10.0 Research and Creative Activity Policies

Research and Creative Activity Policies

Because Missouri State University-West Plains is not a research institution, any research conducted by faculty or students under faculty supervision will follow policies established by the University System, unless a Missouri State University-West Plains policy has been specifically identified. While faculty and staff may be named as Principal Investigators (PI) or Project Directors (PO), the University is the actual recipient of the grant or contract and is legally responsible for assuring that a project is conducted in accordance with governmental regulations and sponsor's guidelines.

1. Extramural Support for Research and Development

   Faculty members must coordinate through the office of academic affairs (and/or the office of sponsored research and programs (OSRP) in Springfield) all requests for outside financial assistance for University research and instructional activities. The office of sponsored research will disseminate current information on government and Foundation financial support, seek potential sponsors for projects, assist faculty in the preparation of proposals, assure that the proposals are processed through the institutional review system prior to submission and maintain adequate time-effort records. Requests for assistance must be submitted on the appropriate forms which are available from the office of sponsored research.

   Prior to submission, the principal investigator (PI) or project director (PD) is to obtain approval from all personnel named in the proposal, as well as their department heads, deans or others whose resources are to be committed to the project. Where applicable, prior approval may be required from institutional committees responsible for assuring that projects are designed and conducted in accordance with federal government regulations. All proposals submitted for external financial assistance must be signed by an authorized representative of the University prior to submission.

   Once a grant or contract is awarded, the PI/PD is primarily responsible for assuring that the administrative, financial and technical matters associated with a project are managed in accordance with the terms of the grant, as well as relevant governmental regulations and University policies. The PI/PD is to work with the office of grants and contracts to assure proper management of financial matters and with the office of sponsored research and programs on post award administration including issuing of sub-awards, as well as seeking approval to changes in key aspects of grants/contracts.

   The OSRP (1) disseminates information about current funding opportunities for federal agencies, foundations and other sources of support; (2) assists faculty in developing proposals and budgets; (3) assures that proposals are in compliance with government regulations and University policies and are processed through the institutional review system prior to submission and (4) assists faculty in implementing grants and contracts. The OSRP also offers training programs to prepare faculty to be competitive in pursuing external financial support.

   Faculty must comply with federal and other governmental regulations and University policies whenever externally or internally supported projects involve human subjects, vertebrate animals, bio-hazardous substances (including the use of recombinant DNA methods) and export controlled information and materials. Compliance includes completion of required training programs, obtaining pre-approval from institutional committees and performance of the research, educational or service projects in accordance with an approved protocol. On occasion, this approval may be required prior to proposal submission. The OSRP assists these committees in implementing the relevant University policies. Information about the application and approval process for each of these areas can be found on the OSRP website, https://www.srp.missouristate.edu.

   Approval by the University is not required for a fellowship which is totally funded outside the University, although all fellowship applications must be filed with the office of sponsored research. Faculty members receiving such fellowships must make appropriate arrangements with the administration if fellowship obligations require release from normal faculty duties.

2. Regulatory Guidelines For Research

   Protection of a research environment for free and unfettered pursuit of knowledge is an important University responsibility. Infringement on this freedom must be restricted to those factors which are clearly essential to the protection of research subjects and the public at large.

   There exist federal and state laws, regulations and guidelines in several areas which are designed for this purpose. In addition, the University community itself acts through its advisory committees or academic governance bodies to ensure that individual research and scholarly projects incorporate appropriate safeguards.

   The University has policies and procedures that assure research, as well as education and service projects where applicable, are conducted in compliance with governmental regulations with regards to animal care and use, bio-hazardous substances, export controlled materials and information and human subjects. Applicable policies and procedures can be found on the office of sponsored research and programs website under University policies, faculty members are to understand that the policies related to animal care and use, biosafety and export control also apply to educational projects, degree or course requirements and service projects.

   Faculty members planning to use live vertebrate animals, bio-hazardous substances and human subjects in research projects regardless of the source of support must submit an application to the appropriate University compliance committee for review and approval prior to the start of the project, regardless of the source of funding. In some cases, external funding agencies require that certification of approval by these committees must accompany a proposal. Externally or internally supported projects will not be approved for expenditure of funds, unless the protocol has been approved by the applicable committee(s).

   All personnel must be certified as having completed training on the federal regulations and University policy and procedures, as well as in topics related to the specific project and work environment before they can participate in these projects. Online training is generally available in all of these compliance areas through the OSRP website, but project and work environment specific training is to be provided by the PI.

   The University also has established a mechanism for persons to report actual or suspected violations of governmental regulations and University policies and procedures related to the aforementioned compliance areas. The University views these "whistleblower" actions as an essential component of its role in monitoring activities to assure compliance with governmental regulations and the ethical standards to which all University personnel should strive.

   1. Animal Care and Use

      The use of animals in research, teaching and outreach activities is subject to federal and state laws and regulations. The University has policies and procedures that assure activities will be conducted in an ethical manner in compliance with these governmental regulations. The Institutional Animal Care and Use Committee (IACUC) is responsible for implementing the applicable policy and procedures. Principal Investigators' (PIs) responsibilities include the following.

      1. Understanding and adhering to applicable governmental regulations and University policies and procedures related to the use of animals
      2. Assuring the humane treatment of animals under their supervision
      3. Assuring that all personnel involved in a project understand and comply with applicable governmental regulations and University policies

      All personnel potentially exposed to animals and their tissues, fluids and waste, have completed required training and are enrolled in the University's Occupational Health and Safety Program before accessing the work environment.

