Aerial view of the 91次元 campus and buildings around UM's Oval in Missoula, MT.

Research Compliance and Tech Transfer

Chapter 1: Introduction and IRB Overview

1. Introduction 

Mission and Purpose

The 91次元 (UM) Institutional Review Board (IRB) ensures the protection of the rights, welfare, and privacy of human research participants. The IRB’s purpose is to protect the rights and welfare of humans participating in biomedical and behavioral research conducted at the 91次元. The IRB reviews and oversees such research to assure that it meets ethical principles and that it complies with federal regulations that pertain to human participant protection at 45 CFR 46 and 21 CFR 50 and 56, and other pertinent regulations and guidance.

This manual outlines the policies and procedures guiding IRB operations in compliance with federal regulations, institutional policies, and ethical principles.

Authority and Scope

The IRB operates under the authority granted by the 91次元 and adheres to all federal regulations governing the conduct of human subjects research in the United States, such as 45 CFR 46 (the Common Rule) and 21 CFR 56 (FDA). The ethical principles which guide the IRB are consistent with The Belmont Report. These principles are defined in the Belmont Report as follows:

  • Respect for Persons – Individuals should be treated as autonomous agents and persons with diminished capacity are entitled to protection
  • Beneficence – Maximize the benefits and minimize the possible harms
  • Justice – The burdens and benefits of research should be justly distributed

The UM IRB recognizes that Montana state and local laws may impose additional requirements and restrictions on human subjects research. To ensure that the applicable requirements are met, the IRB and/or administrative staff will consult with appropriate UM administrators and Legal Counsel when needed. The UM IRB also recognizes that local tribes may impose additional requirements and restrictions on human subjects research that involve their territory, peoples, and cultural and/or intellectual property. To ensure that applicable requirements are met, the IRB may request confirmation or other support of the conduct of the research, including but not limited to tribal IRB approval.

The UM IRB operates under the University’s Federalwide Assurance (FWA) (FWA00000078), negotiated with the Office of Human Research Protections (OHRP). This Assurance authorizes the University to conduct human subject research and authorizes the UM IRB to oversee research. To that end, the IRB is granted the authority to approve, modify, or disapprove studies, as well as to require progress reports, oversee the conduct of ongoing research, and suspend, terminate approval, or place restrictions on active studies in the consideration of human subjects protection.

Research conducted at an institution for which the UM IRB has been appointed as the IRB for that institution also falls under the purview of the University’s FWA. This includes Montana Technological University (Butte, MT), 91次元-Western (Dillon, MT), and Helena College (Helena, MT). Human subjects protocols conducted at these institutions require review by the UM IRB so long as they meet the definition of human subjects research.

All human subjects research conducted under the institution’s auspices must be reviewed and approved by the IRB. This includes any biomedical and/or social-behavioral research involving human participants that is conducted by faculty, staff, and/or students of UM regardless of the source of funding and location of the study if:

  • The research is conducted by or under the direction of any employee, faculty, staff, student or agent of the 91次元 in connection with his/her/their institutional responsibilities;
  • The research is conducted by or under the direction of any employee, faculty, staff, student or agent of the 91次元 using any property or facility of the 91次元;
  • The research involves the use of the 91次元's nonpublic information to identify or contact human research participants; or,
  • The research involves the use or disclosure of protected health information.

The UM IRB also functions as the HIPAA Privacy Board for research for the University of Montana.

The UM-IRB is directly responsible to and shall coordinate its actions and policies with the office of Vice President for Research.

2. IRB Composition and Membership

Membership Requirements

The UM IRB follows the IRB membership requirements as outlined at 45 CFR 46.107 and 21 CFR 56.107. No IRB meeting will be conducted without the necessary quorum, and no Committee decisions will be made lacking the vote of at least one non-scientist and at least one scientist. If a quorum fails for any reason, no further actions are taken until quorum is restored.

Members, including alternates, are expected to attend as many convened meetings of the IRB as possible, but no less than ½ of the convened meetings during a year.

IRB membership is comprised of faculty members from a broad range of disciplines and the Committee includes at least one community (unaffiliated) member, at least one member without scientific expertise, and at least one member with scientific expertise. In addition, a representative from UM Office of Research and Creative Scholarship serves as a member of the IRB in an ex-officio (but voting) capacity.

