500-00 Determination of Whether IRB Review is Required

Florida Department of Health
Request for Determination of Whether IRB Review is Required
For questions, concerns, to provide input, or request a consultation, call HRPP staff at
850-245-4444 ext. 3591
Project Title
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Abstract
Provide a summary of the project (approximately 250 words)
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Purpose of the Project
Describe the purpose, specific aims, or objectives.
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Background and Rationale
Provide the background and rationale for the project:
·  Describe the background, relevant prior experience, and gaps in current knowledge
·  Describe and explain the project design
·  If the project is limited to secondary analysis of existing data, describe the source of the data, methods of analysis, and plans for data storage. List the data fields to be used
·  If the project involves interactions or interventions with people, describe all procedures from the beginning of the proposed research through the conclusion of the project, including surveys, interviews, focus groups, screening, study visits, drug treatments, randomization, and any long-term participant follow-up
·  Describe the number, qualifications, and expertise of staff, their experience in conducting similar projects, and their knowledge of the population being studied (or the data being analyzed)
·  If applicable, provide a brief list of references to support the information provided
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Supporting materials
Provide any written materials related to the research, such as a protocol, consent document, recruitment or advertising materials, description of data fields or a data use agreement, or any other materials relevant to the request.
Attestation
I agree to follow Department policies and provide complete and accurate information concerning projects involving human participants and data.
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Date: Click here to enter text.
For questions, concerns, to provide input, or request a consultation, call HRPP staff at 850-245-4585

Research Outline 1