Jurisdiction of the Institutional Review Board

  1. All research (except as exempted under part B) conducted by faculty, students and staff of Montana State University that involves human subjects must be approved by the Institutional Review Board. 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 Institutional Review Board review and approval. These categories of exempt research are described in the Code of Federal Regulations, 45CFR46.104.
    1. Investigators who wish to conduct exempt research should obtain confirmation from the Institutional Review Board that the research is, in fact, exempt.
    2. To obtain such confirmation, investigators should inform the Institutional Review Board of exempt research which they are proposing by submitting the request for exemption form.
    3. The Institutional Review Board will send the investigator a memo confirming or not confirming that the research is exempt.
    4. Research  to meet degree requirements must either be exempt as defined above or must be approved by the Institutional Review Board.
    5. Classroom  activities and laboratory exercises in which the students serve as subjects should be limited to exempt procedures. Lists of such exempt procedures including the information in section B above should be submitted to the committee before they are carried out.

Rules and Regulations Governing the Institutional Review Board

  1. The Board operates under rules defined in the Code of Federal Regulations 45CFR46, March 8, 1983 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 Board will usually meet monthly, on the third Thursday of the month, and will consider all proposals submitted one week prior to the meeting. Proposals are due by noon on the second Thursday of the month.

Approval and Disapproval of Proposals

  1. Except  for research exempted or waived under Section 104 of the Federal Policy, all human subject research will be reviewed, prospectively approved, and subjected to continuing oversight, as applicable. The Institutional Review Board will have authority to approve, require modifications in, or disapprove the covered human subject research. For a proposal to be approved, its benefits must outweigh the risks to the subjects, it must conform to the ethical principles in the Belmont Report and there must be appropriate methods for obtaining informed consent from the subjects. In summary:
    1. The need to do experiments in humans as opposed to experimental animals must be demonstrated.
    2. Risks to subjects must be minimized.
    3. Risks must be reasonable in relation to anticipated benefits of research.
    4. Selection of subjects must be fair.
    5. There must be procedures for obtaining and documenting informed consent.
    6. There must be provisions to protect the privacy of subjects and maintain confidentiality of records.
    7. There must be appropriate additional safeguards to protect the rights of children, economically or educationally disadvantaged persons, severely ill persons, mentally ill persons and prisoners.
    8. The MSU IRB operates by consensus. To be approved, a protocol must receive a majority vote (>50%) from the members present at a meeting, as long as there is a quorum present at the meeting. To achieve a quorum, at least one more than half the number of regular IRB members (i.e., a majority), including a nonscientist, must be present. The IRB cannot review research if a quorum is not present. The board may lose quorum if members recuse themselves due to a conflict, or if the nonscientist has to leave the room.  If the quorum is lost, then the protocol being considered will be tabled until it can be reconsidered at a meeting where sufficient members are present to meet a quorum, even with recusals. Any member’s request for clarification or revision of an application will be documented in the IRB’s final decision. The numbers of members voting For or Against will be recorded in the minutes.
    9. Consultants: The IRB may use non-member consultants for advice and information in specialized areas as needed. These consultants may be MSU faculty, staff, or students, or may be unaffiliated with MSU. The IRB Chair is responsible for arranging for 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 by phone. 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. In addition, IRB members may directly contact non-member colleagues for information that would be helpful for their reviews; in this case, the IRB member will remind the colleague of confidentiality obligations and will document in the electronic system that an informal consultation took place.

    10. Within 10 days of Board review, investigators will receive written notification of approval, disapproval or the changes necessary before approval will be given. Reasons for disapproval will be communicated to the investigator.
    11. Approvals are for a period of one year, unless the Board votes to impose a shorter period of approval. Approximately one month prior to expiration of approval, the IRB will send renewal forms to the investigator to be returned for reapproval prior to the expiration date. Protocols can be renewed for up to 5 years.
    12. Investigators will be given an opportunity to appeal any disapprovals or unfavorable decisions of the Board.

