In proposed § 164.504, we would define “research” as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. This is the definition of “research” in the Common Rule. This definition is well understood in the research community and elsewhere, and we propose to use it here to maintain consistency with other federal regulations that affect research.
For purposes of determining whether an activity is research under this proposed rule, it would not be relevant whether the information is given gratis, sold, bartered, rented, or otherwise provided for commercial gain. The purpose of this proposed rule regarding disclosure of protected health information for research is to protect the subjects of the information. Where the activity meets the definition of research and involves use or disclosure of protected health information, the rules in this section would apply. We request comments on any aspect of our proposed definition of research.
We understand that research and health care operations often look alike, and may overlap. We have provided definitions for these terms in § 164.504. We solicit comments on ways to further distinguish between research and operations, or otherwise clarify the application of this rule to such activities.