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Office of Research and Sponsored Programs

Compliance

 
 

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 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)

Note:

  1. Please download and save a new copy of the application and forms each time to ensure you are using the current version.
  2. Many of the forms require Adobe Reader 9.0 or later to fully utilize the forms on both the PC and Mac. You may download this free application from Adobe's Web site

Important Changes to the FGCU Human Subjects in Research Training Guidelines

Beginning August 7, 2013

  • The Board will no longer accept the on-Line NIH training program Protecting Human Research Participants, as fulfillment of the human subjects in Research training requirement. Persons who completed the NIH training program prior to August 7, 2013 will be grandfathered in through August 30, 2014.
  • Persons submitting an IRB application or added to a protocol via an amendment who have not a Human Subjects in Research course must complete the appropriate Collaborative Institutional Training Initiative (CITI) Human Subjects in Research training course.
  • Human Subjects in Research training renewal is required every five years. Investigators and key study personnel* will need to renew their training every five years by taking a shorter refresher course offered by CITI. The Office of Research and Graduate Studies will notify investigators of the expiration of their certification 90 days prior to its occurrence.

Beginning September 1, 2014

The NIH Office of Extramural Research’s Course, Protecting Human Research Participants, will no longer fulfill the certification in Human Subjects Research requirement for conducting human subjects research. Certification in Human Subjects Research via the NIH course will be valid through August 31, 2014 provided it was completed prior to August 7 2013. After this date, all investigators and key study personnel conducting human subjects research will need to complete the appropriate CITI course.

*key study personnel include all individuals, including students, who contribute in a substantive way to the development, conduct and monitoring of studies on behalf of FGCU. This includes persons who enroll research subjects, obtain informed consent or screen potential subjects, and who analyze or report research data.

Recent Updates December 2013

Is my Research Human Subjects Research NEW
Informed Concent Form Model December 2013
Child Assent and Parental Consent Form Models December 2013
On-line Consent Model December 2013
Oral Consent Model for In-person or Telephone Interviews December 2013

IRB Application Tool Kit

Application

IRB Application Form [pdf. 2100kb] (updated August 2013)
IRB Application Checklist [pdf. 316kb] (updated August 2013)

Consent Form Models Located in the Forms Library

Informed Consent Form Model (updated December 2013)
Child Assent and Parental Consent Form Models (updated December 2013)
Assent Instructions (issued April 2011)
On-line Consent Model (updated December 2013)
Oral Consent Model for In-person or Telephone Interviews (updated December 2013)
Is my Consent Form Written at the 8th Grade Level? (issued April 2011; minor revision December 2013)
Instead of ...Try This Word (issued April 2011)

Other Forms

Guidelines for Letters from Agencies Cooperating with the Research [pdf 75 kb] (issued March 2011)
IRB Request to Close Protocol [pdf. 1200kb ](issued July 2013)
Is my Research Human Subjects Research? (issued January 2014)
Amendment to IRB Application
[pdf 1158kb] (updated July 2011)
(Protocol amendments may not be instituted until written approval is received from the IRB)


Other Resources

IRB Guidelines for Student Research Involving Human Subjects (issued August 2012; minor revision January 2014)
Is IRB Approval Needed for my Research? [pdf 77kb] (issued March 2011)
Determining IRB Review Category - Exempt, Expedited, or Full Board Review [pdf 74kb] (issued March 2011)

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

Human Subjects Research Training

Beginning August 7, 2013

  • The Board will no longer accept the on-line NIH training program, Protecting Human Research Participants, as fulfillment of the Human Subjects in Research training requirement. Persons who completed the NIH training program prior to August 7, 2013 will be grandfathered in through August 30, 2014.
  • Persons submitting an IRB application or added to a protocol via an amendment who have not completed a Human Subjects in Research course must complete the appropriate Collaborative Institutional Training Initiative (CITI) Human Subjects in Research training course.
  • Human Subjects in Research training renewal is required every five years. Investigators and key study personnel* will need to renew their training every five years by taking a shorter refresher course offered by CITI. The Office of Research and Graduate Studies will notify investigators of the expiration of their certification 90 days prior to its occurrence.

Beginning September 1, 2014

The NIH Office of Extramural Research’s Course, Protecting Human Research Participants, will no longer fulfill the certification in Human Subjects Research requirement for conducting human subjects research. Certification in Human Subjects Research via the NIH course will be valid through August 31, 2014 provided it was completed prior to August 7 2013. After this date, all investigators and key study personnel conducting human subjects research will need to complete the appropriate CITI course.

*key study personnel include all individuals, including students, who contribute in a substantive way to the development, conduct and monitoring of studies on behalf of FGCU. This includes persons who enroll research subjects, obtain informed consent or screen potential subjects, and who analyze or report research data.

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

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 Graduate Studies at least one month prior to the meeting date. Please contact Sandy Terranova for protocol assistance.

