Use of Human Subjects in Research  

Course Introduction  

Definitions    

Federal regulations and the FWA apply to RESEARCH, both medical AND non-medical, involving HUMAN SUBJECTS.

RESEARCH means a systematic investigation designed to produce generalizable knowledge.

Research may involve direct interactions or interventions with subjects, such as obtaining data by taking histories, obtaining blood samples, urine sampling, diagnostic procedures, or treating patients at least in part for the purpose of gaining generalizable information.

Research may also involve indirect activities such as the analysis of specimens or data from people. Participation in these kinds of indirect activities, particularly if anyone plans to publish the results, constitutes human subjects research.

A HUMAN SUBJECT is a living individual about whom an investigator (faculty, staff or student) obtains either

1. data through intervention or interaction with the individual; or
   
   
2. identifiable private information, e.g., school transcripts or medical records.