Activities that May Not Require Submission to IRB

  1. Class Projects and Research Practica involving research methodology and course-assigned data collection. These activities generally do not constitute research because their purpose is to provide training in research as part of the overall educational mission of a program and are not designed to contribute to a possible professional dissemination.  However, if vulnerable or identifiable populations are involved, course instructors must assess carefully whether IRB review is necessary, and are encouraged to contact Pomona IRB for assistance if needed.
  2. Repository Research, Databases, Tissue Banking utilizing stored data or materials. If the investigator cannot readily ascertain the identity of the subject from whom the data or materials originated (i.e. the data is stripped of identifying information, or coded and the investigator does not have access to the key), these activities would not require Pomona IRB review. However, repository research, databases, and tissue banking from individually identifiable living persons must be reviewed by IRB.
  3. Scholarly and Journalistic Activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
  4. Quality Assurance Activities that attempt to measure the effectiveness of programs or services, including program evaluations, model curriculums, or needs assessments. Such activities are not typically designed to be generalizable to the larger community, will not be compared with other assessments, and would not require IRB review. Those responsible for such projects are encouraged to contact the IRB for assistance if uncertain
  5. Case Reports utilizing private identifiable information such as medical information collected from a clinical activity. Case reports are generally carried out by retrospective review of records and highlight a unique treatment, case, or outcome. As the collection and organization of information for such reports usually involves no data analysis or testing of a hypothesis, they do not involve systematic investigation. Therefore, single case reports would not require Pomona IRB review. However, retrospective record reviews that incorporate data collection and data analysis to answer a research question must undergo Pomona IRB review. Additionally, meta-analysis of multiple case reports to examine and compare interventions or cases is considered to be human subjects research.
  6. Research on Institutions or Social Processes when the intent or focus of the research is to gain knowledge of an institution or social process (e.g., a political party, labor negotiations) and this research is not intended to produce generalizable knowledge about any particular individual or groups of individuals. Often, investigators wish to collect information from individuals about institutions or social processes. Such an activity is not human subjects research when the focus of the research is not on characteristics of an individual or groups of individuals because the information collected from the informant is not about the informant. 
  7. Public Health Surveillance Activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).

*Exclusion from IRB review does not imply that researchers are free to ignore ethical considerations such as informed consent or privacy considerations. The ethical and legal standards appropriate for one's discipline still apply.