“Regulatory agencies are government agencies whose primary functions are to police and enforce laws that control various activities from racial discrimination to environmental pollution. These agencies differ from agencies with a primarily administrative functions, such as managing billions of dollars of federal grants, contracts, and other programs.” (Center for Effective Government. Accessed April 27, 2022). "Regulation is broadly defined as the imposition of rules, . . backed by the use of penalties that are intended specifically to modify the economic behaviour of individuals and firms." (Organisation for Economic Co-operation and Development – OECD. Accessed May 10, 2018).
"Research, as it pertains to protections for human subjects in research. . . [is] a systematic investigation designed to develop or contribute to generalizable knowledge." (45 C.F.R. §46.102(l)., National Institutes of Health. Accessed April 37, 2022).
Research with human participants refers to research involving “a living individual about whom an investigator…conducting research [o]btains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or [o]btains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens." ("Definition of Human Subjects Research." National Institutes of Health. Accessed April 27, 2022).
"The conventional view has been that there are fundamental differences between research and clinical care. . . . Research has been defined by the Common Rule as 'a systematic investigation . . . designed to develop or contribute to generalizable knowledge.' . . . In clinical care, on the other hand, clinicians bear a fiduciary duty to act primarily for the benefit of the patient in keeping with established standards of professionalism and ethics." The interface between research and clinical care is currently evolving. (SM Wolf et al. Navigating the Research–Clinical Interface in Genomic Medicine: Analysis from the CSER Consortium. Genetics in Medicine 2017;20:545–553).
In research, the process of alerting a participant to "a finding concerning an individual research participant that has potential health or reproductive importance or personal utility and is discovered in the course of research." Sometimes includes return of incidental or secondary findings. (SM Wolf. Return of Individual Research Results & Incidental Findings. Annual Review of Genomics and Human Genetics 2013;14:557-577).