1300.00 Research Regulatory Compliance
MSU is responsible for managing and administering awards, both Federal and non-Federal, in a manner so as to ensure that funding is expended and associated programs are implemented in full accordance with U.S. statutory and public policy requirements, including but not limited to: those protecting public welfare, the environment, and prohibiting discrimination. MSU has established a number of programs to ensure compliance with policies and procedures such as the Office of Sponsored Programs (OSP), Office of Research Compliance (ORC), Institutional Review Board (IRB), Technology Transfer Office (TTO), Institutional Animal Care and Use Committee (IACUC), Radiation Safety Committee (RSC), Office of Legal Counsel, and MSU Biosafety Committee. This section expands upon the requirements for research projects that entail the use of human and animal subjects, impacts to the environment, and/or potentially involve conflicts of interest. The OSP Electronic Proposal Clearance Form (ePCF) requires the disclosure of any proposed use of human or animal subjects, conflicts of interest, technology transfer, biosafety hazards, or potential impacts to the environment.
1310.00 Office of Research Compliance (ORC) Oversight
The Office of Research Compliance oversees University programs designed to ensure compliance with Federal, state, and local regulations for research, creates and supports an environment that furthers the ethical and responsible conduct of research, including the Conflict of Interest Management Program and the Research Integrity Verification Program. The Office of Research Compliance is the primary office that oversees research activity that may require regulatory compliance. ORC is also directly responsible for managing Export Control, or transfers of controlled information, including technical data, to persons and entities outside the United States, as well as shipment of physical items or goods, technical or scientific information related to export controlled items, or travel to sanctioned or embargoed countries.
1320.00 Export Controls and Regulatory Framework
Export laws and regulations promulgated by the U.S. Department of Commerce, the U.S. Department of State, and the U.S. Treasury Department are the basis for restricting use of and access to controlled information, goods, and technology for reasons of national security or protection of trade. In general, the export control regulations cover four main types of University activities:
- Transfers of controlled information, including technical data, to persons and entities outside the United States;
- Shipment of controlled physical items, such as scientific equipment, that require export licenses from the United States to a foreign country;
- Verbal, written, electronic, or visual disclosures, regardless of where the disclosure takes place, of controlled scientific and technical information related to export controlled items to a foreign national (everyone other than a U.S. citizen, a permanent resident alien, and certain ‘protected individuals’ [refugees and those with asylum], including any company not incorporated in the United States). Such a transfer is termed a “deemed export” and is regulated because the transfer is “deemed” to be to the country where the person is a resident or citizen;
- Travel to certain sanctioned or embargoed countries for purposes of teaching or performing research;
Most exports do not require government licenses. However, licenses are required for exports that the U.S. government considers “license controlled” under:
- The Department of Commerce’s Export Administration (EAR). The EAR is concerned with dual-use items, such as computers or pathogens, which are designed for commercial use but have the potential for military application;
- The Department of State’s International Traffic in Arms Regulations (ITAR). ITAR covers defense-related items and services;
- The Treasury Department’s Office of Foreign Assets Control (OFAC). OFAC administers and enforces economic and trade sanctions that have been imposed against specific countries based on foreign policy, national security, or international agreements.
Fortunately for universities, these regulations exclude publicly available, fundamental research results from the regulatory requirements for approvals or licenses. Both the EAR and ITAR define fundamental research in a similar manner; it is “basic and applied research in science and engineering where the resulting information is ordinarily published and shared broadly within the scientific community, as distinguished from research the results of which are restricted for proprietary reasons or specific U.S. Government access and dissemination controls.” Tangible items, however, do not fall under the fundamental research exemption. In cases where an MSU research is fabricating an item for shipment outside the U.S., then that item must be checked against the EAR, ITAR, and OFAC lists referenced above to see whether a license is required. The Office of Research Compliance works closely with MSU’s Office of Legal Counsel on matters related to export control, and PI’s are advised to contact either the Legal Counsel or ORC for guidance before any research activities are initiated.
