THE UNIVERSITY OF NORTH CAROLINA AT ASHEVILLE FACULTY SENATE Senate Document Number 0393F Date of Senate Approval 12/2/93 Signature of Senate Chair ___________________________ Date _________________ Action of Vice Chancellor: Approval __________________________________ Date ____________________ Denied __________________________________ Date ____________________ Reasons for denial and suggested modifications: - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Statement of Faculty Senate Action: APC #1: HUMAN SUBJECTS POLICY M E M O R A N D U M To: Faculty teaching courses in which students are required to conduct research projects with human subjects From: UNCA Institutional Review Board (IRB) Subject: Protection of Human Subjects The UNCA Institutional Review Board (IRB) monitors proposals of research conducted at UNCA in order to ensure the protection of individuals who participate as subjects in research projects. Student research, whether conducted as an independent project or as a class requirement, must also safeguard the rights of human subjects. Students conducting independent research projects with human subjects must submit a description of their research to the IRB for review and approval. Forms for this purpose are available from the IRB Chair or the Office of the Vice Chancellor of Academic Affairs. All other student research conducted with human subjects, such as projects required of students in research methods classes, can be reviewed by the course instructor alone, acting as a delegate of the IRB. However, proposed student research that cannot be judged minimal risk (research that produces a risk of harm or discomfort no greater than the risk normally encountered in daily life) must be reviewed by the IRB. In addition, faculty members are always welcome to seek consultation on student research by forwarding a description to the IRB for review. In order to keep the IRB informed about student research projects approved by course instructors, the IRB requests faculty members teaching relevant courses (e.g., research methods courses) to complete the attached checklist during each semester such projects are ongoing. In completing this form, faculty members accept the responsibility for ensuring the protection of human subjects. UNCA INSTITUTIONAL REVIEW BOARD Checklist for Faculty Supervising Student Research Projects Instructions. Please complete this checklist and return to (Chair), IRB. Course number/title ____________________________________ Department ___________ Instructor of course __________________________________________________________ 1. Student research projects are ______ required of all students in class ______ optional 2. Number of students in class conducting research projects __________________ 3. Please describe briefly the type of research projects assigned in this course, e.g., typical activities of human subjects involved in research, nature of data collected. ____________________________________________________________________________ ____________________________________________________________________________ ____________________________________________________________________________ 4. Are all students conducting minimal risk research projects? (Minimal risk means that the risk of harm is no greater than the risks incurred by subjects in their everyday lives.) ______ yes ______ no (If no, student must independently apply for IRB approval) 5. Will all student researchers obtain informed consent from individuals participating in their studies? (Informed consent means that subjects are provided with an explanation of the research, their right to withdraw from participation, and a description of any foreseeable risks of participation.) ______ yes ______ no (If no, please attach explanation) Please read and sign the following: I accept responsibility for ensuring that individuals who participate as subjects in my students' research projects will be protected from physical or psychological harm, including deprivation of normal human rights and freedoms, invasion of privacy, or risks beyond those which they might normally encounter in daily life. _______________________________________________________________________________ Signature Date POLICY FOR THE PROTECTION OF HUMAN RESEARCH SUBJECTS (6/3/93) PURPOSE The protection of the rights and welfare of human subjects of research is the primary goal of this policy. By its adoption the university recognizes the dignity, autonomy and privacy of persons who may become the subjects of research that is conducted under the auspices of UNCA. POLICY The UNCA Institutional Review Board (IRB) is charged with the responsibility of reviewing all research proposals involving human subjects, according to the Code of Federal Regulations (45 CFR 46, June 18, 1991.) These regulations require IRB approval for federally-funded research on human subjects and also require that the Institution have a policy on such studies "regardless of whether the research is subject to federal regulation." (#46.103 (b)(1).) This policy allows departments to adopt their own, more restrictive review procedures. The UNCA policy on human subjects applies not only to the research of individual faculty and staff members but also to the research projects assigned to students. Since most of UNCA's research has in the past involved minimal risk to human subjects, the review procedure for most projects is also minimal. PROCEDURES 1. Before beginning any study involving human subjects, a brief proposal must be submitted to the Chair of the IRB. 2. If the Chair or a delegated member of the IRB determines that the study involves only "minimal risk", approval may be given. "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." (46.102 (i).) 