Most of the research reviewed by the IU IRBs falls within the broad categories of biomedical or social/behavioral/educational (SBE) research. While it is difficult to draw a clean line between these two broad categories, consideration is given to the research field, characteristics of the subjects, the research procedures or interventions being employed, and the nature of the research risks. Indiana University’s Human Research Protection Program (IU-HRPP) includes two (2) SBE IRBs and four (4) biomedical IRBs. Human Subject Office (HSO) staff assign studies to an appropriate IRB based on nature of the risks to subjects and expertise of the reviewing IRB as follows:
Categories of research reviewed by IRBs
Social/Behavioral/Educational (SBE) research is a large, multifaceted field, encompassing a wide array of disciplines that focus on the understanding of social, behavioral, and/or educational processes. It refers broadly to research on: human attitudes, beliefs, and behaviors as well as institutional and social functioning and processes.
Data collection methods commonly employed in SBE research include, but are not limited to:
- Focus groups
- Direct participant observation
- Non-invasive physical measurements
Studies that are otherwise considered SBE in nature that involve the use of drugs or devices, radiation, or other procedures presenting greater than minimal physical risk to participants require review by a biomedical IRB.
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 that affect disease and human well-being, including such areas as cellular and molecular bases of diseases, genetics, and immunology. Biomedical research is often patient-oriented and the research involves:
- Studies of mechanisms of human disease
- Studies of therapies or interventions for disease
- Clinical trials
- Studies to develop new technology related to disease
Research involving physical or physiological methods of evaluation that involve primarily physical risks or that are physically invasive must be reviewed by a biomedical IRB.
Research that meets one or more of the exempt or expedited categories is reviewed by an individual IRB member (outside of a convened IRB meeting) based on appropriate expertise.
Greater than Minimal Risk
Research that is greater than minimal risk or includes procedures outside the exempt and expedited categories is reviewed at a convened meeting of the IRB.
IRB-01 meets the 4th Friday of every month; IRB-IUB meets the 3rd Thursday of every month.
IRB-01 also serves as the designated Noncompliance IRB and reviews all Noncompliance Reports, except:
- Noncompliance Reports associated with another item being reviewed at another IRB meeting, such as a Prompt Report or Amendment
- Noncompliance Reports for which HSO staff determine that review by a biomedical board is advisable, either due to concerns regarding the item or timing of review
IRB-02, IRB-03, IRB-04, and IRB-05—meet the 2nd Tuesday, 1st Thursday, 3rd Tuesday, and 4th Wednesday of every month respectively.