Institutional Review Board (IRB) for the Protection of Human Subjects

08/15/2020 Kuali is Marquette University’s new web-based system for data entry and management of IRB applications. Beginning September 1, 2020, all IRB submissions (new, amendments, continuing reviews, and reportable events) are submitted in Kuali. New protocol submissions not completed using Kuali by October 1, 2020 will not be accepted.

06/15/2020 Updates to the MU IRB COVID-19 website have been made. Please visit to learn more about the steps towards resuming human subjects research at Marquette.

01/10/2020 - Beginning this spring, the IRB will be using Kuali for all IRB submissions. Kuali is the new online system for the submission, review and approval of human subject research. The IRB is seeking researchers who are interested in testing the system.  If you are planning to submit a new protocol to the IRB within the next couple of months, the IRB is willing to accept the Kuali submission in lieu of the traditional forms. Please contact Jessica Rice for details.

07/13/2018- The Office of Human Research Protections has made several revisions to the regulations governing human research protections. A few minor changes will be implemented as of 07/19/2018 and the remaining changes will be implemented on 1/20/2019. For more information, please see the FAQ document the IRB office has created. Any questions can be addressed to Jessica Rice, the IRB manager.

**The continuing review submission form has been updated to reflect the new regulations and is required for all continuing review submissions submitted after 07/19/2018. Please see our forms and templates page for the new form.

03/15/2018 - A revised protocol form has been created. This form should be used with any study type (exempt, expedited or full board). A new amendment form has also been developed. Both of these revised forms are available on our forms and templates page.

08/28/2017 - Beginning August 2017, the IRB will be using the Kuali research software for IRB office record management. If the PI is an undergraduate student, the student must complete the Update Kuali Research Student Group: Undergraduate form and submit it to the Office of the Registrar in order to grant permission to allow undergraduate student information to be stored in the research software.

04/27/2017 - New guidance documents are available to provide helpful information to researchers. Visit the Useful Links page for guidance documents on the use of online surveys in research, issues surrounding genetic testing and helpful hints on how to deidentify your dataset.

09/08/2016 - New human subjects training available. The IRB has switched from the NIH online training modules to CITI. Visit the Training & Education page for more information.

06/14/2016 - Marquette School of Dentistry (MUSoD) approval required for all new IRB submissions where MUSoD students and patients will be research subjects. Complete the MUSoD IRB Approval Form and obtain MUSoD approval prior to IRB submission. A copy of the approval must be included with the IRB submission. Contact Dr. Andrew Dentino for more information.

Kuali FAQs

If a project involves Marquette personnel "engaged" in "research" involving "human subjects," Marquette IRB submission and review is required. If there is uncertainty regarding a project meeting the three basic criteria for when a project will require IRB submission, use the Determination of MU IRB Submission as a guide. This document is just a guide- use the Kuali system to submit an actual request to the IRB for a determination.  See Kuali log-in page for more instructions. 

The time from IRB submission to approval varies depending upon the type of review conducted by the IRB. Below is a description of the three review types, their process and expected duration.

1. Exempt: Under federal regulations, certain types of research may be exempt from further IRB review if the study involves no more than “minimal risk” and falls into one or more of six exempt categories. For example: surveys; questionnaires or interviews; benign behavioral interventions; research use of data protected by HIPAA; and research on teaching or instruction. The determination of exemption may not be made by the investigator. Once submitted, allow approximately 1 week for review. Either (a) determination of exemption, (b) request for revisions, or (c) notification that the project does not qualify for exemption, will be sent by email. If the protocol does not qualify for exemption it will be processed for either expedited or full board review.
2. Expedited: The IRB may use an expedited review procedure when the research involves no more than “minimal risk” to the subjects and where the only involvement of human subjects will be in one or more of the expedited categories. For example: blood draws; non-invasive specimen samples; data collected from running on a treadmill; sensitive identified interviews; and secondary data analysis from non-public sources. Once submitted, expect approximately 3 weeks for initial review by a designated member of the IRB. Either (a) determination of expedited approval, (b) request for revisions, or (c) notification that the project does not qualify for expedited review, will be sent by email. If the protocol does not qualify for expedited status it will be processed for either exempt or full board review.
3. Full Board: Submissions that involve more than “minimal risk,” do not qualify for exempt or expedited review, or fail to receive exemption status or expedited approval, are sent to a convened IRB for review. For example: invasive clinical procedures; use of FDA regulated drugs or devices; maximal stress tests; and use of X-ray equipment. Investigators planning to submit a full review protocol should contact the ORC and review information and deadlines related to IRB Meeting Dates. After review at a convened meeting either (a) determination of approval, (b) request for revisions, or (c) notification of disapproval will be issued by e-mail.

The submission should include the following. * Denotes required documents.

• • *Completed Kuali study protocol with the following attachments as applicable:
    • Proof of human subjects training (e.g., CITI, NIH, etc.)
    • Consent/Assent forms
    • Recruitment materials (e.g., flyers, advertisements, scripts, etc.)
    • Data collection instruments (e.g., surveys, interview questions, secondary data sheets, etc.)

Once submitted, IRB staff will review submission for completeness (e.g., consent forms, questionnaires, recruitment materials, data collection instruments) and appropriate review type (exempt, expedited, full board). Expedited studies are sent to an available IRB member; when possible protocols are sent to the member whose expertise most closely matches the research topic. Exempt studies may be reviewed by an IRB member, IRB staff or a designated reviewer. Full board studies undergo a pre-review process allowing for revision prior to review at a convened board meeting. Notifications of approval or revisions will be communicated by email.

Once approval has been granted by the IRB, the following require future submissions to the IRB. All renewals, amendments, reportable events, and completions/closeouts must be submitted in Kuali.

• Renewal or Continuation: Federal regulations require expedited and full board studies be reviewed no less than once per year.
• Amendments: Any modifications to the planned research must be reviewed and approved prior to implementation as they may affect the treatment of human subjects.
• Reportable Events: Events may include adverse events/reaction from subjects, subject complaints, protocol deviations and incidences of non-compliance.
• Study Completions/Closeouts: A research project no longer involves human subjects once the investigators have finished obtaining data through interaction or intervention with subjects or obtaining identifiable private information about the subjects, which includes using, studying or analyzing identifiable private information. Once all such activities described in the IRB-approved protocol are finished, the research project no longer needs to undergo continuing review. For example, when the only remaining activity of a research project involves the analysis of aggregate data sets without individual subject identifiers, no further continuing review is necessary. Similarly, simply maintaining individually identifiable private information without using, studying, or analyzing such information is not human subjects research and thus does not require continuing review. Once a study is completed, a Final Report, Study Complete or Study Closed Form must be filed.

Many research methods and other research courses on Marquette's campus require students to complete a research project. The IRB is charged with reviewing projects involving human subjects that meet the federal definition of "research" involving "human subjects" (see No. 3). Some of these classroom projects require review and approval by the IRB; however, most do not.

Visit the page on Students Conducting Class Projects for more information.

If there is any doubt about whether a project requires IRB review and approval, please contact the Office of Research Compliance at (414) 288-7570 or orc@mu.edu. Please note that there are no provisions for retrospective approval under the federal research regulations.

External researchers where MU personnel are "not engaged" in human subjects researcher should visit the External Researchers Conducting Research at MU page for more information.

A Federalwide Assurance is an agreement with the Office of Human Research Protections and the Department of Health and Human Services. The FWA represents a commitment to the protection of human subjects and specifies the ethical principles under which the research will be conducted. Marquette has its own FWA (FWA00005844) for research conducted by Marquette.