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Regulatory Agency/Regulation

"Regulatory agencies are federal agencies created by an act of Congress that are independent of the executive departments. Though they are considered part of the executive branch, these agencies are meant to impose and enforce regulations free of political influence. The Consumer Product Safety Commission, the Nuclear Regulatory Commission, the Federal Communications Commission and the Securities and Exchange Commission are examples of such agencies." (Center for Effective Government. Accessed May 10, 2018). "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." (Research Involving Human Subjects Glossary, National Institutes of Health. Accessed May 10, 2018). 

Research with Human Participants

Research with human participants refers to "research involving a living individual about whom an investigator obtains either data through interaction or identifiable, private information." ("Human Subjects Research." National Institutes of Health. Accessed May 9, 2018).

Research-Clinical Interface

"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;20:545553).

Return of Results

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 FindingsAnnual Review of Genomics and Human Genetics 2013;14:557-577).