Contents

100. Purpose and Guiding Principles

200. Scope, Jurisdiction, and What the IRB Will Review and Will Not Review

300. Authority, Governance, and IRB Operations

400. Review Levels and Review Processes

500. Noncompliance, Violations, and Corrective Actions

600. Investigator Responsibilities and Ongoing Oversight

700. Post-Approval Monitoring

800. Continuity of Operation

100. Purpose and Guiding Principles

The mission of Montana State University's (MSU) Institutional Review Board (IRB) is the protection of the rights, welfare, and well-being of human participants in research conducted under MSU oversight. MSU's IRB follows the ethical standards described in The Belmont Report and complies with applicable federal, state, local, sponsor, and University requirements.

MSU is committed to a research environment that respects and upholds the diverse traditions, cultures, and sovereignty of Tribal and foreign nations, and that recognizes the heightened ethical considerations that may apply when research involves marginalized or underserved populations. MSU seeks to ensure that research aligns with participating communities' values; supports equitable partnerships; and incorporates appropriate safeguards related to respectful engagement, voluntariness, language access, privacy, and the fair distribution of research burdens and benefits.

In this policy, you may see the term “human subjects research.” This is the federal term used in the Common Rule (45 CFR 46) and is included here for consistency with regulatory requirements. In other communications, MSU may also use “participants” as a more reader-friendly term to describe people who take part in research.

200. Scope, Jurisdiction, and What the IRB Will and Will Not Review

  1. All research (except as exempted under 45 CFR 46.104(b), or otherwise determined not to be human subjects research) by MSU faculty, students, and staff that involves human subjects must be reviewed by MSU's IRB or receive an official determination from the IRB. This requirement applies to unfunded research, federally funded research, and research funded by other sources.
  2. Certain kinds of research involving human subjects may qualify for exempt determination (including categories requiring limited IRB review) as described in the Code of Federal Regulations, 45 CFR 46.104. The IRB (not investigators) makes exempt determinations.
  3. MSU IRB evaluates research protocols to ensure that research complies with ethical standards and regulations. This includes assessing the risks and potential benefits, privacy/confidentiality protections, and the methods for obtaining informed consent/assent where applicable. Risks to participants must be minimized and reasonable in relation to anticipated benefits and the importance of the knowledge expected as a result.
  4. MSU IRB reserves the right to conduct periodic reviews of ongoing research to ensure that participant protections remain adequate. This may involve Post Approval Monitoring (PAM), adverse events reporting, and review of proposed changes to the approved research protocol.
  5. If concerns about the conduct of research or the treatment of human subjects are reported, MSU IRB may review complaints and coordinate appropriate actions to address potential noncompliance.
  6. MSU IRB offers educational resources and guidance to researchers to help them understand and comply with ethical standards and regulatory requirements related to human subjects research.
  7. MSU IRB is responsible for reviewing, approving, and monitoring research protocols to safeguard the rights, safety, and well-being of participants. Additional precautions may be required for populations that warrant extra protections under applicable regulations and MSU policy.
  8. MSU IRB may use non-member consultants for advice and information in specialized areas as needed such as work with prisoners, for example. These consultants may be MSU faculty, staff, or students, or may be unaffiliated with MSU. The IRB Chair will be notified and approve the use of formal consultants. The formal consultants may be asked to present their assessments in writing or to attend IRB meetings in person or virtually. Consultants do not vote during IRB meetings and are bound by the same confidentiality and conflict of interest disclosure requirements as all other attendees at an IRB meeting.

Course-Based Submissions and Classroom Projects (Required Process)

MSU supports appropriate instructional use of IRB concepts. At the same time, the IRB's role is regulatory oversight of research--not reviewing submissions created solely as practice.

To reduce incomplete submissions and ensure course projects are routed correctly, the following requirements apply to any course in which students may submit IRB materials or propose activities involving people, identifiable private information, recordings, surveys/interviews, observation, or student education records:

Instructor Consultation is Required Before Student Submissions are Routed for IRB Review

The IRB Program Manager will meet with the instructor of record to clarify the assignment's intent and end goal (e.g., practice-only vs. research intended for dissemination, publication, thesis/capstone, or presentation outside the course). The IRB Program Manager may also meet with the class to provide IRB process orientation and reduce common compliance errors (especially FERPA/student education records issues and incomplete submissions).

