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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.

Cordell Overby

Cordell Overby
Associate Vice President, Research and Regulatory Affairs

Resources

LEGISLATION
  • Bay Dole Act
  • Export Control and Trade Sanction Memo
  • UD Cost Accounting Standards Guidelines

Bay Dole Act

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Compliance Hotline:
Reporting a Concern

UD is committed to high ethical standards and enforcing its policies, procedures, and all applicable legal requirements.

The UD Compliance Hotline, serviced by EthicsPoint, provides an anonymous, confidential and independent resource for reporting suspected misconduct and other issues of concern in the workplace.

The Compliance Hotline is designed to receive reports regarding compliance, and ethical issues as well as other concerns related to accounting and financial controls, athletics, human resources, information technologies, research, and risk and safety matters. Examples of reportable issues include fraud, misuse of UD resources or information, violation of safety rules and environmental laws, conflicts of interest, NCAA violations, unlawful discrimination or harassment, and research grant misconduct.

Upcoming

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Training

Human Subjects Protection (HSP)

Required for all university members and collaborators, who will directly interact with research participants or have access to identifiable private information.

More Information


Good Clinical Practice (GCP)

Must be completed by all research team members involved in NIH-supported clinical trials.

More Information


Effort Certification

Reporting and confirmation of an employee’s time that typically is expressed as a percentage of the total institutional compensated based time — Institutional Based Salary (IBS).

More Information

Research 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 encouraged to report any concerns they may have by contacting the Associate Vice Provost 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.


Resources
    Compliance Hotline

  • Faculty Handbook
  • Misconduct in Research
  • Student Guide
  • Principles of Responsible Conduct
  • Office of Science and Technology Policy
  • UD Policy for Research Misconduct
  • UD Research Compliance & Ethics Program
Research Office Calendar

UD Code of Conduct

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Resources
    Compliance Hotline

  • Faculty Handbook
  • Misconduct in Research
  • Student Guide
  • Principles of Responsible Conduct
  • Office of Science and Technology Policy
  • UD Policy for Research Misconduct
  • UD Research Compliance & Ethics Program
Research Office Calendar

Ensuring the responsible conduct of research is of paramount importance to the University of Delaware and to the nation.

Compliance Hotline F.A.Q. Roles and Responsibilities

“Scientific research is grounded in values such as integrity, honesty, trust, curiosity, and respect for intellectual achievement. The expression of these values in the diverse styles and approaches of the various scientific disciplines has contributed directly to the discovery of knowledge and thus to the achievements of the U.S. scientific research enterprise,” noted the National Academy of Sciences’ Committee on Science, Engineering, and Public Policy in the report, On Being a Scientist: Responsible Conduct in Research.

However, as the report goes on to say, growth of the U.S. research enterprise, changing social expectations about the accountability of scientists, increasingly complex research that places new demands on scientific oversight, and expanded commercialization of research results have catalyzed the formation and implementation of new policies and regulations by academic institutions and funding agencies to safeguard the process of science in today’s academic research arena.

The University of Delaware holds its faculty and staff to the highest standards of conduct. It is University policy that “employees are expected at all times, to respect the rights of the University, its students, visitors and other members of the University community. Inherent in this responsibility is the obligation to be courteous, respectful, honest, and to protect the University environment.”

These standards of conduct are critical to every step of the UD researcher’s pursuit of the truth — from the formulation of proposals, to interactions with research associates and students, to the collection and handling of data from experiments or other scholarly activity, to the evaluation of that data, peer review, and protection and presentation of results. Furthermore, research involving human or animal subjects must be administered according to established University policies and federal regulations and with a commitment to the highest ethical standards.

Every UD researcher needs to understand and comply with the policies and procedures, established by the University and the federal government, that are relevant to his or her research. You’ll find links to a complete listing of UD’s policies, along with required forms, highlighted in the blue box above and on our Policies & Forms page on this Web site.

Resources
“On Being a Scientist: Responsible Conduct in Research. (Committee on Science, Engineering, and Public Policy, National Academy of Sciences, National Academy Press, 1995).

“Responsible Conduct of Research Education Committee. Part of the Association for Practical and Professional Ethics, this committee provides leadership to the research community in identifying and developing education programs in the responsible conduct of research.

“Responsible Conduct Courses. This Web site, produced by Columbia University with support from the Department of Health and Human Services, presents case studies on conflicts of interest, mentoring, peer review, misconduct, and data management.

