Before any human subject may be included in a clinical research study (prospective, observational, or retrospective), the Duke Institutional Review Board (IRB) must review and approve the study, giving proper consideration to:
- The risks to the subjects
- The anticipated benefits to the subjects and others
- The importance of the knowledge that may reasonably be expected to result
- The informed consent process to be employed User Guides are available on the eIRB website (https://eirb.mc.duke.edu) and additional information is available on the IRB website (http://irb.duhs.duke.edu/).