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.
IRB Guidelines, Forms, and Submission of ApplicationsToggle More Info
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.
- IRB Guidelines
- Guidelines For Letters From Agencies Cooperating With the Research
- Guidelines For Students Conducting Research Involving Human Subjects
- Guidelines For Obtaining Assent From Children Or Minors And Guidelines For Parental Consent
- IRB Amendment / Continuation / Closure Request Form - contact Sherry Alexander for help in filling out this form
- IRB Application - contact Sherry Alexander for help in filling out this form
- IRB Application Checklist
- 2019 Child Assent and Parental Consent Model Instructions
- 2019 Child Assent and Parent Consent Model Form
- 2019 Online Consent Model Instructions
- 2019 Online Consent Model Form
- 2019 Oral Consent Model Instructions
- 2019 Oral Consent Model Form
- 2019 Signed Informed Consent Model Instructions
- 2019 Signed Informed Consent Model Form
Links to Human Subjects Research ResourcesToggle More Info
- Code of Federal Regulations 45CFR46
- Human Subject Protections Office for Human Research Protections (OHRP)
- Human Subjects for Behavioral and Social Science Research National Science Foundation (NSF)
- International Compilation of Human Research Standards (2014 edition)
- U.S. Food and Drug Administration
- PRIM&R Public Responsibility in Medicine and Research
- The Belmont Report
- Office of Behavioral and Social Sciences Research (NIH)
Human Subjects in Research TrainingToggle More Info
All investigators and key study personnel* must hold a current certificate of completion of the appropriate Collaborative Institutional training Initiative (CITI) Human Subjects in Research training course before conducting human subjects research. This requirement includes individuals added to a protocol via an amendment.
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) TrainingToggle More Info
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 the Collaborative Institutional Training Initiative (CITI).
IRB MembersToggle More Info
NAME TITLE DEPARTMENT PHONE Bourgeois, Martin, Chair Professor College of Arts & Sciences, Psychology email@example.com (239) 590-7540 Baer, Erica Program Coord/Instructor I Dept of Justice Studies firstname.lastname@example.org (239) 745-4321 Hariharan, Jenette Visiting Assistant Professor Dept of Bioengineering email@example.com (239) 745-4513 Sinclair, Starlette Assistant Professor Dept of Psychology firstname.lastname@example.org (239) 590-7232 Szecsi, Tunde Professor College of Education, Teacher Education email@example.com (239) 590-7788 van Duijn, Arie Professor Marieb College of Health and Human Services, Rehabilitative Sciences firstname.lastname@example.org (239) 590-7537 Ferguson, Edward Community Member Payton, Alice Community Member Alexander, Sherry, Ex-officio Research Compliance Coordinator Research & Sponsored Programs email@example.com (239) 590-7522
IRB Meeting DatesToggle More Info
DATE TIME LOCATION September 24, 2021 2:00 PM - 3:30 PM TBD October 15, 2021 10:00 AM - 11:30 AM TBD November 19, 2021 10:00 AM - 11:30 AM TBD December 17, 2021 10:00 AM - 11:30 AM TBD January 21, 2022 10:00 AM - 11:30 AM TBD February 18, 2022 10:00 AM - 11:30 AM TBD March 18, 2022 10:00 AM - 11:30 AM TBD April 15, 2022 10:00 AM - 11:30 AM TBD May 20, 2022 10:00 AM - 11:30 AM TBD June 17, 2022 10:00 AM - 11:30 AM TBD