University of Delaware
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Protection of Human Subjects in Research

University policy and federal law (45 CFR 46) require that all research involving human subjects, bio specimens and/or tissue samples from humans, and/or private identifiable data must be reviewed by an Institutional Review Board (IRB).
















Research: means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Human subject: means a living individual about whom an investigator (whether professional or student) conducting research obtains:

  • Data through intervention or interaction with the individual, or
  • Identifiable private information

Intervention: includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.

Interaction: includes communication or interpersonal contact between investigator and subject.

Private information: includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
For questions please contact the UD IRB Office or (302) 831-2137

The University of Delaware has a Federalwide Assurance FWA (#00004379) on file with the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP). Through this document the University commits itself to upholding the Code of Federal Regulations and the ethical principles of the Belmont Report for all research involving human subjects conducted by University faculty, staff, and students.
Submission of research protocols to the UD IRB must be completed in IRBNet. Please see here for further instructions.


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

An Institutional Review Board (IRB) is a committee charged with the protection of the rights and welfare of human subjects recruited to participate in biomedical, behavioral, or social science research. An IRB has the regulatory authority to approve, modify or disapprove research, and suspend or terminate approval of research involving human subjects that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.

The University of Delaware has one IRB registered with DHHS (IORG #0000279). The UD IRB members are appointed by the Deputy Provost for Research and Scholarship. Membership includes diverse backgrounds and expertise to promote adequate review of research commonly conducted by UD researchers. The UD IRB Office supports the functions of the IRB and its Chair, Dr. Jean-Philippe Laurenceau. The IRB can be contacted at:

University of Delaware IRB
210 Hullihen Hall (Research Office)
Phone: 302-831-2137
Email: hsrb-research@udel.edu


Submission of research protocols to the UD IRB must be completed in IRBNet. Please see here for further instructions.
For questions please contact the UD IRB Office or (302) 831-2137

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

Faculty Handbook
Human and Animal Subjects in Research

UD Nurse Managed Health Center (NMHC)
The NMHC can partner with UD researchers providing medical testing and monitoring of research participants

Office of Human Research
Protections (OHRP)

This information is provided by the United States Department of Health & Human Services

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

Definitions
Applicable to human subject research provided by the United States Department of Health & Human Services


For more information please contact the:
UD IRB Office

or Clara Simpers: (302) 831-2137 / csimpers@udel.edu