Official Charge from KU Governance Document
Scope and Purpose
Note: This document represents the general outlines of the scope and purposes of the Kaplan Institutional Review Board (IRB) and is not to be considered a binding policy document. Policies, procedures and instruments to facilitate those policies and procedures will be developed in line with the scope and purpose of the IRB by the active members of the IRB and will be published out to the Kaplan University community, as well as forwarded to the OHRP for assurance review.
Official Charge from KU Governance Document:
1.2.8 Institutional Review Board
1.2.8.1 The Institutional Review Board (IRB) is responsible for approving research studies that involve Kaplan University students. The Director of Institutional Research and Assessment, who chairs the IRB, is responsible for calling quarterly meetings or at such times as is deemed necessary. Members of the IRB will consist of the following:
§ Director of Institutional Research and Assessment—Chair
§ Dean of Graduate Studies
§ Director of the Center for Teaching and Learning
§ Vice President of Legal and HR or delegate
§ Associate Researcher (non-voting)
§ Outside community member appointed by the Chair for a one-year term
§ Graduate Administrative Council Member (elected by the Graduate Council for a one-year appointment)
§ One graduate faculty member elected by the full-time graduate faculty to specifically represent each of the graduate schools (staggered two-year terms)
§ Two undergraduate faculty members elected by the full-time undergraduate faculty (staggered two-year terms)
§ Two at-large, non-voting representatives appointed by the Chair for one-year terms
§ One part-time core faculty member appointed by the Chair of the IRB.
Introduction:
As reflected in the Kaplan University mission statement, scholarly inquiry is essential to the activities of our academic community. This inquiry, its methods, and the objects of its study may be quite different within the various academic departments across the University; however, given our institution’s focus on student-centered, online education, investigations involving human subjects is of central importance to our entire community as we work to accomplish the mission and purposes of the University, and to share that knowledge with larger communities. In the conduct of research, each faculty member, student, and investigator is responsible for the academic integrity, quality, validity, reliability, and merit of their own work, and also are responsible for safeguarding the rights, privacy and well-being of their research subjects. The Kaplan University Institutional Review Board (IRB) has been created to support, guide and oversee research at, or in coordination with, the University in order to help researchers insure that they meet these responsibilities.
The charge and purpose of the Institutional Review Board (IRB) at Kaplan University is to provide informed and independent review, and ongoing monitoring of activities that involve the use of human subjects in research as defined and discussed in the Department of Health and Human Services (HHS) regulations for the protection of human subjects (45 CFR Part 46). This includes all human subject research conducted under the direction of any employee or agent in connection with his/her institutional responsibilities or use of the University’s name or academic or non-academic titles.
Role and Scope:
The Institutional Review Board (IRB) will ascertain the acceptability of all proposed human subject research at Kaplan University in terms of institutional commitments and regulations, applicable law, and the standards of professional conduct and practice. The IRB will be primarily concerned with the protection (level of risk) of human subjects in research.
The Institutional Review Board is guided by the ethical principles regarding all research involving humans as subjects set forth by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in Ethical Principles and Guidelines for the Protection of Human Subjects of Research: The Belmont Report. The Belmont Report includes such principles as respect for autonomy, beneficence, and justice to guide research involving human subjects. In addition, the IRB will attempt to assure compliance with the requirements set forth in Title 45, Part 46 of the Code of Federal Regulations (CFR).
Safeguarding the rights and welfare of human subjects in research is a general institutional policy delegated by the Provost to the Institutional Review Board (IRB). Any research project involving human subjects which is conducted by Kaplan University faculty, staff, or students is subject to review and approval by the IRB. In addition, any data that is to be obtained and/or collected from Kaplan University faculty, staff or students is also subject to review and approval by the IRB. In order to approve proposed research protocols, the IRB shall determine that all of the following requirements are satisfied:
§ Risks to subjects are minimized by using tests or procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risks, and whenever appropriate, use tests or procedures already being used for learning purposes.
§ Risks to subjects are reasonable in relation to the anticipated benefits, if any, to subjects, and the importance of knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB shall consider only those risks and benefits that result from the research (as distinguished from risks and benefits of interventions subjects would receive even if not participating in the research).
§ Selection of the subjects is equitable. In making this assessment, the IRB shall take into account the purposes of the research and the setting in which the research will be conducted.
§ Voluntary informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by 45 CFR 46.116.
§ Informed consent will be appropriately documented, in accordance with, and to the extent required by 45 CFR 46.117.
§ Where appropriate, the research plan makes adequate provision for monitoring the data collected to attempt to insure the safety of subjects. If any serious breech in the procedure or harmful event occurs with a subject it should be reported to the IRB as soon as possible.
§ Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. Where some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as persons with acute or severe physical or mental illness, or persons who are economically or educationally disadvantaged, appropriate additional safeguards must be included in the study to protect the rights and welfare of these subjects.
In addition, since the quality of the research findings reflects on the quality of our institution, and supports the use of the research to improve our institution, and most important the impact of that improvement on student learning, the Kaplan University IRB also will be concerned with the following:
§ Examining the validity and reliability of instruments used in research activities;
§ Examining the quality of the design and methodology of research; and
§ Examining the feasibility of all research conducted on Kaplan populations.
