Overview of Applicable Regulations
and Policies

Research with human subjects at Duke is governed by federal regulations, and Duke policy.

The Institutional Review Board has developed policies as required by the federal regulation and as needed to clarify the application of the regulations.

While it is not a regulatory document, the Belmont Report provides a set of ethical principles to which Duke has agreed to apply to research with human subjects. This agreement is part of Duke's Assurance with the federal government describing how the University will protect human research subjects.

In addition, there are North Carolina laws that affect the conduct of research with human subjects, including mandated reporting requirements for suspected child abuse and laws describing circumstances in which minors may become emancipated from parental authority.

The texts of all applicable regulations and policies are available through this site. One of the functions of the staff and the IRB is to help investigators interpret the regulations and policies. Any questions should be initially addressed to the staff who will consult with the IRB if needed