1330.00 Managing Conflicts of Interest
The University encourages its faculty to participate in sponsored research, to consult with government and industry and to engage in other activities that further the mission of the University. At the same time, the University is committed to ensuring that these activities are conducted in an atmosphere free from biases and interests that could compromise the free and open pursuit and dissemination of knowledge. The University follows all pertinent guidelines and policies in regard to conflicts of interest as outlined in the MSU Legal Policy on Conflicts of Interest, Conflicts of Interest Management Program, 42 CFR Part 50 Subpart F: Promoting Objectivity in Research, 45 CFR Part 94: Responsible Prospective Contractors and Financial COI, as well as any related Federal conflict of interest policies. PI’s are expected to disclose any actual or potential conflicts of interest including but not limited to those related to significant financial interest, or interests in equity, salary or other compensation, consulting fees, and/or intellectual property rights. The Office of Research Compliance in conjunction with the Office of Legal Counsel can provide guidance to PI’s as well as disclosure forms and training to ensure PI’s avoid conflicts of interest.
1340.00 Human Subjects in Research and the Institutional Review Board (IRB)
The Institutional Review Board (IRB) oversees the protection of the rights, welfare, and well-being of human subjects who participate in research at Montana State University. The IRB follows the ethical standards described in the Belmont Report as well as all applicable Federal, state, and local regulations. The IRB is responsible for reviewing and approving all research involving human subjects (including student research projects). All research involving human subjects must be registered with the IRB regardless of funding source or location. The IRB can provide more detailed information as to what constitutes research involving human subjects; what types of research are exempt, how to apply for IRB approval, and other information concerning regulation of human subject research at MSU. Approvals must be granted before research begins or data and results generated must not be used in publications and other forms of dissemination.
1350.00 Animal Subjects in Research and the Institutional Animal Care and Use Committee (IACUC)
The Institutional Animal Care and Use Committee (IACUC) ensures the health, well-being, and humane use of animals in research, following the regulations and guidance of the U.S. Department of Agriculture and the Department of Health and Human Services. MSU’s IACUC is responsible for reviewing all protocols involving live vertebrate animals for research, training, and testing, and ensures compliance with all applicable laws, policies, and Federal regulations. The IACUC ensures that all animals are treated humanely and that research is performed to the highest standards. The IACUC is also responsible for inspection of animal facilities (including satellite facilities) and laboratories, and oversight of training and educational programs.
1360.00 Biological Safety in Research and the Institutional Biosafety Committee (IBC)
The Institutional Biosafety Committee (IBC) at MSU ensures a safe environment for individuals working with biohazardous materials and ensures the protection of the community and environment by preventing exposure to biohazardous materials. The Biosafety Program provides technical advice to PI’s on lab containment, security, and safety procedures. PI’s should consult the Committee before beginning their research with any questions related to approval requirements, processes, or policies. The Biosafety program also works with PI’s on safely managing select agents, which are materials that have the potential for use in bioterrorism or warfare. For a current list of select agents, visit the Federal “Select Agents and Toxins List.” Any materials classified as select agents or toxins must be declared to the Committee and the PI should expect to undergo an application process as well as training and to satisfy any pertinent Federal requirements.
1370.00 Radiation Safety in Research and the Radiation Safety Committee (RSC)
The Radiation Safety Officer (RSO) and Radiation Safety Committee (RSC) is responsible for ensuring that individuals working with radioactive materials or radiation producing equipment are monitored for and protected from physical exposures to radiation. There are enforceable limits established by Federal law to occupational radiation exposures. The Nuclear Regulatory Commission is the rule-making body that promulgates and enforces the radiation protection regulations in the United States. MSU currently has a “Broadscope Type A” license which allows for a variety of radioactive material research to be conducted. MSU is under the Nuclear Regulatory Committee’s jurisdiction and, as such, is required to maintain compliance with Title 10, Code of Federal Regulations, Part 20 (10 CFR 20) governing radioactive material. PI’s who plan to conduct research must contact the RSC to submit a protocol which will be reviewed for approval. Once approved, PI’s must maintain lab safety oversight including correcting problems and discrepancies. Training for radiation safety is available through RSC and may be required depending on the terms and conditions of the sponsor.