Policy No.  76-2
					Date:  6/23/76
					Revised 5/9/2006

PROTECTION OF HUMAN SUBJECTS 1.0 Introduction The University of Wisconsin-Stout has established and maintains an Institutional Review Board (IRB) competent to review projects and activities that involve human subjects. The IRB determines for each research project involving human subjects whether subjects will be placed at risk and if risk is involved, whether, (a) The risks to the subject are so outweighed by the sum of the benefit to the subject and the importance of the knowledge to be gained as to warrant a decision to allow the subject to accept these risks; (b) The rights and welfare of any such subjects will be adequately protected; and (c) Legally effective informed consent will be obtained by adequate and appropriate methods in accordance with the provision of the regulations. IRB review of projects will be conducted at appropriate timely intervals. 2.0 Purpose and Principles 2.1 The purpose of the review procedures on protection of human subjects is to protect the rights of human subjects and researchers involved in activities conducted through UW-Stout. 2.2 Of particular concern are those individuals who may be at risk as a consequence of participation as a subject in research or other activities conducted by the university. An individual is considered to be at risk if he or she may be exposed to the possibility of harm as a consequence of the activity conducted by the university. Harm may be the result of immediate physical risk to the individual and also may be the result of the use of procedures such as personality inventories, interviews, questionnaires, observations, or stored records or data which may involve varying degrees of discomfort, harassment, invasion of privacy, or may constitute a threat to the subject's dignity through the imposition of demeaning or dehumanizing conditions. 2.3. The determination of when an individual is at risk is a matter of common sense and sound professional judgment. This determination should take into account the rights and welfare of the individual, established and accepted methods of meeting the needs of the individual, the potential benefits to the individual, and the importance of the knowledge to be gained. Risks should be weighed against benefits; it is possible that risk to the individual may be outweighed by benefit to a community or society in general with no direct benefit to the individual. At all times, consideration should be given to societal and professional ethical principles which may apply. Wherever possible, the informed consent of the subjects obtained by adequate and appropriate methods must be sought. 2.4 The objectives of the IRB are to: 2.4.1 Protect the welfare of any human subjects involved in UW-Stout projects. 2.4.2 Assure compliance with the Department of Health and Human Services (DHHS) human subjects guidelines. 2.4.3 Minimize liability of individual principal investigators at UW-Stout and project-sponsoring agencies. 2.4.4 Assist principal investigators in developing and implementing effective human subjects procedures for their projects. 2.4.5 Educate researchers on the rights of human subjects and the responsibilities of the researcher. 3.0 Composition of Institutional Review Board, Protection of Human Subjects The committee shall be composed of members of varying backgrounds to assure complete and adequate review of projects and activities conducted through UW-­Stout. Committee membership will follow IRB committee membership guidelines. (see Appendix A for committee membership guidelines) 4.0 Statement of Policy and Procedures To protect the rights of human subjects, proposals that meet the federal definition of research must go through the IRB review process prior to the initiation of the research. The researcher determines whether the project meets the definition of research by using information available on the human subjects web page. If the researcher determines that the project does not meet the federal definition of research, it does not have to go through the IRB review process. The IRB will follow general procedures outlined in Appendix B. 5.0 Records 5.1 UW-Stout will maintain records of all submitted protocols and actions taken on those protocols, including all attachments and related documents according to federal guidelines. The Research Services office will keep records of IRB meeting minutes, government guidelines and written procedures and policies relating to the IRB. Research Services will keep a list of all UW-Stout faculty, staff and students who have completed human subjects training. 5.2 The IRB will assess its policies and procedures at least every three years and make any appropriate changes, including changes to keep the IRB consistent with UW-Stout and DHHS regulations. Appendix A Composition of Institutional Review Board, Protection of Human Subjects Appendix B Institutional Review Board Review Process