University of Delaware

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.

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 /

Institutional Review Board


Mark Greene, Ph.D.
Interim Chair
Maria Palazuelos, Ph.D.
Director, Research Compliance
Deborah Ehrenthal, M.D.
Women’s Health
Michael Gladle, M.S.
Environmental Health and Safety
Roger Kobak, Ph.D.
Brian Little, M.D. , Ph.D.
Pathology, Biochemistry
Susanne M. Morton, Ph.D.
Physical Therapy
Joseph Paesani, M.A.
Criminal Justice, Counseling
Rob Palkovitz, Ph.D.
Human Development and Family Studies
Kristen Ritchey, Ph.D.
Thomas Rocek, Ph.D.
Charles Swanik, Ph.D.
Kinesiology & Applied Physiology
Ivan Sun, Ph.D.
Sociology and Criminal Justice

Heather Bittner-Fagan, M.D.
Family Medicine
Joanna Champney, M.A.
Community Representative
David Coker, Ed. D.
David Edwards, Ph.D.
Kinesiology & Applied Physiology
Mary Ann Ellis
Community Representative
Nicole Farnese, B.S.
Research Compliance
William Fendt, B.A.
Environmental Health and Safety
Carla Guerron-Montero, Ph.D.
Myae Han, Ph.D.
Human Development and Family Studies
Jean-Philippe Laurenceau, Ph.D.
Adam Marmon, Ph.D.
Physical Therapy
John McNutt, Ph.D.
Public Policy & Administration
Melissa Melby, Ph.D. M.
Krista Murray, M.S.
Environmental Health and Safety
Thomas Powers, Ph.D.
Basha Silverman, B.A.
Robert Simons, Ph.D.
Eric Tranby, Ph.D.
Sociology and Criminal Justice
Dr. Donald Unger, Ph.D.
Human Development and Family Studies