University of Delaware
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Human Subjects and IRB

University policy and federal law (45 CFR 46) require that all research involving living human subjects be reviewed and approved by an Institutional Review Board (IRB). Universities and other research institutions agree to follow the federal regulations through a written assurance with the U.S. Office of Human Research Protections (OHRP), Department of Health and Human Services. The assurance document is called the Federalwide Assurance (FWA). By signing 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.  UD’s FederalWide Assurance number is FWA00004379.

As defined by 45 CFR 46, the Common Rule, there are three levels of appropriate review: exemption from full board review, expedited review, and full board review. The level depends on the nature of the research, who the subjects will be and how much risk they will experience. For information on how to decide which type of review may be required, see the section on protocol review and approval procedures.

Additional Resources

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

Institutional Review Board

 

PRIMARY MEMBERS
 
Jean-Philippe Laurenceau, PhD
Chair
Psychological & Brain Sciences
 
Maria Palazuelos, PhD
Director, Research Compliance
 
Michael Gladle, MS
Environmental Health and Safety
 
Brian Little, MD, PhD
Pathology, Biochemistry
 
Susanne M. Morton, PhD
Physical Therapy
 
Joseph Paesani, MA
Criminal Justice, Counseling
 
Rob Palkovitz, PhD
Human Development and Family Studies
 
Kristen Ritchey, PhD
Education
 
Thomas Rocek, PhD
Anthropology
 
Charles Swanik, PhD
Kinesiology & Applied Physiology
 
Ivan Sun, PhD
Sociology and Criminal Justice
 
Carolee Polek, RN, PhD, APN, AOCNS
School of Nursing

ALTERNATE MEMBERS
 
Heather Bittner-Fagan, M.D.
Family Medicine
 
Albert Cavalier, PhD
Education
 
Joanna Champney, MA
Community Representative
 
David Coker, EdD
Education
 
David Edwards, PhD
Kinesiology & Applied Physiology
 
Mary Ann Ellis , BS
Community Representative
 
Nicole Farnese, BS
Research Compliance
 
William Fendt, BA
Environmental Health and Safety
 
Myae Han, PhD
Human Development and Family Studies
 
Adam Marmon, PhD
Physical Therapy
 
John McNutt, PhD.
Public Policy & Administration
 
Melissa Melby, PhD
Anthropology
 
Krista Murray, MS
Environmental Health and Safety
 
Basha Silverman, BA
Counseling
 
Robert Simons, PhD
Psychological & Brain Sciences
 
Christy Visher, PhD
Sociology and Criminal Justice