ORSP

Compliance

Compliance Committees provide to our researchers assistance in complying with the various federal and state regulations. Research involving human subjects (IRB), animal subjects (IACUC), radioactive materials, biohazardous materials, and recombinant DNA (Research Safety Committee) have a multitude of laws and regulations with which they must comply.

The Office of Research and Sponsored Programs also provides assistance with inventions and Intellectual Property issues that arise from externally funded projects.

For assistance with IRB, IACUC, and Research Safety Committee applications,
please contact Ms. Donna Stremke at 239-590-7029 or dstremke@fgcu.edu

FGCU Institutional Review Board for the Protection of Human Subjects in Research and Related Activities (IRB)

Meetings

Protocol Submission Deadlines

Technical Reviews are held weekly.

Full Board Reviews are scheduled on a monthly basis as needed.

Faculty and student researchers are invited to attend the meetings. Please notify Donna Stremke of your intention to attend so she can ensure adequate seating.

Protocols qualifying for an Exempt or Expedited Reviews require a minimum of two weeks after submission for approval.

Please submit all protocols requiring Full Board Review to the IRB in the Office of Research and Sponsored Programs at least one month prior to the meeting date. Please contact Donna Stremke at 590-7029 or dstremke@fgcu.edu for protocol assistance.

IRB Meetings for the fall semester, 2009, are set as follows. Meetings may be changed as necessary. Please watch this website for meeting changes or contact Donna Stremke for more information.

Tuesday, October 13, 2009 3:30 pm HE 109

Tuesday, November 10, 2009 3:30 pm HE 109

Friday, December 4, 2009 2:00 pm HE 109

Committee Members
Clifford Renk, Chair	College of Arts & Sciences
Denise Heinemann	College of Health Professions
Stan Appelbaum	Human Rights Advocacy Comm.
Arthur Rubens	College of Business
Diane Schmidt	College of Education
Linda Martin	College of Health Professions
Edward Ferguson	Community Member
Terry Wimberley	College of Arts & Sciences
Thomas J. Roberts, Non-Voting	Research & Sponsored Programs
On-Call
Bret Shannon	Orthopedic Surgery, Nemours Children's Clinic
Margie Morales	Pediatric Neurology, Nemours Children's Clinic
Alternates
Lakshmi Gogate	College of Arts & Sciences
Dr. Katrina Nedley	Community Member
Rosalyn Gross	College of Health Professions

To submit a protocol to the IRB, please review the following documents:

Faculty Guidelines and Application [.doc - 36kb]
IRB Policy and Procedures [.doc - 135kb]
IRB Policy Regarding Oral History Interviewing [.doc - 42kb]
Frequently Asked Questions [.doc - 34kb]

To use this application form, open it as Read Only and save it to your computer. Each time you revise it, save it with a new name.

Application Form [.doc - 85kb]

The IRB requires completion of human subject training to accompany the protocol. We recommend the following tutorial. Please print the certificate at the end of the tutorial and send it to ORSP.

http://phrp.nihtraining.com/users/login.php

Related Human Subject Sites

FGCU Institutional Animal Care and Use Committee (IACUC)

IACUC meetings are held once a semester; the meeting date/time will be published here as soon as possible.

Meetings

Protocol Submission Deadlines

Wednesday, October 7, 2009 (CANCELED)

Friday, October 30, 2009, 2:30 pm, HE 109

Applications are accepted at any time for an Expedited Approval. If an Expedited Approval is not needed, the IACUC requires applications to be submitted at least two weeks prior to the scheduled meeting.

Committee Members
Darren Rumbold	College of Arts & Sciences
Walter Fohs	Non-Scientist
Charles Mesloh, Chair	College of Professional Studies
Dave Nichols	Veterinarian
John Fitch	College of Arts & Sciences
Aswani Volety	College of Arts & Sciences
Anna Goebel	College of Arts & Sciences
Thomas J. Roberts, Non-voting	Research & Sponsored Programs

To submit an application to the IACUC, please review its policy and use the IACUC application form.

Florida Gulf Coast University's Policy on Animal Care and Use in Education & Research [.doc - 120kb]

Application Form [.doc - 82kb]. This form is designed to be completed electronically and then printed. Please use the TAB key to move from one field to the next.

Related Animal Subject Sites

Animal Welfare Act

Online IACUC Training Opportunities

FGCU Research Safety Committee

The mission of the FGCU Research Safety Committee is to promote and facilitate a safe research environment by requiring that research projects meet all federal, state and local research safety regulations. To ensure compliance, the FGCU Research Safety Committee will review, approve and monitor applicable research projects and serve as an advocate for investigators to meet required infrastructure and personnel training and expertise guidelines.

The Research Safety Committee was established by President William Merwin in 2002 for the purpose of reviewing, approving and monitoring research projects. FGCU received its first Radioactive Materials License in January, 2006, from the State of Florida Department of Health, Bureau of Radiation Control. License Number 3774-1, Category 3L(III) will expire on January 31, 2011.

Meetings are held at least quarterly. The next meetings will be on:

Wednesday, September 23, 2009, at 3:00 pm in HE 109;

Wednesday, October 28, 2009, at 3:30 pm in HE 109;

Tuesday, November 17, 2009, at 3:00 pm in HE 109. CANCELED