Step-by-Step IRB Process

• 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.
• Scholarship of Teaching and Learning (SoTL). 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 research and requires IRB review.
• Evidence or data gathered by instructors related to teaching and learning that will only be used to improve the course, but not presented publicly, is not considered generalizable information – no IRB required.

• All student research, such as student cumulative projects (Thesis, dissertation, etc.) must be conducted under the supervision of a faculty or staff research mentor.
  • Faculty mentors are required to have current CITI training certification to oversee student research.
  • The research mentor must review and approve the IRB application before it is submitted for consideration.
  • IRB review and approval is to occur before the study begins
• Student course-based research projects. Undergraduate and graduate student projects/assignments that are generated exclusively as a class project, typically do not produce generalizable results and therefore do not require IRB review.

• The project involves physically or psychologically sensitive, intrusive, or potentially stressful procedures.
• The project has potential to place participants at more than a minimal risk as judged by the faculty sponsor.
• Projects in which data are collected from human subjects with the intent to produce generalizable knowledge—such as presenting findings in a thesis, dissertation, conference presentation, publication, or other public venue—require IRB review and approval before the study begins.

Cooperative research involves collaboration between two or more institutions and organizations. Each participating institution is responsible for protecting the rights and welfare of human subjects and for complying with federal regulations. The federal regulation, 45 CFR 46, outlines the regulations for the protection of human subjects in research.

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 with an external lead/principal investigator, 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.
  • For cooperative research with other institutions/organizations locaed in the United States, reliance upon approval by a single IRB is allowed except when one or mor 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)
    • a Federal department or agency supporting the research requires more than single IRB review.
    • SCSU students are broadly recruited by an external institution/organization 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.
    

Multi-Center Studies with an External Lead Investigator: If SCSU investigators are working on a multi-center study with an external lead investigator (and multiple IRBs are involved), the SCSU IRB needs evidence of IRB approval from the lead investigator’s institution.

International Cooperative Research: For cooperative research 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.

Letter of Cooperation: For any research conducted at an external site (e.g. SCSU research occurring in a school or business setting), a letter of cooperation is required from the organization or agency. A letter of cooperation serves as documentation from the external entity that it understands the nature of the researcher’s work, outlines its commitment to the project, and states approval of the study as it relates to its involvement. The letter is generally signed by someone in authority at the external entity. Letters of cooperation may be obtained before or after SCSU IRB approval, depending on the policies of the cooperating organization.

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.