• SCSU policies and procedures: IRB Procedures Handbook
• Watch a Human Subjects Research Training Video: SCSU Human Subjects Research Video

Does my project need Institutional Review Board (IRB) approval?

• IRB approval is required for any research project that involves 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."
  • This means that if data collection is from human subjects, with a goal of sharing findings beyond the classroom (for example, in a thesis, dissertation, conference presentation, or publication) then IRB review and approval is to occur before beginning the study.
  • If data and evidence related to teaching and learning practices will be shared publicly in any form (e.g. at a conference or in a publication) - this is considered Scholarship of Teaching and Learning (SoTL) and requires IRB review.

• All student research must be conducted under the supervision of a faculty mentor.
• The faculty mentor must review and approve the IRB application before it is submitted for consideration.
• Faculty mentors are required to have current CITI training certification to oversee student research.

Most undergraduate and graduate student assignments/projects that are generated exclusively as a class project typically do not produce "generalizable results" and thus do not require IRB review.

However, an IRB review may be required if classroom research activity:

• involves physically or psychologically sensitive, intrusive, or potentially stressful procedures.
• In the judgment of the instructor/faculty sponsor, the project has the potential to place participants at more than minimal risk.
• Findings of the project may be presented in a public venue as generalizable knowledge.

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.

Cooperative Research is a human subjects study involving collaboration between two or more institutions/organizations. Each institution/organization is responsible for protecting the rights and welfares of human subjects and complying with federal regulations, 45 CFR 46. 45 CFR Part 46, issued by the U.S. Department of Health & Human Services, outlines federal rule, known as the Common Rule, that protect people who participate in research. It sets standards for ethics, informed consent, Institutional Review Board (IRB) oversight, and additional safeguards for vulnerable groups. This framework helps ensure research is conducted responsibly while protecting participants’ rights, welfare, and safety.

Under the Common Rule, only a single IRB review is needed to avoid redundant review (see exceptions below). The institution/organization that should conduct the IRB depends upon the principal investigator.

Are you serving as the lead principal investigator for the project?

• Yes, please follow the steps below to submit a protocol through SCSU.
• No. If you are participating in cooperative research in which you will serve as a co-principal investigator, and the lead principal investigator is with an external institution/organization (within the United States), please navigate to the Protocols and Forms page to submit an Authorized Agreement form. The SCSU IRB requires evidence of the IRB approval from the lead principal investigator’s institution/organization.
  • Reliance upon approval by a single IRB is allowed, except when one or more of the following are true:
    • 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
    • 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 the lead principal investigator is with an external institution/organization that is not solely conducted in the United States, SCSU requires a single IRB review for the portion 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-Principal Investigators, and Faculty Mentors involved in human subjects research. The online training is free for SCSU faculty, staff, and students. The training may take up to 2 hours to complete the required and elective modules needed. Upon successful completion of the training you will receive a certificate which must be downloaded and attached to your IRB protocol.

For more information, including website login and instruction guide, visit the IRB Training page.

Compile your supporting and supplementary materials that are necessary for your study:

• Data collection instrument(s) and/or survey/interview guides
• Support letter for participant recruitment (if applicable)
  • If an SCSU faculty or staff member (not part of the research team) is assisting with recruitment, a signed letter of support may be required.
  • If an external organization (e.g., school district, medical facility, professional organization, university/college, etc) is assisting with recruitment, a signed letter of support is required
• Debriefing statement or handouts (if applicable)
• Recruitment materials (flyers, email/written scripts, etc)
• Consent form(s)
• Audio/video/photography form (if project includes use of audio, photography or video)
• Other relevant documents being used in the study

Step 1: Submit your Protocol Early. Plan to submit your protocol at least two weeks in advance of the study start date to allow time for review and approval.

Students – please ensure a faculty mentor has been secured for your project as their information is required to be listed in the protocol.

Step 2: Access the Submission Portal. Click the “Apply Here” button to log into Wizehive using your StarID credentials.

APPLY HERE

• Select your protocol type:
  
  • New Data: Your study involves collecting new data, information, or biospecimens from participants.
  • Existing Data: Your study uses previously collected data (e.g., secondary data analysis or non-public datasets).
• Prepare a Complete Protocol Package
  • Before submitting, ensure your protocol includes:
    
    • Completed protocol form (all questions must be answered)
    • CITI training certificate
    • Required templates/forms/documents
  • Co-PI response(s), if applicable
  • Use the “Save Draft” button to save your progress. Do not click “Submit” until everything is complete.

Step 3: Submit Your Protocol. Once everything is ready, click “Submit” to send your protocol for review. No changes can be made after submission.

Important Reminders:

• Your protocol is not considered submitted to the IRB until you click the green Submit button.
• You should not being any human subjects research until you receive official notification of an IRB approval.

Students - Your protocol will be automatically routed for faculty mentor approval. You must notify your mentor that the protocol will be forthcoming for their review.

Step 4: Co-Principal Investigator (Co-PI) Process This step is only required if you have Co-PI(s)

• Complete a Co-PI Request Form for each. Once you click send, the system triggers a notification for them to confirm participation and provide their human subjects training completion certificate.
• You can verify completion by checking for a green box next to their name in the Co-PI section. S

• Exempt review does not mean that you are exempt from IRB review; only that the study is exempt from full IRB review.
• Certain categories of research that pose minimal risk to participants, do not involve vulnerable populations, and maintain participant confidentiality may qualify for exempt review. Only the IRB reviewer can determine whether your protocol meets the exempt-review standards.
• For more information on what constitutes exempt research, visit the NIH infographic page.

• Certain categories of research that pose no more than minimal risk to participants but do not meet the criteria for exempt review may qualify for expedited review.
• For more information on what constitutes expedited research, visit the  expedited reviews page for more information.

• 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.

• When your protocol is up for annual renewal (1 year less 1 day, from your approval date) complete a Continuing Review Form. Protocols can be renewed a maximum of 3 times.

• 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. You will be sent a reminder email about a month prior to the study expiration date.
• If you intend to continue your research beyond three years, you must resubmit a new protocol form for review with the IRB.