Contents

100. Introduction

200. Jurisdiction of the Institutional Review Board

300. Rules and Regulations

400. Types of Reviews and Review Process

500. Violations

100. Introduction

The mission of Montana State University's (MSU) Institutional Review Board (IRB) is the protection of the rights, welfare, and well-being of human subjects who participate in research at MSU. MSU's IRB follows the ethical standards described in The Belmont Report as well as all federal, state, local and University regulations.

MSU is dedicated to fostering a research environment that respects and upholds the diverse traditions, cultures, and sovereignty of Tribal and foreign nations. Our mission is to ensure that research conducted within our University aligns with the ethical principles and values of these communities, honoring their traditions, beliefs, and ways of knowledge. The University strives to protect the rights, welfare, and interests of all research participants, while promoting equitable partnerships and mutual understanding between researchers and communities.

200. Jurisdiction of the Institutional Review Board

  1. All research (except as exempted under 45 CFR 46.104(b)) by MSU faculty, students, and staff that involves human subjects must be approved by MSU's IRB. This requirement applies to unfunded research, research funded by the federal government, and research funded by other sources.
  2. Certain kinds of research involving human subjects require limited IRB review and approval. These categories of exempt research are described in the Code of Federal Regulations, 45 CFR 46.104.
  3. MSU IRB evaluates research protocols to ensure that research complies with ethical standards and regulations. This includes assessing the risks and benefits of the research, as well as the methods for obtaining informed consent from participants. Risks to subjects must be minimized and reasonable in relation to the anticipated benefits of the research.
  4. MSU IRB reserves the right to conduct periodic reviews of ongoing research to make sure that human subjects' rights and welfare continue to be protected. This may involve Post Approval Monitoring (PAM), adverse events reporting, and any changes to the research protocol.
  5. If concerns about the conduct of research or the treatment of human subjects are reported, MSU IRB may investigate complaints and take appropriate actions to address any violations of ethical standards.
  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 focused on safeguarding the rights, safety, and well-being of individuals who participate in research conducted by the institution and are responsible for reviewing, approving, and monitoring research protocols to protect the rights and welfare of research participants. There must be appropriate additional precautions to protect the rights of children, economically or educationally disadvantaged persons, severely ill persons, mentally ill persons, pregnant women, and prisoners.
  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.

300. Rules and Regulations

The IRB operates under rule defined in the Code of Federal Regulations 45 CFR 46 and The Belmont Report (Ethical Principles and Guidelines for the Protection of Human Subjects of Research) prepared by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The IRB reviews all Full Committee Protocols and convened meetings (typically on a monthly basis) along with Interim (annual) Reviews for Full Committee Review.

IRB Committee Member Composition

  • The IRB consists of at least five members who are appointed by the Assistant Vice President for the Office of Research Compliance at MSU with suggestions from other committee members, the IRB Administrator, and members of the faculty.
  • IRB members are appointed for three-year terms by the Assistant Vice President for the Office of Research Compliance. Members can be appointed to consecutive terms indefinitely.
  • At least two members of the IRB must be non-scientists. These members should be able to review the research from the viewpoint of subjects and may have expertise in law, religion, ethics, or matters of relevant committee work.
  • The scientific members of the committee should provide a broad representation of physical, biological, and behavioral sciences as well as health professions.

400. Types of Reviews and Review Process

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

Exempt Determinations

Exempt research must be minimal risk. Research involving minors, pregnant women, prisoners, or other vulnerable populations, is not eligible under the Exempt level category.

Exempt categories include (see regulations for full details):

  1. Research conducted in educational settings, instructional strategies or techniques, curricula, or classroom management methods...
  2. Research involving surveys, interviews, observation of public behavior, education tests (cognitive, diagnostic, aptitude, achievement)...
  3. Benign behavioral interventions in conjunction with the collection of information...
  4. Secondary research use of identifiable private information or identifiable biospecimens...
  5. Research and demonstration projects that are conducted or supported by a Federal department or agency...
  6. Taste and food quality evaluation and consumer acceptance studies...
  7. Storage or maintenance for secondary research for which broad consent is required...
  8. Secondary research for which broad consent is required...

