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The FGCU Institutional Review Board (IRB) reviews all research activities involving
human subjects. The IRB ensures that the rights, safety and welfare of human subjects
are protected as mandated by the appropriate federal regulations, state statutes and
university guidelines. Research with human subjects may not be conducted prior to
receiving IRB approval.
***Important IRB Notice: The IRB application process will transition to the Streamlyne platform on March 1st. The current formstack application will be deactivated and closed to further submissions
on Friday, February 28th. All users are required to complete training to be given access to the new management
platform. To sign up for training, please register at: IRB Streamlyne Training
For questions, please reach out to Samantha Watson, swatson@fgcu.edu.
IRB Guidelines, Forms, and Submission of Applications
Applications and protocols are accepted by ORSP on behalf of the board and reviewed
weekly by the IRB chairperson or designee. Protocols requiring review by the full
Institutional Review Board must be received a minimum of one month prior to the Board’s
meeting date.
The initial renewal of training in Human Subjects in Research is required every five
years. Investigators and key study personnel* must renew their training by taking
a shorter refresher course offered by CITI. Subsequent renewals are required every
three years.
*key study personnel include all individuals, including students, who enroll research
subjects, obtain informed consent or screen potential subjects, and who analyze or
report identifiable research data.
Health Information Privacy and Security (HIPS) Training
The federal HIPAA Privacy Rule protects the privacy of personal health information.
To meet the training requirements of HIPAA and other US statutory/regulatory authorities,
FGCU offers an online course in health information privacy and security through theCollaborative Institutional Training Initiative (CITI).
