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

Trademarks

Trade Secrets

Tangible Materials

Tangible Materials

Tangible research materials are any materials, substances or articles created or used in research including, for example, genes and constructs from a molecular biology program, samples of novel photovoltaic solar cell materials, or composite gaseous diffusion membranes for fuel cells. In recent years, biological materials have proven particularly valuable since they may be cumulative of past developments and be self-reproducing, providing future supplies of the material and technology. A decision to release or accept a tangible research material can have far-reaching consequences since such materials are frequently cumulative of advances in technology and carry personal property rights, which can severely limit the practice of future inventions made using the materials. Premature transfer of tangible research materials can constitute disclosure and/or public use of an invention and trigger statutory bars under the patent statute. They also provide an opportunity to the recipient to quickly advance work in the area and make inventions University staff would have expected themselves. Of greatest concern, however, would be the use of materials acquired by a University researcher without a legal right, thereby blocking future commercialization of the fruits of an entire research program. Careful attention to the right to use acquired material has become critical over the last 20 years with new law being created due to developments in the biotechnology field.

Tangible research materials made by faculty, staff or students in the course of employment at the University of Delaware, or work directly related to professional or employment responsibilities, or work carried out on University time, at University expense, or with substantial use of University resources under grants or otherwise, is the property of the University. Data obtained from the use of tangible research materials in research at the University legally belongs to the University, not to the individuals who produced the data. Tangible research materials made by non-employees working with a faculty or staff member under the above conditions are also the property of the University. If the University or faculty, staff or students wish to make such materials available to the research community, such access is under the aegis of a material transfer agreement executed by the University. Questions or requests to review material transfer agreements for signature should be addressed to the Intellectual Property Center.


 

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.