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

Research Integrity at UD

The University of Delaware is committed to promoting and protecting the responsible pursuit of scientific research. UD faculty and students are obligated to practice intellectual honesty and to observe established professional standards in their fields at all times, from the formulation of proposals, to their interactions with research associates and students, to the collection, handling and evaluation of data, to the peer review process, and the protection and presentation of results.

All members of the UD research community are expected to follow the highest ethical standards and are encouraged to report any concerns they may have by contacting the Interim Associate Vice President for Research & Regulatory Affairs in the UD Research Office directly, or the Compliance Hotline.

UD policy and Federal requirements (Pilot Program) prohibit retaliation against an individual making a misconduct allegation in good faith.

 

UD 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 with 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, complaint and in accord with applicable research-related requirements, guidelines and best practices.

 



 

Code of Conduct

Responsible Conduct

Misconduct

Conflict of Interest

Ethics

Intellectual Property Guide

Overview

Patents

Patents

A patent for an invention is the grant of a property right to the inventor, issued by the U.S. Patent and Trademark Office. Generally, the term of a new patent is 20 years from the date on which the application for the patent was filed in the United States or, in special cases, from the date an earlier related application was filed, subject to the payment of maintenance fees. U.S. patent grants are effective only within the United States, U.S. territories, and U.S. possessions. Under certain circumstances, patent term extensions or adjustments may be available.

The right conferred by the patent grant is, in the language of the statute and of the grant itself, “the right to exclude others from making, using, offering for sale, or selling” the invention in the United States or “importing” the invention into the United States. What is granted is not the right to make, use, offer for sale, sell, or import, but the right to exclude others from making, using, offering for sale, selling, or importing the invention. Once a patent is issued, the patentee must enforce the patent without the aid of the U.S. Patent and Trademark Office.


Patent Timeline

Throughout the world the first party responsible for filing a patent application is the undisputed owner of the invention. The United States has a one-year time period to file a patent application. This period begins at the formal presentation of the invention. A formal presentation of an invention includes any publication, journal, conference presentation, poster session, newspaper article, Internet publication on a Web page, blog, listserve, etc. In most other countries, you are banned from obtaining patent protection once an invention has been publicly disclosed.

You must file in the United States within one year of the first disclosure of the invention — filing of a provisional application may protect international rights.

It takes an extended period of time to obtain a patent. The patent application can be kept secret while it is pending if you request it; otherwise, it is published by the U.S. Patent and Trademark Office 18 months after filing.

See Policy 6–6 — “Intellectual Property Protection, Ownership, and Commercialization” for detailed information on patent procurement costs and the division of patent income.

 

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.