VP Ostrander’s Message to Researchers about Compliance Issues
This message has been approved by Gary K. Ostrander, Vice President for Research, for distribution to all faculty, deans, directors and department heads.
In a time where increasing scrutiny of scientific research and discovery exists, the issue of trust and assurance is critical to every facet of our research enterprise. As a researcher at FSU, how you honor ethics and compliance issues is vital to our university’s reputation as well as your and your department’s success. With that said, and with a new academic year beginning, I feel this is a good time to provide information to new and returning researchers (faculty, staff, and students) about some of the compliance issues we face today. Most of this information is included as a reminder, but in some cases there have been significant changes. Please take the time to (re)acquaint yourselves with each of these critical issues.
Thank you for your time and attention.
Animal Care and Use
FSU is committed to providing the highest care for, as well as responsible use of, animals in research, teaching, and testing. Any research, teaching, or testing involving vertebrate animals by FSU faculty, staff or students must comply with all applicable laws, regulations, policies and guidelines. This covers both funded (internal and external) and un-funded research as well as class, thesis, dissertation, field work, special projects and collaborations with non-FSU researchers.
Oversight of animal use in teaching and research is required by Congress through the Animal Welfare Act and the Public Health Service Policy on the Humane Care and Use of Laboratory Animals. In addition, there are many other federal and state regulations requiring compliance when using animals or animal tissue. University policies and guidelines are developed to maintain compliance with the various rules, regulations and guidelines. A brochure, What Investigators Need to Know About the Use of Animals, provides a succinct resource for investigators to quickly grasp the main expectations and requirements when using animals in research supported by the federal government. Oversight of compliance at FSU is the responsibility of the FSU Animal Care and Use Committee (ACUC). Facilitating the use of animals in research and teaching at FSU is the responsibility of the Department of Laboratory Animal Resources (LAR). If you have questions, please contact Brian Shipe at firstname.lastname@example.org.
Conflicts of Interest
The term “conflict of interest in research” refers to situations in which financial or other personal considerations may compromise, or have the appearance of compromising, a researcher's professional judgment in conducting or reporting research. Conflicts can occur in situations such as consulting, licensing of FSU technology, conducting research for a company in which the investigator has a financial interest, and procurement.
In an effort to promote objectivity, some funding agencies have implemented regulations to ensure that the design, conduct, and reporting of the research is kept free from bias due to a significant financial interest of any Investigator working on the research. To ensure compliance with Federal and State regulations as well as FSU policies, investigator disclosure of conflicts of interest and significant financial interests are required. Detailed information on disclosure requirements is published at https://www.research.fsu.edu/research-compliance/conflict-of-interest/. If you have questions, please contact Diana Key at email@example.com.
Contracts and Grants Management
Sponsored Research Administration (SRA) is responsible for assisting departments and researchers with compliance areas related to proposals and awards from public funding. Some of the significant compliance areas include submitting proposals independently without SRA approval, subrecipient monitoring, equipment and computer purchases late in the project period, cost transfers at project end, financial and technical report submission, extension requests, and unallowable and/or unallocable expenditures. For more information concerning these compliance areas visit https://research.fsu.edu/research-offices/sra/. If you have questions, please contact Pam Ray at firstname.lastname@example.org.
Export control laws are a complex set of federal regulations designed to protect the United States’ (U.S.) national security; to prevent the proliferation of weapons of mass destruction; to further U.S. foreign policy including the support of international agreements, human rights and regional stability; and to maintain U.S. economic competitiveness. The export control regulations govern how information, technologies, and commodities can be transmitted overseas to anyone, including U.S. citizens, or to foreign nationals in the U.S. In addition to controlling exports to countries or individuals who are citizens of or located in those countries, the export control regulations ban exports to individuals and companies that have been involved in terrorist or drug trafficking activities as well as those who are barred from conducting exports because of previous violations of the export control laws. They apply to all internally-and externally-funded research and non-research activities.
FSU is committed to compliance with federal laws and regulations governing exports and ensuring such compliance is consistent with the university's open academic environment that fosters intellectual creativity, freedom to carry out research in an unrestricted manner, and the open dissemination of research results. All activities undertaken by our university community, including research activities, must comply with the export control regulations and university policies, procedures, and standards.
