Forms and Applications
All research involving human subjects must be registered in one way or another with
the Institutional Review Board.
The Code of Federal Regulations, Title 45, Part 46, published by the Office for Human Research Protections, defines the following review levels and definitions:
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.|
Requests for exemption will be reviewed by the IRB Chair and/or IRB Administrator. If this review determines the research to be exempt, an approval email 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.
SUBMISSION INSTRUCTIONS: Send your Exempt application along with the subject consent form and all other relevant materials (i.e., survey, questionnaires, etc.) to [email protected] Provide documents as a set in the following order: application, consent form, supporting documents. A single pdf document with all elements combined is preferred. Any submission not originating from a montana.edu email address must be signed.
**PLEASE EXPECT AND ALLOW 1 WEEK FOR REVIEW RESPONSE TIME BEFORE CONTACTING THE IRB
FOR A STATUS UPDATE.**
For information and/or assistance call 406-994-4706.
MSSE Students must use the Request for Exemption Form for MSSE Students. There are instructions and required wording specifically aimed toward this type of research project. DO NOT USE THIS FORM IF YOU ARE NOT AN MSSE STUDENT.
SUBMISSION INSTRUCTIONS: Send your MSSE Exempt application along with the subject consent form and all other relevant materials (i.e., survey, questionnaires, etc.) to [email protected] Provide documents as a set in the following order: application, consent form, supporting documents. A single pdf document with all elements combined is preferred. Any submission not originating from a montana.edu email address must be signed.
For information and/or assistance call 406-994-4706.
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 is no longer required per the Common Rule.|
Minor changes in previously approved research may be reviewed and approved by the Chair.
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 are due 2 weeks prior to the next committee meeting date by 12:00pm noon.
Expedited & FCR Protocols: Submit an Amendment request via Topaz
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 email will be sent to the investigator.
Full Committee-Reviewed (FCR) protocols must be reviewed once per year via the annual Interim Review. The MSU IRB Office will send out a reminder approximately one (1) month prior to the Interim Review date. FCR protocols may be reviewed in the 30-day window prior to expiration.
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.” It is ultimately the responsibility of the PI to maintain compliance with these regulations.
Per the Common Rule, Expedited level protocols do not require annual continuing review.
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, 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 an MSU IRB template with their initial application which will serve as the basis for documentation of informed consent for participation in human subjects research when the experimentation involves the researcher.