Research Compliance

The Institutional Animal Care and Use Committee (IACUC) ensures that all research and teaching involving live vertebrate animals at Cal State Monterey Bay meets the highest ethical standards and complies with federal, state and institutional policies.

Oversight is guided by the “Public Health Service Policy on Humane Care and Use of Laboratory Animals” and the “Guide for the Care and Use of Laboratory Animals,” under the authority of the National Institutes of Health’s (NIH’s) Office of Laboratory Animal Welfare (OLAW).

If you witness or suspect mistreatment of animals used in research or instruction at CSUMB, please report it to the Dean of Graduate Studies and Research at research_dean@csumb.edu or call (831) 582-3878.

What the IACUC Does

The IACUC is responsible for:

• Reviewing the university’s program for animal care and use at least twice per year
• Inspecting animal facilities and preparing evaluation reports for the Institutional Official
• Reviewing and approving new protocols and significant changes to ongoing projects
• Investigating animal welfare concerns and recommending actions
• Suspending activities that violate approved protocols or policies

Who Serves on the IACUC

By federal regulation, the committee must include at least five members:

• A veterinarian experienced in laboratory animal care
• A scientist with experience in animal research
• A member from a nonscientific background (e.g., ethicist, lawyer, clergy)
• A community member unaffiliated with CSUMB, representing the public interest

When IACUC Review Is Required

All use of live vertebrate animals in CSUMB-related research or instruction must be reviewed and approved by the IACUC before work begins. This includes:

• Research conducted by faculty, staff or students
• Instructional use of animals in classrooms or labs
• Field studies involving capture, manipulation or tracking
• Use of CSUMB-owned animals or facilities
• Studies using bait to attract animals for observation or photography

Submit an Animal Care and Use Protocol Review Application (ACUPRA) for any qualifying activity.

For use of biological materials from deceased animals not specifically collected for your project, submit a Tissue ACUPRA.

Examples that do not require IACUC oversight:

• Passive observation of wild animals without manipulation or disturbance
• Use of privately-owned pets in live art classes
• Studies involving human interaction with registered therapy animals, unless animals are directly sampled or manipulated

If you’re unsure whether your activity requires review, email research_dean@csumb.edu with “IACUC” in the subject line.

How to Apply for IACUC Review

Determine if your activity needs IACUC approval.

Review CSUMB’s Policy on the Humane Care and Use of Animals in Research and Instruction.

Complete the required training.

All personnel must complete CITI’s “Using Animal Subjects in Research” training. See “Training Requirements” below.

Submit your application.

• Use the ACUPRA for live animal use
• Use the Tissue ACUPRA if using biological materials from deceased animals

Submit forms to the Office of Graduate Studies and Research.

Allow processing time.

Applications are reviewed monthly, if needed. Submit at least one month before your project begins.

Comply with all post-approval requirements.

Once approved, follow all reporting and monitoring instructions included with your approval letter.

Training Requirements

Before working with animals, all faculty, staff and students must complete the following:

• CITI Program: “Using Animal Subjects in Research” (ID: 13301)
  Required for anyone listed on an IACUC protocol. Satisfies USDA and OLAW requirements.
• CITI: “Responsible Conduct of Research (RCR) Basic Course”
  Required for students and postdocs supported by NIH or NSF grants.

Training certifications are automatically forwarded to the IACUC administrative support office once completed. Principal Investigators are responsible for ensuring all team members are trained before protocol submission.

At its discretion, the IACUC may require additional training specific to your project.

CITI Training Portal

• Login to CITI
• CITI Help Desk / Knowledgebase

Cal State Monterey Bay and the University Corporation at Monterey Bay (UCorp) are committed to maintaining the integrity of research conducted at the university. To comply with federal and state regulations, Principal Investigators and key personnel on certain sponsored projects must disclose financial interests that could present a conflict with their research responsibilities.

Disclosures are required for many projects funded by:

• The Public Health Service (PHS), including the National Institutes of Health (NIH)
• The National Science Foundation (NSF)
• Certain non-federal sponsors who adopt PHS conflict of interest regulations

For specific details, please review NIH Financial Conflict of Interest website.