A member is considered “unaffiliated” if neither that person nor a member of their immediate family is employed by the 91次元 or its affiliates. A member is considered “non-scientific” if that person’s primary profession or area of interest is in a primarily non-scientific discipline. Alternate members parallel and complement the expertise of the primary members. Unless otherwise noted, “member” in this document will refer to any potential voting member of the IRB, whether designated as a primary or alternate member.

The 91次元 is in compliance with the statutory requirement that a majority of the members (exclusive of the prisoner representative) have no association with prison(s) involved in research other than their membership on the IRB reviewing prisoner studies [45 CFR 46.304 (a)].

Membership reflects basic federal requirements for expertise and advocacy; additional members are added as necessary or appropriate to ensure protection of subjects of a particular population. The IRB may also call upon outside consultants as necessary for additional expertise on a particular topic. Outside consultants are expected to maintain the confidentiality of the research.

The UM IRB Manager is a full board member.

It is desirable to have UM IRB members represent each programs conducting human subject research.

The IRB office maintains a roster of trained alternates who may vote in place of an absent voting member. The alternate member will have similar expertise as the regular committee member for whom they are serving as a replacement (physician to physician; other scientific to other scientific; and non-scientific to non-scientific). The alternate member will assume all of the responsibilities of the committee member for whom they are serving as a substitute. Alternate members may attend IRB meetings without serving as a substitute for a regular committee member; however, in this capacity, the alternate member may not participate in any of the final approval decisions of the committee. IRB minutes will document if a member present at the meeting is an alternate as well as the IRB member for whom the alternate is substituting.

Current and past membership rosters are maintained in the IRB office. Rosters are provided to OHRP per the requirements of 45 CFR 46 Subpart E and 21 CFR 56.106. A current membership roster is also available on the IRB website.

Appointment and Terms

Committee members, including alternates, are appointed by the Institutional Official (IO) to a term of three years. Committee members may be requested to accept reappointment to the IRB for an additional term of three years at the discretion of the Chair. If a member declines full membership, they may be asked to become an alternate member. Alternates will be asked at the end of their three-year term whether they would like to continue as an alternate.

IRB members serve at will and any IRB member may resign from the IRB by written notification to the IRB Manager and/or IRB Chair. IRB members who are unable to fulfill their membership responsibilities are expected to initiate their resignation with sufficient advanced written notice to allow the IRB to identify and appoint an appropriate replacement member. The Vice President of Research/Institutional Official has the authority to remove an IRB member with good cause.

Upon the occurrence of a vacancy, the Chair will request nominations from the current pool of alternates, preferably for a person with expertise similar to the member vacating their membership. If there are several alternate members with similar expertise to the vacating member and who have served as an alternate for a similar amount of time, the Chair will select an appropriate replacement at the Chair’s discretion.

Nominations shall be considered at a regular meeting of the UM IRB and voted upon by members for approval. The nominee selected by UM IRB will then be forwarded to UM Vice President for Research for final approval.

Roles and Responsibilities

The UM Vice President for Research shall appoint a Chair of UM IRB, who shall be a faculty member or staff who functions as a voting member of UM IRB, and a Vice-Chair who also shall be a faculty member or staff member. The Vice-Chair shall conduct UM IRB activities in the absence of the Chair. The Chair shall serve for two years after having served as Vice-Chair for at least one year. The Chair may serve multiple terms. The Vice-Chair may serve for two years, unless they begin service as Chair. Vice-Chair may serve multiple terms. 

The Chair shall be responsible for seeing that:

  1. Meeting agendas are set,
  2. Minutes are kept and maintained,
  3. Meeting agendas are created and distributed to UM IRB members prior to meetings,
  4. Business is conducted efficiently and effectively,
  5. Copies of proposals are kept and maintained, and
  6. UM IRB actions are implemented.

The UM IRB Manager will assist with the above duties as delegated by the Chair.

The Chair has the authority to sign all UM IRB action items. At the Chair’s discretion, this responsibility may be delegated to the UM IRB Manager for routine, minimal risk, and/or administrative approvals, at both exempt and expedited levels, such as, but not limited to: personnel additions, continuations, minor amendments (i.e., wording changes on recruitment materials and other study instruments if the change does not affect the risk level of the study), etc. The UM IRB manager will co-review new protocols and major protocol amendments that fall under an expedited category of review with the UM IRB Chair or the Chair’s designee.

