Regulations and Training
PROCEDURES FOR THE OPERATION OF THE
UNIVERSITY OF WISCONSIN-SUPERIOR
INSTITUTIONAL REVIEW BOARD FOR PROTECTION OF HUMAN SUBJECTS
Approved by the University of Wisconsin-Superior Institutional Review Board
April 3, 2001
Note 1: IRB Policies for approval of research, criteria for review and approval, submission forms, and examples of informed consent are found in the Policies and Procedures for Research Involving Human Subjects, University of Wisconsin-Superior, revised 4-24-2000.
Note 2: "45CFR46" refers to wording of Title 45 Code of Federal Regulations Part 46 Protection of Human Subjects (1991, with 1998 revision to Categories of Research that May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure)
Composition of the IRB
The Institutional Review Board shall consist of at least six members:
Including "at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas."(45CFR 46.107(c))
Including at "least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution." (45 CFR 46.107 (c))
Including, whenever possible, a diversity of members in consideration of gender, race and cultural background. (45 CFR 46.107(a))
Including, whenever possible, members who are knowledgeable about and experienced in working with vulnerable populations, such as children, prisoners, pregnant women, or handicapped or mentally disabled individuals. (45CFR46.107 (a))
Including members representing graduate programs likely to generate research with human subjects.
Determination of IRB members
The Institutional Review Board is a University Committee, reporting to the Dean of Faculties. Members shall be appointed by the Dean of Faculties.
Length of term.
The term of appointment shall be three years, on a staggered basis, with two new members selected each year. A member may serve a maximum of two consecutive terms. Terms begin with the academic year. The committee will meet only during the nine month academic year.
The chair should provide an initial training session to new members prior to the first meeting of the academic year, and additional training as required by current federal regulations.
The chair should provide a copy of the Policies, the Procedures, and access to 45CFR46 to all committee members, yearly.
The chairperson of the committee shall be elected by the committee for a two-year term of service. The chair shall not normally be drawn from members in their first year of service.
The secretary of the committee shall be elected by the committee and shall keep minutes of the full-board meetings.
A quorum consists of a majority of the committee or four members, whichever is greater, including at least one scientific and one non-scientific member. These members may include the chair. (45CFR46.108(b) requires a majority of the members, including at least one nonscientific member).
Voting shall normally occur by a show of hands, in order that the number of affirmative and negative votes may be recorded.
"In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting" (45CFR46.108(b))
"If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing." (45CFR46.109(d)).
IRB member submitting research proposal
When a member, or the chair, of the IRB is also an investigator or advisor for a proposal being submitted, that member may provide information relating to the proposal. However, the member shall not vote, and will be excused from the room at the time of the vote. (45CFR46.107(e)). The member shall also be excused from serving as part of the process of approval when the proposal is submitted as "exempt" or "expedited".
Exempt and expedited processes.
The chairperson (or an experienced member designated by the chairperson) will review proposals submitted as qualifying for "exempt".
The chairperson and another experienced committee member will review proposals submitted as qualifying for "expedited".
Proposals not approved as exempt or expedited will not be disapproved, but will be referred to the full committee for consideration. Notification and reasons for the modifications or referral will be provided in writing to the investigator. If the proposal is referred to the full committee, the investigator may choose to modify the proposal prior to the meeting of the full committee, as long as normal time lines for submission to the full committee are observed.
Meeting minutes should include an informational record of proposals accepted as "exempt" and proposals approved through the expedited process, as well as those considered by the full board.
For proposals considered by the full board, meeting minutes should include a summary of the discussion (Or an indication of no discussion, if warranted), and a specific accounting of the number of "aye," "nay," and "abstain" votes for the proposal. (45 CFR 46.115 (a) (2))
Notification of Approval/Disapproval
Written notification of approval through the exempt or expedited formats shall be provided by the IRB chair to the principal investigators and to the Dean of Faculties.
Written notification of approval or disapproval by the full board, or of modifications required to secure IRB approval of the research activity, shall be sent by the Dean of Faculties to the principal investigators, with copies to the IRB members.
"If the IRB decides to disapprove research activity, it shall include in its written notification a statement of the reasons for its decision, and give the investigator an opportunity to respond in person or in writing."(45 CFR 46.109 (d))
Modifications of Proposal
Once approved, a research protocol may not be modified without resubmission of the proposal to the committee. The investigator should be reminded of this in writing at the time of approval.
Approval is for no more than one calendar year from the official date of approval. If data collection continues past that time, the proposal must be resubmitted for a continuation. The investigator should be reminded of this in writing at the time of approval. (45 CFR 46.109 (e))
The IRB shall speak only to the issues of appropriate treatment of human subjects. Should any member of the committee wish to provide feedback regarding other aspects of methodology, this should be clearly indicated as informal and not part of the approval process, and the member so involved should make clear that any change in methodology would require a resubmission of the proposal.
A copy of the committee policies, minutes, and proposals received and action taken, shall be filed with the university archivist (Jim Dan Hill Library) at the conclusion of the academic year and kept for at least three years. (45 CFR 46.115 (b)) Records of continuation shall include the initial approved proposal. This filing does not preclude transmission of similar copies to the next chair or secretary.
Support staff, in the form of a project administrator, for the IRB shall be provided through the office of the Dean of Faculties.
Consent of the institution whose members will be asked to serve as research subjects.
Prior to conducting research using human subjects, the investigator shall provide a full description of the proposed research to the institutional representative where data is to be collected, and have this approved. (For example, research by a UW-Superior faculty member using participants from a Veteran's Administration clinic would need approval by the appropriate representative of the clinic.)
(1) When the institution where data is to be collected is other than the University of Wisconsin-Superior, an indication of institutional consent should be provided with the proposal given to the UW-Superior IRB.
(2) When the University of Wisconsin-Superior is the institution both for IRB approval and for data collection, IRB approval will constitute institutional consent. Notification of IRB approval should be sent by the IRB chair to the UW-Superior Assistant Vice Chancellor and Director of Enrollment Services.
(3) When data collection occurs at UW-Superior, but the investigator's Institutional Review Board is elsewhere, the UW-Superior Assistant Vice Chancellor and Director of Enrollment Services is the individual authorized to provide approval.