INVESTIGATOR GUIDE  
 
 

ARE YOU CONDUCTING RESEARCH USING

HUMAN SUBJECTS?


Mercer
University
's Institutional Review Board and the Office of Research Compliance (ORC) are responsible for making final decisions as to what constitutes human subjects research and how human subjects' research protections must be implemented. Mercer adheres to the Federal Regulation 45 CFR 46 Protection of Human Subjects, which states: RESEARCH is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. 

HUMAN SUBJECT is a living individual about whom an investigator (whether professional or student) conducting research obtains: Data through intervention or interaction with the individual, or identifiable private information which includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).


To Learn More

U.S. Department of Health and Human Services (DHHS) http://www.hhs.gov   

Office for Human Research Protections (OHRP) http://www.hhs.gov/ohrp/

U.S. Food and Drug Administration (FDA) http://www.fda.gov/
U.S. Department of Education: http://www.ed.gov

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