What was a key consideration for the IRB in determining that a secondary analysis of a publicly available CDC database does not involve human subjects?

The key consideration that supports the determination that a secondary analysis of a publicly available CDC database does not involve human subjects is that the data has no identifiers. This is critical because, under regulations governing human subjects research, data that does not allow for the identification of individuals is not considered to involve human subjects. The absence of identifiers ensures that individual privacy is maintained, and there is no risk of linking the data back to any specific person, which is a fundamental concern in research ethics.

Having no identifiers means that researchers can analyze the data without posing any ethical risks to individuals, aligning with institutional review board (IRB) requirements that protect personal privacy. Therefore, the lack of identifiers is a pivotal factor in deeming that the research complies with ethical standards set for studies involving human subjects.

The other options focus on aspects that, while relevant to research integrity or alignment with guidelines, do not address the core issue of whether individuals are identifiable within the data. Thus, their involvement does not directly impact the assessment of human subjects status defined by the lack of identifiable information.