The principal investigator for a project is responsible for preparing a proposal that adheres to federal, state, and University rules and regulations. It is your responsibility to secure all of the clearances set forth below that apply to your project. The Office of Grants and Research will assist you in determining the need for obtaining official clearances for particular aspects of a project.
- Biological Safety
Investigators involved in biological research or the handling of biological materials must contact the Animal Subjects Review Committee to schedule required reviews and obtain official approval. Biological materials are defined as any plant, animal, or microbial organism, or any substance derived from these organisms (including recombinant DNA molecules) which are themselves the subject of the research or are ancillary reagents or indicators employed for the investigation. For biosafety purposes, chemicals that are biologically active (such as carcinogens and mutagens) or toxic are included in the definition.
- Recombinant DNA Research
If the proposed project involves recombinant DNA research, it is important to thoroughly review the NIH Instructions for Investigators Submitting Research Grant Proposals Involving RDNA Technology. Researchers should consult with the Associate Dean of Graduate Studies and Research when preparing a proposal involving RDNA research.
- Radiation and Hazardous Materials Safety
Research which requires the purchase, possession, or production of radioactive materials is subject to the provisions of the UW System license under the Nuclear Regulatory Commission. Investigators are responsible for adhering to the requirements for training, sign posting, reporting, and laboratory procedures specified in the license. University guidelines for the use and storage of all hazardous materials must also be followed. Specific details are available from the Hazardous Waste Coordinator.
- Human Subjects
If the proposed research will involve the use of human subjects, the principal investigator should contact the Human Subjects Review Committee which serves as the University's Human Subjects Institutional Review Board(IRB) to assure that all required reviews and approvals of the research protocol are obtained. This requirement extends to all research involving human subjects regardless of the source of support.
- Animal Welfare
The University of Wisconsin System policy regarding the use of animals states, "All animals used for teaching, research and other activities on all campuses shall be used and cared for according to the principles stated in the Guide for the Care and Use of Laboratorv Animals regardless of the species or source of funds used to conduct teaching, research or other activities." If a proposed project involves the use of animals, the principal investigator should contact the Animal Subjects Review Committee regarding compliance with these regulations.
- Hazardous Waste
The University must adhere to U.S. Environmental Protection Agency regulations which establish minimum requirements for documentation, storage, shipment, and disposal of hazardous waste. UW-Green Bay has a Hazardous Waste Coordinator who is charged with insuring that proper procedures for the disposal of hazardous waste generated on campus are followed. If your proposed project is likely to generate hazardous waste, you must consult with the Hazardous Waste Coordinator to discuss proper disposal protocol and costs so that they may be included in the proposal.
- Wisconsin Environmental Policy Act
The Wisconsin Environmental Policy Act requires each state agency to consider the environmental implications of all of its proposals, and before proceeding with any major action significantly affecting the quality of the human environment, to prepare a detailed statement concerning the environmental effects of the proposed action. Research activities must be considered on the basis of potential impacts that are likely to occur in the conduct of the research itself. When new technology or policy is proposed or recommended for implementation and such implementation will significantly affect the environment or restrict future alternatives, the implementing agency must comply with WEPA requirements. Contact the Director of Facilities Planning to assure that all required reviews and approvals of the research protocol are obtained.
- University Assurances of Compliance
Several federal agencies require that assurances of compliance with various federal regulations covering grantees be submitted with grant applications. These assurances may require the submission of the actual University policy that establishes compliance or simply attesting to the fact that such a policy is in place and that the stipulations of the policy will be followed. Regulations which require statements of compliance or submission of policies include the Civil Rights Act, the Drug-free Workplace Act, Anti-lobbying legislation, and any of a number of agency-specific policies such as the NIN requirement of submitting the University policy for dealing with misconduct or dishonesty in biomedical research. Contact the Office of Grants and Research if proposal guidelines ask for submission of specific assurances.
- Patents and Inventions
As a condition of participation in any extramurally funded activity at UW-Green Bay, principal investigators must agree to disclose to the Chancellor any invention resulting in whole or part from such extramurally supported activity. Principal investigators who believe they have a patentable invention should contact the Graduate Office to acquire specific information on patent procedures.
The policies of the funding agency must be followed when copyrightable material is developed under any extramural project. The UW-System policy regarding the copyrighting of materials is included as an appendix to this manual.
It is the policy of the University that software developed by faculty or staff shall be the property of the author unless: a) the material is prepared under limitations of extramural grants or contracts that explicitly stipulate otherwise; b) the material is created by a person as an assigned duty of employment; or c) the material is prepared under a University agreement that specifically states otherwise.
- Equipment Screening
You should be aware that all requests to purchase capital equipment with federal funds must go through normal University purchasing procedures, including a review by the Purchasing Office http://www.uwgb.edu/purchasing/ to determine if equivalent alternative equipment may be available at a lower cost. If the purchase of computing equipment or services is involved, University approval must be obtained in advance (contact the Director of Computing Services) www.uwgb.edu/cit/. Campus policy is based on Wisconsin statutes which require a review process for the purchase of hardware, software and professional services that, among other things, ensures "good management practices and cost-benefit justifications." Adherence to any capital purchase guidelines supplied by the funding agency is also required.
- Space and Facilities
If the proposed project will require a) reassignment of space or facilities currently assigned to some other use, b) additional University space, c) rental of off-campus space, or d) remodeling, you must submit a request for approval to the appropriate Dean, who will consult with the Director of Facilities Management and/or the Director of Facilities Planning prior to responding to the request. This must be done regardless of the source of financial support for such changes.
- International Programs
If the proposed project involves the services of University personnel overseas, you should submit an informational copy to the Director of International Education.