The IRB Will Not Review "Practice-Only" Protocols

If a submission is created only for training/practice and there is no intent to conduct the activity as human subjects research, the IRB will not conduct regulatory review. The IRB may provide general educational guidance (e.g., templates, common pitfalls), but it will not function as course grading support or a substitute for instructor review.

Instructor Confirmation is Required for IRB Review of Student Submissions

The IRB will not begin review of course-based submissions unless the instructor of record provides confirmation that they reviewed the submission for completeness and alignment with the course assignment, and that the project intent/end goal stated by the student is accurate. Submissions lacking this confirmation may be administratively closed or returned without review.

300. Authority, Governance, and IRB Operations

The IRB operates under regulations and ethical standards including the Code of Federal Regulations 45 CFR 46 and The Belmont Report. The IRB reviews all Full Committee Protocols and convened meetings (typically monthly) and conducts continuing oversight as required by regulations, MSU policy, and sponsor requirements.

IRB Committee Member Composition

  • The IRB consists of at least five members who are appointed by the Assistant Vice President for Research Integrity & Compliance at MSU, with suggestions from IRB leadership, the IRB Program Manager, and faculty/staff as appropriate.
  • IRB members are appointed for three-year terms by the Assistant Vice President for for Research Integrity & Compliance. Members can be appointed to consecutive terms indefinitely.
  • At least two members of the IRB must be non-scientists, able to review research from a viewpoint of participants and community members, and may have expertise in law, ethics, religion, or other relevant areas.
  • Scientific members will provide broad representation (e.g., physical, biological, behavioral, social sciences, and health professions), consistent with MSU's research portfolio.

Use of Non-Member Consultants

MSU IRB may use non-member consultants for advice and information in specialized areas (e.g., prisoner research, specialized clinical methods, Tribal research considerations). The IRB Chair will be notified and approve the use of formal consultants. Consultants do not vote during IRB meetings and are bound by confidentiality and conflict of interest requirements.

Recusing of Voting Members

Review and voting will be conducted with objectivity and independent judgment. Members must disclose conflicts of interest to the IRB Chair and recuse from deliberations and/or voting as directed. Departmental affiliation alone does not automatically constitute a conflict of interest. 

Voting Procedures

The IRB will vote on actions related to Full Committee protocols at convened meetings when quorum is present. Quorum consists of a majority of the IRB members, including at least one non-scientist. If quorum is lost during the meeting, the IRB may not take a vote until quorum is reestablished. Approval of research and other IRB actions require a majority vote of the members present at a convened meeting. Members with conflicts of interest for a given protocol must be recused and may not be counted toward quorum or vote on that protocol. Consultants may provide input as requested but do not vote.

Federal Regulatory and Sponsor Updates (When Applicable)

When studies are federally funded or otherwise subject to sponsor or federal requirements, investigators are responsible for ensuring compliance with applicable federal and sponsor policies in addition to IRB requirements. Current updates relevant to MSU human research oversight include: 