Expedited Review

  1.  Certain kinds of research involving minimal risks may be approved by expedited review according to the policies and procedures in section 110 of the federal policy.
  2. Such proposals will be reviewed by at least two members of the Board, using the review template, with the following possible outcomes:
    1. The reviewers will unanimously approve or disapprove the proposal.  Either reviewer may require that modifications to the proposal be made prior to approval.
    2. One or both reviewers will recommend that the proposal be reviewed by the full Board, in which case it will be considered at the next meeting.
  3. 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, FDA-funded applications will be the same as for applications reviewed by the full committee.
  4. Minor changes in previously approved research may be reviewed and approved by the Chair.
  5. All members are notified of expedited reviews and their outcomes by listing them on the meeting agenda.

Research Involving Students

  1. Since any request made by a faculty member of a student who is taking one of his or her 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 only 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 Human Research Application.
  3. If compensating subjects for their participation, the compensation must be for the level of participation.
  4. If academic credit is given for participation as a subject in human research, there must be alternative ways to obtain such academic credit and these alternatives must be no more inconvenient, no more uncomfortable, no more risky, and no more time-consuming than 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.

Informed Consent

  1.  Except where specifically waived or altered by the IRB under Sections 116(e) and (f), or 117(c) of the Federal Policy, all human subject research will require written informed consent, in language understandable to the subject (or the subject's legally authorized representative), including the following basic elements per Section 116(a) and (b) of the Federal Policy: 
    1. Identification as research; purposes, duration, and procedures; procedures which are experimental.
    2. Reasonably foreseeable risks or discomforts.
    3. Reasonably expected benefits to the subject or others.
    4. Alternative procedures or treatments, if any, that might be advantageous to the subject.
    5. Extent of confidentiality to be maintained.
    6. Whether compensation or medical treatment are available if injury occurs (if more than minimal risk).
    7. Whom to contact for answers to questions about the research, subjects' rights, and research-related injury.
    8. Participation is voluntary; refusal to participate, or discontinuation of participation, will involve no penalty or loss of benefits to which subject is entitled.
    9. When appropriate, additional elements per Section 116(e) and (f) of the Federal Policy.

Investigator's Responsibilities

  1. Investigators must receive education on the ethical conduct of human research and provide documentation of such education at the time that their proposed research is submitted to the Board. Information about on-line and other sources of education is available from the Institutional Review Board Office or the web site: https://www.citiprogram.org/ 
  2. Investigators must be qualified to perform the proposed research and must obtain Board approval before beginning the research.
  3. Investigators must disclose all conflicts of interest and must develop a management plan for any conflicts relevant to the proposed research.
  4. Investigators must obtain informed consent in the manner approved by the Board.
  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 Board.  If an adverse reaction occurs, the research should be discontinued until the Institutional Review Board has been informed and has given approval to continue the research.
  7. Investigators must report any proposed changes in the experimental protocol to the Board and obtain re-approval before instituting the changes in the experimental design.

Ongoing Review (for FDA-funded protocols and full committee reviewed protocols)

  1. Investigators will be informed of the above investigator's responsibilities.
  2. Approximately one year after the approval of a proposal, investigators will be sent a questionnaire concerning the research.  The response will be reviewed by the Chair or, at his discretion, the Board.  If there are no problems or matters of concern the Chair can re-approve the proposal for a period of one year.  If research is still on-going four years after the original approval, a new application must be submitted.
  3. At the time a proposal is submitted, the Board may request follow-up reports from investigators at shorter intervals than one year.  The Board may also request other mechanisms of oversight for specific proposals.

Violations

  1. Examples of violations include but are not limited to:
    1. Doing human research without prior approval of the Board.
    2. Doing research in a way different from that described in the approved proposal.
    3. Failure to follow approved informed consent procedures
    4. Failure to report adverse reactions, injuries, breaches of confidentiality or detrimental effects.
    5. Doing research after approval has expired.
  2.  Violations will result in immediate termination of approval to do the research and will be reported to the Office of Research Compliance at Montana State University.

Oversight

  •  The MSU IRB reports directly to the Ofice 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.

 

01/24/2019