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  • Policies

Institutional Review Board

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  • Policies

    Definitions of Pertinent Terms

    Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. (45 CFR 46.102)

    Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data or private information. (45 CFR 46.102)

    Risk means the extent to which a human, subject to research procedures, may be exposed to physical, psychological, or other types of harm.

    Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (45 CFR 46.102)

    Informed consent means subjects’ willingness to participate after the researcher communicates to subjects, in language they can understand, information that the subjects may reasonably be expected to desire in considering whether or not to participate, and that minimizes the possibility of coercion or undue influence.

    Assent means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

    Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research.

    Confidentiality
    pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure.

    Privacy is the control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.

    Protocol is the formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data.

    Institutional Review Board is the specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research.

    Full Review means a review of proposals by the entire IRB. This will be conducted for research that involves greater than minimal risk,, or the research is of a psychologically sensitive nature.

    Expedited Review
    means a review by the chair of the IRB and/or one other member of the IRB for research that involves no more than minimal risk, or to review minor revisions in previously approved research, or review revisions for proposals that were approved with contingencies.

    Exempt Status means a research proposal where the subjects are at no more than minimal risk, the subjects' confidentiality is maintained, and the proposal meets one of the six criteria for exemption.

    Jurisdiction of the IRB

    When the University, employees and students, are involved in research conducted with human subjects, the research activity must be reviewed by the IRB. The IRB has the authority to approve, require modification in, or disapprove of all such research activities. The IRB has the authority to suspend or terminate approval of research that is not in compliance with the IRB's determinations and is, or has been, associated with unexpected risk to subjects. For IRB purposes these decisions are based on the criteria set forth in the federal regulations.

    Human subjects are involved if: 1) there is an intervention or an interaction with a living person that would not be occurring or would be occurring in some other fashion, but for this research, or 2) identifiable private data/information will be obtained for this research in a form associable with the individual. For example, secondary analysis of aggregate data does not require IRB approval. 

    IRB Membership

    The IRB at Minnesota State University Moorhead shall consist of at least five members with varying backgrounds from the full-time faculty in addition to the Dean of Graduate Studies. The membership shall include both sexes, representation from racial and cultural backgrounds, representation from social and natural sciences and non-science areas, at least one person who has had experience in the planning and conduct of research on humans. Appointments to the IRB are for three-year revolving terms. Temporary appointments will be made to complete a term in the instance of a vacancy. Faculty members will be appointed by the President of the University with recommendations being made by the designated faculty bargaining unit. For the purpose of dealing with federal agencies a voting member, having no University affiliation and not a member of a family having an affiliation with the University, shall be appointed by the President. All IRB members are required to complete an OHRP approved on-line training course and submit their certificate of training to the IRB chair within thirty-days of being appointed to the committee. The training program is available at: http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp

    The IRB may, at its discretion, invite persons with appropriate competencies to aid in its review of complex issues, but such persons will not have a vote. DRC Chairs (or a DRC representative) will serve as non-voting, ex officio members to the IRB. 

    IRB Chair Duties

    The IRB has a Chair appointed by the Vice-President of Academic Affairs or designated MSUM institutional official. The IRB Chair is a respected, active member of MSUM who is well informed of regulations relevant to the use of human participants in research. The term of service is at the discretion of the institutional official. Whenever the Chair is not available to conduct IRB business, the Chair may assign an experienced member of the IRB to act as a pro-temp chair.

    Summary: Administers the review of research involving human subjects to ensure compliance with federal, state, and institutional regulations and policies. Works with faculty, principal investigators, IRB staff, administrators, the Departmental Review Committees (DRC), and the Institutional Review Board.

    Specific Responsibilities of the Chair include:

    1. Serve as official University contact for all matters regarding research involving human subjects.
    2. Keep abreast of all changes in the regulations governing human subjects research and keep the IRB ad investigators informed.
    3. Work with other IRB offices and institutional leaders to develop and update campus policies and procedures on the protection of human subjects in research.
    4. Certify that investigators have completed the training program ad are qualified to conduct human subjects research and maintain a roster of qualified investigators
    5. Develop and maintain education and training programs for the IRB members, departmental reviewers, and research investigators who use human subjects.
    6. Screen all proposals submitted, determine appropriate review protocol, assign and monitor reviews, and ensure that all records are maintained in accordance with OHRP requirements.
    7. Conduct the IRB meetings.
    8. Inform the IRB of “Exempt” and “Expedited” approvals.
    9. Track continuing reviews and/or project completion forms.
    10. Train, monitor and advise departmental review committees.

    IRB Meetings

    To conduct the business of the IRB, a majority of its members must be present. The IRB shall approve or disapprove research only with the concurrence of a majority of those members in attendance. The IRB will meet at the call of the Chair.

    Research proposals must be submitted to the IRB at least two weeks before its meeting. Any research proposals submitted to the IRB for a full review will be distributed to the members at least seven (7) days prior to a meeting. Notification of the action taken by the IRB will be sent to the researcher no later than five (5) days after the meeting. Notification will be made in a standard form; notification will, if necessary, include a description of any contingencies and, in the case of disapproval, include a statement of the IRB's reasons. 

    Records of the IRB

    The IRB shall maintain the following records:

    1. Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects.
    2. Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.
    3. Records of continuing review activities.
    4. Copies of all correspondence between the IRB and the investigators.
    5. A list of IRB members in the same detail as described in 45 CFR 46.103(b)(3).
    6. Written procedures for the IRB in the same detail as described in 45 CFR 46.103(b)(4) and 46.103(b)(5).
    7. Statements of significant new findings provided to subjects, as required by 45 CFR 46.116(b)(5).
    8. The records required by this policy shall be retained for at least 3 years, and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. All records shall be accessible for inspection and copying by authorized representatives of the department or agency at reasonable times and in a reasonable manner.