Research & Regulatory Affairs

Conducting Research at UD

Our team oversees and advances UD’s strong culture of compliance with federal, state and University policies and regulations across the spectrum of the University’s research-related activities. We are responsible for the review, negotiation and establishment of research agreements, and the administrative transfer of research materials to and from UD. Whether you’re a first-timer or a veteran at developing research proposals, you will find the tools you need here to prepare your proposal, manage your grant, protect your great ideas and inventions, and present your results to the scientific community and the public.

Sean Hayes

Sean Hayes
Interim Associate Vice President, Research and Regulatory Affairs

Research Integrity

Ensuring responsible conduct of research and upholding the highest ethical standards.

Safety

The UD Office for Environmental Health and Safety distributes information made to ensure safe research practices are followed

Research Security

UD Best Practices and Resources.

Intellectual Property

Counsel on the disclosure of innovations, patents, copyrights, trademarks and other research-related agreements.

Export Regulations

Oversight & administration of regulations regarding UD research and its impact on economic and trade sanctions.

Malign Foreign Talent Recruitment Programs

Federal regulations for research compliance regarding malign foreign talent recruitment programs (MFTRP)

Human Subjects

Research involving human subjects, bio specimens and/or tissue samples, and/or private identifiable data

Animal Subjects

Federal regulations require use of non-human vertebrate animals in research, teaching and testing follow established guidelines.

Recombinant DNA in Research

Work involving recombinant DNA must be approved by the UD Biosafety Committee and the Biosafety Officer

Upcoming Events
Research Integrity

Integrity

Code of Conduct

Responsible Conduct

Misconduct

Conflict of Interest

Ethics

Research Compliance & Ethics Program

The University of Delaware (UD or University), its faculty, staff and students are committed to conducting their research and scholarly endeavors with the highest ethical standards. Consistent with Federal Government guidelines and requirements, and with widely-recognized best practices to achieve the responsible conduct of research, the University has developed, conducts and maintains current an effective Research Compliance & Ethics Program (RCEP). In doing so, UD exercises due diligence to prevent, detect and correct any research-related conduct that is not consistent Government and best-practice collective tenets. Additionally, the University creates and promotes (in an ongoing fashion) an institution-wide culture that encourages behavior/conduct that is ethical and complaint, and in accord with applicable research-related requirements, guidelines and best practices.

To those ends, the University established and maintains standards and procedures to prevent, detect and correct research-related behaviors that may be (or have the potential to become) aberrant. Methods to keep UD executive leadership knowledgeable with regard to the University RCEP are in place and maintained, so as to accommodate oversight of Program efficacy. Program standards, guidance and training extend to research efforts that include (or potentially include) matters concerning 1) animal care & use, 2) conflict of interest, 3) confidentiality, 4) cost accounting 5) data management, 6) export controls & trade sanctions, 7) freedom-of-information requests, 8) human subject protection, 9) intellectual property, 10) research integrity and misconduct, 11) research-related agreements, and 12) research-related safety (bio-, chemical & hygiene, hazardous substances, radiation and LASER).

The Vice President for Research, Scholarship and Innovation, is the University’s Chief Research Administrator & Advocate. The UD Research Office ensures the presence and maintenance of an adequately-funded and effective research RCEP. Day-to-day operational responsibility for the Program is delegated to the Associate Vice President for Research and Regulatory Affairs, who with colleagues and in cooperation with UD faculty who serve on and chair University compliance and safety committees are tasked to knowledgeably and competently perform the multi-disciplinary duties needed to ensure that the UD research community goes about its work in a compliant and responsible manner. All University persons performing day-to-day operations aimed at maintaining the integrity of the RCEP 1) have no-known transgressions (past or current) from Program tenets, and 2) have direct access to the Office of the University Research and Regulatory Affairs.

In order to maintain Program effectiveness, the UD Research Office’s Regulatory Affairs unit oversees and provides a wide spectrum of research-related compliance and ethics training. Training media include web-based presentations and face-to-face presentations. Face-to-face training is offered for groups or individuals, and is offered on regularly scheduled intervals and upon request. Training is typically tailored for students, research-support staff, faculty and other research professionals, across the full spectrum of research-related RCEP topics.

To ensure that UD’s research community adheres to the requirements of the Program, provisions for periodic monitoring and audit are in place. Additionally, the Program offers anonymous avenues for the reporting of University-research activities that may be suspected of being inconsistent with the responsible conduct of research. As a result of an institutional-wide adherence to a Program of recognized and required research-related compliance and ethical morays, UD maintains an ability to provide an open and supportive environment for the conduct of research, while remaining able to quickly identify abhorrent behavior and suspend offenders.

Finally, to help ensure (and confirm) institutional commitment to providing an effective RCEP, the UD Program is periodically assessed internally (with the assistance non-Program University personnel), and modified as necessary to remain aligned with, and responsive to, modifications in Federal Government and best-practice standards.

Additional information regarding the University RCEP may be accessed by sending an email request to udresearch@udel.edu.

 

Intellectual Property Guide

Overview

Intellectual Property Overview

The Office of Economic Innovation and Partnerships (OEIP) is responsible for the management of all intellectual property developed at the University of Delaware. In this role, OEIP provides advice and counsel to UD faculty and staff regarding the disclosure of innovations, patents, copyrights, trademarks, contracts and other research-related agreements. Make sure you understand how to protect your research results and who owns the data generated in UD research. Review this guide for a helpful introduction.
 