In the case where a PI is in the same department as the IRB Chair, the IRB Vice-Chair will assume leadership regarding the proposal.

To allow for successful completion of UM IRB Chair duties, the Chair shall be compensated an amount designated by the Institutional Official, commensurate with the amount of time the Chair spends on IRB duties.

IRB Member Training

IRB members, both primary and alternate, are given initial training when appointed to the Committee and continuing training over the course of their membership. Primary and alternate members receive the same initial training and identical opportunities for continuing training.

IRB Meetings

The UM IRB shall meet monthly as needed during the academic year, and during the summer if necessary. Meetings shall occur during the third week of each month, depending on board member availability.

Minutes of UM IRB meetings shall be kept by the UM IRB Manager.

The UM IRB members shall receive the meeting agenda prior to meetings.

A quorum shall consist of a simple majority that includes at least one member whose primary concerns are non-scientific. A quorum must be maintained to conduct business as per 45 CFR 46.107.

As needed, the Chair may invite individuals with special expertise to serve as consultants in reviewing a particular proposal. This individual does not vote.

Additionally, with consent of the Chair, UM IRB meetings may be attended by persons who are not members. Such persons would have submitted proposals which require oral explanation and questioning or have research in progress that requires monitoring.

Meetings of the UM IRB shall follow Robert’s Rules of Order.

Meetings of UM IRB are subject to Article II of the Montana Constitution.

3. IRB Records

The IRB maintains records of all its proceedings, including minutes of each meeting, all correspondence, and all submitted protocols, amendments, consent forms, continuing reviews, unanticipated problems, and statements of significant new findings provided to subjects, as applicable per protocol, including a copy of the IRB-approved consent form for each protocol currently utilizing a written consent form.

Current and past rosters showing qualifications of members are maintained by the IRB office. Rosters are provided to OHRP per the requirements of 45 CFR 46 Subpart E and 21 CFR 56.106. The current membership roster is available on the IRB website.

The IRB maintains records of its policies and practices in its Policies and Procedures Manual. IRB staff are responsible for writing and implementing the standard operating procedures for the UM IRB. New policies and procedures are written and implemented as needs arise.

Revisions to the Policies and Procedures Manual, unless editorial in nature or made at the request of a regulatory auditing body, require review by the IRB Committee prior to implementation. Revisions to internal IRB office operating procedures do not require approval by the IRB Committee or other entities prior to implementation unless otherwise specifically indicated.

The IRB follows all written procedures for:

  1. conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution;
  2. determining which projects require review more often than annually and which projects need verification from sources other than the investigator that no material changes have occurred since previous IRB review;
  3. ensuring prompt reporting to the IRB of changes in research activity; and
  4. ensuring that changes in the approved research, during the period for which IRB approval had already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazard to the human subjects.

The IRB also follows all written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, the Department of Health and Human Services, and the Food and Drug Administration of:

  1. any unanticipated problems involving risks to human subjects or others,
  2. any instance of serious or continuing non-compliance with federal regulations or the requirements and determinations of the IRB, or
  3. any suspension or termination of IRB approval.

IRB individual protocol records are maintained a minimum of 3 years from the date of IRB expiration or termination of the study. Exceptions may be made on a case-by-case basis, dependent upon contractual obligations. IRB minutes are maintained indefinitely.

Relevant Federal Register notices, sections of the Code of Federal Regulations, and NIH and FDA policies, procedures, and regulations are available to faculty from the IRB office or from the IRB website. Scholarly and interpretive articles that pertain to research involving human subjects are also kept in the IRB office as reference items. Such materials are used by the IRB Chair, staff and the Committee, and are available for reference and educational purposes.

4. Conflicts of Interest

The purpose of this policy is to provide guidance on how to assure protection of human subjects in the presence of potential conflicts of interest (COI) with investigators or IRB members. COIs can be financial and/or intellectual.

The IRB must consider whether the specific conflicts of interests (perceived or otherwise) may adversely affect the rights and welfare of subjects. The “reasonable person” test should be used in making this determination. In the absence of an IRB opinion or a financial interest, individuals may self-determine that a conflict of interest exists that may adversely affect the rights and welfare of subjects. This may be in cases where they feel that their decision is being altered by other personal factors such as loyalty to colleagues, business competition with investigators, personal agendas or fear of IRB decisions impacting their non-IRB work.

