Compliance Areas and Specific Reminders
Human Subjects Research (Institutional Review Board – IRB)
The Institutional Review Board (IRB) reviews and oversees all research involving human subjects conducted at UNLV. This includes surveys, interviews, observation, medical records review, biospecimen collection, and any research involving interaction or intervention with human participants. All human subjects research must receive IRB approval before work begins.
- IRB Approval Required: No human subjects research may begin without written IRB approval. Obtain approval letter before recruiting, enrolling, or conducting any research procedures.
- Current Protocol Required: Ensure the protocol you’re using for research matches the currently approved version. All modifications require prior IRB approval before implementation.
- Informed Consent: Use only the IRB approved informed consent form. Consent must be documented according to the approved process. Maintain signed consent forms in a secure, organized manner.
- Training Compliance: All personnel conducting research must complete CITI (Collaborative Institutional Training Initiative) for Human Subjects Research and maintain current certification. A certificate of completion must be documented.
- Protocol Training: Conduct protocol specific training for all research personnel. Document what training was provided, when it was provided, who provided it, and who completed it.
- Continuing Review: Annual continuing reviews must be submitted before protocol expiration. Failure to submit may result in protocol closure.
- Deviation Reporting: All protocol deviations, unanticipated problems involving risks to subjects, and adverse events must be reported to the IRB promptly. Include corrective actions taken.
- Records Retention: Maintain research records for at least 3 years after study completion (or longer if required by funding agency or regulations). Records must include consent forms, source documentation, correspondence with IRB, and safety reports.
- Research Personnel Updates: Maintain a list of all current research personnel involved in the study. Update the list when personnel join or leave the research team.
- Data Security: Store all data containing identifiable information in a secure location (e.g., password protected database, encrypted files, locked cabinet in room with limited access). Have a written data security plan.
- Sponsor/Agency Requirements: If research is sponsored, comply with all sponsor and funding agency requirements regarding protocol modifications, reporting, and compliance.
See the Human Subjects Research/IRB site for more information.
Animal Care and Use (Institutional Animal Care and Use Committee – IACUC)
The IACUC reviews and approves all research involving live animals conducted at UNLV. Compliance with the Animal Welfare Act, the Health Research Extension Act, Public Health Service Policy on Human Care and Use of Laboratory Animals, Office of Research Integrity Animal Welfare Resources, the United States Department of Agriculture Animal and Plant Health Inspection Service, and institutional standards is mandatory. All protocols must receive IACUC approval before animal work begins.
- IACUC Approval Required: No animal research may begin without written IACUC approval. Obtain approval letter before acquiring or working with any research animals.
- Current Protocol: Work only within the scope of your approved protocol. All modifications to procedures, animal species, numbers, or pain categories require prior IACUC approval.
- Animal Welfare: Conduct research procedures as approved, using approved anesthesia, analgesia, and euthanasia methods. Procedures must be performed by trained, qualified personnel.
- Personnel Qualifications: All personnel working with animals must have documented evidence of training/qualifications appropriate to their role (species handling, surgical techniques, anesthesia administration, etc.).
- Training Documentation: Maintain current CITI IACUC training for all animal care personnel. Document all species-specific and procedure-specific training.
- Veterinary Oversight: Maintain communication with veterinary and Vivarium staff regarding animal health, welfare, and any concerns. Report health issues immediately.
- Continuing Review: Annual continuing reviews must be submitted before protocol expiration. Include updates on animal welfare monitoring and any adverse events.
- Incident Reporting: Report all animal injuries, illnesses, unexpected deaths, and welfare concerns to the IACUC promptly (typically within 24 hours of discovery). Include corrective actions.
- Compliance with Protocol: Follow approved procedures for animal identification, housing, feeding, water, environmental enrichment, and veterinary care. Document monitoring activities.
- Records Retention: Maintain protocol files including approved protocol, amendments, training records, incident reports, and continuing review documentation for at least 3 years after the study completion.
- Personnel Changes: Maintain a list of current researchers. Update this list and notify the IACUC when research personnel join or leave the animal research team.
- Procurement Records: Maintain documentation of where animals came from and procurement dates.
See the Institutional Animal Care and Use Committee (IACUC) site for more information.
Institutional Biosafety Committee (IBC)
The Institutional Biosafety Committee (IBC) provides oversight of research involving recombinant DNA, infectious materials, human materials, and other biohazards. The committee ensures all potentially hazardous biological research at UNLV is conducted safely and in compliance with the NIH Recombinant DNA Guidelines and institutional biosafety policies.
