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.
The MU ORC/IRB has developed a decision tool to assist researchers with determining the level of review for research projects. The MU ORC/IRB Flowsheet provides guidance on the appropriate level of review (Exempt, Expedited, Full Review) and specific category of review based on the type of research and subject population. Final determination regarding level of review is made by the ORC/IRB.
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.
- 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, allow 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.
- 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.
- 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.
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.
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 Review 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) 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 and 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. More information about the full review process can be found here. 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, Study Complete or Study Closed Form must be filed.