“UD’s Science, Ethics, and Public Policy Program (SEPP). This new program’s purpose is to integrate ethics and public policy inquiry with scientific research, University curricula, private sector innovation, and government policy-making. SEPP seeks to clarify questions of fact and value of pressing concern in scientific research; to enhance the dialogue among academic, corporate, and public-interest stakeholders; to increase the synergies of public-private cooperation in emerging technologies where there are significant ethical concerns; and ultimately to establish in Delaware a unique center of national excellence to serve the public good.

Research Office Calendar

Misconduct in Research

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Resources
    Compliance Hotline

  • Faculty Handbook
  • Misconduct in Research
  • Student Guide
  • Principles of Responsible Conduct
  • Office of Science and Technology Policy
  • UD Policy for Research Misconduct
  • UD Research Compliance & Ethics Program
Research Office Calendar

Conflict of Interest

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Resources
    Compliance Hotline

  • Faculty Handbook
  • Misconduct in Research
  • Student Guide
  • Principles of Responsible Conduct
  • Office of Science and Technology Policy
  • UD Policy for Research Misconduct
  • UD Research Compliance & Ethics Program
Research Office Calendar

Statement of PI Responsibilities at UD

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Resources
    Compliance Hotline

  • Faculty Handbook
  • Misconduct in Research
  • Student Guide
  • Principles of Responsible Conduct
  • Office of Science and Technology Policy
  • UD Policy for Research Misconduct
  • UD Research Compliance & Ethics Program
Research Office Calendar

Intellectual Property Guide

Intellectual Property Overview

The Office of Economic Innovation and Partnerships is responsible for the management of all intellectual property developed at the University of Delaware. In this role, the Office of Economic Innovation and Partnerships 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. For more information, contact the Intellectual Property and Technology Transfer Office.


Resources
    Compliance Hotline

  • Faculty Handbook
  • Misconduct in Research
  • Student Guide
  • Principles of Responsible Conduct
  • Office of Science and Technology Policy
  • UD Policy for Research Misconduct
  • UD Research Compliance & Ethics Program
Research Office Calendar

What Is an Invention?

The Office of Economic Innovation and Partnerships is responsible for the management of all intellectual property developed at the University of Delaware. In this role, the Office of Economic Innovation and Partnerships 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. For more information, contact the Intellectual Property and Technology Transfer Office.


Resources
    Compliance Hotline

  • Faculty Handbook
  • Misconduct in Research
  • Student Guide
  • Principles of Responsible Conduct
  • Office of Science and Technology Policy
  • UD Policy for Research Misconduct
  • UD Research Compliance & Ethics Program
Research Office Calendar

Patents

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Resources
    Compliance Hotline

  • Faculty Handbook
  • Misconduct in Research
  • Student Guide
  • Principles of Responsible Conduct
  • Office of Science and Technology Policy
  • UD Policy for Research Misconduct
  • UD Research Compliance & Ethics Program
Research Office Calendar

Copyright

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Resources
    Compliance Hotline

  • Faculty Handbook
  • Misconduct in Research
  • Student Guide
  • Principles of Responsible Conduct
  • Office of Science and Technology Policy
  • UD Policy for Research Misconduct
  • UD Research Compliance & Ethics Program
Research Office Calendar

Trademarks

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Resources
    Compliance Hotline

  • Faculty Handbook
  • Misconduct in Research
  • Student Guide
  • Principles of Responsible Conduct
  • Office of Science and Technology Policy
  • UD Policy for Research Misconduct
  • UD Research Compliance & Ethics Program
Research Office Calendar

Trade Secrets

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Resources
    Compliance Hotline

  • Faculty Handbook
  • Misconduct in Research
  • Student Guide
  • Principles of Responsible Conduct
  • Office of Science and Technology Policy
  • UD Policy for Research Misconduct
  • UD Research Compliance & Ethics Program
Research Office Calendar

Tangible Materials

The University of Delaware is committed xxxxxx xxxxxxx xxxxxxxx xxxxx


Resources
    Compliance Hotline

  • Faculty Handbook
  • Misconduct in Research
  • Student Guide
  • Principles of Responsible Conduct
  • Office of Science and Technology Policy
  • UD Policy for Research Misconduct
  • UD Research Compliance & Ethics Program
Research Office Calendar

Data

The University of Delaware is committed xxxxxx xxxxxxx xxxxxxxx xxxxx


Resources
    Compliance Hotline

  • Faculty Handbook
  • Misconduct in Research
  • Student Guide
  • Principles of Responsible Conduct
  • Office of Science and Technology Policy
  • UD Policy for Research Misconduct
  • UD Research Compliance & Ethics Program
Research Office Calendar

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, and 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.

