800.00 Research Regulatory Compliance

810.00 Institutional Review Board and Committees. Research projects which involve the use of human subjects, vertebrate animals, infectious agents, hazardous materials, genetically altered microorganisms, radioactive materials, or radiation sources require special consideration by one of MSU’s several institutional review boards or committees as described below.

810.10 Use of Human Subjects in Research.  Federal law and MSU require that any proposed research project involving human subjects (including student research projects) must be reviewed and approved by the Human Subjects Institutional Review Board (Human Subjects IRB) before the research begins.  Review and approval, or a determination that the project is exempt, is required for any project involving human subjects, including surveys administered to human subjects, regardless of the source of funding. 

MSU’s Proposal Clearance Form requires the disclosure of any proposed use of human subjects and documentation of Human Subject IRB review and approval.

The Human Subjects IRB’s website contains more detailed information such as: what constitutes research involving “human subjects”; what research is exempt from the review and approval requirement (e.g. public observation of human behavior); how to apply for IRB approval; what research is eligible for expedited approvals; and other useful information concerning regulation of human subject research at MSU.  Note, however, that decisions about exemptions, approvals, expedited approvals etc. may only be made by the IRB.

All investigators involved in human subject research must complete and document training in ethical conduct of human research and protection of human subjects.

810.20 Use of Animals in Research and Testing.  Research proposals involving live vertebrate animals in research, training, experimentation, or biological testing, must be reviewed and approved by MSU’s Institutional Animal Care and Use Committee (IACUC).  This requirement is based on federal regulations and MSU internal policy.  IACUC’s overall responsibility is to ensure the humane and sensitive care and use of animals. 

The Proposal Clearance Form requires the disclosure of any proposed use of live vertebrate animals and documentation of IACUC review and approval.  The IACUC website provides detailed information on such matters as approval requirements, the approval process and MSU’s policy concerning use of animals in research.

Training is also required for all personnel using laboratory animals at MSU and for all animal care employees.

810.30 Biological Safety in Research. Research proposals involving the use of infectious agents, hazardous materials, or genetically altered microorganisms must be reviewed and approved by MSU’s Biosafety Committee as required by federal regulations and MSU policy. 

The Proposal Clearance Form requires the disclosure of any proposed use of such agent, materials or microorganisms and documentation of Biosafety Committee review and approval.

The Biosafety Committee website provides detailed information on approval requirements, process, and policy.

Training is also required for all personnel involved in research using infectious agents, hazardous materials, or genetically altered microorganisms.

810.40 Radiation Safety in Research. Research proposals involving any radioactive material or radiation source must be reviewed and approved by the Radiation Sources Committee in accordance with federal regulations and MSU policy.

The Proposal Clearance Form requires the disclosure of any proposed use of any such materials and documentation of review and approval by the Radiation Sources Committee.

820.00 Select Agents.  Select Agents are certain materials designated by the U. S. Government as agents that have potential use in biological terrorism or warfare.  A list of select agents can be found at http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html.  In order to possess, use, send, or receive Select Agents, the University and each individual within the University who will have access to the Select Agents must first satisfy certain federal requirements and receive appropriate training.  Federal approval must be obtained on each required element before possession, use, or transfer of Select Agents.  PIs who anticipate working with Select Agents should contact MSU’s Biosafety Officer, Jo-An Lindstrom, Microbiology, at 406-994-4490 or at lindstrom@montana.edu as soon as possible in order to begin the approval process.  More information on Select Agents is found at http://www.selectagents.gov/.

830.00 Conflict of Interest and Conflict of Commitment.  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 aims of the University to obtain and disseminate knowledge.  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.  Conflicts of interest and commitment are governed by Montana law, Board of Regents policy [http://mus.edu/borpol/bor700/770.pdf], MSU policies [http://www.montana.edu/hraa/handbook.html and http://www2.montana.edu/policy/conflict_of_interest/] and federal regulations [http://grants.nih.gov/grants/policy/coi/index.htm].

830.10 Law and Policy. The University’s policy on conflict of interest (consistent with Montana and Federal law) requires investigators involved in sponsored research to disclose any significant financial interest which may affect, or appear to affect, the sponsored activity. [http://www2.montana.edu/policy/faculty_handbook/]. 

830.20 Significant Financial Interest. Federal regulations [link] define “significant financial interest” to include anything of monetary value of $10,000 or greater (including spouse and dependent children interests).  Monetary interests include, but are not limited to: equity interests, salary or other compensation, consulting fees, and intellectual property rights.

830.30 Investigators. For purposes of reporting significant financial interests, investigators are defined by federal regulations to include anyone who is responsible for the “design, conduct, or reporting of research.”  Disclosure is required on the Proposal Clearance Form and during the sponsored research project whenever such an interest is acquired.  Once disclosed, actual or apparent conflicts of interest in sponsored research are considered and addressed in accordance with MSU policy [http://www2.montana.edu/policy/faculty_handbook/].

830.40 Inventor Interests in Commercializing Company. Board of Regents Policy requires Regent approval whenever an employee/inventor of intellectual property licensed by the University to a business entity intends to become an owner, director, officer, or employee in the business entity which has a license or other agreement concerning the intellectual property that the employee was involved in inventing or creating. [http://mus.edu/borpol/bor400/407.pdf] and to Tech Transfer below.

Questions about conflict of interest should be directed to:
MSU Office of Legal Counsel
406-994-4570 or http://www.montana.edu/legalcounsel/

840.00 Export Controls

840.10 Regulatory Framework. Federal regulations may apply to the export of equipment and technology developed or used in the course of research. There are three primary sets of federal regulations that govern export controls, covering virtually all fields of science, technology, and engineering:
  • Export Administration Regulations (EAR) administered by the Department of Commerce, apply to the export of “dual-use” items and their technology (i.e., items that have both commercial and military applications, such as computers, microelectronics, or pathogens);
  • International Traffic in Arms Regulations (ITAR), administered by the Department of State, apply to munitions, or defense articles and defense services (i.e., those articles and services that are specifically designed for military applications or defense and do not have predominantly civil applications); and
  • Treasury Department's Office of Foreign Assets Control (OFAC) governs trade embargoes, sanctions, and travel restrictions and restricts exportation of information and research articles to embargoed entities and persons.

840.20 When Agency authorization required. Usually, if the sponsored research meets the definition of “fundamental research,” export control regulations do not apply.  And, as long as the University has not agreed to any limitation on publication of the research or to any other national security controls, the research is usually “fundamental research”.   However, in some cases where publication limitations or other security controls have been agreed to, or when embargoed countries or persons are involved, the University may be required to obtain an export license or other authorization from the appropriate agency before a PI will be permitted to: transfer materials overseas; allow foreign nationals to access certain equipment, data, or technology; collaborate with a foreign company or research organization on research or publications; hire a foreign consultant, or share research results with foreign nationals.

For guidance and questions, particularly if a situation that may require further review arises, please contact Office of Legal Counsel.
406-994-4570 or http://www.montana.edu/legalcounsel/