Chapter 9: Regulatory Compliance

There are numerous federal laws and regulations that apply to research to ensure research subjects and employees are protected from harm, ethical standards are upheld, the use of taxpayer funds is transparent, and U.S. national security and economic interests are safeguarded. The exact requirements applicable to each sponsored project vary depending on the purpose of the research and the specific research activities. PIs are fully responsible for complying with all applicable laws and regulations for each sponsored project.

 A list of all University policies governing regulatory compliance requirements for research activities is available on the University’s Research Policies website.

The use of animal subjects in research is highly regulated and is subject to extensive oversight to protect animal subjects from unnecessary harm.

Resources:

• Institutional Animal Care and Use Committee (IACUC) - Responsible for reviewing and approving research on animal subjects and ensuring compliance with applicable laws and regulations governing the use of animals in research projects.
• Office of Laboratory Animal Resources (OLAR) - Serves as the University’s vivarium and provides animal care resources and veterinary services for animal subjects.
• Animal Research Lifecycle – This University website provides information and resources to support animal research throughout the award lifecycle.

The use of human subjects in research activities is heavily regulated to protect the safety and welfare of study participants.

Resources:

• Colorado Multiple Institutional Review Board (COMIRB) - Serves as the University’s institutional review board (IRB) for human subject research.
• Clinical Research Administration – Supports PIs and researchers with human subject research at the University.
• University Guidance and Policies for Human Subject Research – This University website provides resources and guidance on the use of human subjects at the University.
• Human Research Lifecycle – This University website provides information and resources to support human subject research throughout the award lifecycle.

Federal and state laws and regulations govern the procurement, use, storage, and disposal of biological, chemical, and radioactive materials in research activities to protect the health and wellbeing of employees, the community, and the environment.

 Resources:

• Environmental Health and Safety (EHS) – The University office responsible for overseeing biological safety, hazardous materials, occupational health, radiation safety, and research safety and industrial hygiene.
• General Guidance for Researchers – This University website provides guidance on environmental health and safety policies and procedures.
• Office of Research Committee Support (ORCS) – This University website provides links to University review boards.

Federal regulations and University policies governing conflict of interest are designed to promote transparency, prevent undue influences from impacting research activities, and protect the University’s integrity and reputation.

Resources:

• Conflict of Interest – This University website provides information and resources to assist University employees in complying with conflict of interest requirements.
• OGC Conflict of Interest – This OGC website provides information regarding conflict of interest requirements on sponsored projects.

The Fly America Act regulates air travel funded by the federal government. With limited exceptions, federal funds must be used to purchase tickets from a U.S. flag carrier.

 Resources:

• PSC International Travel – The PSC provides resources and guidance for international travel and compliance with the Fly America Act.
• General Services Administration Fly America Act – This website provides additional guidance for the Fly America Act.

 

Export Control laws and regulations restrict the release of certain items, information, and software to foreign nationals within the United States and in international locations. Penalties for non-compliance with export control laws are severe and can lead to civil actions and criminal prosecution for the PI.

Resources:

• Export Control – this University website provides resources and information regarding export control laws and regulations.
• PI Responsibilities –  this University website identifies responsibilities for PIs to ensure compliance with export control laws and regulations.
• Policies and Procedures – this University website identifies University policies and procedures relating to export control laws and regulations.

Ethical conduct is a foundation for research, and the University strives to maintain a culture of integrity. Allegations of research misconduct are treated seriously and are fully investigated. It is the responsibility of University employees to report research misconduct, which includes:

• Fabrication
• Falsification
• Plagiarism

Resources:

• Research Integrity – this University website identifies and explains the University’s policies and procedures relating to research integrity and misconduct.
• Office of Research Integrity (ORI) – the U.S. Department of Health and Human Services’ Office of Research Integrity provides resources and information regarding federal regulations and training materials.
• Scientific Integrity at NSF – this website explains the NSF scientific integrity policy.

Federal law requires certain employees working on research grants to complete mandated Responsible Conduct of Research (RCR) training. The training requirements differ by sponsor and grant program.

NIH requires all trainees, fellows, participants, and scholars receiving support through any NIH training (T), career development (K), research education grant, and dissertation research grant to receive instruction in responsible conduct of research. Please note, CITI online courses do not meet NIH requirements.

NSF requires institutions to have a plan to provide appropriate training and oversight in the responsible and ethical conduct of research for undergraduate students, graduate students, postdoctoral scholars, faculty, and other senior personnel who will be supported by NSF to conduct research. The training must include mentor training and mentorship.

Resources:

• Institutional RCR Plan Information for Proposals – resources to include for proposals regarding the University’s RCR Plan.
• Responsible Conduct of Research (RCR) Training– University website discussing RCR requirements and training information.

Intellectual property (IP) encompasses patents, copyrights, trademarks, and related proprietary matters. When intellectual property is created under federal awards, the University must adhere to the Bayh-Dole Act, which outlines specific reporting requirements for inventions arising from federal funds. The Bayh-Dole Act allows the University to retain ownership of inventions made under federally funded research and contracts, while also granting the government a license to these inventions.

Resources:

• APS Intellectual Property Policy on Discoveries and Patents for Their Protection and Commercialization – The Administrative Policy Statement for the University of Colorado, outlining intellectual property procedures.
• CU Anschutz Campus Policy Intellectual Property Policy on Discoveries and Patents for their Protection and Commercialization – The CU Anschutz campus policy detailing intellectual property management.
• Protecting Your Intellectual Property – Information on patents, copyrights, and trademarks for CU Anschutz personnel.
• CU Innovations – A resource for CU Anschutz personnel to manage and commercialize innovations.
• Venture Partners at CU Boulder – Resources for CU Boulder and CU Denver personnel regarding IP protection and commercialization.

The Health Insurance Portability and Accountability Act (HIPAA) establishes privacy standards to protect patients' medical records and other health information. The University is classified as a hybrid covered entity under HIPAA, meaning that its compliance applies to patient records, human subjects research records, and marketing demographics that contain health-related information. The Office of Regulatory Compliance (ORC) is responsible for coordinating HIPAA compliance within the University.

Resources:

• University HIPAA Policy – The University's official policy regarding HIPAA compliance.
• HIPAA for Researchers – Guidelines and information for researchers
• ORC HIPAA – The Office of Regulatory Compliance's resources and support for HIPAA compliance.

The Freedom of Information Act (FOIA) grants individuals the right to access federal government records, including those related to federally funded sponsored projects. By accepting a federal award, PIs agree to comply with FOIA requirements and requests. If a federal agency receives a FOIA request regarding a project, they will notify the PI and provide a list of documents that must be submitted. PIs may propose redactions to protect confidential, proprietary, or personally identifiable information. It is strongly recommended that PIs consult with University Counsel prior to submitting any documents subject to FOIA to a federal agency.