When an Exempt level protocol is submitted to the IRB, the IRB Administrator will review first and send back any modifications or additional questions to the Principal Investigator. Once theIRB Administrator's modifications and questions have been addressed, theIRB Chair will review and approve the protocol after all modifications have been completed. Exempt level protocols will expire five years after the approval period and require IRB renewal if research activities continue beyond the five 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 by the Federal Office for Human Research Protections may be reviewed by the IRB through the Expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110.

  1. Expedited level protocols will be reviewedinitially by theIRB Administrator who will send back any modifications or additional questions to the Principal Investigator. Protocols will be reviewed by at least two committee members of theIRB with the following possible outcomes: 

                    a. The reviewers will unanimously approve or disapprove the proposal. Either reviewer may

                        require that further modifications to the proposal be made prior to approval.

                    b. Reviewers can recommend that the application be reviewed by Full Committee at a convened

                        IRB meeting.

       2. Protocol decisions will be presented to the full IRB for approval at the next meeting.

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

Expedited level protocols will expire in 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, the protocols will be reviewed through the Exempt process.

Use of Secondary Data

The use of secondary data is allowed at all levels of review. However, when the secondary data is private and identifiable being obtained from sources that were not originally deemed "research", and the researcher will not be gaining consent, it does not fit within the Exempt level categories and will need to be submitted via an Expedited (category 5 or 7) review.

IRB protocols that fall into this category will be reviewed by theIRB Administrator andIRB Chair and will not be handled in the same "Expedited " procedure due to the level of risk (minimal) unless deemed higher risk. If the level of risk is deemed higher than minimal, the standard Expedited review process will be followed.

The two main categories for Exempt review for secondary research are the following:

Exempt Category 4 - Secondary research use of identifiable private information or identifiable biospecimens (consent is not required if at least one of the following criteria is met)

  1. Data is publicly available.
  2. Information is recorded by the investigator in such a manner that the identify cannot be readily ascertained.
  3. Research involves only information collection and analysis involving the investigator's use of identifiable health information; or
  4. Research is conducted by, or on behalf of, a Federal department or agency.

Or

Exempt Category 8 - Secondary research for which broad consent is required.

Based on these two categories, the secondary research explained in this section would not fit this due to the access to identifiable and private information and consent not being used.

Therefore, the Expedited categories (5 and 7) will be used which state the following:

Expedited Category 5 - Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, for non-research purposes.

Or

Expedited Category 7 - Research on an individual group or group characteristics or behavior (e.g., perception, cognition, motivation, identity, language, communication, cultural beliefs/practices, and social behavior) or employing a survey, interview, oral history, focus group, program or human factors evaluation, or quality assurance methodologies.

Full Committee Review (FCR)

Research involving more than minimal risk and/or vulnerable populations (e.g., children, economically or educationally disadvantaged persons, severely ill or mentally ill persons, veterans, pregnant women, or prisoners) must be reviewed by the Full Committee. IRB (FCR) protocols that involve a conflict of interest as well as risk that is deemed higher than Exempt or Expedited levels of review may also be subject to FCR.

When an FCR is submitted theIRB does the following:

  1. Initial review by the IRB Administrator who will send back any modifications or questions for the PI to address.
  2. The IRB Administrator will assign an IRB committee member as a primary reviewer to present the protocol at the meeting.
  3. The IRB Administrator will send the Full committee protocol to the committee for review. All committee members are expected to review theFCR proposals.
  4. The IRB will review and discuss protocols and may make one of three determinations:

               1) Approve: The IRB may make a motion and vote to approve the protocol as submitted.

               2) Return for Modification: If additional information or clarification is required to secure approval, the

                   IRB Program Administrator will communicate the items from the committee to the PI. There are two 

                   options for approval after a return for modification:

                              a) Return for Modification and Approve by Subcommittee Designated Member Review (DMR):

                                  Responses to committee comments are returned and voted upon by a subcommittee. If the

                                  subcommittee votes unanimously that the concerns were adequately addressed, the protocol

                                  is approved. If the subcommittee does not vote unanimously for approval, the protocol is

                                  returned for modification and the PI must resubmit the protocol for full committee 

                                  consideration.

