Institutional Review Board Applications

DEPARTMENT OF HEALTH
Office of Statewide Research

RULE NO: RULE TITLE
64H-2.002: Institutional Review Board Applications

NOTICE OF CHANGE

Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 35 No. 25, June 26, 2009 issue of the Florida Administrative Weekly.

Subsection (1) now reads: Requests for Institutional Review Board review shall be submitted electronically using the Department’s electronic system. For access to the Department’s electronic system, contact the Office of Public Health Research, Florida Department of Health, [phone]. Payment shall be remitted to the Office of Public Health Research, Department of Health, 4052 Bald Cypress Way, Bin #A-24, Tallahassee, Florida 32399, [phone].

Subsection (4) now reads: Requests for review of studies involving only confidential information, and where there is no direct intervention or interaction with human subjects, and where the information is collected by the Department under statutory authority that provides for release of identifiable private information for research purposes shall be charged according to the following schedule:

Subsection (5)(c) was published in error in Vol 35, No 30, July 31, 2009 issue of the Florida Administrative Weekly. Paragraph (5)(c) correctly reads: Continuing Reviews $1,000.

Subsection (7) now reads: Fees do not apply for non-research determinations or studies that are exempt per 45 CFR 46.101(b), June 23, 2005.