To the extent permitted by law, all statements, letters, other records and information submitted will be maintained confidentially by the IRB and IRB members. Statements, other records and information, however, may be made available to any federal agency funding research upon written request of the agency, and otherwise as required by law.

Investigator Conflicts of Interest

An investigator conflict of interest is defined as a set of conditions where an investigator’s judgment concerning the design or conduct of a study, including but not limited to subject welfare and the integrity of the research project, could be biased by personal or financial gain.

Individuals directly involved in the conduct, design or reporting of research involving human subjects should not have more than a minimal personal financial interest in a company that sponsors the research or owns the technology being studied. A conflict of interest arises when a researcher is or may be in a position to put his or her own interest before the best interests of research subjects. To manage such conflicts, the IRB must be informed of potential conflicts of interest. Researchers submitting protocols using human subjects must disclose all interests that may be perceived as a conflict with the best interest of the subject in order for the research to be considered for approval.

It is up to the IRB, not the investigator, to make the final determination as to if an actual, potential or perceived conflict of interest is significant enough (or of the mitigation plan worked in conjunction with the Institutional Official or research sponsor is sufficient enough) to require additional steps to be taken to minimize the potential for bias or harm; however, the IRB would usually support any efforts volunteered by the investigator.

In the event the conflict cannot be eliminated, for the study to be approvable, the IRB must be assured that the potential conflict of interest is managed to the point that any potential effects to human subject protections are minimized. The circumstances of the protocol, the subjects and the nature of the conflict will determine the best management plan for the conflict; some examples include:

  1. Disclosing the potential conflict of interest during the Informed Consent process.
  2. Having another non-conflicted person perform informed consent interviews or collect data.
  3. Establishment of a more sufficient monitoring plan.

IRB Member Conflicts of Interest

An IRB member conflict of interest is defined as “…any situation or relationship that biases or has the potential to bias the conduct or outcome of IRB review” (Institutional Review Board Management and Function 2022, 935). Management of IRB member COIs is outlined in the Common Rule (45 CFR 46.107(d)) and the FDA regulations (21 CFR 56.107(e)).

IRB members are determined to be conflicted when: (1) they have a proprietary interest in the tested product, including, but not limited to, a patent, trademark, copyright or licensing agreement; (2) they are involved in the design, conduct, or reporting of the research; (3) they are in a subordinate role to the investigator (i.e., employee, student, etc.); or (4) they have any other interests that would impair their ability to make fair and impartial judgments about an application.

For a conflicted IRB member whose role is limited only to voting on the study, the risk must be managed via the following without exception:

  1. The conflicted member(s) may not serve as the primary reviewer, expedited reviewer, determiner of exempt status or consultant for the given research activity.
  2. During convened meetings, the conflicted member(s):
    1. May provide information germane to the discussions but must leave the meeting room during deliberations and voting; AND
    2. Are not counted towards a quorum, thus a quorum must be re-validated after they leave in order to vote, AND;
    3. Documentation of such absence must be in the minutes.

No person may use their authority to unduly influence how individual IRB members vote and that any violation of this policy should be immediately reported to the IRB Manager and/or the UM Institutional Official. Depending on the severity and circumstances, the outcome of such investigations could range from requiring education to disciplinary action.

Noncompliance with this Policy

The IRB (or designee) shall assist the 91次元 in any retrospective review they are required to do for DHHS or other funded studies when notified of any of the following:

  1. that an Investigator failed to disclose (or inaccurately disclosed) to the IRB a significant financial interest that is determined by the Institution (or IRB if assigned to do so by Institution) to constitute a financial conflict of interest;
  2. that the IRB failed to review or manage such a financial conflict of interest; or 
  3. that the Investigator failed to comply with a financial conflict of interest management plan.

The IRB shall be involved, as necessary, in the 91次元 drafting of any corrective and preventative action plans.

5. Amendments to Policies and Procedures

The IRB Chair and Manager shall review UM-IRB’s policies and procedures at least every 5 years, or sooner if necessary, to monitor potential updates and/or modifications of said policies and procedures.