Regulatory Information
Home Page VCU IRB HIPAA Algorithm (Adobe PDF format) Informed Consent Assessment
IMPORTANT NOTICE: April 14, 2003 was the start date of HIPAA regulations that included clinical research.Impact of HIPAA on Clinical Research 1. STUDIES THAT ARE COMPLETED, NO LONGER GATHERING DATA, AND HAVE DATA RETAINED IN STORAGE.
These completed studies are grandfathered and do not require any action. The data may continue to be used in the future but only as stated in the Informed Consent. If a different study is designed that intends to use the same data it cannot be done without a new submission to the IRB, and must comply with all the new HIPAA rules.2. STUDIES THAT ARE IRB APPROVED, SOME RESEARCH SUBJECTS HAVE BEEN STUDIED, AND NEW SUBJECTS CONTINUE TO BE ENROLLED.
The Protocol is grandfathered and those Research Subjects already consented need no action. However, all Research Subjects enrolled from 4/14/03 forward must be provided with HIPAA privacy information and must sign a Research Authorization form. Both their Protected Health Information and research data are covered by the new rules. The signed Research Subject Authorization form should be retained with the signed Informed Consent Document.3. STUDIES THAT ARE IRB APPROVED BUT NO RESEARCH SUBJECT ENROLLMENT HAS OCCURRED.
The Protocol is grandfathered but all Research Subjects enrolled must be provided with HIPAA privacy information and must sign a Research Authorization form. Both their Protected Health Information and research data are covered by the new rules. The signed Research Subject Authorization form should be retained with the signed Informed Consent Document.4. PROTOCOLS SUBMITTED BUT NOT YET APPROVED.
The HIPAA rules state that after the deadline, all HIPPA regulations are in force.5. STUDIES THAT ARE GRANDFATHERED BUT ARE ALTERED AND NEW CONSENT DOCUMENTS ARE REQUIRED.
Consent processes and documents used after the deadline are all subject to the new HIPAA regulations.
VCU Informed Consent Assessment Tool Our Goal is to develop a generic informed consent survey document having potential to:
- Assess the level of understanding achieved by a research subject after the completion of the informed consent process of almost any clinical research protocol;
- Provide principal investigators with the tool to assess the quality of the informed consent process in his or her research study and the ability to compare it to others;
- Provide principal investigators with a tool to assess modifications to an informed consent process intended to improve performance.
Download - Instructions (Adobe PDF file)
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