University policy requires that all protocols submitted from individuals NOT employed by or students of Montana State University be charged a $500 review fee per application. Renewals for those proposals will be at no charge. Applications from private entities (i.e. projects not administered by MSU's Office of Sponsored Programs) will be charged the $500 fee per application. Renewals for those proposals will also be at no charge.

All research involving human subjects must be registered in one way or another with the Institutional Review Board. Some research in which there is essentially no risk to subjects is exempt from the requirement that they be reviewed by the full Board. They still need to be reviewed by the Chair of the IRB.

The Code of Federal Regulations, Title 45, Part 46, published by the Office for Human Research Protections defines the following review levels and definitions:

Request for Exemption Form

Research in which there is essentially no risk to subjects is exempt from the requirement that it be reviewed by full committee (Code of Federal Regulations, Part 46, section 101). If your research involves minors, pregnant women, prisoners or other vulnerable populations, it is  not eligible under the "Exempt" category.

1. Examples of such research are:  
  (b) (1) Research conducted in established or commonly accepted educational settings, involving normal educational practices such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.  
  (b) (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability, or be damaging to the subjects’ financial standing, employability, or reputation.  
  (b) (3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.  
  (b) (4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available, or if the information is recorded by the investigator in such a manner that the subjects cannot be identified, directly or through identifiers linked to the subjects.  
  (b) (5) Research and demonstration projects, which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.  
  (b) (6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed, or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA, or approved by the EPA, or the Food Safety and Inspection Service of the USDA.  
       
2. If the research is believed to be exempt, the investigator should submit the form entitled Request for Designation of Research as Exempt. These applications must still be accompanied by documentation that all investigators involved in the research have received education and instruction in the protection of the rights of human subjects and the ethical conduct of human research.  
       
3.

Requests for exemption will be reviewed by the IRB Chair and/or IRB Administrator. If this review determines the research to be exempt, a memorandum of concurrence will be sent to the investigator. The title of the research and the decision will be reported to the IRB at its next meeting. Any member of the IRB may request that the investigator submit a full application for expedited or full IRB review.

Submit (1) copy of the application along with (1) copy of the subject consent form and all other relevant materials (i.e., survey, questionnaires, etc.). Staple or clip the documents as a set in the following order: application, consent form, supporting documents. Do not staple each section separately. As long as there is a signature on the application, it can be submitted via e-mail to the IRB Administrator: Cheryl Johnson, cherylj@montana.edu, (406) 994-4706

If sending by mail, send to: INSTITUTIONAL REVIEW BOARD, P.O. Box 173610, MONTANA STATE UNIVERSITY, BOZEMAN, MT 59717-3610.  For information and/or assistance call 406-994-6783 or 406-994-4706.

Request for Exemption for MSSE Students Only

MSSE Students must use the Request for Exemption Form for MSSE Students. There are instructions and required wording specifically aimed toward their type of research projects. DO NOT USE THIS FORM IF YOU ARE NOT AN MSSE STUDENT.

Submit (1) copy of the application along with (1) copy of the subject consent form and all other relevant materials (i.e., survey, questionnaires, etc.). As long as there is a signature on the application, it can be submitted via e-mail to the IRB Administrator: Cheryl Johnson, cherylj@montana.edu, (406) 994-4706

If sending by mail, send to: INSTITUTIONAL REVIEW BOARD, P.O. Box 173610, MONTANA STATE UNIVERSITY, BOZEMAN, MT 59717-3610.  For information and/or assistance call 406-994-6783 or 406-994-4706.

Request for Expedited Review Application

Certain kinds of research involving minimal risks may be approved by expedited review or by the IRB Chair according to the policies and procedures in section 110 of the federal policy. Research with minimal risks involving minors may qualify to be reviewed by expedited review.

1. Such applications will be reviewed by at least two members of the Committee with the following possible outcomes:
  a. The reviewers will unanimously approve or disapprove the proposal.  Either reviewer may require that modifications to the proposal be made prior to approval.
  b. Reviewers can recommend that the application be reviewed by the full IRB, in which case it will be considered at the next meeting.
2. The decision of the reviewers will be presented to the full IRB for approval at the next meeting. Should the IRB wish to add restrictions or clarifications, the investigators will be asked, in writing, to suspend the research until these adjustments have been made. Continuing review of expedited applications will be the same as for applications reviewed by the full committee, if applicable.
3.

Minor changes in previously approved research may be reviewed and approved by the Chair.

Instructions: Submit (3) copies of the application, consent form, and other supporting documents such as surveys, questionnaires, etc. Staple or clip the copies as individual sets in the following order: application, consent form, supporting documents. Do not staple each section separately.