  • Terminology alignment (NIH + federal standards): For NIH-supported studies (and other federally regulated/sponsored research as applicable), MSU IRB materials and investigator guidance will use terminology consistent with current federal regulations and sponsor requirements.
  • IRB written procedures guidance (OHRP/FDA): MSU IRB operating procedures will be maintained to align with current OHRP/FDA expectations for IRB written procedures (e.g., documentation requirements, reporting pathways, decision documentation, and consistency across review types), as applicable to MSU's regulatory scope.
  • NOT-OD-25-131 (Revision to NIH inclusion policy): NIH revised its inclusion policy and guidelines for women and racial and/or ethnic minority groups and their subgroups in clinical research, including terminology updates (e.g., use of "sex" language and updates to race/ethnicity alignment with federal standards).
  • NOT-OD-25-134 (Flexibilities for registration/results reporting for prospective BESH): NIH indefinitely extends policy flexibilities/delayed enforcement regarding registration and results reporting for a subset of NIH-funded prospective basic experimental studies with humans (BESH) submitted under designated BESH funding opportunities/NOFOs.
  • NOT-OD-25-153 (Disposition of biospecimens collected from Tribal populations): NIH describes options permitting tribes to request transfer or return of certain NIH-held de-identified biospecimens with Tribal affiliation(s), subject to feasibility and NIH processes. 
  • NOT-OD-25-159 (Required security and operational standards for NIH controlled-access data repositories): NIH describes required security and operational standards for NIH controlled-access data repositories and access management systems. When MSU studies use NIH controlled-access repositories or access systems, investigators must follow NIH requirement and any repository-specific access, security, and data use conditions.
  • NOT-OD-25-160 (NIH policy on enhancing security measures for human biospecimens): NIH describes enhanced security expectations for NIH-supported human clinical and research biospecimens obtained from U.S. persons. When MSU collects, obtains, stores, uses, or distributes NIH-supported human biospecimens, investigators must follow applicable NIH requirements and implement appropriate biospecimen security measures consistent with the notice.

400. Review Levels and Review Processes

The Code of Federal Regulations (45 CFR 46) defines review levels and related requirements. MSU IRB uses the following levels of review as applicable.

Submission Intake and Administrative Screening (Applies to All Levels)

When a protocol is submitted, the IRB Program Manager will conduct an administrative screening for completeness and routing, including (but not limited to): training status, required documents, site permissions/letters, course-based instructor confirmation, and whether the activity appears to be human subjects research or practice-only.

Submissions may be returned without review when required components are missing or when the IRB determines the submission is practice-only with no intent to conduct research.

Exempt Review

Research activities that (1) present no more than minimal risk to human subjects, and (2) fall wholly within one or more exempt categories under 45 CFR 46.104 may be reviewed by the IRB through the exempt determination process. Some exempt categories require limited IRB review as specified in 45 CFR 46.104(d). Exempt determinations are made by the IRB, not the investigators.

Exempt categories include (see regulations for full details):

  • Research established or commonly accepted educational settings involving normal educational practices
  • Educational tests, surveys, interviews, or observation of public behavior (with category-specific limitations, including limitations related to children in certain contexts)
  • Benign behavioral interventions with adults (with specific conditions).
  • Secondary research use of identifiable private information or identifiable biospecimens (when criteria are met)
  • Federally supported research and demonstration projects meeting criteria
  • Taste and food quality evaluation and consumer acceptance studies
  • Storage/maintenance or secondary research involving broad consent (when needed)

Process (Exempt):

When an exempt level protocol is submitted to the IRB, the IRB Program Manager will review first and send back any modifications or additional questions to the Principal Investigator. Once modifications and questions have been addressed, the IRB Chair will review and approve the protocol after all modifications have been completed for final approval.

Duration/Renewal (Exempt):

Exempt level protocols will expire five years after the approval period and require IRB renewal if research activities continue beyond 5 years.

Expedited Review

Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more categories authorized for expedited review may  be reviewed through the expedited procedure authorized by 45 CFR 46.110 (and when applicable, 21 CFR 56.110).

Process (Expedited):

Expedited level protocols will be reviewed initially by the IRB Program Manager who will send back any modifications or additional questions to the Principal Investigator. Protocols will be reviewed by designated reviewers per MSU procedures with possible outcomes, including: approval, required modifications prior to approval, or referral to Full Committee Review when warranted. Protocol decisions will be documented per MSU requirements.

Duration/Renewal (Expedited):

Expedited level protocols will expire five years after the approval period and will need to be renewed for continued research. Some protocol submissions qualify for Exempt but are submitted as Expedited; in these situations, protocols may be reviewed through the Exempt process if appropriate.

Use of Secondary Data

The use of secondary data is allowed at all levels of review depending on identifiability, privacy risk, consent status, and the context in which the data were collected accessed.

When secondary data are private and identifiable and obtained from sources not originally collected for the investigator's current research purpose (or where consent is not being obtained for the current use), the protocol may not fit within exempt categories and may require expedited or full committee review depending on the specifics.