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 follows.Meetings may be changed as necessary. Please watch this website for meeting changes or contact Sandy Terranova for more information.

Meeting Schedule
Location
Friday December 6, 2013 2:30 HH 221
Friday January 17, 2014 1:30 HH 221 cancelled
Friday February 21, 2014 1:30 HH 221 cancelled
Friday March 21, 2014 1:30 HH 221
Friday April 11, 2014 1:30 HH 221
Friday May 16, 2014 1:30 HH 221
Friday June 20, 2014 1:30 HH 221

IRB Committee Members

Dr. Clifford Renk, Chair

College of Arts & Sciences

239-5907-482
crenk@fgcu.edu

Dr. Robert Triscari, Vice Chair College of Education 239-590-7202
rtriscari@fgcu.edu
Dr. Terry Wimberley College of Arts & Sciences 239-590-7752
twimber@fgcu.edu
Dr. Linda Martin College of Health Professions and Social Work 239-590-7556
lmartin@fgcu.edu
Mr. Thomas Bevins College of Health Professions and Social Work 239-590-7534
tbevins@fgcu.edu
Mr. Stan Appelbaum Community Member
Dr. Edward Ferguson Community Member
Dr. Arthur Rubens Lutgert College of Business 239-590-7840
arubens@fgcu.edu
Dr. Lisa Zidek U.A. Whitaker College of Engineering 239-590-7392
lzidek@fgcu.edu
Dr. Talal El-Hefnawy College of Arts & Sciences 239-590-7566
telhefnawy@fgcu.edu
Dr. Christine Wright-Isak Lutgert College of Business 290-7346
cwright@fgcu.edu
Dr. Tachung Yih, Ex-officio Office of Research and Graduate Studies 239- 590-7021
tcyih@fgcu.edu
Ms. Sandy Terranova, Staff Office of Research and Graduate Studies 239-590-7522
sterranova@fgcu.edu

On-Call

Dr. Bret Shannon Orthopedic Surgery, Nemours Children's Clinic
Dr. Margie Morales Pediatric Neurology, Nemours Children's Clinic

Alternates

Dr. Katrina Nedley Community Member

 


FGCU Institutional Animal Care and Use Committee (IACUC)

IACUC meetings are held at a minunum, once a semester in Howard Hall, 221; 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).

Related Animal Subject and Guideline Sites

Associations

Online IACUC Training Opportunities

Meetings

Protocol Submission Deadlines

November 22, 2013, 4:00
Howard Hall room 221 To be rescheduled

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

Dr. Darren Rumbold

College of Arts & Sciences

239-590-7527
drumbold@fgcu.edu

Dr. Dean Croshaw, Chair

College of Arts & Sciences

239-590-7428
dcroshaw@fgcu.edu

Mr. Walter Fohs

Non-Scientist

239-267-3525
wfohs@comcast.net

Dr. Anna Goebel

College of Arts & Sciences

239-590-7431
agoebel@fgcu.edu

Dr. Dave Nichols

Veterinarian

239-481-4746
dbnvet@gmail.com

Dr. John Cassini Community Member

239-690-5718
jcassani@comcast.net

Dr. James Douglass

College of Arts & Sciences

239-590-1268
jdouglass@fgcu.edu

Dr. Tachung Yih, Ex-officio Office of Research and Graduate Studies 239- 590-7021
tcyih@fgcu.edu
Ms. Sandy Terranova, Staff Office of Research and Graduate Studies 239-590-7522
sterranova@fgcu.edu

 

 

Letter of Cooperation

IACUC Classifications


 

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 November 30, 2015.

Meetings are held at least semi-annually.
The next meeting is scheduled for Thursday, November 14, 2013 at 2:00 in Howard Hall, room 221.

 

 

 

 

Committee Members


Name

College/Expertise

Contact Information

Ms. Rhonda Holtzclaw Environmental Health & Safety
Radiation Safety Officer

590-7224
rholtzcl@fgcu.edu

Dr. Takashi Ueda Arts & Sciences, Biology
Plants

590-7236
tueda@fgcu.edu

Dr. Jorge Torres

U.A. Whitaker College of Engineering
Bioengineering

590-7346
jtorres@fgcu.edu

Dr. Scott Michael, Chair Arts & Sciences, Biology
Animals; rDNA technology

590-7439 smichael@fgcu.edu

Dr. Kevin Davies Arts & Sciences, Chemistry & Math
Laser Technology

590-1459
kdavies@fgcu.edu

Dr. Mitchell Harris Rosner

Community Member
Algenol Biofuels

284-1167

Dr. Tachung (TC) Yih

Office of Research and Sponsored Programs
Institutional commitments and policies; applicable law; standards of professional conduct and practice (non-voting member)

590-7021
tcyih@fgcu.edu

Ms. Sandy Terranova

Office of Research and Sponsored Programs
Staff to Committee

590-7522
sterranova@fgcu.edu

 

 

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

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

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 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.

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