Phronetik™ IRB Descriptions
An IRB is a committee — operating under federal regulations, state laws and institutional policy — that reviews research involving human subjects to ensure the ethical and equitable treatment of those subjects.
An IRB specializes in certain types of research. Studies are assigned based on the following:
The primary criteria is 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).
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.
Phronetik Organization Number: IORG001128
Phronetik IRB Number: IRB00013784
Federalwide Assurance Number: FWA00033081
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:
Studies of mechanisms of human disease
Studies of therapies or interventions for disease
Studies to develop new technology related to disease
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:
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.
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.