The two main exempt categories commonly applicable to secondary research are:

  • Exempt Category 4 - Secondary research use of identifiable private information or identifiable biospecimens, when required criteria are met
  • Exempt Category 8 - Secondary research for which broad consent is required (when applicable)

When exempt criteria are not met, expedited categories commonly used may include: 

  • Expedited Category 5 - Research involving materials (data, documents, records, or specimens) collected (or to be collected) for non-research purposes
  • Expedited Category 7 - Research on individual or group characteristics/behavior, including use of survey, interview, focus group, program evaluation, quality assurance methodologies, etc.

Full Committee Review (FCR)

Research involving more than minimal risk and/or requiring additional safeguards (including studies involving vulnerable populations), or protocols raising complex ethical considerations, must be reviewed by the convened IRB. Full committee review may also be required when conflicts of interest of other factors warrant convened review.

Process (FCR):

  • Initial review by the IRB Program Manager who will send back any modifications or questions to the PI to address.
  • Assignment of an IRB committee member as a primary reviewer to present the protocol at the meeting.
  • Distribution to the committee for review. 
  • IRB discussion and vote, with determinations including: approve, return for modification (with MSU-defined pathway for confirming changes), or withhold approval.

Continuing Review (FCR):

Full Committee level reviews expire in five years; an interim review is required annually to continue research.

Tribal IRB Reviews and Tribal Approvals

Research occurring on reservations or involving interaction with Tribal members may require review/approval by the appropriate Tribal authority, including a Tribal IRB where applicable. A second, dual review is not required by MSU IRB when Tribal review is the primary review and appropriate documentation is provided;; however, researchers must submit Tribal application materials, approval letters, and continuing review letters to MSU IRB for documentation.

Tribal partners may request MSU conduct a pre-review, request a dual review, or cede primary review to MSU IRB with documentation from an appropriate Tribal authority (e.g., Council/legislature/THPO/other authorized body). MSU IRB is available to assist when helpful.

For more information, see Tribal IRBs.

Research Involving Students (Focus: Student Education Records / FERPA)

MSU researchers often hold multiple roles (e.g., teacher, administrator, instructor). In school settings--especially for educator-researchers (including those in MSU's online programs who are practicing teachers)--a frequent compliance issue is unrecognized use of student education records.

In the research context, educations must separate their professional access ("educator role") from research access ("researcher role"). Access to student information for routine educational duties does not automatically authorize access for research purposes.

Education records commonly used in research (examples include, but are not limited to):

  • Student grades, GPA, transcripts, test scores, and assessments
  • Student course schedules, class lists, rosters
  • Student work products (graded tests, homework, journals, essays, projects)
  • Audio or video recordings of students in classroom or instructional settings
  • Student ID photos
  • LMS/virtual discussion posts/responses and online learning system interactions linked to a student
  • Student financial information maintained by the educational institution
  • Student discipline files
  • Student health-related records maintained as educational records

If investigators can ascertain a student's identify from the record at the time of access, FERPA may apply. Protocols using student education records must clearly describe what records are accessed, identifiabililty at each stage, permissions/consent plan (parent/guardian vs. eligible student), site authorization documentation, coercion minimization protections, and the data security plan (storage, access control, retention, destruction).

Since requests made by someone in authority over students may be perceived as coercive, it is recommend that investigator-researchers seek participants from populations outside their direct instructional authority when feasible. If academic credit is offered as an incentive, an alternative options must be available that is comparable in time and effort, and participation must not affect grades or standing.

