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

Dr. Paul Solano
Chair
Public Policy & Administration

Ms. Jody-Lynn Berg
Research Office

Dr. Stuart Binder-MacLeod
(alternate for Dr. Galloway)

Dr. Heather Bittner-Fagan
Physician, Christiana Care
Community Representative
(alternate for Dr. Ehrenthal)

Ms. Joanna Champney
Community Representative
(alternate for Mr. Paesani)

Dr. David Coker
Education
(alternate for Dr. Ritchey)

Dr. David Edwards
Kinesiology & Applied Physiology
(alternate for Dr. Swanik)

Dr. Deborah Ehrenthal
Physician, Christiana Care
Community Representative

Mr. William Fendt
Environmental Health and Safety
(alternate for Mr. Gladle)

Mr. Michael Gladle
Environmental Health and Safety

Ms. Mary Ann Ellis
Community Representative

Dr. Cole Galloway
Physical Therapy

Dr. Mark Greene
Philosophy

Dr. Carla Guerron-Montero
Anthropology
(alternate for Dr. Rocek)

Dr. Myae Han
Human Development and Family Studies
(alternate for Dr. Palkovitz)

Dr. Roger Kobak
Psychology

Dr. Adam Marmon
Physical Therapy
(alternate for Dr. Galloway)

Dr. John McNutt
Public Policy & Administration
(alternate for Dr. Solano)

Dr. Melissa Melby
Anthropology
(alternate for Dr. Rocek)

Ms. Krista Murray
Environmental Health and Safety
(alternate for Mr. Gladle)

Mr. Joseph Paesani
Community Representative

Dr. Maria Palazuelos
Director, Research Compliance
(alternate for Jody-Lynn Berg)

Dr. Rob Palkovitz
Human Development and Family Studies

Dr. Thomas Powers
Philosophy
(alternate for Dr. Greene)

Dr. Kristen Ritchey
Education

Dr. Thomas Rocek
Anthropology

Ms. Basha Silverman
Community Representative
(alternate for Mr. Paesani)

Dr. Robert Simons
Psychology
(alternate for Dr. Kobak)

Dr. Charles Swanik
Kinesiology & Applied Physiology

Dr. Ivan Sun
Sociology and Criminal Justice

Dr. Eric Tranby
Sociology and Criminal Justice
(alternate for Dr. Sun)

Dr. Donald Unger
Human Development and Family Studies
(alternate for Dr. Palkovitz)

CONSULTANTS TO THE BOARD
(non-voting)

Dr. Lisa Barkley, Physician
Dr. Michael R. Zaragoza, Physician