Compliance Committees provide our researchers assistance in complying with the various federal, state and university 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. 

The FGCU Misconduct in Research procedures apply to individuals (other than students involved in regular classroom assignments) engaged in any form of research and scholarship, funded or otherwise, in every discipline throughout FGCU.

For assistance with IRB, IACUC, and Research Safety Committee applications, please contact Sandy Terranova at 239-590-7522 or sterranova@fgcu.edu.

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

The IRB is working to increase the number of resources that will assist FGCU researchers with the IRB process.   Please download and save a new copy of the application and forms each time to ensure you are using the current version.  The new postings and updates are documented in the following table.

Navigating the IRB

Is IRB Approval Needed for my Research?   [pdf 77kb] (issued March 2011)
A decision tree with a secondary ‘help’, Determination if Research is Humans Subject Research form, to assist in determining if IRB approval is required before the research can be undertaken.

Determining IRB Review Category - Exempt, Expedited, or Full Board Review  [pdf 74kb] (issued March 2011)
A decision tree to assist in selecting the IRB review category.

IRB Review Process   [pdf 54kb] (issued March 2011)
A flow chart of the IRB application submittal to approval process.

 IRB Toolkit

IRB Application and Application Checklist

IRB Application Form (Adobe format) [pdf. 1720kb] (updated March 2013)

The application, redesigned using Adobe software in early 2012, guides the investigator in his/her explanation of the study to collect the information the IRB needs to approve a protocol, thereby reducing the time from application submittal to approval.  Adobe Reader is required to fully utilize the form on both the PC and Mac.  

If you have any questions about the revised form, please contact the IRB through Sandy Terranova in the Office of Research and Sponsored Programs (sterranova@fgcu.edu or 590-7522).

IRB Application Checklist [excel - 57kb] (issued November 2012)

 The checklist, based on the items reviewed during the initial or "technical review" of an IRB application, will assist in streamling the review and approval process.

Consent Helps and Models

Informed Consent Form Model [.doc - 95kb] (updated November 2012)
The consent model includes instructions, guidance, both suggested and required text, and refers the researcher to the pertinent sections in the application he/she should consult when writing the form.


Child Assent and Parental Consent Form Models  [.doc 76kb] (updated November 2012)
The assent and consent models include instructions, guidance, both suggested and required text, and refers the researcher to the pertinent sections in the application he/she should consult when writing the forms.  Guidance in selecting the correct assent form is found in Assent Instructions [pdf 84kb] (issued April 2011).

On-line Consent Model [doc. 68kb] (updated November 2012)
The model includes instructions, guidance, both suggested and required text, and refers the researcher to the pertinent sections in the application he/she should consult when writing the form.

Oral Consent Model for In-person or Telephone Interviews [doc. 42kb] (updated April 2012) 
The modelincludes instructions, guidance, both suggested and required text, and refers the researcher to the pertinent sections in the application he/she should consult when writing the oral consent form for telephone or “on the street” interviews.

Is my Consent Form Written at the 8th Grade Level?   [pdf 140kb] (issued April 2011)
To determine the readability of your consent document(s), activate the Microsoft WordTM readability function following the instructions in the above link.  The function calculates the U.S. grade school level the document is written for and rates one’s ease in understanding the document.  To improve the readibility of your  form Instead of …Try This Word  [pdf 63 kb] (issued April 2011) 
The document provides alternate word selections to increase the readability of your form.

IRB Amendment

Amendment to IRB Application (Adobe format) [pdf 1158kb]  (updated July 2011)
Use this form to request an amendment to an exempt, expedited or full board review protocol awaiting approval or approved by the IRB.  

The amendment, redesigned using Adobe software in early 2012, guides the investigator in his/her explanation of the amendment to collect the information the IRB needs for approval.  Adobe Reader is required to fully utilize the form on both the PC and Mac. If you have any questions about the revised form, please contact the IRB through Sandy Terranova in the Office of Research and Sponsored Programs (sterranova@fgcu.edu or 590-7522).

Protocol amendments may notbe instituted until written approval is received from the IRB. 

Other IRB Guides 

Guidelines for Letters from Agencies Cooperating with the Research [pdf 75 kb] (issued March 2011)
The guidelines identify the critical components to be included when soliciting a letter of cooperation from a cooperating agency.

Please send any questions or comments about the new application and resources to Sandy Terranova, Research Compliance Coordinator, at sterranova@fgcu.edu.

