review all research protocols involving human subjects to be conducted at or supported by Marian University. The chair of the IRB reports to the Provost.
The Marian University IRB has two subcommittees – Biomedical Research and Social/Behavioral Research – each of which comprises a chair and at least five members. Board membership includes representative faculty from every aspect of Marian University as well as an external community member not officially affiliated with Marian University to serve on each subcommittee.
The IRB adheres to policies and procedures (see below) that are in compliance with Title 45 Code of Federal Regulations Part 46 (the "Common Rule") and have been approved by the IRB Chair and Provost.
How to Proceed
If you are conducting a research study that involves human subjects, your first step is to fill out and submit MU IRB Form 1 to the IRB Chair electronically through Beverly Day (Social/Behavioral) or Claire Rutledge-Sakha (Biomedical). The chair will review the form and, if your study fulfills the criteria for exemption from IRB review, you will be notified and may proceed with your study. If the chair determines that your study requires expedited or full review, you will be asked to submit a full IRB application, which will be sent to you by the appropriate subcommittee chair. You, and any affiliated researchers, will also be required to complete a CITI training course or present a CITI completion certificate dated within four years (see below). The subcommittee chair will inform you if your study will be subject to expedited or full review upon receipt of your application.
Application Due Dates and Meeting Times
Applications should be submitted 2 months prior to submission of a grant or recruitment of subjects. The IRB meets (in full or in subcommittee) to review protocols that require expedited and full IRB review.
Please submit an electronic copy of your application through Beverly Day (Social/Behavioral) or Claire Rutledge-Sakha (Biomedical). More information on the Marian University IRB process is available in the MU IRB Policies and Procedures document or in this "Human Subjects Research and the Marian University Institutional Review Board (IRB)" presentation.
If you have any questions about whether your project is subject to IRB review or if you need help with filling out the application or if you have any other questions, please contact the IRB Chair.
Marian University has an institutional subscription to the online Collaborative Institutional Training Initiative (CITI) program. This training is mandatory for all researchers working with human subjects whose research protocol is subject to review by Marian University’s IRB. This requirement includes students conducting research that is subject to IRB review. Completion of the CITI program fulfills the federal government’s requirements for ethics training for researchers working with human subjects.
If you have never registered before (you do not have a CITI Program username) please go to https://www.citiprogram.org and register an account in the system by clicking on the "Register" button under "Create an account" from the homepage. After typing and selecting your institution from the dynamic drop down list, follow the prompts to create your account. Please note that there are two ‘Marian University’s’ listed in the drop down list. We are ‘Marian University – Indianapolis’ – the other school is in Wisconsin.
If you already have a CITI Program username, please log into your account, go to Main Menu, and follow the "Click here to affiliate with another institution" link. Type and locate your institution via the dynamic drop down list. Researchers who have completed CITI training at another institution and can produce their completion certificate validated from within the past four years do not need to complete the course until their previous certificate expires.
New Learner Instructions are available at http://citiprogram.desk.com/customer/portal/articles/1231781-new-learner-account-registration-2-0.
There are different CITI courses based on whether you primarily conduct biomedical or social/behavioral research. Select the course which best fits your research profile; however, completion of either course will suffice if your research sometimes crosses domains. Thus, a researcher who primarily conducts biomedical research should enroll in that course and does not need to also complete the social/behavioral course, even if they occasionally conduct or become involved in social/behavioral research, and vice versa.
Once you’ve completed the *required* modules for the course, there are a number of *elective* courses of which you must complete a minimum number (4) in order to receive a completion certificate. You may, however, complete additional elective modules as well as any of the *supplemental* courses that may be listed.
Elective courses should be chosen based on the topics that are most pertinent to the type of research one typically conducts. E.g., a faculty researcher who typically conducts educational research with children and sometimes mentors undergraduate students in research should enroll in the social/behavioral course and complete the following electives: Research with Children – SBE, Research in Public Elementary and Secondary Schools – SBE, and Students in Research; for the fourth elective, they may wish to complete Cultural Competence in Research.
Once you have completed the required and minimum number of elective modules, you will receive a completion report that will also be reported to the IRB Chair. No research protocols will be approved by the IRB unless all of the researchers involved – including faculty mentors in the case of student research – have completed CITI training. Your completion certificate will be valid for four years, when a refresher course will be required.