Back to IRB Handbook Table of Contents
What is the Human Subjects Review Board?
The Human Subjects Review Board (HSRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research conducted by faculty, staff and students at Kent State University.
Research is defined by federal regulations as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." The question to ask is "what will be done with the data collected?" If it will be disseminated by making a presentation, publishing or writing a class paper, it is considered research and must be reviewed by a departmental reviewer who serves on the Human Subjects Review Board.
Every other week during the academic year the HSRB meets to review Level III protocols, accept Level II reviews, approve annual reviews and modifications to existing protocols.
The Kent State HSRB has 18 members, 13 of whom are designated as departmental reviewers. The departmental reviewers are experienced researchers who are highly qualified to determine the level of research risk. Their selection is based upon the referral of a Board member and approval of the Vice Provost and Dean, Research and Graduate Studies. Also on the Board are two physicians, a non-affiliated representative, the chairperson of the HSRB and the Research Subjects Administrator. The Board is composed of both men and women of various ethnic backgrounds. A current vita of each member is kept on file in the office of Research and Graduate Studies.
Terms are for four year periods and members can be reappointed. Attendance is required at all meetings. The Research Subjects Administrator must be notified if a member is going to be absent. If a member has more than three unexcused absences, he/she will be removed as a full member and placed on alternate status for a period of one year, after which he/she will be dropped from the Board roster.
Members are expected to have knowledge of current regulations, policies and procedures regarding the protection of humans sued as subjects in research projects. In addition, the reviewer is expected to assist the investigator in meeting the requirements for approval as well as maintaining professional ethics for research. The reviewers' primary obligation is to ensure that the subjects' rights and welfare are protected and that risks are minimized and reasonable in relation to anticipated gains. Reviewers must be able to serve as resource persons for their department or school. A board member cannot review a research project in which he/she is involved as a project director, faculty advisor, or subject.
The Board may invite individuals with special competencies to assist in the review f complex areas that require expertise beyond or in addition to that available on the Board. These individuals may not vote with the Board. A physician must attend Board meetings at which projects involve drugs or medical procedures are reviewed.
Meetings of the Human Subjects Review Board are held biweekly during each semester and as needed during the summer. Members will be contacted about their availability for meetings before the beginning of each semester. A reminder will be sent to members one week before each meeting, which should be singed and returned to the Research Subjects Administrator indicating whether or not the member will be able to attend. Projects using human subjects should be reviewed by a departmental reviewer and sent to the RSA one week before the scheduled meeting. Projects will be copied and mailed to Board members at least four days before the meeting. Level III reviews and any changes to Level III protocols will be reviewed by the full Board. The Board will be notified of all Level II reviews and annual reviews for continuing Level II and Level III projects that have taken place since the last meeting. Members will also receive an agenda and a copy of the minutes of the previous meeting.
Meetings and minutes are open to the public.
A quorum consists of one-half the Board membership plus one. A majority of votes is required to pass a motion. All Board members are eligible to vote. The Chair will vote in a tied vote situation.
An explanation must be given for all negative votes cast so Board records will indicate the concerns that led to the negative vote.
A member may not vote on any project in which he/she is involved as a project director, co-director, assistant, faculty advisor or subject.
The Board will vote to:
1. Approve. Research proposal is approved as submitted.Notification of Board Action
The project director will be notified in writing of the Board's decision to approve, disapprove or revise consent forms, introductory letters, etc. If the Board disapproves a project, a statement of the reasons for its decision will be given to the project director and he/she will have an opportunity to respond in person or in writing.
Complaints
If the subject or a colleague registers a complaint, the principal investigator will attempt to relieve the problem. If the complaint cannot be satisfied, the principal investigator must refer the complaint to his departmental reviewer. The reviewer will notify RAGS in writing of the problem. The Vice Provost and Dean for Research and Graduate Studies and/or the Chair of the HSRB will discuss the problem with the subject and the investigator. If the problem cannot be rectified, the full Board will then discuss the matter to determine if the research should be allowed to continue. If the proposal is funded, the sponsoring agency will be notified of the problem and the action taken.
Suspension or Termination of Approved Research
The Board has the authority to suspend or terminate research not being conducted in accordance with the Board's requirements or associated with unexpected serious risk to subjects. The Board will notify the project director in writing and will state the reasons for the action. If the research is funded, the Board will also notify the sponsoring agency.
Open the original version of this page.
Usablenet Assistive is a UsableNet product. Usablenet Assistive Main Page.