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:

The Memo on Export Controls and Trade Sanctions gives general information about the Export Control regulations as they apply to the academic research community

The Travel with or Transportation of Research- Related materials and Data Memo explains the issues and steps for compliance when traveling

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 – Associate Vice President for Research and Regulatory Affairs, Cordell Overby, overbyc@udel.edu, or University Research Advisor Sean Hayes, hayes@udel.edu – 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.

The Export Control Decision Tree may be used to help determine if projects are subject to the Export Control Regulations and how to obtain further project-specific information to make sure the work remains in compliance with the laws

Our Export Control FAQs provide basic information to help you understand the Export Control regulations and how they might apply to you

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. Please contact Dr. Cordell Overby, Associate Deputy Provost for Research and Regulatory Affairs (overbyc@udel.edu) for assistance.


Resources
    Compliance Hotline

  • Faculty Handbook
  • Misconduct in Research
  • Student Guide
  • Principles of Responsible Conduct
  • Office of Science and Technology Policy
  • UD Policy for Research Misconduct
  • UD Research Compliance & Ethics Program
Research Office Calendar

Frequently Asked Questions

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Resources
    Compliance Hotline

  • Faculty Handbook
  • Misconduct in Research
  • Student Guide
  • Principles of Responsible Conduct
  • Office of Science and Technology Policy
  • UD Policy for Research Misconduct
  • UD Research Compliance & Ethics Program
Research Office Calendar

OMB Uniform Guidance

OMB Uniform Guidance Overview

The federal Office of Management and Budget (OMB) has made a major change to the underlying guidance by which university recipients of federal awards have operated for decades. OMB combined eight separate circulars, applicable to different types of grantee organizations, into a single document, “CFR Title 2, Part 200: Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards,” commonly referred to as the Uniform Guidance (UG).

The three previous circulars applicable to universities are: A21 – Cost Principles for Educational Institutions, A110 – Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals and other Non-profit Organizations and A133 – Audits of States, Local Governments and Non-Profit Organizations. There are similar documents applicable to states, local governments and Indian Tribes. The UG includes portions from all of the previous documents as well as new sections and some deletions. While much of it is similar to the previous guidance, there is the potential for both major and minor changes to university recipients of federal awards. In addition, the OMB document is actually guidance to federal agencies and each granting agency must issue its own implementing regulations. While agency implementation plans were due to OMB in June, final versions have not yet been published.

The effective date is December 26, 2014 and is applicable to new grants and funding increments.

The UG encompasses a wide variety of compliance areas, including what constitutes an allowable charge to a federal award, what costs may be included in the Facilities and Administrative Cost Rate, minimum information required in funding announcements, information needed in equipment records, how long records must be retained, requirements for monitoring subrecipients, the frequency and minimum content of programmatic reporting and a host of other topics.

The University of Delaware must be compliant with the UG in order to remain eligible to receive federal awards. The University’s comprehensive implementation plan is described below. The University community will be kept informed of progress through this website, the research-admin listserv, the newly created UD Research Administrators E-Newsletter and topic specific trainings. Your participation and feedback is encouraged.


Resources
    Compliance Hotline

  • Faculty Handbook
  • Misconduct in Research
  • Student Guide
  • Principles of Responsible Conduct
  • Office of Science and Technology Policy
  • UD Policy for Research Misconduct
  • UD Research Compliance & Ethics Program
Research Office Calendar

UD’s Implementation

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Resources
    Compliance Hotline

  • Faculty Handbook
  • Misconduct in Research
  • Student Guide
  • Principles of Responsible Conduct
  • Office of Science and Technology Policy
  • UD Policy for Research Misconduct
  • UD Research Compliance & Ethics Program
Research Office Calendar

USE CONTENT BELOW FOR HELP WITH CONTENT ABOVE

The UD Compliance Hotline, serviced by EthicsPoint, provides an anonymous, confidential and independent resource for reporting suspected misconduct and other issues of concern in the workplace.