Who Must Disclose?

You must disclose if you are:

• Responsible for the design, conduct or reporting of a PHS- or NSF-funded research project
• Considered senior/key personnel or anyone contributing substantively to a project
• A spouse, registered domestic partner or dependent child of someone in the above roles

When Must Disclosure Occur?

Disclosures must be submitted:

• At the time of proposal submission for PHS or NSF funding
• At least annually for the duration of the award
• Within 30 days of acquiring or discovering a new significant financial interest

What Must Be Disclosed?

Under PHS rules, you must report financial interests related to your institutional responsibilities if they meet any of the following:

• Publicly traded equity exceeding $5,000 in value (excluding mutual or retirement funds not under your control)
• Non-public equity or ownership exceeding $5,000
• Compensation for services exceeding $5,000 within the past 12 months (excluding income from seminars or teaching at government or nonprofit institutions)
• Payments for intellectual property exceeding $5,000, unless from the CSU Regents
• Sponsored or reimbursed travel, unless from a government agency or U.S. academic institution

Mandatory FCOI Training

All PHS-funded investigators are required to complete Financial Conflict of Interest (FCOI) training prior to beginning work on a funded project.

CSUMB uses the CITI Program (Collaborative Institutional Training Initiative) to provide online certification. The training meets federal requirements and is also recognized for professional development.

• Login to CITI
• CITI Help Desk / Knowledgebase

Upon completion, your certification is automatically sent to CSUMB’s Sponsored Programs Office. You may return to CITI to update your training or print certificates as needed.

Cal State Monterey Bay’s Institutional Review Board (IRB) reviews and authorizes research involving human participants or their identifiable private information. The IRB ensures research protects human subjects and complies with federal regulations and institutional policy.

The IRB is administered collaboratively by research compliance staff and IRB committee members. Leadership oversight is provided through CSUMB’s Federalwide Assurance Institutional Officers, including the Provost and Vice President for Academic Affairs.

For Researchers

Preparing for IRB Review

Before submitting a protocol to the IRB, all members of the research team who interact with research participants, access personally identifiable private information, or could reasonably identify a participant must complete the required human subjects protections training.

Step 1 — Training Requirements

All personnel must complete basic human subjects training through the CITI Program before submitting a protocol. Additional training may be required depending on your research design and population.

Required training steps:

• Log in to CITI Program
• Confirm whether IRB review is required
• Watch CSUMB’s video on the Revised Common Rule
• Complete additional CITI modules, as needed
• Optional: OHRP informational videos

Certifications must be valid at the time of submission and throughout the conduct of research involving human subjects. Training in FERPA, data security or other relevant topics may be required based on the risks or population involved.

Step 2 — Review Applicable Policies and Guidelines

Understanding CSUMB’s policies helps you prepare a complete and compliant protocol. Key resources include:

• Human Subjects Research Guidelines
• CSUMB Human Subjects Research Policy

Step 3 — Federal and Institutional Requirements

If your research is externally funded (e.g., NIH or NSF), coordinate with the Sponsored Programs Office and review additional requirements, such as data monitoring and sharing plans.

Researchers are also responsible for knowing and complying with:

• FDA regulations for clinical trials and human subject protections
• NIH policies on human subjects research
• Privacy laws such as FERPA and PPRA
• International human research standards, when applicable

For Research Participants

Understanding what it means to participate in research helps you make informed decisions. The Office for Human Research Protections (OHRP) provides short videos with basic information on:

• How research works
• Rights of research participants
• Questions to ask before participating

OHRP Informational Videos:

• English
• Español

The OHRP’s mission is to protect the rights, welfare and well-being of volunteers in research.

For Regulatory Partners

Regulatory partners support researchers by providing access authorizations for populations or data protected by other regulations (e.g., FERPA, data security, biosafety).

Activities that frequently require additional authorization:

• Access to CSUMB student, staff or alumni personal data
• Collection of sensitive data (biosamples, biometric data)
• Access to protected data under institutional or external policies

If you have questions about access authorizations for a research project, contact the IRB.

