Phronetik IRB Descriptions

The Phronetik Institutional Review Boards (IRBs) are the committees designated by Phronetik to review the conduct of research involving human subjects that is conducted by Phronetik staff (conducting studies involving human subjects within the course and scope of their duties) as well as any interns or other research personnel (conducting studies involving human subjects within the course of their job duties).

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The function of the IRBs is to ensure adherence to all federal, state, local, and institutional regulations concerning the protection of human subjects in research. Phronetik IRB review is required for both funded and non-funded human subjects research.

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

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• The primary criteria are the Principal Investigator's home organization or institution; 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

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Social-behavioral research

 

Social-behavioral research refers broadly to research that deals with human attitudes, beliefs, and behaviors and is often characterized by data collection methods such as questionnaires, interviews, focus groups, direct or participant observation, and non-invasive physical measurements. The research may be qualitative or quantitative. Social-behavioral research also includes epidemiological or outcomes research and health services research:

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• Epidemiological and behavioral studies: These types of studies examine the distribution of disease, the factors that affect health, and how people make health-related decisions.

• Outcomes and health services research: These studies seek to identify the most effective and most efficient interventions, treatments, and services.

 

Important Notes:

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• Social-behavioral studies that involve the use of drugs or devices, radiation and radiolabeled tracers, and other invasive procedures require review by a medical IRB.

• Prospective collection of biological specimens (e.g., blood, saliva) and/or collection of data via non-invasive measures (e.g. magnetic resonance imaging without the use of radiotracers, tests of sensory acuity, electrocardiography) that are usually considered clinical in nature may require review by the Phronetik Office of Sponsored Research.​