Administrative policy regarding research involving human subjects
(A) Purpose. In order to protect the rights, well-being, and personal privacy of individuals, to assure a favorable climate for the conduct of scientific inquiry, and to protect the interests of the university, the policies and procedures described below have been established for the conduct of investigations and educational projects involving human beings. To implement these policies and procedures, the Kent State University institutional review board (the human subjects review board hereinafter called IRB), under the direction of the provost or designee, will be established. The IRB and policies and procedures are in accordance with United States department of health and human services regulations for the protection of human research subjects (45 CFR 46, as amended).
(B) Responsibilities of the IRB. The IRB, under the direction of the provost affairs or designee, has the following responsibilities:
(1) To review on a continuing basis the university's policies and procedures with respect to the use of human subjects, and to establish guidelines and to make policy recommendations as desirable or necessary;
(2) To review all research projects involving human subjects with authority to approve, require modification, disapprove, or terminate. The IRB must determine that:
(a) Risks to subjects are minimized,
(b) Risks are reasonable in relation to benefits,
(c) Selection of subjects is equitable,
(d) That informed consent is obtained and documents, when appropriate, and
(e) There are adequate provisions to protect privacy of subjects and confidentiality of data.
(3) To provide assistance and advice in research involving human subjects, and to implement the guidelines and policies of the university and the federal government through the office of research and graduate studies which has general administrative responsibility for human subject matters.
(C) General principles. The following general principles apply equally to all research projects involving human subjects, whether carried out solely with university resources or with the assistance of outside funds. The university has responsibility for communicating and explaining these principles to university personnel, and for providing procedural guidelines to effect their observance.
(1) The university and the individual members of its faculty, staff, and student body engaged in research projects recognize their responsibility for protection of the rights and welfare of human subjects.
(2) No investigation shall be initiated until approval has been granted by the IRB.
(3) All externally funded projects involving human subjects will be reviewed before submission of the proposal or within thirty days after submission if allowed by agency guidelines.
(4) Appropriate professional attention and facilities shall be provided to insure the safety and well-being of human subjects. No subject in an investigation shall be exposed to unreasonable risk to physical, psychological, or social health or well-being. In the event of risk it must be determined that the benefits derived outweigh the risks and no appropriate alternative procedures apply.
(5) The confidentiality of information received from subjects in experiments or respondents to questionnaires, profiles and interviews shall be fully protected, both during and after the conduct of an investigation.
(6) The confidentiality of information received from subjects in experiments or respondents to questionnaires, profiles and interviews shall be fully protected, both during and after the conduct of an investigation.
(7) Where a consent form is required, the subject must be provided a copy of the form.
(8) A request by any subject for withdrawal from an investigation shall be honored promptly without penalty.
(9) The university shall negotiate and maintain necessary assurance of compliance as required by the office for protection from research risks, United States department of health and human services.
(D) Scope. It is not the intent of these rules to interfere with the normal delivery of health care and clinical services by members of the university, or with usual instructional practices. Otherwise, this policy applies as follows:
(1) To all research investigations involving human subjects whether supported by university funds, private funds, or governmental funds. This includes graduate theses or dissertations and other student directed research. (For student research the faculty advisor is assumed to be the responsible investigator.)
(2) Investigations conducted by university students in connection with academic work must be supervised by a faculty member, who will refer such proposals to the institutional review board designee for initial review and for decision as to whether full IRB review is necessary.
(E) Procedures. The specific review procedures are as follows:
(1) Experienced IRB members are assigned responsibility for preliminary review of all human subject research in a specified department or group of departments.
(2) Before beginning a project, the investigator shall submit an "Application For Approval To Use Human Subjects In Research" form to the designated reviewer. The investigator shall include in the application a description of all research procedures and the manner in which the rights and welfare of the participants are assured, copies of consent forms, and questionnaires to be used.
(3) The reviewer makes the determination whether the research is level one and exempt from further review and can begin immediately; level two can require expedited approval; or level three requiring full board review for approval.
(4) Upon receiving notification of approval, the investigator can initiate the research project.
(5) Subjects must be informed of the purpose of the research, the procedures to be used, the degree of risk or discomfort and the anticipated benefits. The subject must know that participation is voluntary and that he/she can withdraw at any time without penalty. Consent of the subject is usually documented on a consent form which the subject or guardian signs. The consent form contains the basic elements of informed consent in language understandable to the subject including information on whom to contact for answers to questions or problems.
(6) Any approved investigation which undergoes subsequent modifications affecting the rights or welfare of the human subjects involved must be resubmitted. It shall be the responsibility of the investigator or project director to request such review prior to initiating the modification.
(7) Research involving other than legally competent adults (such as children, people with mental disabilities, etc.) shall require written informed consent from parents, guardian or other appropriate authority as well as the subject's assent.
(a) For the purpose of this rule, “people with mental disabilities” means persons aged 18 and older with any mental or psychological disorder, such as mental retardation, organic brain syndrome, emotional or mental illness, and specific learning disabilities. Or any other condition defined in Title II of the Americans with Disabilities Act of 1990, 28 CFR 35.
(8) Research involving special populations such as pregnant women and prisoners must be conducted in accordance with appropriate regulations.
(9) Approval of a proposed investigation is granted for a period of no more than one year. Continuation or renewal proposals must receive the same critical review as initial applications.
(10) If a subject registers a complaint, the investigator shall attempt to relieve the complaint. If the investigator finds that the complainant cannot be satisfied, the investigator shall refer the complainant to the institutional review board or to the office of research and graduate studies.
(11) If a subject experiences any harm, physical, emotional, or mental, as a result of an approved investigation, the principal investigator must fully report the circumstances to the institutional review board or to the office of research and graduate studies.
Effective: June 1, 2007
Prior Effective Dates: 11/4/1977, 3/11/1982, 7/19/1985, 5/5/1995, 12/20/2004