Clinical Research Processes
Human subjects research approval is a federally mandated process. The U.S. Department of Health & Human Services (HHS) through the Office of Human Research Protection (OHRP) provides oversight of the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted and supported by HHS. As such, an institutional review board (IRB) is formally designated to review and monitor research involving human subjects. This group serves an important role in the protection of the rights and welfare of human research subjects.
Prior to research being conducted, institutional approval must be obtained. The appropriate IRB and approval process depend on the source of patient data.
Florida Atlantic University
FAU Medicine data, data collected at FAU, or data collected by FAU employees not involving hospital data.
Baptist Health
Data owned by a Baptist Health South Florida facility, including Bethesda Hospital East/West and Boca Raton Regional Hospital.
Tenet Healthcare
Data owned by a Tenet Healthcare facility, including Delray Medical Center, St. Mary’s Medical Center, and West Boca Medical Center.
Private Practice
Data that resides in a practice of a private physician/group not directly employed by a larger institution.
Multiple Institutions
Data obtained from more than one different institution.