TO: UNLV Faculty Members, Principal Investigators, Project Directors, Laboratory Supervisors
FROM: Stanley D. Smith, Associate Vice President for Research
DATE: October 12, 2010
RE: Research Information and Responsibilities at the University of Nevada, Las Vegas
This annual reminder provides formal policy guidance for the conduct of research that is essential to promote a safe, ethical, and productive research environment. Every faculty member, Principal Investigator/Project Director (PI/PD), and laboratory supervisor at the University of Nevada, Las Vegas (UNLV) is responsible for fostering an environment that enables the highest level of academic inquiry while simultaneously complying rigorously with all federal, state, and University regulations related to the conduct of research. I urge each PI/PD and/or supervisor to review and communicate the guidelines outlined in this memorandum with all co-workers and individuals engaged in research.
Responsible Conduct of Research (RCR)
Conducting research in a responsible manner is a core responsibility of all faculty at UNLV. UNLV has created an Office of Research Integrity (http://research.unlv.edu/compliance/) to aid faculty in this pursuit. The Office of Research Integrity provides guidance on general ethical principles and support for compliance requirements.
All faculty must encourage ethical behavior in their trainees (graduate and undergraduate students and post-doctoral scholars) and provide training in RCR to these individuals. To aid this process, a formal responsible conduct of research training course is offered each semester. All faculty with funding from either the NIH or NSF are responsible for ensuring their trainees complete this RCR course. All other faculty are encouraged to send their trainees through RCR training.
RCR training is offered each semester, and instructors are experienced faculty members. Topics include general ethical responsibilities in research; collaborative research; mentor/trainee responsibilities; acquisition, management, sharing, and ownership of data; publication practices and responsible authorship; conflict of interest and commitment; research misconduct; and peer review. More information is available at: http://research.unlv.edu/compliance/responsible-conduct/.
Responsibility for Management of Sponsored Projects
University faculty and staff members who direct sponsored projects have the principal responsibility to carefully manage these programs. The legal status of the Principal Investigator or the Project Director (PI/PD) should be clearly understood: the PI/PD, as an individual, is not the recipient of the grant, and has not entered into a contract with a sponsor. The University has entered into the contract or the University has been awarded a grant.
However, the monies must be spent by the University in accordance with the proposal and as initiated by the PI/PD. Although the University signs the agreement and the University is legally and financially responsible to the sponsor, the PI/PD is responsible for the administration of the project, submission of the technical reports, and proper fiscal management of the project. The Office of Sponsored Programs will provide administrative and financial services to assist in the handling of these responsibilities and has established procedures to help meet federal, state, sponsor, and University administrative requirements.
One of the most important responsibilities of the PI/PD is to keep track of expenditures and commitments and to prevent expenditures from exceeding the budget or from being used for unauthorized purposes. Even if the responsible account holder designates other persons as "authorized signatures," he or she remains the person solely responsible for ensuring that the project is conducted within the budget or that the account balance is not exceeded. In case of overruns or account deficits, the University holds the PI/PD, the department, or college responsible for covering such costs.
To aid the PI/PD in avoiding overruns or account deficits, the University provides monthly Balance and Activity Reports, furnishes account balances as requested, monitors transactions and advises of potential or real account deficits. In addition, online access is available to approved personnel.
Additionally, the PI/PD is responsible for tracking his/her committed effort on sponsored projects. PI/PDs may not exceed 100% effort in performing all university duties, which include research, instruction, administration, and other types of effort. Extra compensation is not available on sponsored projects, except in extraordinary circumstances, which must be pre-approved.|
The UNLV Office of Sponsored Programs Handbook (OSP Handbook) provides guidance to faculty and authorized professional research staff in seeking and administering external financial support for sponsored projects. The handbook outlines requirements, support functions, and other information related to proposing, conducting, and reporting on projects supported by external funds from federal, state, or private entities.
The OSP Handbook is available electronically at: http://research.unlv.edu/osp/OSP%20Handbook%2011-13-08.pdf.
Specific administrative questions are addressed in the OSP Frequently Asked Questions (FAQs) at: http://research.unlv.edu/osp/faqs.html.
Oversight of Individuals Engaged in Research
PI/PDs and/or supervisors are responsible for the oversight of all individuals engaged in research under their direction, whether or not the University compensates the students and/or employees. This responsibility extends to visiting scholars, trainees, postdoctoral appointees, graduate students, undergraduate student assistants, staff employees, pre-collegiate students, or participants in life-long learning or other special programs. The PI/PD and/or supervisor must ensure that any such person understands and adheres to all applicable regulations, follows all University policies, participates in relevant training, and adheres to high ethical standards of honesty and integrity in research.
