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

Conflict of Interest (COI) in Research

All UD employees are expected to conduct their research-related duties with integrity, and to avoid association with any activities that could diminish, or could be perceived as diminishing, the effectiveness of their commitment to the University.

Involvement of faculty and staff with appropriate commercial enterprises aligns with University mission as it is an important part of the transfer of knowledge and it is encouraged by the University to enhance both teaching and research programs. Association of faculty and staff with commercial enterprises should be such that it benefits all the parties involved, including the University.

University of Delaware’s Conflict of Interest in Research Policy defines a potential conflict of interest (COI) as an occurrence when there is a divergence between an individual’s private interests and his or her professional obligations, such that an independent observer might reasonably question whether the individual’s professional judgment, commitment, actions or decisions could be influenced by considerations of personal gain, financial or otherwise.

In addition to the Conflict of Interest in Research Policy, the University has another conflict of interest policy which allows the University to identify, evaluate and address conflicts of interest that might call into question the fiduciary duties of its Trustees, Officers and Senior Administrators. It is called the Financial Conflicts of Interest for Senior Administrators Policy and requires all Senior Administrators and Trustees to complete a COI Disclosure annually.

The two policies have different scopes. Depending on the institutional roles and responsibilities of certain positions some individuals are required to fulfill the disclosure requirements from both. Any questions about the Financial COI for Seniors Administrators Policy and procedures should be directed to the Office of the General Counsel.
 

COI in Research Disclosure and Management Proceduress

Faculty and professional staff must complete a new COI disclosure on an annual basis. A new disclosure must be completed annually, even when they do not have any Significant Financial Interests (SFI) to disclose. COI disclosures must be submitted, via web form, on an annual basis and within 30 days of any change to previous disclosures. Please click on the link below, and log in using your UDNet ID and password. If the link does not take you directly to the form, look for “Conflict of Interest Disclosure Form” under the tab “Blanks.”

  • The form describes the different categories of SFIs that are required to be disclosed. A table of examples is provided as a reference. This is not an all-inclusive reference list, rather just a few examples for illustrative purposes.
  • If answering “Yes” to any of the listed questions, a pull down menu of required information will appear. Please provide enough detail to facilitate its assessment.
  • COI web forms will be automatically routed to the chair or direct supervisor and the dean for review and approval.

 

COI Management Procedures

  • If a COI is determined to exist, a COI management plan is to be developed by the chair and/or dean in concurrence with the employee.
  • Please use the template for the COI management plan.
  • Examples of conditions or restrictions that might be imposed to manage a COI include, but are not limited to:
    1. Public disclosure of the conflict (e.g., when presenting and/or publishing affected research);
    2. Appointment of an independent monitor capable of taking measures to protect against bias resulting from COI;
    3. Change of personnel or personnel responsibilities and/or modification of the research plan;
    4. Reduction or elimination of a financial interest; and/or
    5. Severance of relationships that create the conflict(s).
  • In addition, please see below for a detailed guidance for the development of COI management plans in the context of SBIR/STTR awards.




 

Conflict of Interest Guidance

Guidance: Management of Conflict of Interest (COI) in Collaborations under Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR) programs.

The University of Delaware (UD or University) encourages the involvement of its faculty and professional staff with appropriate commercial enterprises in ways that will enhance the teaching and research programs at UD. The Small Business Innovation Research (SBIR) and the Small Business Technology Transfer Research (STTR) are programs funded by the federal government that enable small businesses to enrich their research and development (R&D) efforts and explore the commercialization potential of innovative technologies and products. These two programs allow, and in the case of STTR agreements require, collaborations between small businesses and not-for-profit research institutions. UD may collaborate as a subcontractor with small businesses receiving funding under the SBIR and STTR federal programs.

These types of partnerships sometimes can present complicated conflict of interest (COI) situations when the involved investigators at the University, or their immediate family members, have ties with the small business receiving the award. The following guidelines may assist University employees and their supervisors in establishing appropriate COI management plans as prescribed by federal requirements and UD policies and procedures.

SIGNIFICANT FINANCIAL INTEREST DISCLOSURE REQUIREMENT

In accordance with the University “Conflict of Interest Policy and Procedures for Faculty and Staff “ (Research Policy 6-11), faculty and professional staff must disclose their significant financial interest as defined in the Policy, in addition to those of their spouses and dependent children. Disclosures must be completed via UD web form annually and within 30 days of any changes to previously disclosed interests.

CONFLICTS OF INTEREST (COI) MANAGEMENT

A COI may result when a UD employee, his/her spouse, and/or dependent children have ties (e.g., a financial, technical and/or managerial relationship, etc.) with a small business that is proposing to enter into a sub-contractual agreement with the University. Whenever a conflict is identified, a COI management plan must be developed by the associated department chair, college dean or unit head jointly with the faculty or staff member. COI management plans may include, but are not limited to, the following elements:

  • Elimination of conflicting role: The investigator for the small business SBIR/STTR application and the investigator for the subcontract to UD must be different individuals. A UD investigator may be requested to forgo any fiduciary role with the small business while the proposed research is active. Alternatively, a different UD employee, with no ties to the small business, may be assigned by the chair and/or dean to serve as the principal investigator for the University research effort.
  • Clear delineation of roles: The proposal must clearly delineate the roles of each participant in the agreement/partnership. No individual shall have conflicting technical or managerial roles simultaneously in the small business research and the University research. In addition, the small business must have evidence of functioning space in which R&D activities can and will take place. Small business research must be conducted using the small business facilities and personnel. Collaborative research may be carried out at UD facilitates consistent with the terms and conditions of the subcontract agreement.
  • Independent oversight (Arbitrator): If deemed necessary, a UD faculty member who does not have a significant financial interest in the small business should be appointed by the chair and/or dean to act as a technical arbitrator for COI-related concerns for the project. The chair and/or dean may assume the arbitrator role as part of the management plan.
  • Intellectual property protection, ownership and commercialization: Intellectual property rights and interests typically will be addressed consistent with UD Research Policy 6-6 and the applicable terms of the subcontract agreement.
  • Increased reporting: In addition to clearly delineating roles in the proposal, more frequent reporting or meetings at the department or college level may be required.
  • Public disclosure: Written disclosure of financial interests in the small business shall be required to collaborators in the effort, and in publications or other public presentations of research results.
RESPONSIBILITIES

Faculty and Investigators – are responsible for submitting their annual significant financial disclosure in accordance with the UD policy and procedures. In addition, faculty and investigators should seek guidance from their supervisor(s), and the Research Office if needed, to discuss potential COI concerns.

Arbitrator(s) (independent scientific reviewer(s)) – are responsible for the review of manuscripts, presentations and completed data resulting from the collaboration to ensure no bias due to the COI.

Department Chairs and College Deans – review significant financial disclosures, make COI determinations, develop COI management plans, as deemed appropriate, and ensure compliance with such management plans.

Vice President for Research, Scholarship and Innovation – if the faculty or staff members object to the resolution offered by the chair and dean, the matter shall be referred to the University VPR who will intercede in accordance with UD Research Policy 6-11.

DEFINITIONS

“Significant Financial Interest” refers to a financial interest, as described in Section V of UD Research Policy 6-11, that reasonably appears to be related to the employee’s institutional responsibilities.

“Financial conflict of interest (FCOI)” refers to a significant financial interest that could directly and significantly affect the design, conduct or reporting of research.

“Investigator” refers to the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research.

 

 

Ethics

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.