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South Florida VA Foundation for Research & Education |
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South Florida VA Foundation for Research & Education |
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Human Studies |
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See below for information of interest to investigators and other personnel involved in human subjects research at the Miami VAMC. Please check frequently - updates are posted often. For additional forms not listed on this page, please go to the Forms page. |
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Miami VAMC IRB Investigator Manual
The Investigator Manual describes how to prepare informed consent documents and submit materials for IRB review, what the nature of the IRB review process is and what the possible outcomes are, and what is expected from the Principal Investigator
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Guidelines for New Protocol Applications
A NEW version is available - and it must be used for June Review! - The form "Application and Checklist for Human Research Project" is required for all new Human Studies protocols. This form is designed to assist researchers in gathering the appropriate documents for submission to the IRB.
Requirements for All Monitoring Visits
New rules require that the Research Office be informed of all monitoring visits by pharmaceutical companies or Contract Research Organizations as soon as possible. The CRO or study monitor must sign in as a visitor at the Research Office before the visit. See "Notifying the Research Office of Audits and Site Visits" for more details.
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HIPPA Guidance
HIPAA Guidance Document (6/1/04)
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Informed Consent Assistance
Informed Consent - Blank Form (4/26/04) Informed Consent - Example Form (11/06/07) Informed Consent Preparation - Investigator Checklist (05/13/08) Decisional Capacity and Surrogate Consent (6/23/05)
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GCRC Access and Use
GCRC has moved to the University of Miami and will not be available for VA Research protocols.
Human Studies Training
All personnel involved in VA Research must take annual courses in:
1. VA Research Data Security & Privacy, 2. VHA Privacy Policy Training, and 3. VA Cyber Security Awareness
In addition to the above courses, all personnel participating in the design, conduct or analysis of research involving human subjects must obtain certification of human studies training by completing all modules of the Collaborative IRB Training Initiative (CITI). See the Investigator Manual above for more details.
Self Assessments for Human Studies Research
Informed Consent Compliance Checklist
Additional Human Studies Information
Flow Chart of IRB Review Process for New Protocols (v1.0)
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