What must be reviewed by the IRB?

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.

Summary:

Many activities fail to meet the definition of research and therefore, do not require IRB review and approval. Most case reports and much of the Quality Improvement activities that take place do not meet the definition of research. The IRB may review these to assure that they are not research and therefore, do not need to be reviewed.

Summary:

The definition of who is a human subject determines whether or not the research must be submitted to the IRB for review and approval or not. The Common Rule defines a human subject as any living individual about whom an investigator conducting research obtains data: through intervention or interaction with the individual, or their identifiable private information.

Summary:

QQuality improvement activities are an important component of hospital operations. Because QI activities are data-driven and involve human participants, it is not surprising that there can be overlap with research methodologies common to human subjects research. Where an overlap exists between QI and research methodologies, the federal regulations that protect human research participants may apply. Whether the QI activity is human subjects research or not, it is vital that it be executed in a manner that strives to respect the the rights and welfare of the human participants.

Summary:

For many clinical studies, the role of some members of the investigative team might not meet the definition of human subjects research (HSR). For example, if a laboratory technician receives a blood specimen that is coded and they have no way to re-identify the individual from whom the specimen was obtained, the technician is not engaged in HSR.

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