The IRB is frequently consulted regarding studies that do not meet the definition of human subjects research . At CHOP, there is no obligation to consult the IRB regarding this category of research. The determination is left to the investigator.
Examples of Not Human Subjects Research
Activities that are not research
Case reports, small case series, many Quality Improvement initiatives and Morbidity and Mortality conferences are some of the common examples of activities that don't meet the Common Rule or FDA definitions of human subjects research. These activities could be part of hospital operations (e.g., QI) or might not follow a protocol or might not be generalizable.
- Case reports and case series
- Quality Improvement activities that do not involve research methodologies
- Educational presenations
- Morbidity and mortality conferences
Research that isn't human subjects research
Research using de-identified data or samples isn't human subjects research (unless the investigator was involved in the collection of the data or the consent of the subjects). For example, consider a study where investigators obtain consent, collect medical history data and blood samples. The data and specimens are sent to a data coordinating center without any readily identifiable information attached. The individuals collecting the blood and data are doing human subjects research. The individuals analyzing the data or doing measurements using the specimens are doing human subjects research. The individuals at the data coordinating center and the associated laboratories are not doing human subjects research. The one exception to this is if the data coordinating center is funded by federal research dollars.
- Research involving data or specimens that are not readily available (e.g., receipt or analysis of data/specimens)
- Research involving analysis of data or specimens collected by clinical investigators but not readily identifiable to the researcher (e.g. laboratory analysis of deidentified specimens;
- Research where the subjects are decedents or inanimate (e.g., survey or characteristics of hospitals or residency training programs)
Even if the research does not involve human subjects, it may still be subject to regulation if it is funded by the federal government.