IRB Process

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:

• Class activities/classes designed to teach research methods, where the purpose is research
  training and no results dissemination will occur outside the classroom. Faculty are
  responsible for overseeing their student research activities. Such activities will follow
  professional ethics and have the permission of any external organization which is being
  studied.
• Activities designed for educational purposes that teach research methods or demonstrate
  course concepts only; instructors ensure students meet professional and ethical standards.
• Activity is solely pedagogical and results intended for classroom use only.
• Student volunteers or other participants are clearly informed that the activities are an
  instructional exercise and not actual research and/or will not be used as research data.
• Internal management purposes only such as program evaluation, quality assurance,
  quality improvement, fiscal or program audits or marketing studies.
• University assessment and strategic planning initiatives (i.e. university collection and
  assessment of data on student retention; focus groups on mandatory on-campus housing;
  external organization assessment and strategic planning initiatives about university
  operations, budgets, etc. from university spokespersons or data sources).
• Initiatives whereby the university collects and submits or permits collection and
  submission of identifiable data to an outside entity to aggregate the data with information
  from other institutions and report benchmarking standards to the participating
  institutions, unless the sharing of data is for research purposes.
• Activities designed solely to ensure university programs or services meet regulations or
  standards established by outside entities and applicable to postsecondary or professional
  education institutions (i.e. reports to and evaluations by accrediting bodies).
• Internal customer service or academic program evaluation surveys (i.e. dining services
  satisfaction surveys, department surveys to assess interest in proposed courses).
• Reports to federal or state agencies for quality measurement of public health monitoring
  which are required by law.
• Collection of external organizational policies, practices and/or procedures which does not
  include personal or demographic information. Professional ethics is expected. Permission
  from the external organization(s) may be required.
• Program evaluation of an organization such as a business, school, programs within
  schools, government programs or after school programs which does not include personal
  identifiers or demographic information. Professional ethics is expected. Permission from
  the external organization(s) may be required.

**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).

• If SCSU investigators are working on a multi-center study with an external lead investigator (and multiple IRBs are involved), the SCSU IRB will want to see the IRB approval from the lead investigator’s institution.
• For cooperative research not solely conducted in the United States, St. Cloud State University must rely on a single IRB review for the portion(s) of the research conducted in the United States. For the remainder of the research, St. Cloud State University may enter into a joint review arrangement, rely on the review of another IRB, or make similar arrangement to avoid duplication of effort.

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.

Step 1.  Look to complete and submit your protocol at least two weeks in advance of the study start date.

• When applying you will select either "New Data" or "Existing Data" as your protocol type.
        Note: New Data - study involves the collection of data, information or biospecimens from participants.
        Note: Existing Data - study does not involve the collection of new data from participants and only makes use of data that have already been collected (e.g., secondary data analysis, the use of non-public data sets).
• Students will be required to list their faculty mentor on their protocol. 
• For assistance using Wizehive, please click on the Wizehive Tutorial to access the tutorial.
• Wizehive allows you to save your progress as you work on completing your protocol (save draft button).
• Do not click on the "Submit" button until your protocol is complete.  A complete protocol includes the finished protocol, CITI certificate and all other required templates/forms/documents, and, if applicable, the Co-PI response(s).

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.

• Changes/updates cannot be made once your protocol is submitted.
• The protocol will be automatically routed in Wizehive to obtain the necessary approvals (signatures) from faculty mentors.
• To ensure timely reviews, it is the student's responsibility to ensure their faculty mentor knows the protocol is coming.

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.

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. 

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.