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

Copyright

Copyright

Copyright is a form of protection provided to the authors of “original works of authorship” including literary, dramatic, musical, artistic, and certain other intellectual works, both published and unpublished. The 1976 Copyright Act generally gives the owner of copyright the exclusive right to reproduce the copyrighted work, to prepare derivative works, to distribute copies or phonorecords of the copyrighted work, to perform the copyrighted work publicly, or to display the copyrighted work publicly.

The copyright protects the form of expression rather than the subject matter of the writing. For example, a description of a machine could be copyrighted, but this would only prevent others from copying the description; it would not prevent others from writing a description of their own or from making and using the machine. Copyrights are registered by the Copyright Office of the Library of Congress.

As defined by the U.S. Copyright Office, copyright is a form of protection provided by U.S. law to the authors of “original works of authorship” fixed in any tangible medium of expression. The manner and medium of fixation are virtually unlimited. Creative expression may be captured in words, numbers, notes, sounds, pictures, or any other graphic or symbolic media. The subject matter of copyright is extremely broad, including literary, dramatic, musical, artistic, audiovisual, and architectural works. Copyright protection is available to both published and unpublished works.

Under the 1976 Copyright Act, the copyright owner has the exclusive right to reproduce, adapt, distribute, publicly perform, and publicly display the work. In the case of sound recordings, the copyright owner has the right to perform the work publicly by means of a digital audio transmission. These exclusive rights are freely transferable and may be licensed, sold, donated to charity, or bequeathed to the copyright owner’s heirs. It is illegal for anyone to violate any of the exclusive rights of the copyright owner. If the copyright owner prevails in an infringement claim, the available remedies include preliminary and permanent injunctions (court orders to stop current or prevent future infringements), impounding, and destroying the infringing articles.

The exclusive rights of the copyright owner, however, are limited in a number of important ways. Under the “fair use” doctrine, which has long been part of U.S. copyright law and was expressly incorporated in the 1976 Copyright Act, a judge may excuse unauthorized uses that may otherwise be infringing. Section 107 of the Copyright Act lists criticism, comment, news reporting, teaching, scholarship, and research as examples of uses that may be eligible for the fair use defense. In other instances, the limitation takes the form of a “compulsory license” under which certain limited uses of copyrighted works are permitted upon payment of specified royalties and compliance with statutory conditions. The Copyright Act also contains a number of statutory limitations covering specific uses for educational, religious, and charitable purposes.


The Fair Use Doctrine

The fair use of a copyrighted work for purposes such as criticism, comment, and teaching (including multiple copies for classroom use), scholarship, or research, is not an infringement of copyright. In determining whether the use made of a work in any particular case is a fair use, the factors to be considered shall include:

  1. the purpose and character of the use, including whether such use is of a commercial nature or is for non-profit educational purposes;
  2. the nature of the copyrighted work;
  3. the amount and substantiality of the portion used in relation to the copyrighted work as a whole; and
  4. the effect of the use upon the potential market for or value of the copyrighted work. The fact that a work is unpublished shall not itself bar a finding of fair use if such a finding is made upon consideration of all the above factors.

Transfer of Copyright

Any or all of the copyright owner’s exclusive rights or any subdivision of those rights may be transferred, but the transfer of exclusive rights is not valid unless that transfer is in writing and signed by the owner of the rights conveyed or such owner’s duly authorized agent. Transfer of a right on a nonexclusive basis does not require a written agreement.

A copyright may also be conveyed by operation of law and may be bequeathed by will or passed as personal property by the applicable laws of interstate succession.

Copyright is a personal property right, and it is subject to the various state laws and regulations that govern the ownership, inheritance, or transfer of personal property as well as terms of contracts or conduct of business.

Transfers of copyright are normally made by contract. The Copyright Office does not have any forms for such transfers. The law does provide for the recordation in the Copyright Office of transfers of copyright ownership. Although recordation is not required to make a valid transfer between the parties, it does provide certain legal advantages and may be required to validate the transfer as against third parties. For information on recordation of transfers and other documents related to copyright, request Circular 12 Recordation of Transfers and Other Documents.
 

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.