Submit all documents to: INSTITUTIONAL REVIEW BOARD, P.O. Box 173610, MONTANA STATE UNIVERSITY, BOZEMAN, MT 59717-3610.  For information and/or assistance call 406-994-6783 or 406-994-4706.

Full Committee Review

Research involving more than minimal risk and/or vulnerable populations (i.e., children, economically or educationally disadvantages persons, severely ill or mentally ill persons, veterans, pregnant women, or prisoners) must be reviewed by the full committee. Applications received which require full committee review will be reviewed at the next scheduled meeting.

Instructions: Submit (14) copies of the application, consent form, and other supporting documents such as surveys, questionnaires, etc. Staple or clip the copies as individual sets in the following order: application, consent form, supporting documents. Do not staple each section separately.

Submit all documents to: INSTITUTIONAL REVIEW BOARD, P.O. Box 173610, MONTANA STATE UNIVERSITY, BOZEMAN, MT 59717-3610.  For information and/or assistance call 406-994-6783 or 406-994-4706.

Requests for minor modifications can be made by submitting the "Request for Minor Modifications/Amendments" form and attaching it to an e-mail to: cherylj@montana.edu. If the consent form is being modified, submit a copy of the revised consent form for approval. Changes cannot be implemented prior to IRB approval except when necessary to eliminate apparent immediate hazards to subjects. Minor changes may include change in PI, revision of survey questions, addition or removal of research team members and other minor changes. The Chair will determine approval of requested changes. The Chair may require additional information or documentation to make a determination of approval. If approved, an approval letter will be sent to the investigator.

NOTE: “The IRB and investigators must plan ahead to meet required continuing review dates. If an investigator has failed to provide continuing review information to the IRB or the IRB has not reviewed and approved a research study by the continuing review date specified by the IRB, the research must stop..." Enrollment of new subjects cannot occur after the expiration of IRB approval.”

The MSU IRB Office will send out renewal forms approximately one (1) month prior to the renewal date. The approval number assigned to the protocol is indicated in brackets after the title of the protocol. The approval number is usually two or three letters (PI's initials) followed by six numbers, which is the date the protocol was approved. So, if John Doe's protocol was approved on October 24, 2014, his assigned approval number would be JD102414. This way you know when your renewals are due. If you know that your protocol is nearing the expiration date and you have not received the renewal forms from our office, please contact our office as soon as possible so that your approval does not lapse. It is ultimately the responsibility of the PI to maintain compliance with these regulations. There is a 30-day window in which protocols can be renewed (not more than 30 days prior to renewal date and absolutely not after the renewal date).

The guidance document for renewals is found at: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-continuing-review-2010/index.html

If an adverse event happens during your research project, use this form:

Adverse Event Reporting Form

Can researchers be subjects in their own studies? Does self-experimentation require IRB review?

Yes, researchers can be subjects in their own studies. However, MSU policy regards this type of research (investigator self-experimentation) as research with human participants, and generally requires the same review and approval as research that recruits other people as subjects.

Though investigator self-experimentation may not raise the conventional ethical concerns outlined in the Belmont Report (http://www.hhs.gov/ohrp/policy/belmont.html), all human research projects should undergo ethical review to assure the safety of people involved and the integrity of the research at the university. While researchers may be aware of the risks of self-experimentation, they may also be more willing to accept risks that are ill-advised. Application for review with the IRB office allows a neutral third party to raise concerns and/or propose measures to promote the welfare of researchers.

The Common Rule and FDA regulations also require that informed consent be obtained from all research participants unless certain conditions are met.  The IRB recommends researchers provide a consent document based on the template provided on the MSU IRB website, with their Initial Review Application which will serve as the basis for documentation of informed consent for participation in human subjects research when the experimentation involves the researcher.

For information on how applications are processed see: Review Process and Submission Instructions 

These applications must be accompanied by documentation that all investigators involved in the research have received education and instruction in the protection of the rights of human subjects and the ethical conduct of human research. CITI training is the only certification that MSU will accept. The required CITI training can be found here.

After the Institutional Review Board reviews a proposal, a written response (usually via e-mail) will be sent from the Chair or Administrator notifying the applicant of the action taken by the Board. If the protocol has been approved, the applicant will receive an approval letter within one week of the meeting. If revisions are requested from the Board, the applicant will be notified as to the suggested revisions. If no problems are found with the proposal, the applicant will be granted approval for a period of one year. If the Board raises concerns regarding the protocol, the applicant will be asked to address these before the proposal will be approved.

Investigators are required to indicate conflicts of interest on protocol forms. If a conflict is indicated, the investigator will be referred to the Office of Research Compliance to develop a plan for managing the conflict, and the file will be updated when the plan has been developed. Protocols will not be approved until the conflict management plan has been implemented.