                              b) return for Modification and approved by the IRB Administrator: Minor modifications such as

                                   updating personnel training or other entity approval letters may be approved by theIRB 

                                   administrator upon resubmission.

               3) Withhold approval: If a majority of the IRB believes that the proposed research activities pose too much 

                    risk for the subjects, the proper expertise or facilities are not available, or the protocol lacks sufficient

                    details, the protocol will be disapproved. In such cases, the IRB will provide feedback to the PI and 

                    make recommendations regarding potential resubmission.

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

MSU IRB operates by consensus. To be approved, a protocol must receive a majority vote (>50%) from theIRB committee. Any member's request for clarification or revision of an application will be documented in the IRB's final decision and will be recorded in the minutes of the IRB committee meeting.

Recusing of Voting Members

Review of protocols and modifications will be conducted with objectivity and in a manner to the independent judgment of each member. Members may not participate in a vote by the IRB Committee on actions concerning projects or activities in which they have an active research role or have an actual, perceived, or potential conflict of interest. The IRB Committee members must make any conflict of interest known to the IRB Chair. The fact that a protocol is submitted by another investigator from an IRB Committee member's department does not, in and of itself, constitute a conflict of interest. members that have a potential conflict of interest will be required to recuse themselves from the meeting room during voting. Failure to abide by these provisions may be a cause for removal of a member from the IRB.

Tribal IRB Reviews

research that will occur on reservations or interaction with Tribal members must be reviewed by the local Tribal IRB where the research will take place. A second, dual review is not required by MSU IRB. However, researchers must submit their tribal application materials, approval letters, and continuing review letters to MSU IRB for documentation.

Alternatively, Tribal partners may wish for MSU to conduct a pre-review, can specifically request a dual review, or may cede primary review to the MSU IRB with documentation from the appropriate Tribal authority (e.g., letter from Council, legislature, THPO, or other Tribally authorized body). MSU IRB is available to tribes and researchers to assist if helpful.

MSU IRB may be able to review studies involving non-specific tribe or urban Indian populations and will do so for studies that include a combination of tribe-specific and non-specific approaches.

For more information, see Tribal IRBs.

Research Involving Students

MSU researchers, both faculty and students, wear many hats. In particular, MSU Education Graduate Students may also be teachers, principals, administrators, and superintendents. In those school roles, educators have natural access to Student Education Records like tests, grades, and homework, to fulfill their regular job duties. However, in the MSU research context, these same individuals must put on their “researcher hat” and view the students they see daily under a special research lens. This means that the Student Education Records that they regularly access must be treated differently for research purposes because this research activity is subject to FERPA.

In the research context, it is no longer possible to simply log into the gradebook and pull data for research – this action requires parent or Eligible Student consent. An MSU Educator Researcher has an academic task to conduct research to fulfill their graduate school requirements. Per the regulations, that research is considered a personal objective rather than a legitimate educational interest in the records they otherwise freely handle on a regular basis.

  1. Since any request made by a faculty member of a student who is taking one of their courses could be construed as coercive, it is recommended that faculty members seek student subjects from populations of students outside of their own courses.
  2. Faculty members should seek student subjects in their own courses if the research has educational value (for the subject) that is relevant to the course in which the subject is enrolled. The educational benefit for the student should be described in the protocol application.
  3. If academic credit is given for participation as a subject in human research, there must be alternative ways to obtain such academic credit. These alternatives must be no more convenient, no more uncomfortable, no more risky, and no more time-consuming that participating as a subject in the research. Also, if academic credit is used as an incentive to attract subjects, it is mandatory that an educational component relevant to the course be built into the experience of the subject.
  4. Family Educational Rights and Privacy Act (FERPA) in research. FERPA is a federal law that protect the privacy of student education records. The term "education records" means records that contain information directly related to a student and which are maintained by an educational agency or institution or by a party acting for the agency or institution. Education records may include but are not limited to: 

               a) Student grades, GPA or transcripts

               b) Student course schedules, class lists

               c) Student work products: graded tests, class homework, submitted journaling assignments

               d) Audio or video recording of students in classroom

               e) Student ID photos

               f) Virtual class discussion posts/responses or interactions with online learning systems

               g) student financial information

               h) Student discipline files

                i) Student health records

By definition, student education records are directly related to a student. If you will be able to ascertain the identity of a student from the education record at the time of access, FERPA applies. See FERPA in Research Guidelines for more information.

