Multiple Institutions Clinical Research Processes

Approvals must be obtained from each of the involved institutions where data is acquired. One institution would be the institutional board (IRB) of record and each other institution must also give approval as an external IRB. See the individual institutions' research approval processes for details.

Private Practice Clinical Research Processes

Regulatory compliance and approvals must be obtained from a commercial institutional review board (IRB). Neither FAU nor hospital systems may provide oversight of research studies involving private practice data. Commercial IRBs commonly used are WCB IRB and Advarra.

Human subjects research involving patient data from the FAU Medicine practice, other data collected at FAU, or data collected by FAU employees not involving hospital data must be approved by FAU. The principal investigator (PI) must be an FAU-employed faculty member and the PI must sign off on all submissions.

For additional detailed information regarding regulatory compliance, visit the  Training and Regulatory Compliance  webpage.

FAU Clinical Research Processes

Prerequisite Requirements

• CITI Program affiliation with Florida Atlantic University and completion of courses Biomedical Research Investigators, Information Privacy and Security (IPS), and Responsible Conduct of Research (RCR). CITI certifications are good for three years.
  1. Log on to  citiprogram.org  and affiliate with Florida Atlantic University.  (Note: You can see your institutional Courses and affiliations from the My Courses tab.)
  2. Select Florida Atlantic University     View Courses tab     Complete the following courses:
     • Biomedical Research Investigators
     • Information Privacy and Security (IPS) for Clinicians
     • Responsible Conduct of Research (RCR)

IRB Approval Process

1. Access  fau.novelution.com/.
2. From the IRB tab, select Create IRB Protocol
3. Follow the prompts to enter all relevant information.
4. After entering all necessary information, submit the protocol. It will be routed to your department chair for appropriate approval signatures.
5. Revise as required - Receive IRB approval or exempt status.
6. After receiving letter from the IRB, start your study.  Study data can now be accessed or received.

Contacts

• FAU College of Medicine Office of Research
• FAU Division of Research

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.