For IRB Members

Resources for IRB members include:

• Cayuse Human Ethics Reviewer Tools
• Reviewer Guidance and Decision Charts
• PRIM&R Resources on the Revised Common Rule
• OHRP Training and Tutorials

These tools support efficient and compliant review of human subjects research protocols.

Preparing and Submitting Protocols in Cayuse

All IRB submissions use Cayuse Human Ethics. Templates, guidance documents and form instructions are available through shared resources.

Standard Human Subjects Protocol

A standard protocol includes:

• Completed Cayuse application form
• Required training certification
• Study instruments or diagrams
• Recruitment materials
• Consent documentation (including translated versions if needed)
• Site authorization documents
• Safety and privacy monitoring plans (for greater than minimal risk studies)

Not Human Subjects Research Verification

If your activity does not meet the federal definition of human subjects research, you may request an official determination from the IRB through Cayuse.

Post‑Approval Activities

Use Cayuse to:

• Request amendments, modifications or extensions
• Report unanticipated problems or adverse events
• Submit safety and monitoring reports

Single IRB Requests

For collaborative research involving multiple institutions, submit single‑IRB (sIRB) reliance requests using Cayuse.

Transferring Protocols

Researchers joining CSUMB from another institution may transfer existing protocols, data or materials. Contact the IRB to begin the transfer process.

External Researchers

External researchers wishing to conduct research involving CSUMB populations or data must submit home IRB‑approved protocols for validation before contacting CSUMB participants.

Additional Policies and Procedures

Human subjects research may involve multiple laws and institutional policies. Commonly applicable areas include:

• FERPA and student privacy protections
• CSU and CSUMB research and sponsored programs policies
• Data security and information privacy procedures
• Site authorization requirements

Researchers are responsible for understanding all applicable requirements related to their study.

Many funding agencies now require a Data Management Plan (DMP) as part of the grant application process. These plans outline how research data will be collected, stored, shared, and preserved throughout the entire lifecycle of a project.

Each sponsor has its own guidelines for what should be included in a DMP. To help meet these expectations, we recommend using the DMPTool.

Create Your Data Management Plan

Visit dmptool.org and:

• Select your funding agency to load the correct template
• Complete the sections according to your project needs
• Download your completed plan in Microsoft Word format (.docx)
• Send the downloaded document to spo@csumb.edu, or directly to your Sponsored Programs Officer

Sponsor-Specific Resources

National Science Foundation

Each National Science Foundation (NSF) directorate has its own DMP requirements. Review them carefully through the DMPTool or directly from NSF’s website.

National Institutes of Health

Visit National Institutes of Health’s (NIH’s) Data Management and Sharing Policy page for guidance and templates.

Useful NIH resources include:

• Privacy best practices for protecting participant data

Additional Planning Tools and Guidance

For help developing strong, funder-aligned DMPs, explore the following resources:

• Arizona State University’s Data Management Checklist
• Research Data Management Librarian Academy (RDMLA)

Export control regulations are federal laws that restrict the transfer of certain information, technologies, and goods to foreign countries or foreign nationals.

These laws are designed to:

• Protect U.S. national security
• Prevent the spread of weapons of mass destruction
• Support U.S. foreign policy and international agreements
• Promote human rights and regional stability
• Maintain the nation’s economic competitiveness

Export controls apply to physical shipments, digital communications and even verbal exchanges, whether abroad or within the U.S.

What Regulations Apply?

The main export control regulations are:

• International Traffic in Arms Regulations (ITAR) — governs defense-related articles and services
• Export Administration Regulations (EAR) — covers dual-use items and technologies
• Office of Foreign Assets Control (OFAC) — enforces trade sanctions and embargoes

How Export Control May Affect You

Export control may apply to your activity if you:

• Travel internationally with research materials or equipment
• Communicate with foreign nationals about non-public or proprietary research
• Ship or carry items overseas
• Receive or purchase items from foreign vendors
• Share controlled data or software with foreign nationals, even within the U.S.

