The Institutional Review Board (IRB) for Marquette University (MU) is responsible for the review and approval of all research activities involving human subjects. The IRB is charged with protecting the rights and welfare of human subjects. All research activities involving human subjects conducted by MU faculty, staff and students must be approved by the MU IRB prior to any study related activities taking place.
An 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. MU has its own FWA (FWA00005844) for research conducted by MU.
All Marquette faculty, student (graduate and undergraduate), and staff engaged in "research" involving "human subjects” must file a submission to the IRB PRIOR to any research related activities (e.g., advertising, recruiting, consenting, or conduct research procedures). See Determination of MU IRB Submission and Overview of IRB Process for additional guidance.
Full-Board Review: Studies are reviewed by a fully-convened IRB committee. MU's fully-convened IRB meets monthly and are subject to deadlines for submission. The committee discusses the study and makes a decision about the approval of the study. Studies greater than minimal risk to subjects and those that may not qualify for Expedited or Exempt review are subject to Full-Board review.
Expedited Review: Studies are reviewed by a qualified member of the IRB committee. Studies involving no greater than minimal risk and falling under one of the eligible expedited research categories may be given Expedited review. There is no set deadline for submission.
Exempt Review: The ORC staff reviews and makes determinations for exemptions. If a study fits into an exempt category of research and no greater than minimal risk, it will be given Exempt review will.
After submission, the IRB will correspond with you most often by email. They may request further information or to inform you of IRB questions/comments that require you to submit a response. Approval of your project may be delayed if responses to comments are not received promptly.
Once approval has been granted by the IRB, the following require future submissions to the IRB:
Continuation: Federal regulations require expedited and full board studies be reviewed no less than once per year. Research that continues after the approval period expires is considered research conducted without IRB approval. Research activities cannot continue, unless the IRB determines that continued involvement is in the best interest of enrolled subjects who are still receiving study-related interventions. Continuing review applications MUST be submitted in sufficient time to ensure the non-interruption of studies.
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 the 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.
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" invloving "human subjects" (see #3). Some of these classroom projects require review and approval by the IRB, however, most do not.
Vistit 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 email@example.com. Please note that there are no provisions for retrospective approval under the federal research regulations.