Institutional Review Board (IRB)

Protocol Review Process

Step 1 - Determine if project requires review

Determine if your project is human subjects research:

Research

Systematic investigation designed to develop or contribute to generalizable knowledge.

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Human Subjects

A living individual whose information is collected via intervention/interaction or private/identifiable data.

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IRB REVIEW

  • If yes, proceed to Step 2
  • If no, IRB is not required

Definitions

Systematic investigation
Systematic Investigation is typically a predetermined method for studying a specific topic, answering a specific question(s), testing a specific hypothesis(es), or developing theory.

Generalizable knowledge
Developing or contributing to generalizable knowledge means that intent or purpose of the systematic investigation is dissemination of findings. Common ways of disseminating results include publishing or presenting.

Human subjects
Human subjects are defined as living individual(s) about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information.

Classroom assignments/student projects

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.

Thesis/dissertation research involving human subjects requires IRB review.

All student research must but supervised by a faculty mentor, therefore, faculty mentors must review and approve a protocol prior to submission to the IRB.

Data collection

Non-identifying information

If your research project involves any active data collection, federal regulations and St. Cloud State policy require that ALL research involving intervention or interaction with human participants, must be submitted for review PRIOR to beginning the research study.

Previously collected data

Federal regulations require that if the study will use existing data, documents, records, pathological specimens or diagnostic specimens from human subjects, it is to be submitted for review.

Please visit the Protocol/Related Forms for protocol materials for the use of existing date.

Step 2 - Prepare for review

Complete preparation requirements

Step 3 - Prepare supplemental materials for review

Required supplemental materials

Compile required supplementary materials:

  • Data collection instrument(s)
  • If applicable, support letter for participant recruitment
  • If an organization (school districts, medical facilities, professional organizations, universities/colleges, ect.) will be assisting with recruitment, a letter of support is required.
  • If applicable, debriefing statement or handouts

Submission

Compile protocol packet for submission:

  1. Completed, signed IRB protocol form
  2. Consent form(s)
  3. Required supplementary materials from above

Submit your COMPLETE packet to Research and Sponsored Programs at AS 210 or ResearchNow@stcloudstate.edu. Incomplete packets will delay review process.

Step 4 - Await review

Allow 2-3 weeks for the exempt or expedited review process.

The IRB will review protocol materials according to the Reviewer Checklist.

If the IRB has questions, comments or needs additional information, you will get an email to your St. Cloud State email address. Respond promptly to ensure your review continues.

Types of Review

Exempt Review

Exempt Review includes minimal risk research may be determined to be exempt if the research fall under one of the federally identified six categories of research that are exempt from IRB review.

Expedited Review

Expedited Review includes certain types of minimal risk research that falls within an expedited category

Full Board Review

Full Board Review includes 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

Step 5 - After approval

Upon receiving your approval letter from the IRB, your research project can begin.

It is the researchers’ responsibility to provide secure storage of the Informed Consent forms and any audio/video tapes or photographs. These records must be maintained for three years.

Modifications after approval

If there are significant changes involving any of the study protocols, study design, informed consent procedures, or principal investigator team submit a Modification/Continuing Review/Final Report Form and revised documents (consent, recruiting materials, surveys, etc.) to the IRB for review and approval.

All changes to an approved protocol must be submitted for review and approval before you incorporate the changes into the research project, including but not limited to, changing surveys/questionnaires, adding participants, sampling a different target population, a title change, change in principal investigator, change of funding source, increased time for participant participation, etc.

Annual review (Required for expedited/full review protocols)

It is the responsibility of the researcher to submit the Modification/Continuing Review/Final Report Form and associated documents (consent, recruiting materials, surveys, etc.) to the IRB for review and approval.

If the protocol is allowed to expire, all research on the study must cease until renewed approval is granted.

After three years of a project, a new data collection protocol must be submitted and reviewed.

Submitting a final report

Only researchers with an approved protocol falling under expedited or full review must submit a Modification/Continuing Review/Final Report Form.

Protocol expiration

If the protocol expires, all study procedures related to the research must cease, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection of private identifiable information. Continuing human research procedures without a currently approved protocol is a violation of federal regulation.

You need to complete a new application and resubmit the protocol to the IRB for review. When the research has been approved again, the researcher can restart the research activities.

Please note that there is no flexibility in the federal regulations to "extend" the expiration date.