USE CONTENT BELOW FOR HELP WITH CONTENT ABOVE

UD’s CODE OF CONDUCT

As presented in the University of Delaware’s Faculty Handbook, it is University policy that “employees are expected at all times, to respect the rights of the University, its students, visitors, and other members of the University community. Inherent in this responsibility is the obligation to be courteous, respectful, honest, and to protect the University environment.”

On April 3, 1995, the University Faculty Senate adopted the following statement on professional ethics, taken from the 1990 edition of the AAUP Policy Documents and Report.

From its inception, the American Association of University Professors has recognized that membership in the academic profession carries with it special responsibilities. The Association has consistently affirmed these responsibilities in major policy statements, providing guidance to professors in such matters as their utterances as citizens, the exercise of their responsibilities to students and colleagues, and their conduct when resigning from an institution or when undertaking sponsored research.

  • 1961 — Statement on Recruitment and Resignation of Faculty Members
  • 1964 — A Statement on Extramural Utterances (Clarification of sec. 1c of the
  • 1940 Statement of Principles on Academic Freedom and Tenure)
  • 1965 — On Preventing Conflicts of Interest in Government-Sponsored Research at Universities
  • 1966 — Statement on Government of Colleges and Universities
  • 1967 — Joint Statement on Rights and Freedoms of Students
  • 1970 — Council Statement on Freedom and Responsibility
  • 1976 — On Discrimination
  • 1984 — Sexual Harassment: Suggested Policy and Procedures for Handling Complaints

The Statement on Professional Ethics that follows sets forth those general standards that serve as a reminder of the variety of responsibilities assumed by all members of the profession.

In the enforcement of ethical standards, the academic profession differs from those of law and medicine, whose associations act to ensure the integrity of members engaged in private practice. In the academic profession the individual institution of higher learning provides this assurance and so should normally handle questions concerning propriety of conduct within its own framework by reference to a faculty group. The Association supports such local action and stands ready, through the general secretary and Committee B, to counsel with members of the academic community concerning questions of professional ethics and to inquire into complaints when local consideration is impossible or inappropriate. If the alleged offense is deemed sufficiently serious to raise the possibility of adverse action, the procedures should be in accordance with the 1940 Statement of Principles on Academic Freedom and Tenure, the 1958 Statement of Procedural Standards in Faculty Dismissal Proceedings, or the applicable provisions of the Association’s Recommended Institutional Regulations on Academic Freedom and Tenure.

  1. Professors, guided by a deep conviction of the worth and dignity of the advancement of knowledge, recognize the special responsibilities placed upon them. Their primary responsibility to their subject is to seek and to state the truth as they see it. To this end professors devote their energies to developing and improving their scholarly competence. They accept the obligation to exercise critical self-discipline and judgment in using, extending, and transmitting knowledge. They practice intellectual honesty. Although professors may follow subsidiary interests, these interests must never seriously hamper or compromise their freedom of inquiry.
  2. As teachers, professors encourage the free pursuit of learning in their students. They hold before them the best scholarly and ethical standards of their discipline. Professors demonstrate respect for students as individuals and adhere to their proper roles as intellectual guides and counselors. Professors make every reasonable effort to foster honest academic conduct and to ensure that their evaluations of students reflect each student’s true merit. They respect the confidential nature of the relationship between professor and student. They avoid any exploitation, harassment, or discriminatory treatment of students. They acknowledge significant academic or scholarly assistance from them. They protect their academic freedom.
  3. As colleagues, professors have obligations that derive from common membership in the community of scholars. Professors do not discriminate against or harass colleagues. They respect and defend the free inquiry of associates. In the exchange of criticism and ideas professors show due respect for the opinions of others. Professors acknowledge academic debt and strive to be objective in their professional judgment of colleagues. Professors accept their share of faculty responsibilities for the governance of their institution.
  4. As members of an academic institution, professors seek above all to be effective teachers and scholars. Although professors observe the stated regulations of the institution, provided the regulations do not contravene academic freedom, they maintain their right to criticize and seek revision. Professors give due regard to their paramount responsibilities within their institution in determining the amount and character of work done outside it. When considering the interruption or termination of their service, professors recognize the effect of their decision upon the program of the institution and give due notice of their intentions.
  5. As members of their community, professors have the rights and obligations of other citizens. Professors measure the urgency of these obligations in the light of their responsibilities to their subject, to their students, to their profession, and to their institution. When they speak or act as private persons they avoid creating the impression of speaking or acting for their college or university. As citizens engaged in a profession that depends upon freedom for its health and integrity, professors have a particular obligation to promote conditions of free inquiry and to further public understanding of academic freedom. (Added by Faculty Senate 4/95; renumbered 2/99) (Last editorial update 2/12/99)

Researcher’s Toolbox


PI Statement of Responsibilities

Serving as a Principal Investigator (PI) at the University of Delaware brings significant rewards and confers concomitant responsibilities. PIs are responsible for the intellectual direction of research and scholarship and for the education and training of students. In carrying out these critical tasks, PIs are also responsible for compliance with laws and regulations that touch on all aspects of the research enterprise.

