Institutional Review Board

Overview

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

You may not begin human subjects research until an IRB decision is reported to you.

If you are conducting a research study that involves human subjects, your first step is to fill out and submit MU IRB Form1 electronically by clicking the following link:  MU IRB Form 1

Copy this into your browser and follow the instructions. In this online application you will be asked for a description of your research in no more than 300 words and it may be useful to prepare this text before going to the online application, so you can copy and paste the text when prompted. If you would like to prepare your application prior to filling out the online form, you may download a MS Word version by clicking here.

If you have any questions prior to preparing the submission, you may feel free to correspond through the following email account:  IRB@marain.edu.

After receiving your MU IRB Form1 electronically, the IRB Chair will conduct an initial screen to determine if your research fulfills the criteria for exemption from IRB review, and if it does you will be notified that you may proceed with your study. 

If your protocol does not qualify for exempt status, you will be supplied a complete IRB application packet, which will be sent to you and may be returned electronically to IRB@marian.edu. The application will receive either "expedited review" or "full committee review" by the relevant subcommittee.  The IRB may request additional information in order to complete its deliberation.

Once approved, a determination letter is sent to you allowing commencement of the project.  You and any affiliated researchers will also be required to complete a CITI training course or present a completion certificate dated within four years (see below).

Application Due Dates and Meeting Times

Applications should be submitted (ideally) 2 Months prior to submission of a grant or intended start date for recruitment of human subjects.  Because many applications are eligible for exempt or expedited status, which does not require a convened IRB meeting, IRB meetings are convened on an as needed basis.  Thus, early submission allows IRB administrators to arrange a review meeting.

The IRB serves the public to ensure protection of human subjects and the scientific value of studies, and seeks to expeditiously meet the needs of the investigator.  Questions about the process or help in preparing the application are welcomed at IRB@marian.edu.

CITI Training

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 human subjects research. The biomedical human subjects course is listed as "Group 1: Biomedical Researchers" and the social/behavioral human subjects research course is listed as "Group 2: Social-Behavioral-Educational Researchers". Note that there is also a course named "Group 1: Biomedical Lab Researcher" which does not pertain to human subjects 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.

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