Phronetik IRB Descriptions

An IRB specializes in certain types of research. Studies are assigned based on the following:

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• The primary criteria is the Principal Investigator's home department (see descriptions of committees below); and

• Also taken into consideration are the type of study based on the protocol's hypothesis or research question (social behavioral or biomedical) and the types of study procedures being used (see examples and notes below).

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Phronetik's IRB is used to review research involving human subjects conducted or supported by the Department of Health and Human Services, or other federal departments or agencies that apply the Federal Policy for the Protection of Human Subjects to such research; and/or Clinical investigations regulated by the Food and Drug Administration (FDA) of the Department of Health and Human Services.

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Phronetik Organization Number: IORG001128

Phronetik IRB Number: IRB00013784

Federalwide Assurance Number: FWA00033081

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Biomedical research

Biomedical research refers to the study of specific diseases and conditions (mental or physical), including detection, cause, prophylaxis, treatment and rehabilitation of persons; the design of methods, drugs and devices used to diagnose, support and maintain the individual during and after treatment for specific diseases or conditions; and/or the scientific investigation required to understand the underlying life processes which affect disease and human well-being, including such areas as cellular and molecular bases of diseases, genetics, immunology. This research is typically quantitative and not qualitative.  Biomedical research is often patient-oriented and the research involves:

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• Studies of mechanisms of human disease

• Studies of therapies or interventions for disease

• Clinical trials (see here for definitions of clinical trial)

• Studies to develop new technology related to disease