What Is an Invention?

What is an invention, and who owns the inventions made by UD faculty, staff or students?

The University of Delaware Policies and Procedures Manual defines an invention as follows:

“An invention shall constitute any discovery, machine, new and useful process, article of manufacture, composition of matter, life form, design, algorithm, software program, or concept that may have commercial value. University faculty, staff or students employed by the University who discover or invent or develop a device, product, plant variety, method or work while associated with the University must cooperate with the University in defining and establishing the rights to such inventions, works, materials and data.”

It is the policy of the University of Delaware that “all inventions and discoveries, together with any tangible research materials, know-how, and the scientific data and other records of research including any related government protections (collectively “Intellectual Property”), which are conceived or reduced to practice or developed by University faculty, staff, or students in the course of employment at the University, or result from work directly related to professional or employment responsibilities at the University, or from work carried out on University time, or at University expense, or with the substantial use of University resources, shall be the property of the University.”

The University of Delaware is required by law to report its inventions made under federal grants/contracts to the agency, and may elect to own and promote them for commercialization. If you are a UD researcher with an invention to protect, please review these policies and forms and contact the Intellectual Property and Technology Transfer Office of the UD Research Office for more information.

 

Patents

Copyright

Trademarks

Trade Secrets

Tangible Materials

Data

Export Regulations

Export Regulations Overview

University research is subject to U.S. Export Control laws that protect national security and trade, including the International Traffic in Arms Regulations (ITAR), implemented by the U.S. Department of State; the Export Administration Regulations (EAR); and the Commerce Control List (CCL), implemented by the U.S. Department of Commerce. The Office of Foreign Asset Control (OFAC), which is part of the U.S. Department of the Treasury, also is responsible for administering and enforcing economic and trade sanctions against certain nations, entities and individuals.

These regulations control the export of strategic information, technology and services to foreign countries, as well as to foreign nationals inside the United States. Temporary export of controlled items, including laptop computers with controlled technologies, such as encryption software or technical project data, also falls under the regulations. Failure to comply with these laws can result in serious consequences, including penalties of up to $1 million in fines and up to 10 years in prison per violation.

The Research Office will work with individual researchers to make all necessary checks of the ITAR, EAR and OFAC regulations to determine when licensing is necessary for shipment or disclosure to foreign countries or nationals. For assistance, please contact Interim Associate Vice President for Research and Regulatory Affairs Sean Hayes.


 

Export Regulations at UD

It is important for members of the University of Delaware research community to be aware of the University of Delaware Policy on Export Controls (Research Policy 6-17). Additionally, the following tools are available to help researchers become more aware of the issues surrounding Export Controls and to assist them in determining when the regulations are applicable:

Note: University personnel traveling to OFAC sanctioned/embargoed countries, which at the time of this writing include Cuba, Iran, North Korea, Syria and Sudan, should contact the Research Office – Interim Associate Vice President for Research and Regulatory Affairs Sean Hayes – for guidance prior to travel. UD personnel should travel with a “clean” laptop that contains software and data that are not export controlled. In this way, previously utilized and generated export controlled software and unpublished research data will remain at home or work and, therefore, are neither exported nor deemed-exported.

Malign Foreign Talent Recruitment Programs

Federal Regulations

Federal regulations for research compliance regarding malign foreign talent recruitment programs:

The CHIPS and Science Act of 2022 (Public Law 117-167, 42 U.S.C. § 19232) sets forth the following malign foreign talent recruitment program (MFTRP) restrictions and requirements for federal research and development projects:

  1. Individuals participating in a MFTRP are prohibited from serving in a senior/key personnel role.
  2. Federal agencies are prohibited from funding a proposal which includes a senior/key person who is a party to a MFTRP.
  3. Recipient institutions must prohibit MFTRP participants from serving as senior/key personnel.
  4. Certifications:
    1. In each research proposal and annually thereafter, each senior/key person must certify they are not a party to a MFTRP.
    2. Proposing institutions must certify that all individuals identified as senior/key personnel have been made aware of and have complied with their responsibility to certify that they are not a party to a MFTRP.
    3. False representations regarding either of the above certifications may be subject to prosecution and penalties pursuant to, but not limited to, the False Claims Act.
  5. As a requirement of a federal award, recipient institutions must provide training on the risks of malign foreign talent recruitment programs to senior/key personnel employed at such institutions.

Federal sponsors are establishing and implementing MFTRP policies which flow down these requirements to UD.

 

Sponsor Policies

MFTRP Definitions

Policy

Health and Safety

Environmental Health & Safety

Streamlined access to the health and safety programs include compliance with national and local environmental, health and safety regulations, which assure laboratory and occupational workplace safety; Chemical Hygiene and Biological Safety Program compliance, training and waste management; reaction and prevention programs to fire, hazardous materials and other building emergencies; training and compliance to clean air, water and radiological usage; and the safety committee program which includes accident/injury reporting, prevention and building assessments.

The department provides a multitude of laboratory, health and safety training opportunities through EHS Assistant Online Training, monthly scheduled training and special training requests.

Their mission is to serve you and ensure you are provided with healthy and safe living, work, academic and recreational facilities and programs.



Health and Safety Website
*NOTE: The University of Delaware’s Office of General Counsel oversees all legal services for the University of Delaware. Matters pertaining to research (including research-related agreements, research-related compliance, and research-related intellectual property) may be directed to the Research Office, which will coordinate with the General Counsel’s Office, as appropriate.