The use of human subjects in research at UW-Whitewater is governed by the Manual of Policies and Procedures for the Protection of Human Subjects, full copies of which are available from the Graduate Office. Below is an abbreviated version of key parts of the manual. The UW-Whitewater Protocol Packet for the protection of human subjects is available at: http://www.uww.edu/learn/.
The University of Wisconsin-Whitewater encourages and supports free
and responsible investigation by faculty, staff and students. When research
is conducted using University facilities or otherwise under its sponsorship,
the individuals conducting the inquiry act as University representatives.
The policies and procedures of the University of Wisconsin-Whitewater for
protection of human subjects have been established to protect the rights
and welfare of human subjects utilized in research projects. Safeguarding
human subjects protects not only the individual subject, but the researcher
and the institution sponsoring the research project as well.
Any research project, either funded or unfunded, originated at or supported
by the University that involves human subjects must be reviewed and approved
by the Institutional Review Board for the Protection of Human Subjects
(hereafter IRB). Approval by the IRB is required before initiating any
collection of data from human subjects for research purposes. This includes
research involving human subjects conducted by faculty and staff and student
research supervised by faculty or staff. Although some research may be
ruled exempt all research involving human subjects should be submitted
to the IRB for review to determine its status.
INSTITUTIONAL REVIEW BOARD
The Department of Health and Human Services requires that institutions establish an Institutional Review Board for the Protection of Human Subjects and the Board is delegated authority by the Secretary of Health and Human Services to act in assurance and certification in the protection of the rights and welfare of human subjects in research. UW-Whitewater has constituted an Institutional Review Board for the Protection of Human Subjects (IRB), and the composition and procedures for Whitewater's IRB have been approved by the Secretary.
The IRB has authority to approve college level human subject committees
(see below) for description on campus which consist of qualified members
to review certain categories of research and act upon review for approval
or disapproval or recommend final approval to the IRB. College level committees
report in writing a record of their actions to the IRB in a timely manner.
IRB COMPOSITION AND PROCEDURE
In accordance with federal regulations, the IRB consists of members with varying background to promote complete and adequate review of research activities, considering racial and cultural background of members and sensitivity to such issues as community attitudes and safeguarding the rights and welfare of human subjects; the IRB will include persons knowledgeable of institutional commitments, regulations, applicable law and standards of professional conduct and practice to ascertain the acceptability of proposed research.
Members shall serve three-year staggered terms and shall be eligible for reappointment once. The UW-Whitewater Committee shall consist of ten persons:
COLLEGE HUMAN SUBJECTS COMMITTEES
Each college may elect to create a College Human Subjects Committee
(CHSC). The committees shall be appointed by the college dean and consist
of at least five persons from the faculty, academic staff or administrators
who are knowledgeable about human subject research issues. The five persons
may not be all of the same gender nor from the same department. The CHSC
may review some categories of human subject research and agrees to be fully
cognizant of the policies of the University of Wisconsin-Whitewater regarding
the utilization of human subjects in research. Furthermore, the CHSC agrees
to comply with the principles and procedures outlined in the
of Policies and Procedures for the Protection of Human Subjects.
PROJECTS REQUIRING REVIEW AND APPROVAL BY THE UW-WHITEWATER IRB
All research involving human subjects should be examined by the IRB to determine whether or not a formal review is required. In addition, the following projects require formal review:
TIMING OF REVIEW
All research proposals involving human subjects should be reviewed and
acted upon for approval by the Institutional Review Board, the College
Human Subjects Committee, or an instructor with a certificate of course
form authorized by the Institutional Review Board prior to the research
being conducted. In the case of a proposal for extramural funding to a
federal agency, in the event that such prior review and approval is not
feasible before the proposal is sent, the review and approval must be completed
and the Institutional Review Board must submit written certification to
the federal agency within 60 days of the application deadline.
IRB REVIEW OF RESEARCH
The IRB may review and has authority to approve, require modification, or disapprove all research activities involving human subjects. It may require that information given to subjects as part of informed consent is in accordance with regulations. The Chair of the IRB will notify investigators in writing of decisions to approve or disapprove, or modify, and if disapproval, a statement of the reasons for that decision and an opportunity for the investigator to respond. In addition, the IRB will conduct a continuing review of research at intervals appropriate to the degree of risks, but not less than once each year in an ongoing project.
An informational copy of all protocol review forms in which subjects
are students in K-12 schools will be sent to the Director of Student Teaching
and Clinical Experiences after IRB approval. This is to assist in the coordination
and communication regarding relations between UW-Whitewater and area schools.
