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NOTICE: Effective July 1st 2008, all Human Subjects Protocols must be submitted using the Human Subjects Protocol Form.
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 the Human Subjects Review Board (HSRB). This body is also commonly referred to as an Institutional Review Board (IRB). This requirement applies to all research involving humans subjects conducted by University faculty, staff, and students.
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. Assurances are approved by OHRP for a period of three years; UD's FederalWide Assurance number is FWA00004379 and was last updated and approved on February 12, 2007.
As defined by federal law, there are three levels of appropriate review: exemption from full board review, expedited review, and full board review. The level depends on 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. Stuart Binder-Macleod,
Physical Therapy
Dr. William Farquhar,
Health Nutrition Exercise Science
*Dr. Albert Cavalier,
(alternate for Dr. Nandakumar)
Mr. Raheen Darden,
Community Representative
(alternate for Dr. Robbins)
Dr. Mark Greene,
Philosophy
Ms. Mary Ann Ellis,
Community Representative
* Dr. Michael Kuhlman,
Psychology
Dr. Brian W. Little, Physician,
Christiana Care, Community Representative
Dr. Raelene Maser,
Medical Technology
(alternate for Dr. Farquhar)
Rev. Joy Walton
Community Representative
Dr. Cynthia A. Robbins,
Sociology
Dr. Thomas Rocek,
Anthropology
Dr. Lynn Snyder-Mackler,
(alternate for Dr. Binder-Macleod)
*Dr. Paul Solano,
Urban Affairs and Public Policy
* Dr. Donald G. Unger,
Individual and Family Studies
Dr. Ratna Nandakumar,
Education
Ms. Elizabeth Peloso,
Research and Graduate Studies
Dr. Danilo Yanich, Urban Affairs and Public Policy (alternate for Dr. Solano)
CONSULTANTS TO THE BOARD
(non-voting)
Dr. Lisa Barkley, Physician
Dr. Michael J. Pasquale, Physician
Dr. Michael R. Zaragoza, Physician
(* denotes chair for human subjects in their department)