- IBC Registration/Approval: All research involving biohazards must be registered with or approved by the IBC before materials are received or work begins.
- Biosafety Level Compliance: Conduct work at the approved biosafety level using required equipment, containment practices, and personal protective equipment (PPE).
- Approved Procedures: Follow approved procedures for material handling, containment, decontamination, and disposal as specified in the IBC protocol.
- Personnel Training: All personnel must complete biosafety training before beginning work. Document training completion date and retain certificate of completion for training records.
- Access Control: Restrict access to BSL-2+ facilities to authorized and trained personnel.
- Material Tracking: Maintain records of biohazardous material receipt, storage, use, and disposal. Document quantities, lot numbers, and dates, as required.
- Equipment Maintenance: Biosafety cabinets and equipment must be certified/tested at least annually, when serviced, and when moved. Maintain certification records.
- Incident Response: Report spills, exposures, or incidents involving biohazardous materials to the IBC immediately. Follow decontamination procedures and medical evaluation if needed.
- Waste Decontamination: All biohazardous waste must be decontaminated before disposal into a regular waste stream. Use approved methods (e.g., autoclave, bleach, etc.) and maintain documentation of decontamination.
- Continuing Review: Annual continuing reviews must be submitted before protocol expiration.
- Facility Inspections: Cooperate with IBC facility inspections and maintain required records of inspections.
See the Institutional Biosafety Committee (IBC) site for more information.
Conflict of Interest and Commitment
UNLV requires disclosure of financial conflicts of interest and significant commitment conflicts that could impact research objectivity or institutional interests. Disclosure and management of conflicts ensure research is conducted with integrity and maintains public trust. Disclosure forms must be completed annually, and whenever new conflicts arise.
- Annual Disclosure Required: All UNLV employees must complete annual conflict of interest/financial interest disclosures and provide information on the nature and extent of their compensated outside services.
- Timely Updates: Disclose new conflicts within 30 days of discovery or when they arise (e.g., starting a business, obtaining equity, consulting arrangements, etc.).
- Completeness: Disclose all significant financial interests including equity ownership, consulting fees, consulting arrangements, paid positions, royalties, grants, and research funding.
- Threshold Amounts: Report all financial interests in entities related to research, regardless of amount. Note any income received or expected.
- Family Members: Disclose significant financial interests of spouse and dependent children if related to research.
- Management Plans: If conflicts are identified, work with ORI to develop a management plan specifying conditions for research participation (e.g., excluding from certain decisions, independent monitoring, etc.).
- Compliance with Plans: Adhere to any conflict of interest management plan as assigned. Noncompliance may result in removal from the research project.
- Disclosure Accuracy: Ensure disclosures are accurate and complete. Inaccurate or incomplete disclosures may be considered for disciplinary actions.
- Commitment Conflicts: Disclose outside commitments that could interfere with fulfilling institutional research responsibilities before starting the activity.
- Disclosure Certification: Certify that disclosures are true, accurate, and complete.
- Record Retention: Maintain documentation of disclosures and any management plans for at least 3 years.
See the Conflict of Interest and Commitment site for additional information.
Radiation Safety Committee (RSC)
The Radiation Safety Committee (RSC) oversees all radioactive materials (RAM) and radiation producing devices (RPD) at UNLV. All research involving RAM and RPE must be approved by the RSC and comply with Nevada Administrative Code (NAC) 459 and Nuclear Regulatory Commission (NRC) regulations, and policies and procedures described in the UNLV Radiation Safety Manual.
- Radioactive Material Inventory: Maintain current inventory of all radioactive material including radionuclide, quantity, form, acquisition date, and location.
- Secure Storage: Store radioactive material in a properly shielded, designated, and secure location accessible only to authorized personnel. Ensure that there are two levels of security when radioactive material is not in use.
- Radioactive Material Use Documentation: Document all use of radioactive material including date, user, material, quantity used, and purpose.
- Contamination Monitoring: Monitor work areas and equipment regularly for contamination. Document results of all surveys. Report contamination outside controlled areas immediately.
- Spill and Incident Response: Report spills and incidents immediately to the Radiation Safety Officer. Document incident and response.
- Waste Management: Segregate radioactive waste in labeled designated containers. Complete waste log indicating the date of disposal, radionuclide, activity, physical form, and initials of the person who disposed the material.