To ensure compliance, please contact the Office of Research before proceeding with international research, collaboration, or data sharing.

Resources and Training

Export Control Guidance

• U.S. Bureau of Industry and Security Training

CITI Export Control Certification

CSUMB researchers may complete export control training through the CITI Program, which meets compliance standards.

To get started:

• Visit citiprogram.org
• Log in or create an account
• Search for and “Add a Course” in Export Compliance
• Follow the instructions in the CITI Getting Started Guide

For help with course selection or CITI access, refer to the CITI Knowledgebase.

The Institutional Biosafety Committee (IBC) ensures that all research and teaching involving biological materials at Cal State Monterey Bay is conducted safely and in compliance with federal guidelines.

CSUMB’s IBC operates under the National Institutes of Health (NIH) Guidelines and maintains an official IBC Charter, which outlines the committee’s responsibilities and safety procedures for research involving recombinant DNA, synthetic nucleic acids and other biohazardous materials.

National Biosafety Guidance

NIH Guidelines

NIH provides nationally recognized practices for safely constructing and handling recombinant or synthetic nucleic acid molecules, including associated cells, organisms and viruses. Institutions must follow these guidelines to remain eligible for NIH and related federal funding.

Biosafety in Microbiological and Biomedical Laboratories (BMBL)

Jointly developed by the NIH and Centers for Disease Control and Prevention (CDC), Biosafety in Microbiological and Biomedical Laboratories (BMBL) is the primary reference for lab biosafety in the U.S. It outlines containment practices and lab operations for protecting researchers, the public and the environment.

IBC Membership

The IBC includes faculty, staff, and external experts who bring a range of scientific, public health, and regulatory experience.

Core Members

• Cheryl Logan, Chair (Marine Molecular Biology, CSUMB)
• Denise Lopez (Public Health Lab Manager, Tulare County)
• Zurine DeMiguel (Psychology & Neuroscience, CSUMB)
• JP Dundore-Arias (Plant Pathology, CSUMB)
• Mitch Reid (Environmental Health and Safety, CSUMB)

Community Members

• Karen Tuttle (Applied Water Science, Monterey Bay Aquarium)
• Daniel Hasegawa (Research Entomologist, USDA)

Ex-Officio Members

• Amy Thomas (Director of Environmental Health and Safety & Risk Management, CSUMB)
• Doug Smith (Interim Dean of Graduate Studies and Research, CSUMB)

Do You Need IBC Review?

IBC review is required if your research involves:

• Bloodborne pathogens — Any human or non-human primate–derived materials must be treated as biohazardous and handled under BSL-2 conditions in compliance with Cal/OSHA’s Bloodborne Pathogens Standard
• Transgenic plants — Laboratory or greenhouse use requires IBC oversight; field releases are governed by USDA permits
• Transgenic animals — Creating or breeding transgenic rodents or other animals requires IBC registration; simple use of BSL-1–cleared strains may be exempt
• Select agents and toxins — CSUMB does not currently support use of federally regulated select agents or toxins
• Dual Use Research of Concern (DURC) — CSUMB does not currently support DURC

For help determining if your research requires IBC review, contact the Office of Research.

Other Biohazard Controls

Academic Environmental Health and Safety

University Risk Management collaborates with the IBC to oversee biohazard waste disposal and environmental health compliance.

Chemical and Lab Safety

Supported by Campus Police’s Health and Safety team, chemical safety operations ensure responsible and compliant use of substances in teaching and research labs. Connect with the Academic EH&S Specialist for chemical safety support.

IBC Application Process

To initiate review:

• Review the [IBC Charter] to understand responsibilities and procedures.
• Complete required biosafety training (see below).
• Download and complete the Biological Use Application (BUA).
• Submit your application and await review by the IBC.
• If approved, follow post-approval reporting as outlined in the charter.

Required Training

Biosafety training is mandatory before submitting a BUA. Complete the 14-module CITI Biosafety Training course, plus any additional modules relevant to your research.

