Jurisdiction of the Institutional Review Board
- 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.
- Certain kinds of research involving human subjects do not require Institutional Review Board approval. These categories of exempt research are described in the Code of Federal Regulations, 45CFR46.101 sections b & i.
- Investigators who wish to conduct exempt research should obtain confirmation from the Institutional Review Board that the research is, in fact, exempt.
- 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.
- The Institutional Review Board will send the investigator a memo confirming or not confirming that the research is exempt.
- Research to meet degree requirements must either be exempt as defined above or must be approved by the Institutional Review Board.
- 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
The Board operates under rules defined in the Code of Federal Regulations 45CRF46, 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
- Except for research exempted or waived under Sections 101(b) or 101(i) of the Federal
Policy, all human subject research will be reviewed, prospectively approved, and subjected
to continuing oversight. 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:
- The need to do experiments in humans as opposed to experimental animals must be demonstrated.
- Risks to subjects must be minimized.
- Risks must be reasonable in relation to anticipated benefits of research.
- Selection of subjects must be fair.
- There must be procedures for obtaining and documenting informed consent.
- There must be provisions to protect the privacy of subjects and maintain confidentiality of records.
- 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.
- The IRB operates by consensus. To be approved proposals must receive the unanimous approval of a quorum of Board members at the meeting at which the proposal is considered. Any member's request for clarification or revision of an application will be included in the IRB's final decision. In the event that the IRB cannot arrive at a unanimous position, a vote will be taken. In this case, a proposal can be approved by a majority (> 50%) of those present at the meeting.
- Within 10 days of Board review, investigators will receive written notification of approval, disapproval or the changes necessary before approval will be given.
- Approvals are for a period of one year, unless the Board votes to impose a shorter period of approval.
- Investigators will be given an opportunity to appeal any disapprovals or unfavorable decisions of the Board.
- 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.
- Such proposals will be reviewed by at least two members of the Board with the following
- The reviewers will unanimously approve or disapprove the proposal. Either reviewer may require that modifications to the proposal be made prior to approval.
- 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.
- 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 will be the same as for applications reviewed by the full committee.
- Minor changes in previously approved research may be reviewed and approved by the Chair.
Research Involving Students
- 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.
- 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.
- If compensating subjects for their participation is necessary and appropriate, the best form of compensation is cash.
- 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.
- Except where specifically waived or altered by the IRB under Sections 101(i), 116(c)
and (d), 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:
- Identification as research; purposes, duration, and procedures; procedures which are experimental.
- Reasonably foreseeable risks or discomforts.
- Reasonably expected benefits to the subject or others.
- Alternative procedures or treatments, if any, that might be advantageous to the subject.
- Extent of confidentiality to be maintained.
- Whether compensation or medical treatment are available if injury occurs (if more than minimal risk).
- Whom to contact for answers to questions about the research, subjects' rights, and research-related injury.
- Participation is voluntary; refusal to participate, or discontinuation of participation, will involve no penalty or loss of benefits to which subject is entitled.
- When appropriate, additional elements per Section 116(b) of the Federal Policy.
- 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/
- Investigators must obtain Board approval before beginning research.
- Investigators must obtain informed consent in the manner approved by the Board.
- Investigators must keep records of numbers of subjects studied and any adverse reactions.
- Investigators must monitor subjects for and immediately 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.
- 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.
- Investigators will be informed of the above investigator's responsibilities.
- 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.
- 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.
- Examples of violations include but are not limited to:
- Doing human research without prior approval of the Board.
- Doing research in a way different from that described in the approved proposal.
- Failure to follow approved informed consent procedures
- Failure to report adverse reactions, injuries, breaches of confidentiality or detrimental effects.
- Doing research after approval has expired.
- Violations will result in immediate termination of approval to do the research and will be reported to the Office of Research and Development and the Office of Academic Affairs at Montana State University.