- Personnel Dosimetry: Wear dosimetry badges during work with radioactive materials. At the end of the work period, place dosimetry badge on the control rack.
- Bioassay Participation: Participate in the bioassay program if working with RAM at RAD Level 3 or higher (routine bioassay), prior to starting work with RAM (baseline bioassay), or no longer working with RAM at UNLV (exit bioassay).
- RAM and RPD Procurement: Follow UNLV procedures for RAM/RPD procurement. Only Authorized Users may purchase and receive RAM and RPD.
- RAM and RPD Protocol: Follow approved procedures for RAM and RPD handling, containment, decontamination, and disposal as specified in RSC approved protocols.
- RAM and RPD Shipping and Receiving: Follow UNLV procedures for RAM/RPD shipping or receiving. Only Authorized Users may request RAM/RPD shipment or receipt through the Radiation Safety Office.
- Training: All personnel must complete radiation safety training and RAM/RPD protocol training before using radioactive materials or radiation producing devices and complete annual refresher training. Retain training completion records.
See the Radiological Safety site at the Office of Risk Management & Safety for additional information.
Export Control
Research involving controlled technical data, software, or equipment may be subject to federal export control regulations administered by the U.S. Department of Commerce (EAR) or State Department (ITAR). Researchers must obtain proper authorizations before sharing research with non-U.S. individuals or collaborators or transferring controlled items.
- Export Control Screening: Before sharing research with foreign nationals or collaborators, conduct export control screening to determine if research data/technology is controlled.
- ECCN and License Determination: If research is controlled, determine the Export Control Classification Number (ECCN) or item category. Determine if a license is required.
- License Requirements: If a license is required, obtain written authorization from Bureau of Industry and Security (BIS) or State Department before sharing.
- Technology Control Plan: If sharing technical data with foreign nationals, maintain a Technology Control Plan (TCP) specifying what may be sharing and access restrictions.
- Foreign Affiliation Disclosure: Disclose all foreign affiliations, collaborations, and funding sources to the Export Control Office.
- Restricted Party Screening: Screen all foreign collaborators and exchange participants against U.S. government restricted party lists (SDN, Entry List, Denied Persons List, Unverified List).
- Authorized Access: Provide technical data/research to foreign nationals only through authorized channels (license, exemption, or non-controlled).
- Visa Screening: Screen international visitors for visa status and authorized access areas (especially sensitive research areas).
- Training: Complete export control training before starting international collaboration. Maintain current training documentation.
- Documentation: Maintain records of export control screening, license applications, approvals, and compliance procedures.
- Reporting: Report any suspected export control violations immediately to the Export Control Office.
- Retention: Maintain export control documentation for at least 3 years.
See the Export Control Office and UNLV Export Control Manual for additional information.
Research Misconduct
UNLV is committed to maintaining research integrity and addressing allegations of research misconduct. Research misconduct includes fabrication, falsification, or plagiarism in proposing, conducting, or reporting research. Although federal policies apply only to federally funded research, UNLV applies federal research misconduct policies to all research.
- No Fabrication: Do not invent or create data that was not actually collected or observed. All reported data must reflect actual research results.
- No Falsification: Do not alter, manipulate, or omit data, results, or findings. Report results accurately even if unexpected or negative.
- No Plagiarism: Properly attribute ideas, text, images, and work of others. Obtain permission when required.
- Attribution: Properly acknowledge contributions of colleagues, students, technical staff, and funding sources.
- Record Keeping: Maintain accurate and complete research records supporting reported results. Retain primary data and laboratory notebooks.
- Transparency: Disclose all data, including data supporting conclusions and data not supporting conclusions. Disclose methodology completely.
- Reporting Results: Report research findings accurately and completely. Distinguish between speculation and findings supported by data.
- Correction of Errors: If errors are discovered in published work, promptly notify the journal editor and request correction or retraction.
See the Research Misconduct site for additional information.
Responsible Conduct of Research (RCR) Training
Federal funding agencies (NIH, NSF, USDA) require RCR training for all supported researchers and trainees. RCR training includes an online component that provides a general overview of responsible research topics and in-person modules that cover each topic in greater depth with case studies and discussions. Current RCR modules include data management, mentoring, collaborative research, publication practices and authorship, conflict of interest and commitment, research misconduct, and peer review.
- Training Requirement: Complete RCR training if you are a researcher supported by NIH, NSF, or USDA-NIFA funds. RCR training is required to be completed within one year of receiving funding. Refresh training prior to the 4-year certification expiration date.