Additional CITI Modules (as applicable):

• Animal Biosafety
• Human Gene Transfer Trials
• Nanotechnology
• Dual Use Research of Concern (DURC)
• Select Agents and Biosecurity
• NIH rDNA Guidelines
• Shipping Regulated Biological Materials
• Biohazard Spill Response
• OSHA PPE and Bloodborne Pathogens
• Biosafety Officer or Committee Member Training

Access all training via CITI Program.

Protecting the confidentiality of research participants and their data is critical, especially in social, behavioral and educational research (SBER), where breaches of privacy are among the most common risks.

Research involving protected health information (PHI), as regulated by the Health Insurance Portability and Accountability Act (HIPAA), requires even stricter safeguards. With the growing use of email, websites and cloud-based storage in research, the risk of accidental exposure or malicious data breaches has increased significantly.

Federal and state regulations impose serious penalties for security failures, and also for inadequate responses. Institutional Review Boards (IRBs), including CSUMB’s IRB (CPHS), work closely with information security teams to help researchers:

• Build strong data protection plans
• Respond quickly and thoroughly to any incidents
• Comply with legal reporting requirements

Required Information Privacy and Security Training

CSUMB researchers are required to complete training on data protection and participant privacy, especially if their research involves sensitive, identifiable or regulated data.

Training is available through the CITI Program (Collaborative Institutional Training Initiative). This certification meets or exceeds standards required by:

• CSUMB’s IRB (CPHS)
• CSUMB’s Institutional Animal Care and Use Committee (IACUC)
• NIH, NSF and other research sponsors

Getting Started with CITI Training

• Visit citiprogram.org
• Create or log in to your account
• Add CSUMB as your affiliated institution
• Under Question 5 in course registration, select "Data Security"
• Complete the Information Privacy and Security module and any additional modules assigned

Visit the CITI Program Support Center.

Your certification is automatically shared with the Sponsored Programs Office. You can log in any time to update your training, add new modules or print your certificate.

NIH Guidance: Protecting Participant Privacy

If your research includes data sharing, especially under NIH guidelines, it’s important to understand how to safeguard participant privacy.

NIH now offers resources on:

• Principles and best practices for privacy protection
• Controlled access to sensitive datasets
• Informed consent for data sharing
• Working with American Indian/Alaska Native (AI/AN) communities

Visit NIH’s Scientific Data Sharing Site for the latest guidance.

View Principles and Best Practices for Protecting Participant Privacy on NIH Nexus.

Cal State Monterey Bay supports academic freedom and the creation of new knowledge through research, scholarship and innovation. Intellectual property — including scholarly writing, creative work, inventions and discoveries — is an important part of that mission.

For systemwide policies on intellectual property, including copyright and patent guidelines, visit the CSU Chancellor’s Office website.

For questions specific to CSUMB, contact the Office of Graduate Studies and Research at research_dean@csumb.edu.

Cal State Monterey Bay is in the process of developing a formal X-ray Safety Program to support the safe and compliant use of radiation-producing equipment in research and academic settings.

During this interim period, please direct all questions or requests related to radiation safety to the Office of Research at research_dean@csumb.edu.

We appreciate your commitment to maintaining a safe research environment. Updates will be posted as the program develops.

Cal State Monterey Bay is committed to fostering a culture of integrity in research. Responsible and Ethical Conduct of Research (RECR) training prepares students, faculty and staff to engage in ethical decision-making and meet the expectations of funding agencies, academic institutions and the public.

RECR instruction helps researchers:

• Understand ethical issues in scientific work
• Navigate institutional policies and best practices
• Make responsible choices when faced with dilemmas in research settings

Who Needs RECR Training?

Many funding agencies — including the National Science Foundation (NSF), National Institutes of Health (NIH), and U.S. Department of Agriculture National Institute of Food and Agriculture (USDA NIFA) — require RECR training for undergraduate and graduate researchers, postdoctoral scholars and faculty supported by grant funding. Training must be ongoing and may include mentor training and formal certification.