3. If it is decided that more than "minimal risk" to human subjects may be involved, the full IRB will consider the proposal. The research (or faculty member assigning student projects) will be invited to explain the project to the IRB. 4. According to Federal Regulations (46.109), the IRB shall "have the authority to approve, require modifications in (to secure approval) or disapprove all research activity covered by this policy." The Regulations further state that the Institution (UNCA) may reverse an approval given by the IRB, but it cannot overrule a negative decision by the IRB. 5. Independent research projects which individual students design and carry out under faculty supervision must be reviewed and approved by the IRB. 6. All other student research assignments, such as those in research methods courses, etc., will be reviewed by the course instructor, who will be acting as the delegate of the IRB. The instructor will report to the IRB through means of a check list. 7. IRB approval of a project is limited to one calendar year. 8. A quorum shall be a majority of the five members of the IRB. Approval of a project requires the approving vote of the majority of those present. MEMBERSHIP Membership of the IRB shall conform to federal guidelines (46.107). a. There shall be five members, approved by the Chancellor. Faculty members as well as administrative staff are eligible for appointment to the IRB. b. Three-year terms shall be staggered so that at least one is appointed each year. Reappointment to a second term of three years is allowable for the sake of continuity. c. Members shall not be all male or all female. d. There must be representation from the natural science, social science, and humanities areas of the university. e. One member must not be otherwise affiliated with UNCA. DATE __/__/__ IRB NO:_____ A C D COVERSHEET REQUEST FOR REVIEW OF HUMAN SUBJECTS RESEARCH Please submit two copies to the Chair, IRB, c/o Office of Vice Chancellor for Academic Affairs 1. Principal Investigator _________________________________________________ Faculty Advisor (if PI is student) _________________________________________________ 2. Department _________________________________________________ 3. Telephone No. _________________________________________________ 4. Project Title _______________________________________________________________________ 5. Check all that apply: ( ) a specific project ( ) a grant proposal ( ) a protocol change ( ) faculty ( ) staff ( ) graduate student ( ) undergraduate 6. Funding source _____________________________________________________ 7. This is: ( ) a new project ( ) renewal (existing projects must be reviewed annually) 8. Type of Review Requested: ( ) Expedited Review for Minimal Risk Project ( ) Full UNCA uses Title 45 Code of Federal Regulations Part 46, revised June 18, 1991 for the Protection of Human Subjects. _______________________________________________________ Signature of Principal Investigator Date If PI is student, signature of Faculty Advisor Date ------------------------------------------------------------------ 9. IRB Chair recommendation ( ) Expedited Review ( ) Full Review 10. Final Recommendation ( ) Approved ( ) Not Approved ( ) Approved with conditions __________________________________________________________ Chair or Designee Date Second Reviewer - Expedited Review Date EXPEDITED REVIEW MINIMAL RISK RESEARCH "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 and tests." (46.102i) Please discuss in no more than a typewritten page the following items: a. Purpose/objectives of the research b. Methods of data collection c. Subject of study (Please note special precautions may be necessary if research involves prisoners or children) d. Potential harm, if any, for subjects e. Protection of subjects' confidentiality Are subjects offered informed consent, whether written or oral concerning: General purpose of research Foreseeable risks and discomforts to subject Confidentiality Contact person for questions Voluntary participation and discontinuation ______ Yes (please attach copy of statement) _____ No (please explain) Will the subjects be fully aware of their participation in this project, and aware of the general purposes of the research project and methods used in data collection? _______ Yes ______ No If No, please provide an explanation.