To ensure compliance with applicable rules, regulations, and contract requirements, the University of Delaware requires all PIs to receive training in the financial management of sponsored projects. Developed for PIs already at the University, the University’s training program focuses on stewardship of funds, mandatory reporting requirements, and particularized training in the fundamentals of federal grant and contract accounting. PIs must complete mandatory training before the University will release project funding.

For questions please contact the UD IRB Office or (302) 831-2137

Intellectual Property

Your research has yielded important results. Be sure you get credit for your work by properly protecting your ideas and inventions. This section includes UD’s Guide to Intellectual Property and other helpful resources.

  1. What Is an Invention?
  2. Patents
  3. Trademarks
  4. Copyrights
  5. Trade Secrets
  6. Tangible Materials
  7. Data


What makes a competitive proposal? This section covers the basics, from funding opportunities to required forms. UD’s online Proposal Guide can help answer your questions about budgets and more!

  1. Research Communications
  2. Peer-Reviewed Journals
  3. Preparing for an Interview with the Media
  4. Public Lectures & Exhibits
  5. Scientific Meetings
  6. Scientific Posters
  7. UD News Coverage

RESOURCES

Preparing Your Proposal

Make sure your proposal gets noticed. Here, we cover the basics, from funding opportunities to required forms.

1. Proposal Guide

Proposal Guide
  • FAQ’s
  • PI Eligibility
  • Proposal Checklist
  • Budget Categories
  • Campus Information
  • Equipment
  • Administrative Salaries
  • Rates / IDC Calculations
  • Facilities & Administrative Costs
  • Off-Campus

Databases

COS PIVOT Database
Detailed professional information for scientists and scholars worldwide.

Foundation Directory (UD Paid Version)
Provides information on U.S. grantmakers and their grants. The database has full-text search capability across more than 250,000 990s.

Government Grants database
Grants.gov system houses information on over 1,000 grant programs and vets grant applications for federal grant-making agencies.

Grant Forward
A funding and research service which provides information on federal and private funding opportunities in the sciences, social sciences, arts, and humanities.

Recently Funded Projects

TITLEPISPONSORAMOUNT
Prison Research and Innovation NetworkDaniel O’ConnellUrban Institute$ 100,000
Delaware Victim Needs AssessmentRonet BachmanCriminal Justice Council$ 149,998
Prevention and Behavioral Health: Mobile Response Stabilization ServiceBrian FreedmanHHS$ 150,000
Biological Nitrogen Removal in Sediment Plumes of Watershed ModelsShreeram InamdarUSDA$ 263,901
Mesenchymal Stem Cells in Knee OsteoarthritisDaniel WhiteLisa Dean Moseley Foundation$ 296,197
Umpolung Methods with Electron Rich Aromatic Systems: Aza-ortho-Xylylenes, and N,N-Dialkylaniline N-Oxides in SynthesisWilliam ChainNSF$ 450,000
Graph-Based Quantum Error Correcting CodesJavier Garcia-FriasNSF$ 500,000
Overcoming Challenges in Classification Near the Limit of DeterminationKarl BookshNSF$ 500,000
Reverse Engineering Methods for Elucidating the Molecular Assembly Mechanisms of Thermoresponsive Peptide-Based ConjugatesArthi JayaramanNSF$ 518,481
Measurements of Turbulence and Coherent Structures on Bothside of an Wind-Driven Air-Water InterfaceFabrice VeronNSF$ 549,848
Enhancment of Scene Projector Evaluation And Research FacilityFouad KiamilevDOD$ 577,383
Demonstration of Vehicle-to-Grid (V2G) Power and Value of V2G Grid ServicesWillett KemptonExelon Corporation$ 603,747
Transformation and Cross-shelf Export of Freshwater from Antarctic ShelvesCarlos Moffat VarasNSF$ 787,525
Advancing and Integrating Animal-borne Tags into Regional Ocean Observatories in the Northwest AtlanticAaron CarlisleDOC$ 1,176,902
Elucidating Biogenesis and Cargo Sorting Mechanisms for Discrete Extracellular Vesicle Subpopulations in C. elegansJessica TanisHHS$ 1,645,565
Mechanisms of Neural Crest Induction and Craniofacial DisordersShuo WeiHHS$ 1,861,050
Composite Manufacturing Technologies for Aerospace Performance at Automotive Production RatesJohn GillespieNASA$ 5,893,843
Discovery of Chemical Probes and Therapeutic LeadsJoseph FoxHHS$ 11,868,452

