IRB Purpose
The IRB exists to facilitate adherence to Federal Policies and Regulations for the protection of Human Subjects involved in research whether it be an adult, child, or fetus (see Office of Human Research Protection (OHRP) and Department of Health and Human Services (HHS)).
HHS regulations define research at 45 CFR 46.102(d) as follows:
Research: means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
HHS regulations define human subject at 45 CFR 46.102(f) as follows:
Human Subject(s): means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
In addition, if your research does include human subjects, it is important to gain a greater understanding of how the offices of OHRP and HHS define "Coded Private Information and Biological Specimens".
