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FSU researchers who submit applications for IRB review at Tallahassee Memorial Regional Medical Center ("TMRMC") are advised that the Center has adopted a new policy to charge researchers for IRB reviews. The review fee will depend on the type of review, and whether the research is federally funded. Student conducted research will not be charged (unless federally funded). The TMRMC will consider requests for waiver of the IRB review fee if the applicant meets certain criteria. Any questions should be directed to Ms. Julie Haltiwanger at 644-7900, email at jth5898@fsu.edu.

FSU researchers are advised that the Florida Department of Health has posted a notice of proposed rule making regarding the imposition of an IRB Review Fee for research projects under the jurisdiction of the Florida Department of Health. The notice provides as follows:

The following notice was published in the Florida Administrative Weekly today, April 25, 2008:

Notice of Proposed Rule

DEPARTMENT OF HEALTH 64H Office of Statewide Research RULE NO: RULE TITLE 64H-2.002:
Institutional Review Board Applications PURPOSE AND EFFECT: The purpose of this rule is to provide an application mechanism and fee schedule requesting IRB review pursuant to the provisions of Section 381.86(5), F.S. SUMMARY: Rule 64H 2.002, F.A.C., adopts a fee schedule for review of human subjects research pursuant to Section 381.86(5), F.S. SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: Number of people affected: 46; Number of entities affected: 10; Dollar impact $26,400; Cost to agency: $10,000 first year and $7,000 thereafter; Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

SPECIFIC AUTHORITY: 381.86 FS.
LAW IMPLEMENTED: 381.86(5) FS.

A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW: DATE AND TIME: May 8, 2008, 10:00 a.m. - 11:00 a.m. PLACE: Conference Room 280N, 4030 Esplanade Way, Tallahassee, FL 32399 THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Ronique Hall, Office of Public Health Research, Department of Health, 4052 Bald Cypress Way, Mail Bin A24, Tallahassee, FL 32399, (850)245-4444, x3927

THE FULL TEXT OF THE PROPOSED RULE IS:

64H-2.002 Institutional Review Board Applications.
(1) Requests for Institutional Review Board review shall be submitted electronically using the IRBWise system available at the program's website http://FLpublichealthETHICS.net/. The website address is also available by contacting: Office of Public Health Research, Department of Health, 4052 Bald Cypress Way, Bin #A-24, Tallahassee, Florida 32399, (850)245-4585.
(2) A fee shall be charged for review of each study according to the following schedule: Initial Requests for full board or expedited review $500, Amendments $100, and Continuing Reviews $500. Requests for continuing review are due 60 days prior to study expiration; requests for review after a study has expired will be assessed a $1,000 fee.
Fees are due at the time a request for review is made. IRB determinations will not be granted until payment is received by the department. Fees are nonrefundable, except if the investigator pays a fee when none is due. Specific instructions on how to pay the fee are available at the website indicated in subsection (1).
Fees do not apply to Department of Health employees, including contracted employees, or investigators conducting research involving human subjects at the request of the Department under a contract, memorandum of understanding, or similar agreement. Fees are waived for any student who is a candidate for a degree at a university regardless of location. Specific Authority 381.86 FS. Law Implemented 381.86(5) FS. History-New.

NAME OF PERSON ORIGINATING PROPOSED RULE: Robert Hood, Assistant Director, Office of Public Health Research NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Susan Phillips, Director, Office of Public Health Research DATE PROPOSED RULE APPROVED BY AGENCY HEAD: April 3, 2008 DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: July 20, 2007

Any questions should be directed to Ms. Julie Haltiwanger at 644-7900, email at jth5898@fsu.edu.

Update in regard to the Florida Department of Children and Families

A related update in regard to the Florida Department of Children and Families. In previous years, the Florida Department of Children and Families ("DCF") relied on the Florida Department of Health to conduct IRB reviews of DCF-related research, pursuant to a Memorandum of Agreement. As of March, 2008, it is our understanding that this Agreement is no longer in effect. We have been advised that DCF is reviewing other options regarding an appropriate Institution to conducted IRB reviews of DCF related research. Ms. Jackie Beck at the Florida Department of Children and Families is the contact for this information at ph. 921-5699, or you may contact our office, Ms. Julie Haltiwanger at 644-7900, email at jth5898@fsu.edu for additional information.

News on FSU Conditional Approvals

Researchers are advised that a conditional approval status from the FSU IRB will only last for 60 days from the date of notification of the status from the IRB. If the required conditions are not submitted within 60 days from the date of notification of the status ("conditionally approved by the IRB contingent on the following..."), then the application will be administratively closed, and the researcher will have to re-submit his/her application for review. Too often researchers submit an application for review, a conditional approval is granted by the IRB, and the researcher never gets back to the IRB with the required submissions to complete the review and approval process, creating administrative confusion and compliance jeopardy.

Florida Department of Health IRB has revised its policies regarding continuing reviews (renewals) 1/4//2008

This is a notice for Principal Investigators doing research that falls under the jurisdiction of the Florida Department of Health IRB: The Florida Department of Health IRB has revised its policies regarding continuing reviews (renewals). It is vitally important that PIs have a timely response to DOH IRB continuing review notices. If you do not timely respond (60 days prior to expiration of approval date), and inform DOH whether you are continuing your research, closing your research, or any other status prompts that are requested by DOH, your study will expire and be considered in noncompliance. Once in noncompliance, the DOH may determine that your protocol is to be terminated, impose conditions on whether any data collected may be utilized, and may report the noncompliance to OHRP for further action. In short, an "expiration" at DOH is considered noncompliance with the DOH IRB policies and OHRP regulations. All PIs are encouraged to take timely action and respond to the continuing review notices. For more information, please contact the FSU IRB office at 644-7900

IRB Investigator Training Required by January 1, 2008

Effective January 1, 2008, the Office of Research is requiring that FSU faculty, staff, and students (graduate or undergraduate) complete the Protection of Research Subjects/Human Subjects training course on the FSU website, and secure certification before protocols for research will be approved and accepted by the IRB. For those researchers with ongoing human subjects research protocols, training must be completed prior to the annual re-approval (renewal) of the protocol. The FSU IRB will accept the NIH human subject training or CITI training taken at another institution in lieu of the FSU human subjects training course if completed within the last 3 years prior to submission date. Evidence of having completed the CITI training or NIH training must be provided to the IRB with the protocol submission. Note: NIH requires all NIH funded researchers to complete the NIH human subjects training course to be compliant with NIH requirements.

The FSU IRB reserve the right to require than an investigator complete any or all of the training modules before approving a protocol. All investigators named on an FSU IRB application (and "Research Staff") who are engaged in research must be compliant with the above requirements for training in the protection of research subjects.

HSRS (Online System) News

The IRB is in the process of transferring to an online system. As of January 1, 2008 all new applications must be submitted in the online system. The paper application is being phased out and it is recommended that all researchers use the online application. If a college/department would like training on the new system, please contact Julie Haltiwanger at 644-7900 or jth5898@fsu.edu.