- Documentation: Maintain proof of training completion as part of the training record.
- Personnel Tracking: Maintain a current list of all personnel on the project and their training status.
See the Responsible Conduct of Research site for additional information.
Research Security
Researchers must protect institutional research security and comply with requirements related to intellectual property, proprietary information, foreign affiliations, and undisclosed foreign influence. Research security includes cybersecurity, information security, and protection of sensitive research.
- Foreign Affiliation Disclosure: Disclose all current and pending foreign support, research collaborations, and foreign institutional affiliations to ORI.
- Talent Programs: Disclose participation in foreign talent programs and any recruitment efforts by foreign institutions.
- Funding Disclosure: Disclose all sources of research funding, including foreign government funding, to ORI and the funding agency.
- Research Data Security: Implement robust cybersecurity for research data, especially sensitive information. Use strong passwords, two-factory authentication, and encryption when possible.
- Device Security: Ensure laptops, external drives, USB devices are password protected and encrypted. Update security patches promptly.
- Network Security: Use secure, institutional network when handling sensitive research data. Avoid public WiFi for sensitive work.
- Cloud Security: If using cloud storage (Box, OneDrive, Google Drive), ensure permissions are set to restrict authorized personnel only.
- Intellectual Property: Understand intellectual property ownership and licensing for your research. Disclose inventions to the technology transfer office.
- Proprietary Data: Protect proprietary data from collaborators. Maintain confidentiality agreements when required.
- Personnel Security: Screen research team members for research security concerns (conflicts, undisclosed affiliations).
- Incident Reporting: Report suspected research security incidents (unauthorized access, data breach, intellectual property theft) to ORI immediately.
- Training: Ensure Research Security training has been completed for all research personnel. Maintain certificates of completion as training record documentation.
See the Research Security site for additional information.
Research Agreements and Sponsored Programs
The Office of Sponsored Programs (OSP) manages all external research funding, funding agreements, and institutional agreements related to research. This includes sponsored research agreements, material transfer agreements (MTAs), data use agreements (DUAs), and collaborations with external partners.
- Agreement Review: All research agreements must be reviewed and approved by OSP before execution. Do not sign agreements independently.
- Funding Agreements: Ensure funding agreement clearly specifies award amount, period, budget, allowable costs, reporting requirements, and compliance obligations.
- MTAs and DUAs: If transferring materials or data to/from external partners, execute Material Transfer Agreement (MTA) or Data Use Agreement (DUA) before transfer.
- Intellectual Property: Understand intellectual property ownership and publication rights per funding agreement. Sponsor may require IP disclosure.
- Budget Compliance: Ensure spending complies with approved budget. Do not charge unallowable costs. Obtain prior approval for budget modifications.
- Reporting Requirements: Comply with all sponsor reporting requirements (progress reports, final reports, financial reports). Ensure timely and complete submissions.
- Regulatory Compliance: Research must comply with all applicable regulations regardless of funding source.
- Data/Records Access: Provide access to research records/data to sponsor or auditor upon request for audit purposes.
- Equipment: Track equipment purchased with grant funds. Inventory and accountability are required in accordance with sponsor and federal guidelines.
- Subaward Management: If subawarding work to other institutions, the subaward must include all applicable federal compliance requirements.
- Agreement Termination: If research ends early or is terminated, follow termination procedures (closeout, final reporting, equipment return, etc.).
- Continuation Proposals: Submit continuation proposals on schedule if research continues beyond initial award period.
- Conflicts of Interest: Disclose any conflicts of interest to sponsor in accordance with funding agreement requirements.
See the Office of Sponsored Program site for additional information.
Risk Management & Safety (RMS)
UNLV’s Risk Management and Safety department protects the health and safety of all researcher personnel, the campus community, and the public. This includes laboratory safety, emergency preparedness, and mitigation of research related hazards.
- Safety Training: Complete required safety training before beginning work in the laboratory. Maintain current certifications.
- Chemical Safety: Follow the UNLV Chemical Hygiene Plan, use Safety Data Sheets (SDS) for all chemicals, store chemicals appropriately, use engineering controls such as fume hoods for hazardous materials.
- Personal Protective Equipment (PPE) Compliance: Use appropriate personal protective equipment, such as safety glasses, gloves, lab coat, etc.). Inspect PPE for damage before use.
- Lab Attire: Wear long pants and closed-toe and closed-heel shoes to enter any laboratory on campus, regardless of work being performed.