It is the responsibility of university faculty, staff, and administration to be aware of the export control requirements under Federal regulations. The Office of Research Compliance Programs provides tools, resources, and guidance on export control regulations and how to implement measures to ensure that projects or activities comply with these regulations. FSU's Export Control Policy, Export Controls Compliance Plan, and more are published at https://www.research.fsu.edu/research-compliance/export-controls/. If you have questions, please contact Diana Key at email@example.com.
Environmental Health and Safety
FSU’s Department of Environmental Health and Safety (EH&S) promotes a safe and healthy environment for all members of the university community. EH&S provides technical support and regulatory guidance in many areas, such as workplace safety, insurance (including worker’s compensation), fire safety and other areas. The Research Support section within the department provides focused expertise to help the research community achieve their goals. The following points highlight some of the specific areas of support:
- Biological Safety: Provides programs related to control of and exposure to bloodborne pathogens, recombinant DNA, biological safety level determination and facility use, biomedical waste disposal, etiological agent importation, select agent and toxin control, and medical monitoring.
- Chemical Safety: Works to reduce potential health and environmental hazards associated with chemicals on campus by providing consultation for proper handling and storage, and coordinates the ethical and lawful disposal of waste chemicals, while maintaining environmental compliance.
- Laboratory Safety: Consults with researchers regarding safety issues and provides assistance with laboratory setup as it relates to safety; for example, chemical storage and the use of safety equipment (fume hoods and safety showers). Additionally, the section coordinates and conducts laboratory safety inspections and works with researchers to develop specific hazard guidance, protocols, and hazard specific training. This section also assists researchers in obtaining the necessary exemptions and licenses from state and federal agencies for controlled substances, prescription drugs, and diethyl ether.
- Radiation Safety: Provides guidance and support to researchers on hazards associated with the use of radioactive materials, radiation producing machines, lasers and other non-ionizing radiation sources on campus, stressing the control and reduction of exposure.
EH&S also provides numerous training programs and outreach for all technical areas. For additional information about EH&S please contact them at 644-6895 or visit their website at http://www.safety.fsu.edu/.
Human Subjects Use
The mission of the FSU Human Subjects Committee is to protect the welfare of human subjects participants and facilitating the research efforts of FSU faculty, students and staff. FSU holds a Federalwide Assurance of Protection for Human Subjects (Department of Health and Human Services), Number 00000168, approved on March 26, 2001, in which it agrees to uphold the ethical principles of The Belmont Report and to apply the Code of Federal Regulations (45 CFR Part 46) to all research involving human subjects regardless of sponsorship or support. The Vice President for Research is responsible for exercising appropriate administrative oversight to ensure that the university’s policies and procedures designed for protecting the rights and welfare of human subjects are effectively applied in compliance with its Federalwide Assurance with the Office for Human Research Protections (“OHRP”), Department of Health and Human Services. Additional information is located at https://www.research.fsu.edu/research-offices/human-subjects/. If you have questions, please contact Jane Mostoller at firstname.lastname@example.org.
In accordance with Article 18 of the BOT-UFF Collective Bargaining Agreement, a work made in the course of independent efforts is the property of the faculty member, who has the right to determine the disposition of such work and the revenue derived from such work. If the work was not made in the course of independent efforts, it is the property of FSU and the faculty member shall share in the proceeds. Consult the bargaining agreement for details and examples.
Based on Florida Statues and FSU Policy, FSU requires disclosure and assignment by inventors/authors of university-supported inventions or copyright works to FSU. This policy does not include articles submitted for publication, class notes, scholarly and professional books texts, or works of art that were developed without the use of appreciable university support and used solely for the purpose of assisting or enhancing the faculty member’s instructional assignment.
The Office of Commercialization is responsible for the commercial assessment, protection, and commercialization of the inventions or copyright works. FSU inventors receive forty percent of the license revenue from patented inventions and fifty percent of the license revenue from copyright works. The remaining revenues are distributed to the inventor’s/author’s Department and College and to the Office of Research. The Office of Research is responsible for the costs of protecting and commercializing the invention or copyright. If you have questions, please contact Brent Edington at email@example.com.
