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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
Office of Human Research
Protections (OHRP)
This information is provided by the United States Department of Heath & Human Services
Belmont Report
Ethical principles for the protection of humans subjects in research.
Definitions
Applicable to human subject research provided by the United States Department of Health & Human Services
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. Jane Case
Community Representative
Nemours Foundation
Dr. Zoubeida Dagher
Education
(alternate for Dr. Ritchey)
Dr. David Edwards
Kinesiology & Applied Physiology
(alternate for Dr. Farquhar)
Dr. Deborah Ehrenthal
Physician, Christiana Care
Community Representative
Ms. Mary Ann Ellis
Community Representative
Dr. William Farquhar
Kinesiology & Applied Physiology
Dr. Cole Galloway
Physical Therapy
Dr. Mark Greene
Philosophy
Dr. Carla Guerron-Montero
Anthropology
(alternate for Dr. Rocek)
Dr. Adam Marmon
Physical Therapy
(alternate for Dr. Galloway)
Dr. Melissa Melby
Anthropology
(alternate for Dr. Rocek)
Dr. Steven Most
Psychology
Dr. Rob Palkovitz
Human Development and Family Studies
Ms. Elizabeth Peloso (Missy)
Community Representative
(alternate for Dr. Case)
Dr. Thomas Powers
Philosophy
(alternate for Dr. Greene)
Dr. Kristen Ritchey
Education
Dr. Thomas Rocek
Anthropology
Ms. Yvonne Shannon
Community Representative
(alternate for Ms. Silverman)
Ms. Basha Silverman
Community Representative
Dr. Robert Simons
Psychology
(alternate for Dr. Most)
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