- Emergency Equipment: Ensure all emergency exits and equipment such as fire extinguishers, first aid kits, electrical panels, emergency showers, and eyewash stations are always accessible.
- Hazard Communication: Ensure all chemicals are labeled with the full name of the chemical and any applicable hazards.
- Documentation: Maintain a laboratory safety manual that consists of training records, incident reports, safety inspections, and standard operating procedures.
See the Risk Management & Safety site for additional information.
Data Privacy and Security
Researchers must ensure all research data is handled securely and in compliance with applicable privacy regulations including HIPAA, FERPA, and state data protection laws. Data management plans should address data collection, storage, security, sharing, and retention.
- Data Management Plan: Develop and maintain a data management plan addressing collection methods, storage locations, access controls, security measures, sharing agreements, retention period, and disposal procedure.
- Data Classification: Identify what type of data is being collected (PHI, PII, controlled data, export-controlled, etc.). Different data types have different security requirements.
- Secure Storage: Store data containing identifiable information in a secure location, such as a password-protected database, encrypted external drive, secure cloud storage, or locked cabinet with limited access.
- Access Controls: Restrict data access to research personnel with an approved need. Document who has access to the data and why.
- Encryption: Use encryption for data at rest (storage) and in transit (transmission). Ensure encryption methods meet or exceed NIST standards.
- Data De-identification: If appropriate, de-identify data in accordance with HIPAA standards (removal of 18 identifiers) or the Expert Determination method.
- Limited Data Set: If using limited data sets, maintain a Data Use Agreement (DUA) with recipient organization specifying permitted uses and security requirements.
- Backup and Recovery: Maintain regular backups of research data in separate, secure location. Have data recovery procedure in place.
- Personnel Training: Ensure all research personnel receive training on data security, privacy regulations, and proper handling of sensitive data.
- Breach Notification: If unauthorized access to data occurs, notify ORI immediately. Follow HIPAA breach notification procedures if applicable.
- Record Retention: Maintain data according to funding agency and regulatory requirements (typically 3-7 years). Document retention schedule.
- Secure Disposal: When data is no longer needed, securely delete or destroy it. Document disposal method and dates.
See the Data Management Plan guidance document for additional information.
Clinical Trials Administration
Clinical trials are regulated research studies that evaluate medical interventions in human subjects. UNLV’s Office of Clinical Trials (OCT) provides comprehensive support for industry sponsored, investigator initiated, and federally funded clinical research. Clinical trials involve special regulatory requirements including Federal Drug Administration (FDA) oversight, protocol approval, informed consent, safety monitoring, adverse event reporting, and quality assurance. All clinical trials research at UNLV must be conducted in compliance with federal regulations, FDA guidance, international Good Clinical Practice (GCP) standards, study protocols, and institutional policies.
- IRB Approval: Obtain IRB approval before initiating any clinical trial. Maintain current IRB approvals throughout the study.
- Regulatory Files: Maintain accurate and current regulatory files including protocol(s), informed consent form(s), FDA forms (Form 1571, 1572, 1571-S), CV of investigator(s), IRB approval letters, institutional commitment letters, and conflict of interest disclosures.
- Informed Consent: Obtain documented informed consent from all study participants using the IRB-approved form before any study related activities begin. Document consent in study records.
- Protocol Adherence: Follow the approved study protocol and IND/IDE. Report any protocol deviation or amendments to the sponsor and IRB immediately for review and approval.
- Safety Monitoring: Implement data and safety monitoring procedures. Report all adverse events and anticipated problems to the sponsor and OCT in accordance with protocol and regulatory requirements.
- Subject Documentation: Maintain detailed study records documenting subject eligibility, enrollment, study procedures, observations, and outcomes. Keep records organized and readily accessible.
- Financial Disclosure: Complete and maintain current financial disclosures for all investigators as required by Form 3454 and 5455. Track all clinical trial related funding.
- Study Team Training: Ensure all personnel performing study procedures are trained on the protocol, GCP principles, informed consent procedures, and safety requirements. Document all training completion.
- Data Integrity: Maintain accurate and complete source documents supporting all study data. Implement data quality controls and procedures.
- Study Sponsor Coordination: Maintain regular communication with the study sponsor regarding subject recruitment, enrollment, protocol adherence, safety events, and study status.
- Site Readiness: Prepare for potential sponsor audits or FDA inspections. Maintain organized regulatory files and study records readily accessible for review.
See the Office of Clinical Trials site for additional information.