Use of Human Subjects
All research activities involving the use of human subjects must be reviewed and approved by the Institutional Review Board (IRB) prior to initiation of the project. The IRB is responsible for safeguarding the rights and welfare of subjects who participate in the research activity. IRB policies and other information can be viewed at: http://www.unlv.edu/Research/ORI-HSR/.
IRB approvals are valid for one year, and it is the responsibility of the PI to obtain yearly renewals from the IRB. Researchers who wish to apply for a new IRB submission may either submit online (information available at: http://research.unlv.edu/ORI-HSR/CyberIRB.htm) or obtain forms at: http://research.unlv.edu/forms/unit.html.
The responsible conduct of research involving human subjects requires training of all key personnel involved in the research. The University’s Institutional Review Board (IRB) requires documentation of participation in such training by all PIs conducting research projects involving human subjects, in accordance with the Department of Health and Human Services (DHHS) regulations. Training may be initiated at: http://research.unlv.edu/ORI-HSR/citi-info.htm.
Research on Vertebrate Animals
In accordance with federal regulations for the review of animal research protocols (Public Health Service Policy, USDA, and Animal Welfare Regulations), the University requires that all researchers who conduct research utilizing vertebrate animals must obtain written approval from the Institutional Animal Care and Use Committee (IACUC) prior to ordering animals and beginning work. IACUC information can be viewed at: http://research.unlv.edu/compliance/lacs/. Applications for IACUC protocols may be obtained by sending a request to email@example.com.
Public Lands Permits
If you will be conducting research or class-based field trips on public lands, you must obtain and carry a permit. The Research Office assists with obtaining these permits from the federal agency where the activity is to occur. Please visit: http://publiclands.unlv.edu/permits/index.htm to request assistance with permitting.
Misconduct in Science and Other Scholarly Activities
PI/PDs and/or supervisors are expected to adhere to the highest ethical standards when conducting research and scholarly work. Misconduct in science and other scholarly activities is contrary to the standards of the University. Definitions of misconduct and procedures for handling allegations of misconduct can be found at: http://research.unlv.edu/compliance/misconduct/
Conflict of Interest and Compensated Outside Service
The University of Nevada, Las Vegas promotes objectivity in research by carefully reviewing any potential conflicts of interest or commitment. All UNLV faculty and staff must complete a Conflict of Interest/Compensated Outside Services Disclosure annually and at the initiation of a new project that involves a potential conflict or outside compensation. More details are available at: http://research.unlv.edu/compliance/coi/.
Federal Export Laws and Regulations
All research projects must be in strict compliance with federal export laws and regulations. The University and all its employees are required to comply with the laws and implementing regulations issued by the Department of State, through its International Traffic in Arms Regulations (ITAR), the Department of Commerce, through its Export Administration Regulations (EAR), and the Department of Treasury through its Office of Foreign Assets Controls (OFAC). Further information regarding export control requirements is set forth on the ORI web site at: http://www.unlv.edu/Research/export/index.html.
Material Transfer Agreements
All agreements related to research activities including, but not limited to, Sponsored Research Agreements, Memoranda of Understanding, Participation and Cooperative Agreements, Teaming, Confidentiality and Non-Disclosure Agreements, and Material Transfer Agreements (MTAs) must be processed through the Office of Sponsored Programs (OSP). Biological and chemical materials transferred from the University to another entity require the transfer to be completed only after an MTA has been fully executed with the other entity. Contact the Office of Sponsored Programs at 5-1327 or firstname.lastname@example.org for assistance with Material Transfer Agreements.
The University of Nevada Las Vegas owns the intellectual property (IP) developed by PI/PDs (as further defined in: http://research.unlv.edu/techtransfer/policies.htm).
The Office of Technology Transfer (OTT) is responsible for managing intellectual property and commercializing research results in which the University asserts an ownership interest.
Additional information about the OTT office can be found at: http://research.unlv.edu/techtransfer/index.htm.
The PI/PD is responsible for reporting all patentable inventions through the completion of an invention disclosure form found at: http://research.unlv.edu/techtransfer/forms.htm. The completed forms should be submitted to the OTT in a timely manner, so that the University can: (1) comply with the Sponsored Research Agreement (SRA) if the invention was supported by a sponsor; (2) take appropriate actions related to possible encumbrances of the invention by other agreements (e.g., collaboration agreements, inter-institutional agreements, license agreements, other SRAs); and (3) work with the inventor to make a determination regarding whether to protect the IP or release it to the inventor. Software and other copyrightable materials follow a similar process.