Public Access, Data Management, and Authorship & Research Integrity
FSU, consistent with the university’s mission to preserve, expand, and disseminate knowledge, is committed to disseminating its research and scholarship as widely as possible. In addition, the university recognizes the importance of systematically preserving and retaining research data. In light of this position and in response to Federal regulations, the Office of Research worked with the Faculty Senate and the University Libraries to develop two new policies. Those policies are the Public Access Policy for Research Publications and the Research Data Management Policy. The Policy on Authorship and Research Integrity was also updated to be consistent with these new policies. Faculty are encouraged to thoroughly read these documents to understand their responsibilities related to public access, data management, and authorship. Additional information is located at https://www.research.fsu.edu/research-compliance/public-access-data-management-authorship/. See also the University Libraries website http://openaccess.fsu.edu/. If you have questions, please contact Diana Key at firstname.lastname@example.org.
Responsible Conduct of Research
Certain federal agencies have adopted requirements for training on the responsible conduct of research for certain individuals supported by or participating in projects funded by those agencies. FSU’s Policy on Responsible Conduct of Research (RCR) Training outlines policy and procedures for ensuring compliance with these requirements. Postdoctoral fellows, graduate students, and USDA/NIFA project staff must complete their training within two months of their initial appointment or assignment to the grant. Undergraduates must complete their training within one month of their initial appointment or assignment to the grant. Training options are explained at https://www.research.fsu.edu/research-compliance/rcr/. If you have questions, please contact Diana Key at email@example.com.
It is the policy of FSU to uphold the highest standards of integrity in research, creative activity, scholarship, and performance; and to protect the right of its employees and students to engage in these activities. The university is committed to complying with and enforcing applicable federal, state, and local laws and to following procedures required by the university or by funding agencies from which contract and grant funds are secured. It is also the policy of the university to inquire into and, if necessary, investigate and resolve promptly and fairly all instances of alleged misconduct; and to comply in a timely manner with university and funding agency requirements for reporting cases of possible misconduct.
Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.
Because the consequences of research misconduct can be quite severe, researchers are strongly urged to review the information provided at https://www.research.fsu.edu/research-compliance/research-misconduct/, which includes policies, procedures, guidelines, and regulations. If you have questions, please contact Diana Key at firstname.lastname@example.org.
Unpaid Visiting Scholars/Researchers
The university has published an Unpaid Visiting Scholar/Research Policy (Policy 3A-100). The purpose of the Policy is to ensure that all visiting scholars/researchers are properly identified, classified, and supervised during their stay on campus and that all applicable university, state, and federal laws, policies and regulations are followed. The overall university policy is that no unpaid visiting scholar/researcher will be accepted to come to the FSU campus for more than 14 days unless: (1) invited by a hosting FSU faculty or staff member with full approvals from the appropriate Chair/Director, Dean, and the Vice President for Research, and (2) an unpaid visiting scholar/researcher courtesy appointment for the approved visiting scholar/researcher has been entered into OMNI by Human Resources and a criminal background check completed, if applicable.
Faculty who wish to host a visitor should consult the policy. If you have questions, please contact Diana Key at email@example.com.
Researchers often collaborate on research or share research tools with other scientists or institutions without receiving funding. For many unfunded collaborations, a formal agreement is beneficial or necessary. Unfunded agreements set out expectations, terms, and requirements that protect the interests of the investigators and the participating organizations. Often these agreements are incorporated (by attachment or reference) within funded agreements. It is important to note that an unfunded agreement may involve the provision or exchange of something of value, and the relevant department will need to determine whether what FSU provides under the agreement is commensurate in value with what it is receiving. Further, unfunded agreements sometimes contain restrictive language that may conflict with basic academic rights, intellectual property rights, and/or other terms that must be negotiated. All unfunded agreements are legal contracts between two parties; therefore, only an authorized institutional official (e.g., the Vice President for Research) has the authority to sign these agreements on behalf of the university. See the responsibility matrix at https://www.research.fsu.edu/research-compliance/unfunded-agreements/ for further information. If you have questions, please contact Diana Key at firstname.lastname@example.org.
The Office of Research Compliance Programs (ORCP) is responsible for the development, oversight and monitoring of the research compliance program for Florida State University. ORCP is your one-stop shop for research compliance matters.