Required Training and Tools

• CITI Program — CSUMB’s official platform for RECR training
• Annual Certification of RECR Training — RECR Certification Form
• Proposal Planning Support — email the Office of Research to request the RECR Plan Templates

Funding Agency Policies

National Science Foundation

Institutions must include a plan for RECR training in all National Science Foundation (NSF) proposals. Training is required for all students, postdocs and senior personnel.

Training must include:

• Topics like mentorship, authorship, data management and research ethics
• Plans for instruction format, participation and frequency

National Institutes of Health

Applicants for NRSA grants (e.g., T32, T34) must include a detailed RCR education plan covering:

• Conflict of interest
• Human and animal research ethics
• Data integrity
• Publication and peer review

Public Health Service

Although currently suspended, the Public Health Service (PHS) has previously required education in RCR for all funded researchers. Institutions are encouraged to maintain programs in preparation for policy updates from the Office of Research Integrity (ORI).

U.S. Department of Agriculture National Institute of Food and Agriculture

USDA requires adherence to its regulations on research misconduct and RECR. Guidelines are available on the NIFA website.

Additional Resource

ORI YouTube Channel

Explore video resources on research integrity from the U.S. Department of Health and Human Services.

Visit the ORI YouTube channel.

Recreational drone flights are not permitted on CSUMB property.

All Uncrewed Aerial System (UAS) (drone) flights conducted on campus or for CSUMB purposes must be approved in advance.

This includes any flight for teaching, research, videography, surveying or other CSUMB-affiliated activities, whether on campus or off site.

How to Request Flight Approval

To request approval for a UAS flight:

• CSUMB students, staff and faculty — Use the CSU Drones App (OtterID required)
• Non-CSUMB entities — Use the CSUMB sUAS Flight Request Form

Submit your request at least five full business days before the planned flight. If flying near residential areas or submitting insurance documentation, allow seven business days.

For approval, your request must include:

• Proof of FAA Part 107 certification or valid COA/Section 333 exemption
• FAA registration number (clearly marked on aircraft)
• Detailed sUAS specifications
• Complete flight plan with coordinates and map
• Proof of insurance (for non-CSUMB operators)
• Compliance with FAA regulations, including Remote ID rules

If you have questions, please email uassafety@csumb.edu.

Frequently Asked Questions

Can I fly a drone recreationally at CSUMB?

No. Recreational or hobbyist drone flights are prohibited by CSUMB and FAA rules.

I’m flying off campus. Do I still need approval?

Yes, if your flight is connected to CSUMB (e.g., academic, research or promotional use). Flights not affiliated with CSUMB do not require university approval.

I’m a contractor flying for a CSUMB project. Do I need approval?

Yes. All UAS flights on behalf of CSUMB — on or off campus — require approval through the appropriate process.

What is the Otter LZ?

The Otter LZ is CSUMB’s dedicated drone flight area, designed for testing, instruction and data collection. It is FAA-recognized as a FRIA (FAA-Recognized Identification Area) and features permanent ground control points for precise mapping.

What happens after my flight is approved?

• Fly only at your approved time and location
• Follow all FAA Part 107 rules
• Report incidents immediately to uassafety@csumb.edu
• Submit your post-flight report within three days

Insurance Requirements for Non-CSUMB Operators

Outside entities must provide proof of:

• Aviation Liability Insurance — $1M per occurrence, $2M aggregate
• General Liability Insurance — $2M per occurrence
• Workers’ Compensation — As required by California law

Additional requirements:

• CSUMB and its affiliated organizations must be listed as additional insured
• Coverage must be primary and non-contributory
• Policy must include a 30-day notice of cancellation

Questions about insurance? Contact CSUMB Risk Management.

Additional Resources

Otter LZ Weather Dashboard

This live dashboard from Ambient Weather provides real-time weather data for CSUMB’s Otter LZ drone flight area. It displays current conditions such as temperature, wind speed, humidity and barometric pressure.

View the Otter LZ Weather Dashboard.

LAANC and the FAA

The FAA (Federal Aviation Administration) LAANC (Low Altitude Authorization and Notification Capability) website provides drone pilots with access to real-time airspace authorizations in controlled airspace at or below 400 feet.

Visit the LAANC website.