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INTRODUCTION

Institutional Review Boards (IRBs) are committees charged by the federal government with protecting the rights and welfare of human subjects involved in research. MU has one IRB which is comprised of MU faculty, staff, and community representatives. The IRB reviews research conducted by MU faculty, staff, and students.

If a project involves MU personnel "engaged" in "research" involving "human subjects," IRB submission and review is required. If there is uncertainty regarding a project meeting the basic criteria for review, use the following form as a guide Determination of MU IRB Submission.

Once a determination has been made that IRB submission is required it is important to understand (a) awareness of time, (b) submission requirements, (c) IRB review process, and (d) what to know once IRB approval has been granted.

TIMELINE

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: anonymous surveys; non-sensitive questionnaires or interviews; secondary data analysis on public data; and research on teaching or instruction. The determination of exemption may not be made by the investigator. Once submitted, expect approximately 1-2 weeks 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 e-mail. 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 4 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 e-mail. 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 are neither exempt nor expedited and involve more than “minimal risk” 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. Protocols must be submitted a minimum of four weeks before the scheduled meeting date. The committee typically meets once a month, although meetings are subject to cancellation (see Meeting Dates). Once submitted, the study will be reviewed at the next scheduled meeting. Either (a) determination of approval, (b) request for revisions, or (c) notification of disapproval will be issued by e-mail.
   

SUBMISSION REQUIREMENTS

MU requires that anyone engaging in human subjects activities (e.g., recruiting, consenting, interacting, intervening, obtaining or accessing identifiable data must have appropriate training to assure that the rights, welfare, and safety of human participants involved are protected. Click here for more information on human subjects training. MU accepts proof of training from NIH or CITI (Collaborative Institutional Training Initiative). Other training may be accepted on a case-by-case basis. Proof of training (for new researchers) must be included in the submission.

NEW Submission Process has changed as of 9/1/13: Studies are submitted to the IRB for review via email. Please see the Electronic Submissions page for details.

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

• *IRB Protocol Summary Form
• 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.)
• Grant application if federally funded

IRB REVIEW PROCESS

Once submitted, IRB staff will review submission for completeness (e.g., consent forms, questionnaires, recruitment materials, data collection instruments, etc.) and appropriate review type (exempt, expedited, full board). Full board studies are placed on the agenda for the next scheduled IRB meeting. Expedited studies are sent to the board member(s) with expertise most closely matched to the research topic. Exempt studies are reviewed by the IRB staff or designated reviewer. Notifications of approval or revisions will be communicated by e-mail.

AFTER IRB APPROVAL

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.
• 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. Once a study is completed a Final Report Form must be filed.

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Mission Statement

The mission of the Office of Research Compliance, in cooperation with and in support of the Institutional Review Board, Institutional Animal Care and Use Committee, Radiation Safety Committee, and Institutional Biosafety Committee, is to facilitate safe and ethical research conducted by Marquette faculty, staff and students in the areas of human subjects, animal subjects, radiation safety and biosafety.