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

Review Board Meeting Dates

Human Subject Training Dates

Human Subject Protocol Review & Approval Procedures

Policies and Forms

CITI Online
(Human Subjects Training)

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.

Institutional Review Board