Stony Brook University Committees on Research Involving Human Subjects (CORIHS) |
General Information |
This handbook is an elaboration of campus policy P202R titled "Research Involving Human Subjects". This policy applies to all University faculty, staff and students using University facilities, the facilities of another institution, or any other off-campus site. The policy also applies to visitors and users of the campus or off-campus University facilities. Stony Brook University has a Federal-Wide Assurance (FWA #125) on file with Office for Human Research Protections (OHRP; subdivision of the Department of Health and Human Services). This document provides written assurance that all research conducted at this institution that involves human subjects will be in compliance with the Federal Policy for the Protection of Human Subjects, specifically 45CFR46, and 21CFR50 and 21CFR56 (for clinical research activities regulated by the FDA). The basic ethical principles that underlie the Federal Policy are summarized in The Belmont Report. These regulations, specifically covering research from grants funded by the National Institutes of Health, have been adopted by Stony Brook University to cover ALL research activities involving human subjects, regardless of source of funding. CORIHS operates in compliance with Sections 3 and 5.11 of the International Conference on Harmonization (ICH) The Committees on Research Involving Human Subjects (CORIHS) are the only designated Institutional Review Boards for the University. CORIHS is charged with the responsibility of protecting the rights and welfare of human subjects involved in research, as mandated by OHRP, the Food and Drug Administration and the State of New York. The makeup of CORIHS' membership, and the number of members on the committees is in accordance with the Federal Policy. Members of CORIHS are appointed by the Institutional Official, as designated on SBU's FWA, following consideration of recommendations from applicable administrators, current IRB members, and/or members of the community (for non--University positions). Members are appointed for a renewable, two year term. All members have full voting rights; no proxy voting is permitted. Attendance records and member contributions to the committee are reviewed by the Institutional Official, with consultation with the CORIHS chairs as needed, to determine if appointments will be renewed. Appointments of Chair and co-Chair are made by the Institutional Official whose decision is based on length and quality of service to the committee, as well as leadership ability. There is no remuneration for individuals serving as CORIHS members. No CORIHS member participates in the review of any study on which s/he is an investigator or co-investigator or where a potential for conflict of interest exists. The chair of one IRB shall serve as alternate chair on the other IRB for:
Since the 2 CORIHSs are constituted committees of the State University of New York (SUNY), liability coverage is provided by SUNY for members serving on the committee (excluding personal liability coverage). The Institutional Official, or his/her designee conducts an orientation for new members in which training and relevant materials are provided (Belmont Report, federal regulations, University Policy, CORIHS Guidelines), and the details concerning committee function and procedures are discussed. The new member is mentored and attends at least one CORIHS meeting for the purpose of observation, without participating in the review of studies. CORIHS may, at its discretion, invite individuals with competence in special areas (Consultants) to assist in the review of complex issues that require expertise beyond, or in addition to that available on the committee. The consultant does not take part in voting with the committee. Similarly, investigators may request, or be invited, to attend CORIHS meetings to clarify issues with the members concerning their proposed research activity. Such guests do not take part in committee deliberations or voting. CORIHS reports to the Institutional Official for Human Subject Protections (IO). The IO, in turn reports to the Vice President for Research (VPR). The IO attends CORIHS meetings, and, along with the VPR, is kept apprised of committee actions via receipt of all committee minutes. The IO and VPR are consulted regularly on matters pertaining to human subject protections. The Office of Research Compliance (ORC), within the Office of the Vice President for Research is responsible for regularly monitoring CORIHS' and investigator compliance, and updating CORIHS' policies and procedures with current and/or new relevant federal or state regulations. Administrators within the ORC, who serve as IRB members (one on each committee), serve as liaisons between the research investigators and CORIHS. The administrators provide administrative and secretarial support for the committee, and assist the investigators through the application and approval process. They act on behalf of the committee and University when providing assurance of human subjects approval to sponsoring agencies, or when dealing with regulatory agencies. CORIHS routinely circulates important correspondence pertaining to research involving human subjects to the CORIHS-approved investigators and Chairpersons within the University for circulation to their faculty. Chairpersons are often copied on correspondence that deal with matters affecting their faculty. The ORC administrators frequently meet with Chairs, their administrative assistants, and their faculty to discuss CORIHS policies and procedures, and federal regulations that govern clinical research. The Human Radiation Research Committee (HRRC) was established March 2007. The HRRC is a sub-committee of, and reports to, the CORIHS committees. All research procedures involving ionizing and non-ionizing radiation (radioactive materials) must be reviewed and approved by the HRRC prior to commencement. The only exceptions are studies originating at Brookhaven National Laboratory, which undergo a distinct review through that entity. The ORC will review all submitted IRB proposals for use of radiation/radioactive use and will forward copies of applicable studies to the HRRC for review. HRRC findings will be sent by the ORC to the investigator for appropriate action. IRB and HRRC modifications must be satisfied in order to secure IRB approval for the activity in question.
Stony Brook University uses IRBNet as its electronic web-based program for the paperless administration and management of IRB processes. Information and guidance pertaining to use of the program is available at http://www.stonybrook.edu/research/irbnet/. Applications and necessary forms should be obtained directly from the IRBNet site to ensure that the most current versions are being used. Outside Entities Proposing Use of SBU Faculty, Staff, Students or Facilities for Research Purposes: There are times when outside entities wish to involve some aspect of our campus community in research activities that don’t otherwise involve SBU. Another university may wish to have our students fill out a survey for a study they are doing on college students. Or a national organization wants to assess undergraduate programs across America and wants to ask our faculty some questions.
SBU becomes ‘engaged’, and SBU IRB approval is required, when the proposed activities requested by the outside entity require that an SBU-affiliated individual, e.g.,:
Alternatively, SBU is not ‘engaged’, and SBU IRB approval is not required, when the proposed activities require that an SBU affiliated individual only, e.g.,:
It is important to note that even if we are not ‘engaged’ in the research activity and IRB approval is not required, approval for the outside entity to come on to campus (e.g., set up a table, post ads, stand in the SAC and hand out flyers etc) will be required by the Office of University Affairs. General (not study-specific) correspondence to the IRBs may be directed to: Office of Research Compliance Return to Human Subjects Research at SBU |