500. Noncompliance, Violations, and Corrective Actions

Examples of violations include, but are not limited to: 

  • Conducting human subjects research without required IRB approval/exempt determination
  • Performing research differently than what is described in the approved protocol without IRB approval when approval is required
  • Failure to follow approved informed consent/assent procedures
  • Failure to protect privacy/confidentiality as approved, including breaches of confidentiality
  • Failure to report required events (e.g., unanticipated problems, participant complaints, protocol deviations as required)
  • Conducting research after approval has expired
  • Using student education records for research in a manner inconsistent with what was approved (or without the required permissions/consent plan)

IRB Actions and Corrective Measures

Violations may result in actions appropriate to severity and pattern, including: 

  • Immediate suspension or termination of IRB approval when warranted
  • Required corrective action plans and mandatory training
  • Increased monitoring requirements
  • Referral to Research Integrity & Compliance and other institutional offices as appropriate
  • Sponsor and/or regulatory reporting when required

600. Investigator Responsibilities and Ongoing Oversight

As a condition of IRB approval/exempt determination, the Principal Investigator (PI) and research team are responsible for complying with all applicable human research protections requirements, including MSU policy, IRB determinations, and sponsor/regulatory requirements. At minimum, the PI/research team is responsible for the following: 

  • Receive education/training on the ethical conduct of human research prior to conducting human subjects research (including sponsor-required training when warranted).
  • Be qualified to perform the proposed research and obtain IRB approval/exempt determination before beginning any human research activities.
  • Disclose conflicts of interest and work with Research Integrity & Compliance to develop and follow a management plan for any conflicts relevant to the proposed research.
  • Obtain informed consent/assent in the manner approved by the IRB and maintain appropriate study documentation and records.
  • Keep records of numbers of participants studied and any adverse events/unanticipated problems.
  • Monitor participants for and report any adverse reactions, injuries, breaches in confidentiality, or other detrimental effects to the IRB in accordance with MSU reporting requirements.
  • Report any proposed changes in the protocol to the IRB and obtain approval, via an amendment submission, before implementing changes, except when necessary to eliminate apparent immediate hazards to participants (which must be reported promptly).

Oversight

The MSU IRB reports to Research Integrity & Compliance. Research Integrity & Compliance has ultimate responsibility for IRB functions and may revise or override IRB decisions if necessary.

The MSU IRB Chair is responsible for addressing participant complaints, concerns, or questions. Research Integrity & Compliance may be included in these discussions as needed.

700. Post-Approval Monitoring

Post-Approval Monitoring (PAM) is a process to help ensure that research involving human subjects complies with IRB requirements, federal regulations, sponsor requirements, and institutional policies. PAM supports participant protections, identifies and addresses deviations/noncompliance, provides educations, and strengthens research integrity.

The PAM process applies to IRB-approved research involving human subjects research at Montana State University. PAMs may be conducted for reasons including: requested by the RIB, risk level to participants, vulnerability of the study population, past compliance history of the PI, study complexity, or random selection.

The PAM Coordinator will work with the IRB Program Manager to identify a protocol, notify the PI of the selected study, and schedule a monitoring visit. The PI is informed about the scope and purpose of the visit.

Conducting the PAM visit may include: 

  • Opening meeting with the PI and research team
  • Document review (study records, consent forms, reporting, data management practices)
  • Interviews with the research team
  • Observation of study procedures
  • Preliminary discussion of findings and follow-up actions
  • Written report and presentation of findings to the IRB when required

Outcomes:

  • Minor deviations may be addressed through corrective actions implemented by the PI
  • Major deviations/serious or continuing noncompliance may be reported for further review and action, including possible suspension or termination.

The PAM process will be reviewed and updated periodically to address emerging issues and improve effectiveness.

800. Continuity of Operation

In the event the IRB is unable to continue oversight of ongoing projects due to disruption (e.g., disaster, major operational interruption, loss of access to critical systems), oversight may be transferred temporarily or permanently pursuant to existing agreements (e.g., reliance arrangements) or to a commercial IRB if necessary, consistent with applicable requirements and institutional determinations. 

For disruptions limited in scope, severity, and duration, a partner IRB may provide services on behalf of MSU IRB when permitted by agreement and applicable requirements. Otherwise, transfer of oversight for the life of the study will follow regulatory and sponsor guidance for transferring research oversight. The IRB Chair and/or Research Integrity & Compliance leadership will be responsible for managing and communicating any transfer of oversight.

Review and Approval Cycle

This documents is reviewed at least every three (3) years, and all changes must be reviewed and approved by the IRB Committee as part of MSU's standard policy and procedure maintenance process.

 

Approved January 2026