The CHOP IRB permits investigators to apply the definitions of research and human subjects in order to determine whether or not their proposed activities meet the definition of human subjects research.
Investigators are frequently unsure whether or not their proposed project meets the definition of human subjects research and therefore requires review by the IRB. The most frequent questions received by the IRB concern the following:
- receipt or use of deidentified or coded biospecimens or data,
- quality improvement/assurance activities;
- educational presentations; and
- reports of notable or unique cases (case reports and case series).
Understanding the regulatory definitions of research and human subjects research can help distinguish between activities regulated by the IRB and those that fall outside its domain. Whenever there is uncertainty, the IRB should be consulted.