§ Further, as the edification of our students, faculty and colleagues at Kaplan University is part and parcel of our mission and a primary focus of research conducted, or through, Kaplan University, the IRB also will be concerned with the following:
§ Identifying methods to educate students, faculty and other stakeholders participating in research about the research being conducted; and
§ Communicating to Kaplan community the results and methods of the research undertaken.
Establishment of an Institutional Review Board:
The University will designate an Institutional Review Board Administrator from the University community whose experience in research and its ethical conduct is recognized by her or his colleagues and who is capable of expeditiously moving the work of the committee. The IRB Administrator will act as University liaison on issues and policies regarding the protection of human subjects with government and private funding agencies.
The Institutional Review Board will consist of at least 10 members including a chair and a vice-chair. The members will represent areas of expertise from which protocols are expected to be generated. The IRB may not consist entirely of men, women or members of one profession. The IRB shall include at least one member whose primary concerns are in non-scientific areas (e.g., lawyer, ethicist, member of the clergy). The IRB shall include at least one student member. The Board may invite individuals with competence in special areas to assist in the review of complex issues that require expertise beyond that available on the Board. That invited individual may not vote. The IRB may not have a member who participates in the IRB's initial or continuing review of any project in which the member has a vested interest, except to provide information requested by the IRB. The specific make up of the IRB is detailed in the table below:
The IRB will establish and review the written procedures that those engaged in research involving human subjects must utilize in applying for committee approval. These include policies and procedures for investigators seeking:
a. Exemption from review
b. Expedited review
c. Full Board review
d. Continuing Review of protocol approval
e. Amendments of approved protocol
The Institutional Review Board office will maintain:
§ Copies of all research proposals reviewed, supporting documentation, progress reports and injury reports.
§ Summary form for the completed or terminated research upon completion of the research project.
§ Minutes of IRB meetings that include attendance, actions, voting records, bases for any required changes and summaries of controversial issues and resolutions.
§ Copies of correspondence between the IRB and investigators.
§ A list of IRB members identified by earned degree, representative capacity, indications of experience (licenses, certifications and current employment title).
§ All records shall be retained for at least three (3) years after completion of research.
§ All records must be maintained in a secure space that guarantees privacy and confidentiality to the human subjects involved.
§ All records shall be accessible for inspection by authorized personnel. Authorization must be granted by the IRB Chair.
Minutes of all meetings are sent to the Provost. A brief annual report is sent to the Provost. The IRB will monitor as appropriate those research situations where human subjects are placed at substantial risk to verify that consent is being properly attained and protocol properly adhered to.
The Institutional Review Board will attempt to satisfy federal regulations and the requirements of federal, state, local, and private funding sources. More importantly, the establishment and the conscientious work of the IRB will demonstrate Kaplan University’s commitment and dedication to research conducted in an ethical manner.
Meetings
The IRB will meet one time per month via conference call, on the second Wednesday of the month at 1:00 pm. IRB members will receive reminder notices and researchers who wish to make a presentation in support of their proposal review request will be notified at least five (5) working days prior to the meeting. If a conflict exists with the scheduled meeting, IRB members must respond in writing and are encouraged to offer comments on any proposal(s) to be discussed at the meeting. Such correspondence from members shall become part of the documentation of the project review. Minutes for the meetings will be recorded and shared with the IRB. The IRB will also be available on an ad hoc basis.
Duties and Responsibilities
The IRB will review all proposals involving human subject research conducted at Kaplan University and/or in collaboration with other institutions. The IRB will approve, require modifications or disapprove all research activities that involve human subjects. The IRB will notify applicants of decisions made by the board concerning their proposed research. The IRB will conduct periodic reviews of on-going research projects and maintain records of review proceedings, decisions and activities, in accordance with Federal and University guidelines, for at least three (3) years following termination of projects.
Legal Review of Proposed Research Protocols
All proposed research protocols need to be reviewed by the Legal Department of the University in accordance to company policy which will occur simultaneously with the IRB review process.
Policy on the Use of Human Subjects in Research
According to 45 CFR 46.102(f), a human subject is defined as a living individual about whom the investigator (whether professional or student) conducting research obtains either (1) data through intervention or interaction with the individual or (2) identifiable private information.
§ Intervention generally includes both physical procedures by which one gathers data and manipulations of the subject that are performed for research purposes.
§ Interaction includes communication or interpersonal contact (e.g., questionnaires, interviews, surveys) between the investigator and the subject.
§ Identifiable means that the identity of the subject is or may be readily ascertained by the investigator or associated with the information.
§ Private information includes behavioral information within a context in which the individual can reasonably expect that no observation or recording is taking place. Thus, the individual will have provided information for specific purposes and can reasonably expect that information associated with his or her identity will not be made public.
According to 45 CFR 46.102(d) research is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”.
Any activity that meets this broad criterion and that is conducted by Kaplan University faculty, staff or students or that uses Kaplan University faculty, personnel or students is considered research and is subject to IRB approval. It does not matter whether the activity takes place within or as part of another activity (for instance, within the classroom setting) or whether the research is the whole of the project.
Instances of Non-Research
There are numerous forms of data gathering from human beings that do not constitute research, such as:
§ Data gathering for classroom training in research methods for which the only foreseeable purpose is teaching.
§ Data gathered for administrative purposes alone within the context of the normal efforts of a department or an institution to find out what is happening or how to improve services or operations. No dissemination of the information outside the unit or institution is foreseen or anticipated.