The purpose of the data collection defines whether or not IRB is required. IRB is required for research projects defined as a "systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge that requires collection of data from human subjects."
Thesis/dissertation research involving human subjects requires IRB review.
All student research must be supervised by a faculty mentor. The faculty mentor must review and approve the IRB application prior to submission. In addition, the faculty mentor must be current on their CITI training.
Most undergraduate and graduate student assignments/projects are unlikely to lead to "generalizable results" and thus do not require IRB review. However, if classroom research involves physically or psychologically invasive, intrusive, stressful procedures or, in the judgment of the instructor/faculty sponsor, has the potential for placing subjects at more than minimal risk IRB review may be required.
Examples of activities that do not meet the definition of research may include:
**You can also find more information regarding human subjects research in the IRB Procedures handbook here: IRB Procedures Handbook (specifically pages 10-12) of the PDF document.
Cooperative research projects involves more than one institution/organization, and each institution is responsible for safeguarding human subjects' rights and welfare and complying with 45 CFR 46.
If you are involved in cooperative research as the lead/principal investigator, please procced with the steps below to submit an IRB protocol.
If you are involved in cooperative research with an exernal lead/principal investigator, please navigate to the Protocols and Forms page to submit an Authorized Agreement form.
St. Cloud State University will, for cooperative research with other institutions located in the United States, rely upon approval by a single IRB, except when more than a single IRB review is required by law (e.g., tribal law passed by the official governing body of an American Indian or Alaska Native tribe), when a Federal department or agency supporting the research determines and documents that the use of a single IRB is not appropriate for that particular context, or when SCSU students are broadly recruited for participation (i.e., recruited from the general student body and not from a single or targeted set of classrooms).
CITI Training is required for all Principal Investigators, Co-Prinicpal Investigators, and Faculty Mentors involved in a human subjects research project. It is an online training provided free of charge for St. Cloud State faculty, staff, and students. You will be presented with a certificate of completion which will need to be downloaded and attached in your protocol submission.
For more information about CITI training, including the website address and instructions on training (located under additional resources), please click here.
Compile your supporting and supplementary materials that are necessary for your study:
Step 1. Look to complete and submit your protocol at least two weeks in advance of the study start date.
Step 3. If you have one or more Co-PI's, you are required to complete a Co-PI Request form for each Co-PI participating in the project. This process will trigger a notification to your Co-PI(s) requiring them to acknowledge participation in the project.
Step 4: If applicable, confirm your Co-PI(s) have completed their Co-PI Request forms. You can confirm this by looking for the green box next their name(s) within the Co-PI Request section of your protocol.
Step 5: Click on "Submit" to put forward your COMPLETE protocol for consideration.
Step 6: For students: Once your completed protocol is electronically approved in Wizehive by your faculty mentor, your protocol will be distributed to a review panel for review and consideration. Please note that the review process takes time, so please be patient. Updates will be sent out as soon as the review process is concluded.
Allow 2-3 weeks for the review process.
If the IRB reviewer has questions or needs additional information, an email will be sent to your St. Cloud State email address. Respond promptly to ensure your review continues.
Certain categories of research that pose minimal risk to participants, do not involve vulnerable populations, and maintain participant confidentiality may quality for exempt review. Exempt review does not mean that you are exempt from IRB review; only that the study is exempt from full review. Only the IRB reviewer can determine whether your protocol meets the exempt-review standards. For more information on what constitutes exempt research, see Exempt Review Infographic provided by the National Institutes of Health.
Non-Exempt Review includes certain types of minimal risk research that falls within an expedited category.
Research that poses greater than minimal risk to research participants will be reviewed at a convened meeting of the IRB. If a protocol requires full committee review, please submit your protocol at least two weeks prior to a scheduled meeting.
Once you have received official notification from the IRB administrator that your protocol has been approved, and you have received stamped copies of your recruitment documents and consent forms, your are ready to begin your research! Make sure that only the official, stamped documents from the IRB are used in recruitment and consent processes.
If you need to make substantive revisions to your procedure (i.e., any revision that would impact participant experience, risk, or confidentiality), complete a Protocol Revision or Modification Form.
When your protocol is up for annual renewal (1 year from your approval date, or on the expiration date listed on the approval stamp), complete a Continuing Review Form.
When your study is complete, or when your approval has been active for three years, you must close the study by submitting a Final Report Form. If you intend to continue your research beyond three years, you must resubmit a new protocol form.