UW-Whitewater University Handbook


Last policy revision: 9/1/97

Protection of Human Subjects, Policies and Procedures

An Abbreviated Manual

SOURCE: Office of the Provost and Vice Chancellor for Academic Affairs

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/.

INTRODUCTION

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. 
 

APPLICABLE RESEARCH

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:

  1. ex-officio chairperson, Associate Dean for Research (non-voting member, except in ties)
  2. ex-officio, an MD or RN from Student Health Service
  3.  1 faculty member from College of Business/Economics
  4. 2 faculty members from College of Education
  5.  1 faculty member from College of Arts
  6. 1 faculty member from natural sciences in College of Letters and Sciences
  7.  1 faculty member from social sciences in College of Letters and Sciences
  8. 1 faculty member from humanities in College of Letters and Sciences
  9.  1 non-University member, preferably an attorney


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 Manual 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:

  1. Projects for which federal monies are allocated or are being sought except those explicitly designated as exempt.
  2.  Projects for which the level of risk is greater than minimal.
  3. Projects which involve sensitive or protected populations.


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 projects. 
 

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:

  1. Graduate and undergraduate student research which is part of a regular on-campus course may be approved by an instructor if the instructor has an approved Certification of Course Form for the Protection of Human Subjects. The instructor will act as the principal investigator for the research and will ensure that ethical principles are followed in all student research. An instructor may decide that student research requires college level or University level review. An instructor alone does not have the authority to approve of human subject research that involve the following:
    1. Inflicting physical pain, more than minimal risk, or the use of special populations;
    2. an independent study course or masters thesis research;
    3. subjects in an extension, off-campus location;
    4. other than expedited review according to the guidelines of the relevant CHSC or the University IRB.
  2. A CHSC may approve some types of human subject research conducted by students, faculty or staff. If that research meets the following conditions:
    1. The research does not involve funding by an agency outside the University nor receives funds from a University-wide program. If funding is from within a college or department the CHSC may review a proposal if the research meets the other conditions;
    2. the research does not require a full IRB committee review, but would receive an expedited review by the University IRB;
    3. the research does not involve collaboration across college lines or collaboration with any institution or agency outside the college.
    The IRB conducts two types of review expedited or a full review. Both reviews are based on the IRB Review Form which the principal investigator has completed and signed. An expedited review shall be completed within 5 working days of receipt. A full review may be chosen by a principal investigator and shall apply to all research that does not meet the criteria for expedited review. It shall require a quorum of IRB members and shall be made within 22 working days of receipt or the next regularly scheduled IRB meeting whichever comes sooner.


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 process. 
 

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. 
 
 

POLICIES AND PROCEDURES FOR INVASIVE PROCEDURES

AND DRAWING OF HUMAN BLOOD

(Effective 8/28/97)

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:

  1. Protocols must be specific, detailed in a step-by-step manner and consistent with the department's procedures, national standards or practice, the UW-Whitewater's bloodborne pathogen exposure control plan, and UW-System policy and recommendations for bloodborne pathogens.
  2. All protocol involving human blood and invasive procedures must receive full Institution Review Board approval, including informed consent. Once approved the protocol must be followed.
  3. The protocol for obtaining samples of human blood or other body fluids must be reviewed and approved by medical staff such as a UW-Whitewater Student Health Center physician, nursing supervisor or an appropriate equivalent. Blood samples shall be drawn by, or obtained under the general supervision of a licensed medical provider as noted above. Any UW-Whitewater faculty, staff or student who is to conduct supervised blood drawing activities must obtain appropriate prior training by a licensed medical provider as noted above in a clinical setting.
  4. A plan for the disposal of blood and other potentially infectious material, sharps, etc. and infectious waste must be developed, approved and follow the UW-Whitewater bloodborne pathogen exposure control plan.
  5. All potentially exposed faculty, staff and students must have bloodborne pathogens training, and employees must be offered Hepatitis B vaccine (paid for by the department performing the blood drawing activity) prior to the onset of invasive procedures or blood drawing activity. This includes those who draw blood, run tests on blood and in any way handle or dispose of blood.
  6. Procedures for handling medical emergencies must be in place and detailed in the activity protocol submitted for IRB approval and will include:
    1. A faculty or staff person trained in CPR, first aid, and the UW-Whitewater bloodborne exposure control plan must be on hand at all times during the blood drawing from human subjects, blood testing and disposal procedures.
    2. A telephone must be readily available to call outside medical emergency response staff.
    3. Written emergency response procedures must be posted by the telephone.
  7. Other procedures may be required as state, federal and university regulations change.

 

POLICIES AND PROCEDURES FOR HUMAN STRESS TESTING

(Effective 8/28/97)

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:

  1. Protocols must be specific, detailed in a step-by-step manner and consistent with the department's procedures and national standards of practice.
  2. All protocols involving human stress and aerobic testing must receive full Institution Review Board approval. Once approved the protocol must be followed.
  3. Procedures for handling a medical emergency during testing must be in place and detailed in the activity protocol submitted for IRB approval and will include:
    1. A faculty or staff person trained in CPR and first aid must be on hand at all times during the testing.
    2. A telephone must be readily available to call outside medical emergency response staff.
    3. Written emergency response procedures must be posted by the telephone.
  4. Each participant must:
    1. Complete a health questionnaire appropriate for the level of exercise. According to the American College of Sports Medicine Guidelines for Exercise Testing and Prescription, the UW-System modified PAR-Q is adequate for low to moderate intensity exercise or submaximal exercise testing. Individuals participating in more vigorous exercise or maximal exercise testing should complete a medical history questionnaire. The health questionnaire should be reviewed by the laboratory director prior to the commencement of exercise.
      1. An informed consent must be completed by all who participate in research or service activities.
    2. Those who must have a physical examination by a licensed physician prior to testing would include:
      1. Submaximal exercise test or low to moderate intensity exercise: According to the American College or Sports Medicine Guidelines for Exercise Testing and Prescription, individuals with coronary artery disease or symptoms of coronary artery disease should have a medical examination and approval prior to testing and after informed consent. Other individuals planning to perform submaximal or low to moderate intensity exercise, regardless of age may not need a medical examination.
      2. Maximal exercise test or vigorous/maximal exercise: According to the American College of Sports Medicine Guidelines for Exercise Testing and Prescription, men over 40 years old and women over 50 years old should have a medical examination. Regardless of age, individuals in the following categories should have a medical evaluation and approval prior to testing and after informed consent:
        1. Individuals who have signs or symptoms suggestive of possible cardiopulmonary or metabolic disease,
        2. Individuals with two or more major coronary risk factors (age: men > 45 years, women > 55 years; family history; cigarette smoking; hypercholesterolemia; diabetes; and sedentary lifestyle)
        3. Individuals with coronary artery disease or symptoms of coronary artery disease.

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