Research is defined as “systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” (45 CFR 46.102(d)) Research can occur in many settings with organisms, animals, and humans. Institutional Review Boards only review research that involves living persons or their private identifiable information. Private identifable information can be found in indivdiual records or it can occur in settings where a person would expect that no observation or recording was taking place.
Research with humans is governed by a set of regulations put forth by the federal government. The two most common regulatons used are those from the Department of Health and Human Resources (DHHS) and the Food and Drug Administration (FDA). These regulations provide the parameters under which a study must be designed, reviewed, and approved before any person may be enrolled or any information may be accessed.
Research that uses, accesses, creates, or stores private identifiable information is further governed under the Health Information Privacy and Portability Act (HIPAA).
Indivdiuals who agree to participate in a research study are known as research participants or participants.