Government Sponsors

Training

Training in the protection of human subjects in research is required for all university members (i.e., faculty, students, researchers, and staff), and collaborators, who will directly interact with research participants or have access to identifiable private information. Training in human subjects protections (HSP) must be completed, and the completion report obtained, prior to seeking review and approval from the IRB to conduct research.

Research Office Calendar

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In addition to the required training in human subjects protections, and as per NIH policy, training in Good Clinical Practice (GCP) must also be completed by all research team members involved in NIH-supported clinical trials. NIH defines a clinical trial as any research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

All personnel actively engaged in human subjects research must maintain current training by completing the required courses every three years. Training is available, and must be completed, online through the Collaborative Institutional Training Initiative (CITI) Program. Principal Investigators submitting a research proposal for review to the IRB are responsible for ensuring all researchers to be engaged in human subjects research under his/her supervision hold valid and current training certifications. If researchers have not linked their training certification to their user profile in IRBNet, certifications of training completion for all research.


Compliance Hotline

HIPAA

In the context of research, the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule establishes the conditions under which protected health information (PHI) may be used or disclosed by covered entities for research purposes. The Privacy Rule protects the privacy of individually identifiable health information, while at the same time ensuring that researchers continue to have access to medical information necessary to conduct research.

How the Rule Works:

Under HIPAA, researchers may obtain, create, use, disclose and/or otherwise access PHI for research purposes through one of the following methods:

  • By obtaining individual authorization: an Authorization is basically an individual’s written permission or consent to use his or her PHI for research purposes. HIPAA requires that an Authorization be written in plain language and contain certain “core” elements. Research authorizations may be combined with an informed consent form or set forth in a separate Authorization document. See forms and templates in IRBNet for further guidance on what to include in a HIPAA Authorization for research.
  • By obtaining IRB waiver or alteration of the authorization requirement: the following three criteria must be satisfied for an IRB or Privacy Board to approve a waiver of authorization under the Privacy Rule:
    1. The use or disclosure of protected health information involves no more than a minimal risk to the privacy of individuals, based on, at least, the presence of the following elements:
      • an adequate plan to protect the identifiers from improper use and disclosure;
      • an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law; and
      • adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as permitted by this subpart;
    2. The research could not practicably be conducted without the waiver or alteration; and
    3. The research could not practicably be conducted without access to and use of the protected health information.
  • By using de-identified information: Health information that has been “de-identified” in a manner required by HIPAA is not considered PHI and may be used or disclosed for research purposes without individual authorization. De-identification can be done by removal of all 18 elements that could be used to identify an individual and/or the individual’s relatives as described in the Privacy Rule. Alternatively, de-identification may be established by the use of statistical methods.
  • By using limited data sets with a data use agreement: A limited data set is described as health information that excludes certain, listed direct identifiers but that may include city; state; ZIP Code; elements of date; and other numbers, characteristics, or codes not listed as direct identifiers. It is the responsibility of the researcher and the party releasing the PHI to have in place and maintain a copy of a data use agreement that meets HIPAA requirements.
  • By using only decedents’ information, with certain assurances
  • By using PHI for purposes preparatory to research, with certain assurances and with no removal of any PHI from the covered entity (physically or electronically)

ASSISTANCE

Compliance Hotline
Phone: (302) 831-2792

E: UD IRB Office
P: (302) 831-2137
F: (302) 831-2828

HUMAN SUBJECT LINKS

UD Policy & Procedure Manual
Involvement of Human Subjects in Research and Research-Related Activities

Belmont Report
Ethical principles for the protection of human subjects in research.

Common Rule
The Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991 and codified in separate regulations by 15 Federal departments and agencies, as listed here.

Office of Human Research Protections (OHRP)
United States Department of Health & Human Services Information

FDA Regulations relating to GCP and Clinical Trials

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