Standards for Privacy of Individually Identifiable Health Information. Final Privacy Rule Preamble.. Research.

12/28/2000

We proposed to define "research" as it is defined in the Federal Policy for the Protection of Human Subjects, at 45 CFR 46, Subpart A (referred to elsewhere in this rule as "Common Rule"), and in addition, elaborated on the meaning of the term "generalizable knowledge." In § 164.504 of the proposed rule we defined research as "... a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 'Generalizable knowledge' is knowledge related to health that can be applied to populations outside of the population served by the covered entity."

The final rule eliminates the further elaboration of "generalizable knowledge." Therefore, the rule defines "research" as the term is defined in the Common Rule: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.