500. Violations

1. Examples of violations include but are not limited to:

  • Conducting human subjects research without prior approval of the IRB.
  • Performing research in a way differently than what was described in the approved IRB protocol. 
  • Failure to follow approved informed consent procedures.
  • Failure to report adverse reactions, injuries, breach of confidentiality or detrimental effects.
  • Conducting research after approval has expired

2. Violations will result in immediate termination of the IRB approval to do research and will be reported to the IRB      and the Office of Research Compliance at Montana State University.

Post Approval Monitoring (PAM)

Post Approval Monitoring (PAM) is a critical process to ensure that research involving human subjects complies with Institutional Review Board (IRB) requirements, federal regulations, and institutional policies. This process helps protect the rights and welfare of research participants and ensures that the research is conducted with integrity. Post Approval Monitoring also helps to identify and address any deviations or non-compliance, provides education and support to researchers, and enhances the quality of research through continuous oversight.

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

The PAM Coordinator will work with the IRB Program Administrator 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

  1. Opening Meeting: Meet with the PI and research team to explain the monitoring process and address any questions.
  2. Document Review: Examine study records, consent forms, adverse event reports (if warranted), and data management practices.
  3. Interview: Discuss with the research team to understand the study's conduct and any issues encountered.
  4. Observation: If applicable, observe study procedures (such as a blood draw) to ensure they align with the approved protocol.
  5. Provide a preliminary report of findings to the PI and research team at the end of the visit.
  6. Prepare a detailed report outlining findings, any deviations, and required corrective actions. The report is presented by the PAM Coordinator at the next IRB Committee meeting.

The PI is required to respond to the findings, addressing any deviations and outlining corrective actions. The PAM Coordinator will follow up with the PI to ensure corrective actions are implemented.

  • Minor Deviation: Addressed through corrective actions implemented by the PI.
  • Major Deviations/Non-Compliance: Reported to the IRB for further review and action, which may include suspension or termination of the study.

The PAM process will be regularly reviewed and updated to address emerging issues and improve effectiveness. Incorporating feedback from researchers and IRB members will also enhance and streamline the PAM process.

Investigator's Responsibilities

  1. Investigators must receive education on the ethical conduct of human research prior to conducting human subjects research. See training information. 
  2. Investigators must be qualified to perform the proposed research and must obtain IRB approval before beginning the research.
  3. Investigators must disclose all conflicts of interest and must work with the Office of Research Compliance to develop a management plan for any conflicts relevant to the proposed research.
  4. Investigators must obtain informed consent in the manner approved by the IRB.
  5. Investigators must keep records of numbers of subjects studied and any adverse reactions.
  6. Investigators must monitor subjects for and immediately (within 3 calendar days) report adverse reactions, injuries, breaches in confidentiality or detrimental effects to the IRB. If an adverse reaction occurs, the research should be discontinued until the IRB has been informed and has given approval to continue the research.
  7. Investigators must report any proposed changes in the experimental protocol to the IRB and obtain re-approval before instituting the changes in the experimental design.

Oversight

  • The MSU IRB reports directly to the Office of Research Compliance. The Office of Research Compliance has the ultimate responsibility for all IRB functions and may revise or override IRB decisions if necessary.
  • The MSU IRB Chair is responsible for addressing subject complaints, concerns, or questions. If  necessary, the Office of Research Compliance will be included in the discussion with the subjects.

Contingency Plan

  • In the event that the IRB is unable to continue oversight of ongoing projects, such as loss due to fire or a natural disaster or the IRB closes, oversight will be transferred temporarily or permanently to the University of Montana IRB, with which we have an ongoing agreement, or to a commercial IRB if necessary. For disruptions limited in scope, severity, and duration, the role of the University of Montana IRB will be to provide services on behalf of the MSU IRB, which would not constitute transfer of oversight to the commercial IRB. Otherwise, the transfer of oversight for the life of the study will follow the FDA recommendations for transferring research oversight. The IRB Chair and/or Office of Research Compliance will be responsible managing the transfer of oversight.