Filing a Request

According to action taken by the Minot State University Institutional Review Board for the Protection of Human Research Subjects (IRB), all members of the Minot State University faculty, staff, and student body (whether full or part-time), who are conducting research with human beings as subjects, must conform with certain procedures prescribed by the U.S. Department of Health and Human Services. 

The first step in securing IRB approval for research is to file the correct form.  Most studies qualify under one of the six Exemption Categories.  For research studies meeting one or more of the exemption categories, complete the IRB Exempt Status Review.  For research not qualifying under an exemption category, complete the  IRB Expedited or Full Board Review  Before initiating any such research the principal investigator of the project should review The Approval Process, Exemption Guidelines, and Common Terms and Definitions. The forms should be submitted to the IRB Chair, electronically at irbchair@minotstateu.edu.                                                                              

*Most research studies now qualify under one of the Exemption Categories. REVIEW PROCEDURE: The IRB Chairperson initially assesses Exempt Status Reviews and Expedited or Full-Board Reviews to determine if the correct form has been submitted.  The principal investigator is contacted by the IRB chairperson concerning any further action to be taken (see Approval Process Flowchart).  Exempt Status Reviews are completed by the IRB chairperson or designee; Expedited Reviews are sent to three IRB members for review.  Full Board Reviews are arranged as needed. 

In reviewing projects, the IRB decides whether the human subjects are at risk, and if so, whether the following criteria for approval have been satisfied:

  1. Risks to subjects have been minimized, by using procedures which are consistent with sound research design and which do not unnecessarily expose subject to risk.
  2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to the subjects, and to the importance of the knowledge that may reasonably be expected to result.
  3. Selection of subjects is equitable.
  4. Informed consent when required will be sought from each prospective subject or the subject's legally authorized representative.
  5. Informed consent will be appropriately documented.
  6. Where appropriate, the research plan makes adequate provision for monitoring the data to ensure the safety of subjects.
  7. Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain confidentiality of data.
  8. Where some or all of the subjects are likely to be vulnerable to coercion or undue influence, appropriate additional safeguards have been included in the research plan.

These criteria, and the other rules and regulations under which the IRB operates, are set forth in the CODE OF FEDERAL REGULATIONS: 45 CFR 46, Revised January 17, 2017 ("PROTECTION OF HUMAN SUBJECTS"). Both IRB Exempt Status Review and IRB Expedited or Full Board Review protocols required additional documentation to accompany the Review form. These requirements are provided on the Review form.

IRB decisions will be communicated to investigators electronically. Occasionally, an investigator may be asked to appear before the IRB to provide additional information and/or clarification.