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The Institutional Review Board (IRB) and its functions. Theresa M Boyd Associate Professor of Pathology Howard University College of Medicine Director Transfusion Medicine Howard University Hospital. Howard University IRB. Information. IRB Review Process.
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Theresa M Boyd
Associate Professor of Pathology
Howard University College of Medicine
Director Transfusion Medicine
Howard University Hospital
IRB Review Process
The principles of the Belmont Report govern all research supported by the U.S. Government. The ethical principles outlined in the report are the basis for subsequent regulations designed to ensure protection of human subjects in research.
Respect for Persons
RESPECT FOR PERSONS
Privacy & ConfidentialityProtection of subjects (especially vulnerable populations)
AssentIRB Decision Matrix
Subject selection - equitable
Favorable Risk/Benefit Analysis
Good Experimental Design
Competent &Qualified PI
J. Cooper, Albany Medical Center
The two general rules formulated from the principle of beneficence are:
An injustice occurs when:
The “Common Rule” is the set of regulations which were developed to ensure compliance with the principles of the Belmont Report. The regulations fall under the Department of Health and Human Services. These regulations have been adopted by many other federal departments which regulate human research.
There are many other regulations with which UVM/FAHC are required to comply, such as the Food and Drug Administration, but these are all in addition to the “Common Rule”.
All research projects are categorized into one of three categories for the IRB review process. Each category is different in the level of scrutiny and submission procedures. The IRB is responsible for making the final decision of which category a research project falls under.
Beyond the Consent Form
Informed consent is not a single event or just a form to be signed -- rather, it is an educational process that takes place between the investigator and the prospective subject.
The basic elements of the consent process include:
Articles in most popular magazines are at the 8th grade level. Factors that improve readability include the following:
Most faculty regarded the new streamlined
IRB Process as an improvement