About the Institutional Review Board
Table of Contents
About Human Subjects Research
IRB Authority and Responsibilities
Composition of the Institutional Review Board
Confidentiality of The Review Process
The Office of the Vice President for Academic Affairs is responsible for the administration of research ethics at Northeastern State University. This Office oversees the functioning of the Institutional Review Board (IRB). Representatives from various academic and scientific disciplines, as well as members from outside the academic community compose the IRB. The IRB is responsible for conducting initial and continuing reviews and providing oversight for all research activities involving the use of human subjects performed on any NSU campus. The IRB reviews human subject research projects according to three principles: first, minimize the risk to human subjects (beneficence); second, ensure all subjects consent and are fully informed about the research and any risks (autonomy); third, promote equity in human subjects research (justice). All human subjects research must be approved by the IRB before data collection can commence. The IRB typically approves projects for one year, thereafter conducting annual reviews. All review procedures will meet or exceed the requirements set forth in 45 CFR 46.
The Institutional Review Board (IRB) shall review and have the authority to approve, require changes in prior to approval, or disapprove research activities involving human subjects which are conducted at or sponsored by Northeastern State University, including research activities (a) performed by NSU faculty, staff, and/or students, (b) performed in Northeastern State University facilities, or (c) otherwise supported by University resources which are under the control of NSU officials. The IRB shall also have the responsibility and authority to adopt appropriate procedures adequate to assure compliance with the approved consent process and other requirements for the protection or human subjects.
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To fulfill the requirements of DHHS regulations and this policy, the IRB shall have the following authority and responsibilities:
1. The IRB shall have the responsibility to review and the authority to approve, require modification in, or disapprove all research activities covered by this policy.
2. The IRB shall approve or disapprove proposed research activities based on the criteria given in this guide.
3. Except when an expedited review is used, the IRB shall review proposed research at convened meetings at which a quorum of the members of the IRB are present. For the research to be approved, it must receive the approval of a majority of those members present at the meeting.
4. The IRB shall not allow any member to participate in the initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
5. The IRB is responsible for reporting to the Vice President for Academic Affairs any serious or continuing noncompliance by investigators with the requirements and determinations of the IRB.
6. The IRB shall have the authority to observe or have a third party observe the consent process and the research.
7. The IRB shall conduct continuing reviews of research at intervals appropriate to the degree of risk but not less than once per year. The IRB shall have the authority to determine which research requires review more often than annually.
8. The IRB shall determine which research projects need verification from sources other than the research investigators that no material changes have occurred since the previous IRB review and shall have the authority to obtain that verification.
9. The IRB shall have the authority to suspend or terminate approval of research that is not being conducted in accordance with this policy and the IRB decisions, conditions, and requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of reasons for the IRB action and shall be reported promptly to the investigator and appropriate NSU officials.
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The Northeastern State University IRB is appointed by the President, and composed of a sufficient number of members to assure complete and adequate review of research activities conducted at the University. The President appoints members to the IRB so that the membership complies with 45 CFR 46 to include: one member from each College (Education, Liberal Arts, Business and Technology, Science and Health Professions, Optometry, and Graduate), one member representing Psychology, one non-scientist, one community member, and the Chair. Faculty representatives are appointed to the IRB for three years (including the Chair), on a staggered basis with replacement of one-third of the board each year. The Chair must have had at least one previous term as a member of the IRB before appointment to the Chair position. Members may serve two consecutive terms. The community member is appointed on a yearly basis and may be reappointed as necessary.
At the first meeting of the academic year, IRB members will choose a Vice-Chair who is authorized to conduct business in the absence of the Chair. Member files are kept in the Office of Academic Affairs. They include: 1) a letter of appointment, 2) a current curriculum vitae, and 3) documentation of education related to the protection of human subjects. Educational sessions are offered during each academic year to members of the IRB. Members can also complete the online NIH tutorial and receive a certificate which will be kept in their file.
The NSU IRB will hold regularly scheduled meetings each academic year. Scheduled meetings will be announced at the beginning of Fall and Spring semesters.
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During the process of initial or continuing review of an activity, material provided to the Institutional Review Board shall be considered privileged information and the Board shall assure the confidentiality of the data contained therein.
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