      Persons covered by this policy include faculty, staff and students working with live vertebrate animals, as well as visiting researchers, educators and other bona fide volunteers involved in these activities. Students whose exposure to vertebrate animals is restricted to participation in academic courses and other educational activities are exempt from the policy. These students are to receive training in the care and use of animals from the activity supervisor.

   2. Bio-Hazardous Waste Substances

      The University has policies and procedures to assure that activities related to the use of bio-hazardous substances are conducted in a manner that complies with federal and other governmental regulations. Bio-hazardous substances include chemicals, infectious agents, pharmaceuticals, recombinant DNA, genetically engineered organisms and radioactive materials. In addition, there are specific regulations that address agents and toxins defined by federal regulations as being targets of potential terrorist activities. All individuals who work with hazardous substances must accept shared responsibility for operating in a safe manner once they have been informed (a) about the extent of risk and (b) about safe procedures that should be followed.

      The Institutional Biosafety Committee (IBC) is responsible for implementing the applicable policy and procedures. Principal Investigators' responsibilities include: Understanding and complying with governmental regulations, University policies and procedures that apply to the acquisition, labeling, use, storage, transport, spill response and disposal of hazardous materials; Assuring that other personnel accessing the work environment understand and comply with these regulations, policies and procedures and general safety requirements applicable to a specific project and laboratory; Posting warnings and restricting entry to work areas containing potentially hazardous materials and Assuring that laboratory personnel have completed required training.

      Employees who handle toxic or hazardous substances on behalf of the University are required to maintain, use and dispose of such substances in accordance with applicable state, federal and local laws and regulations as a condition of their employment. The employee may obtain assistance in ascertaining his or her obligations under these laws and regulations from the business office. Any employee who violates any such laws, unless such violation occurs despite reasonable reliance upon advice given by the business office, shall be deemed to have acted outside the scope of his or her authority.

   3. Export Control

      U.S. export control laws apply to the University and its employees and students. In most cases, University based projects are exempt because the work is considered as fundamental research, i.e., the work and its results will be made freely accessible through presentations at professional conferences or published in professional journals. Export control laws are applicable if dissemination of information about the project is controlled by a sponsoring agency or due to the use of a partner organization's confidential information. The following actions by a University employee fall within the export control laws: Sending or transporting materials, hardware, software (or related information) listed on the Department of Commerce's Commodity Control List outside of the U.S. Conveying materials, hardware, software (or related information) listed on the Department of Commerce's Commodity Control List to foreign nationals in this country. Providing "defense services" such as technical assistance or training to foreign persons in the design or use of defense articles then the exemption may not apply.

      Faculty also should be sensitive to export control requirements when hosting visiting scientists from other nations. Before embarking on a project that may fall within the export control laws, faculty must review and comply with all Federal Export Control Regulations and the University policy. The office of sponsored research and programs is responsible for implementing the policy and procedures that will assure. University activities are conducted in accordance with export control laws.

   4. Human Subject Protection

      Research involving human subjects may lead to physical, psychological and/or social damage and so the university has a responsibility to safeguard subjects' welfare. All research involving human subjects in any way, regardless of the source of support funds, may need to be reviewed and approved by the Protection of Human Subjects Institutional Review Board (IRB) before it is undertaken. Research undertaken by students with faculty supervision is included in this policy.

      The University is committed to the ethical standards for the use of human subjects in research as described in the Belmont Report—respect for persons, beneficence and justice—and as required under federal regulations. The Institutional Review Board for the Protection of Human Subjects (IRB) is responsible for implementing the University policy and procedures. In accordance with federal regulations, research is defined as systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Principal Investigators' responsibilities include the following.

      1. Understanding and complying with federal regulations and University policies and procedures regarding the ethical treatment of human subjects
      2. Assuring that other personnel involved in a project understand and comply with these regulations and policies

      Assuring that all individuals involved in the design of a research project, as well as the collection and analysis of data have completed training on human subject protection.

      This training may include federal regulations and University policies and procedures related to the Health Insurance Portability and Accountability Act (HIPAA) when the research involves individually identifiable health information.

3. Whistleblower Protection Policy

   The University expects faculty, staff and students to conduct activities related to the aforementioned compliance areas in a manner that is consistent with applicable governmental regulations and University policies. The University provides various mechanisms to assist and encourage persons to come forward in good faith with reports or concerns about suspected compliance issues. Diligent efforts will be made to protect the complainant from retaliation for his/her activities in cooperation with or initiation of, an inquiry or investigation, provided the complaint is not undertaken in bad faith. Procedures for reporting concerns can be found on the OSRP web site under University Policies. The University also provides an Ethics Hotline that allows anonymous telephone or on-line reporting of ethics violations. The Ethics Hotline site is maintained by an independent third party.

4. Copyright/Patent Policy

   The ownership of intellectual property created by faculty members is determined by the University's Intellectual Property Policy. Faculty members should consult this policy to determine, under particular circumstances, ownership of intellectual property which they have created. The Intellectual Property Policy is included in the Faculty Handbook as Appendix A. The policy will not be changed by the University except through the procedures specified for the amendment or the Faculty Handbook, Section 16.0.