EXPEDITED REVIEW PROCEDURES
Under an expedited review procedure, the IRB chairperson or one, or more experienced reviewers designated by the chairperson from among members of the IRB, may carry out the review. In reviewing the research the reviewer(s) may exercise all the authority of the IRB, using IRB criteria for approval, except that the reviewers may not disapprove the research. Whenever the expedited review procedure is used, all IRB members must be advised of approval actions on research proposals under the expedited procedure at the next scheduled meeting.
All research eligible for expedited review must meet federal criteria
for expedited review. In addition, proposed human subject research will
receive an expedited review if it has already been approved by a CHSC,
or was previously approved by the IRB but the period of initial approval
has expired and involves very minor or no changes. To receive expedited
review, the research cannot involve more than minimal risks and cannot
involve federal funding.
SUSPENSION OR TERMINATION OF IRB APPROVAL OF RESEARCH
The IRB has the authority to suspend or terminate approval of research
that is not being conducted in accordance with the IRB's requirements,
or that has been associated with unexpected serious harm to subjects. Any
suspension or termination of approval shall include a statement of the
reasons for the IRB's action and shall be communicated promptly to the
principal investigator, to the Chancellor and Vice Chancellor, and the
Secretary of the Department of Health and Human Service for federally funded
DELEGATION OF REVIEW AUTHORITY
In cases of cooperative research, ordinarily a review of the IRB of
each institution involved will occur. The UW-Whitewater IRB may decide
to delegate review to another qualified IRB to avoid unneeded duplication
and effort. The UW-Whitewater IRB must approve such delegation to the IRB
of a cooperative institution in writing.
SUMMARY OF THE REVIEW PROCESS
Faculty or staff who plan to conduct research using human subjects should pick up a copy of the UW-Whitewater IRB Review Form and complete it. Faculty or instructional staff who will be having students conduct research should also obtain a copy of the UW-Whitewater IRB Student Protocol Review Form. Copies of the forms are available from the Graduate School or College Human Subject Committees where they have been formed. The forms with attached copies of accompanying documents (e.g. survey questionnaires, parent permission forms) will permit a speedy review of human subject research procedures and provide a written record of the decision-making process. Completed forms should be submitted to the Graduate School for the University IRB or to a College Human Subject committee.
Proposed research involving human subjects can be approved in three ways:
GUIDELINES FOR CERTIFICATION OF COURSES INVOLVING HUMAN SUBJECTS RESEARCH
The instructor must submit the Certification of Course Form for the Protection of Human Subjects (which may be obtained from the Graduate School) prior to the initiation of any data collection by students even though said data is intended for instructional purposes only. Further, an instructor shall not allow student research projects to begin until course certification approval has been received. This form must be submitted every two years by the instructor of each course in which instruction-related research is performed. If more than one instructor teaches a section of the same course, each instructor must submit the Certification of Course Form. The submission of this form through appropriate channels will certify to the IRB that the instructor is fully cognizant of the policies of the University of Wisconsin-Whitewater regarding the utilization of human subjects in research.
Furthermore, the instructor will certify to the IRB that she/he will
exercise reasonable and customary instructional supervision in an attempt
to ensure that all student research projects will be conducted in compliance
with these policies. Faculty and instructional staff who utilize the course
certification process are responsible for informing their students about
all regulations contained in The Manual of Policies and Procedures for
the Protection of Human Subjects. NOTE: ALL undergraduate independent
study projects involving the use of human subjects must be individually
approved by the IRB or CHSC before a student can begin her/his data collection
GRADUATE STUDENT RESEARCH
Research projects involving human subjects that are conducted by graduate
students as part of independent study or thesis research must be submitted
for IRB review. In such cases the graduate student must name a faculty
advisor or instructor employed by UW-Whitewater who shall serve as a co-principal
investigator. The advisor or instructor shall use reasonable and customary
care to supervise the design and conduct of research to ensure that it
is conducted in a responsible, ethical manner.
SOURCE: Office of the Provost and Vice Chancellor for Academic Affairs
It shall be the policy of the University of Wisconsin-Whitewater that whenever human blood or other invasive procedures are used in an academic setting whether for the purpose of instruction, research or service that the rights and the health and safety of the human subject be first and foremost protected.
The following procedures will be followed when conducting human testing or experimentation involving blood and/or invasive procedures:
SOURCE: Office of the Provost and Vice Chancellor for Academic Affairs
It shall be the policy of the University of Wisconsin-Whitewater that whenever human subjects are subjected to stress or aerobic testing in an academic setting whether for the purpose of instruction, research or service that the rights and the health and safety of the human subject be first and foremost protected.
The following procedures will be followed when conducting human testing or experimentation involving stress or aerobic testing:
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