For existing IP, the OTT works with inventors and industry to (1) execute non-disclosure agreements, (2) negotiate and license technologies, (3) facilitate formation of companies around the IP, and (4) perform other activities that help turn research results into industrial products. The OTT manages licensee compliance and processes licensee royalties, equity, and inventor distributions.
Unfortunately, given recent staffing reductions due to budget cuts, the OTT does not currently have a Director. OTT activities have therefore been assumed by several members of the Research Office.
Providing a Safe Working Environment
An essential requirement of all University projects, whether sponsored or not, is to provide a safe working environment for all students, staff, and faculty engaged in teaching and/or research. The PI/PD or supervisor is responsible for the day-to-day management of all research conducted under his/her supervision or in University facilities assigned to that individual.
The responsibilities of a PI/PD or supervisor include, but are not limited to:
- Ensuring the routine availability of any equipment or facilities required to conduct specific research;
- Providing any necessary safety equipment for the conduct of research under his/her supervision;
- Ensuring that each individual complies with the standards for safe behavior in the laboratory; and
- If chemicals are used in research, ensuring that each individual is trained in accordance with all applicable federal, state, and University regulations and completes UNLV Chemical Hygiene training as required by the UNLV Chemical Hygiene Plan.
Strict compliance with all safety standards outlined in the Risk Management and Safety websiteis required. These standards aresupplemented by any additional safety precautions adopted by the University, the researcher’s college, department, or organized research unit (ORU).
Laboratory Safety informationis available at: http://rms.unlv.edu/environmental-and-lab/
Information on the use of radioactive materials and radiation-producing equipment can be found at: http://rms.unlv.edu/radiological/
Safety training offerings are listed at: http://rms.unlv.edu/occupational/training/.
If you have questions regarding Safety Training, please contact Ben Fausett at (702) 895-4226 or email email@example.com.
Strict compliance with the regulations for the use of controlled substances in research is required by all researchers.
The Drug Enforcement Agency (DEA) regulates the use and possession of DEA-controlled substances, such as pentobarbital. Please note that many chemicals that were not controlled substances in the past now are controlled by DEA. A federal DEA license and a state license are required for these substances.
A list of DEA controlled substances can be viewed at: http://www.deadiversion.usdoj.gov/schedules/index.html.
If you have any controlled substances and you do not have a license for that particular controlled substance, contact Risk Management and Safety (RMS). RMS will arrange for legal disposal or assist you in obtaining the proper licenses.
Compliance with the regulations for the use of select agents (certain biological agents and toxins) is required in research. All research utilizing select agents is controlled by the Centers for Disease Control and/or the United States Department of Agriculture (USDA). The current list of select agents can be found at: http://www.cdc.gov/od/sap/docs/salist.pdf.
If you wish to work with or locate one of these agents, contact Risk Management and Safety for assistance.
Institutional Biosafety Committee
Researchers conducting either sponsored or non-sponsored research with recombinant DNA, infectious agents, toxins, primary human cell lines, human stem cells, human blood, or human tissue must have their research approved in advance by the Institutional Biosafety Committee (IBC). Approvals are valid for three years. It is the responsibility of the PI to obtain renewals from the IBC after the initial three-year approval. A submission form is available at:
Contact Aurali Dade, Executive Director of Research Integrity, for questions regarding the Institutional Biosafety Committee (firstname.lastname@example.org).
It is the policy of UNLV to maintain a workplace free of sexual harassment and intimidation. The University's Sexual Harassment Policy is found at: http://hrfs.nevada.edu/hrwebgen/.
Visiting Scientist/Scholar Agreement
PI/PDs and supervisors are encouraged to execute a Visiting Scientist/Scholar Agreement with any visiting scientist or scholar working under his/her guidance (but who is serving in this capacity without University support or University employment), to ensure that the Visiting Scientist/Scholar is informed of and is in compliance with the terms of the agreement. The Visiting Scientist/Scholar Agreement is available in hard copy at the Office of Sponsored Programs. Contact the Office of Sponsored Programs at 5-1327 or email@example.com for assistance.
Clearance of Faculty/Researcher Terminating Employment
Guidelines for clearing faculty who terminate their employment with the University are located on the web site of the Office of Sponsored Programs at: http://research.unlv.edu/forms/all/ResearcherExitChecklist.doc.
The clearance process enables faculty to exit the University in good standing by appropriately verifying clearances, as applicable, with the Risk Management and Safety Office, Office of Sponsored Programs, and the Office of Research Integrity.
Transfer of Equipment
Requests for the transfer of research equipment to another institution must be processed through the Office of Sponsored Programs and Delivery Services per the university’s Equipment Disposition policy:
This process supplements existing internal inventory checks that each department chair or unit director has developed for faculty/researchers that leave the University.