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

• IRB Policy and Procedures [.doc - 113kb]
• [pdf 113 kb]
• Guidelines for Internaional Research Involving Human Participants [pdf 73kb]
• IRB Policy Regarding Oral History Interviewing [.doc - 42kb]
• Frequently Asked Questions [.doc - 34kb]

Protocol Submission Deadlines

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 Sandy Terranova for protocol assistance.

Human Subjects Research Training

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

Additional training is available through CITI (Collaborative Institutional Training Initiative).  The link will take to you the registration instructions for CITI and guide you through your initial log on to CITI and the selection of your course(s).

Related Human Subject Sites

• Code of Federal Regulations 45CFR46 

• U.S. Food and Drug Administration

• PRIM&R Public Responsibility in Medicine and Research

• Responsible Conduct of Research training through CITI

IRB Meeting Schedule

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 Sandy Terranova of your intention to attend so she can ensure adequate seating.

The IRB meeting schedule for academlic year 2010-2011 follows.Meetings may be changed as necessary.  Please watch this website for meeting changes or contact Sandy Terranova for more information.

 IRB Committee Members

FGCU Institutional Animal Care and Use Committee (IACUC)

IACUC meetings are held at a minunum, once a semester in HE 109; the meeting date/time will be published here as soon as possible.  To submit an application to the IACUC, please review its policy and use the IACUC application form. 

IACUC Toolkit

IACUC Appplication Form   (Adobe format) [pdf. 1831kb] (updated October 2012)
The application, redesigned using Adobe software, guides the investigator in his/her explanation of the study to collect the information the IACUC needs to approve a protocol, thereby reducing the time from application submittal to approval.  Adobe Reader 9.0 or later is required to fully utilize the form on both the PC and Mac.  You may download this free application from Adobe's Web site.

If you have any questions about the revised form, please contact the IACUC through Sandy Terranova in the Office of Research and Sponsored Programs (sterranova@fgcu.edu or 590-7522).

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

  Related Animal Subject and Guideline Sites

• Animal Welfare Act
• USDA Animal Welfare Home Page
• Office of Laboratory Animal Welfare (Office of Extramural Research, National Institutes of Health
• OLAW Brochure for PIs and their Compliance Responsibilities 
• U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training
• Guide for the Care and Use of Laboratory Animals, National Research Council (pdf 1.3 mb) 
• Guidelines for the Treatment of Animals in Behavioral Research and Teaching (pdf 173 kb)
• Wildlife in Field Studies (USDA)
• Studies of Wild Animals in or from Natural Settings (pdf 1.96 mb)
• Guidelines of the American Society of Mammalogists for the use of Wild Mammals in Research (pdf, 5.6 mb)
• Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research (pdf 5.5 mb)
• Guidelines for the Use of Fishes in Field Research (pdf 729 kb)
• Information Resources on Fish Welfare
• Guidelines for the Use of Live Amphibians and Reptiles in Field and Laboratory Research (pdf 92 kb)
• Recommendations for the Care of Amphibians and Reptiles used in Research
• Guidelines for the Use of Wild Birds in Research (pdf 1 mb)
• Recognition and Alleviation of Pain in Laboratory Animals
• American Veterinary Medical Association’s (AVMA) Guidelines on Euthanasia (pdf 549 kb)
• Net Vet

Associations

• American Association for Laboratory Animal Science (AALAS)
• American Fisheries Society
• American Psychological Association (Guidelines for Ethical conduct in the Care and Use of Animals)
• American Society of Ichthyologists and Herpetologists
• American Society of Mammalogists
• Animal Welfare Information Center (USDA-AWIC)
• Federation of Animal Science Societies (FASS)
• Institute for Laboratory Animal Resources (ILAR)
• Lab Animal
• Ornithological Council
• Scientist Center for Animal Welfare (SCAW)
  

Online IACUC Training Opportunities

• Laboratory Animal Training Association
• Institutional Animal Care & Use Committee Training & Learning Consortium
• Association for Assessment and Accreditation of Animal Care page for IACUC's #

 Daily Housing Log  

Letter of Cooperation

IACUC Classifications  

 Research Safety Committee Policy and Procedures Manual [.doc - 218 KB]

• Radiation Safety Manual [.doc - 1.01 mb]
• Research Safety Application [.doc - 89kb]
• Biosafety Manual web site
• HHS and USDA Select Agents and Toxins [.pd - 32kb]

Biological Inventory List:  http://itech.fgcu.edu/hazmat/biological.asp

Chemical Inventory Form:  http://itech.fgcu.edu/hazmat/chemical.asp

Intellectual Property Policy & Invention Disclosure

• Intellectual Property Policy [.pdf - xxkb]
• Invention Disclosure Form [.doc - 157kb]