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NOTE: Effective July 9, 2009, all Human Subjects Protocols must be submitted using IRBNet
Questions? E-mail: hsrb-research@udel.edu

Human Subjects in Research

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 Heath & Human Services

For More Information Contact:
Elizabeth Peloso

Human Subjects Review Board

Dr. Thomas DiLorenzo,
Chair,
Psychology

Dr. Cole Galloway,
Physical Therapy

Dr. William Farquhar,
Health Nutrition Exercise Science

Dr. Albert Cavalier,
Education

Dr. Mark Greene,
Philosophy

Ms. Mary Ann Ellis,
Community Representative

Dr. Michael Kuhlman,
Psychology

Dr. Brian W. Little, Physician,
Christiana Care, Community Representative

Ms. Basha Silverman
Community Representative

Dr. Thomas Rocek,
Anthropology

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

Dr. Paul Solano,
Urban Affairs and Public Policy

Dr. Donald G. Unger,
Human Development and Family Studies

Dr. Kristen Ritchey,
Education
(alternate for Dr. Cavalier)

Ms. Elizabeth Peloso,
Research Office

Dr. Steven Most,
Psychology
(alternate for Dr. Kuhlman)

Ms. Yvonne Shannon,
Community Representative
(alternate for Ms. Silverman)

CONSULTANTS TO THE BOARD
(non-voting)


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